[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test formulation irbesartan tablets (strength: 0.15 g) and the reference formulation Ambroxol® (strength: 0.15 g) in healthy adult participants in the fed state

主要研究目的：研究餐后状态下单次口服受试制剂厄贝沙坦片（规格：0.15 g，浙江亚太药业股份有限公司生产）与参比制剂厄贝沙坦片（安博维®，规格：0.15 g，Sanofi Winthrop Industrie生产）在健康参与者体内的药代动力学，评价餐后状态下口服两种制剂的生物等效性。次要研究目的：评估受试制剂厄贝沙坦片（规格：0.15 g）和参比制剂厄贝沙坦片（安博维®，规格：0.15 g）在健康参与者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation irbesartan tablets (specification: 0.15 g, produced by Zhejiang Asia Pacific Pharmaceutical Co., Ltd.) and the reference preparation irbesartan tablets (Ambovi®, specification: 0.15 g, produced by Sanofi Winthrop Industrie) in healthy participants after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. The secondary purpose of the study is to evaluate the safety of the test preparation irbesartan tablets (specification: 0.15 g) and the reference preparation irbesartan tablets (Ambovi®, specification: 0.15 g) in healthy participants.

Start Date09 Jul 2025

Sponsor / Collaborator

Lingyao Biotechnology (Shanghai) Co., Ltd.

100 Clinical Results associated with Irbesartan

100 Translational Medicine associated with Irbesartan

100 Patents (Medical) associated with Irbesartan

3,266

Literatures (Medical) associated with Irbesartan

01 Dec 2025·Water Research X

Micropollutants removal, residual risk, and costs for quaternary treatments in the framework of the Urban Wastewater Treatment Directive

Author: Antonelli, Manuela ; Piraldi, Sara ; Ianes, Jessica ; Cantoni, Beatrice

The revised Urban Wastewater Treatment Directive (UWWTD) imposes stringent regulations for the removal of micropollutants from urban wastewater treatment plants.The analyses conducted in this study are based on current knowledge extrapolated from literature WWTPs, to investigate the occurrence, removal and environmental risk related to the 12 target micropollutants: Amisulpride, Benzotriazole, 4,5-Methylbenzotriazole, Carbamazepine, Clarithromycin, Citalopram, Candesartan, Diclofenac, Hydrochlorothiazide, Irbesartan, Metoprolol, and Venlafaxine.The goal is to provide valuable insights into the challenges and opportunities associated with implementing quaternary treatment processes to comply with the UWWTD.It indicate that the conventional biol. treatment is insufficient, with median removal rates below 50% for most target micropollutants (except for Benzotriazole and Irbesartan).The implementation of quaternary treatment processes, namely ozonation and activated carbon adsorption, significantly enhances WWTP micropollutants removal, with median removal efficiencies exceeding 80% for all the target micropollutants, with Candesartan being the most recalcitrant.Environmental risk assessment reveals that some micropollutants pose a significant threat to aquatic ecosystems even with 80% removal efficiency (Irbesartan, Candesartan, Diclofenac, and Venlafaxine), while others do not pose a risk even at WWTP influent concentrations (4,5-Methylbenzotriazole, Hydrochlorothiazide, Amisulpride, Citalopram, and Metoprolol).Economic anal. shows that the selection of specific operating parameter values significantly impacts the cost of each treatment process, changing the economic feasibility ranking of the different treatment options.

01 Nov 2025·JOURNAL OF HAZARDOUS MATERIALS

Patterns of pharmaceutical contamination in streams of European cities across urbanisation gradients: Potential impacts on One Health

Article

Author: Silva, Liliana J G ; Calapez, Ana R ; Freitas, Andreia ; Rodrigues, Fernanda ; Moen, Anne ; Schmeller, Dirk S ; Piscopo, Nadia ; Simões, Nuno E C ; da Silva, Janine P ; Feio, Maria J ; Durães, Luisa ; Forio, Marie Anne Eurie ; Henni, Silje H ; Loyau, Adeline ; De Cock, Andree ; Bouchali, Rayan ; Goethals, Peter ; Pereira, André M P T

Pharmaceuticals are Contaminants of Emerging Concern, with known effects on aquatic organisms such as increased mortality and reproduction inhibition. This study aimed to provide a comprehensive overview on occurrence of pharmaceuticals in European urban streams, and to assess the patterns and factors influencing their presence in the water. Sixteen pharmaceuticals from 6 therapeutic groups were detected in 102 sites sampled in 2022-2023 within 5 European cities (Coimbra-Portugal, Toulouse-France, Benevento-Italy, Ghent-Belgium, and Oslo-Norway). Pharmaceuticals and their mixtures were observed in 91 % and 79 % of the sites, respectively. Irbesartan, bisoprolol and carbamazepine were found in more than 50 % of the sites. Acetaminophen had the highest median concentration (near 1 μg/L). Toulouse had the higher total pharmaceutical concentration, followed by Ghent, Benevento, Coimbra and Oslo. Contaminants from the European Union Watch List (ofloxacin, propranolol, fluoxetine) were detected. The pharmaceutical patterns differed among cities, except between Coimbra and Oslo. The contamination by pharmaceuticals, considering all sites, was predicted by population and tree cover densities, but also by morphological condition, riparian zone, water pollution and imperviousness within some of the cities. This study reveals a high contamination of urban streams by pharmaceuticals, which could lead to risks for the health of aquatic organisms and humans.

01 Nov 2025·MEDICAL CARE

Prescriber-Level Responses to the 2018–2019 Valsartan, Irbesartan, and Losartan Recalls and Drug Shortages

Article

Author: Good, Chester B. ; Suda, Katie J. ; Callaway Kim, Katherine ; Roberts, Eric T. ; Donohue, Julie M. ; Sabik, Lindsay M.

Background::

Global shortages for 3 angiotensin receptor-II blockers (ARBs)—valsartan, losartan, and irbesartan—occurred in 2018–2019 after recalls due to ingredient impurities. Provider-level responses to the ARB shortages in the United States and spillovers to other antihypertensive classes are unknown.

Objective::

To estimate changes in provider-level prescribing for ARBs and non-ARB antihypertensives up to 18 months after the 2018–2019 recalls and shortages.

Research Design::

National cohort study of prescribers using all-payer pharmacy claims. Mixed interrupted time series models quantified changes in prescribing postshortages and heterogeneous changes by specialty, region, medical school graduation cohort, sex, and level of prerecall prescribing.

Patients and Methods::

Active providers exposed to the 2018–2019 valsartan, irbesartan, and losartan shortages (defined as top-25th percentile for these drugs in 2017).

Measures::

Within-class changes in prescribing for ARBs (recalled and nonrecalled). Between-class substitutions to non-ARB antihypertensives (ACE-Is, alpha- and beta-adrenergic blockers, calcium channel blockers, diuretics, and other agents).

Results::

Among 138,032 prescribers who met the inclusion criteria, per-prescriber fills for valsartan decreased by 57%–59% after it was recalled in July 2018. We observed concurrent increases for losartan and irbesartan fills and no change in overall ARB prescribing. There were no significant changes in fills for ACE-Is or for other antihypertensives. Absolute decreases in valsartan fills were greatest among providers with higher levels of prescribing at baseline. However, relative changes did not differ by prescriber characteristics.

Conclusions::

In this prescriber level, national study, substitutions to other ARBs mitigated decreases in valsartan fills after it was recalled. There were no spillovers to non-ARB anti-hypertensives. The availability of close substitutes during drug shortages may mitigate gaps in access for prescribers and their patients.

135

News (Medical) associated with Irbesartan

06 Nov 2025

·www.businesswire.com

Travere Therapeutics Announces Late-Breaking Data from Phase 3 DUPLEX Study of FILSPARI in FSGS Presented at the American Society of Nephrology (ASN) Kidney Week 2025

SAN DIEGO--(BUSINESS WIRE)--Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced new data from the Phase 3 DUPLEX Study demonstrating that patients with focal segmental glomerulosclerosis (FSGS) treated with FILSPARI® (sparsentan) were significantly more likely to reach proteinuria levels below 0.7 g/g compared to those receiving the maximum labeled dose of irbesartan, and achievement of this threshold correlated with reduced risk of kidney failure. The data were presented as a late-breaking poster at the American Society of Nephrology (ASN) Kidney Week 2025 in Houston, TX, November 6-9. We are pleased to present new data from the pivotal DUPLEX Study, highlighting the correlation between proteinuria reduction and the potential of FILSPARI to reduce long-term kidney failure events. “We are pleased to present new data from the pivotal DUPLEX Study, highlighting the correlation between proteinuria reduction and the potential of FILSPARI to reduce long-term kidney failure events,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics. “People living with FSGS face a serious and progressive disease that often leads to kidney failure and dialysis. The PARASOL Project has determined that reducing proteinuria to the lowest possible levels is key to protecting kidney function in FSGS, and these analyses from the DUPLEX Study reinforce its findings." The PARASOL Project previously identified urine protein-to-creatinine ratio (UPCR) below 0.7 g/g as a clinically meaningful proteinuria target in FSGS. This late-breaking poster reported the proportion of FILSPARI-treated patients reaching this threshold compared to the maximum labeled dose of irbesartan in the DUPLEX Study, and the effect of reaching this target on progression to kidney failure. A DUPLEX-aligned cohort of patients with FSGS (n=386) from the UK National Registry of Rare Kidney Disease (RaDaR) was then utilized to model the impact of achieving UPCR below 0.7 g/g on five-year kidney failure risk, during a 24-month period. Key findings from the late-breaking analyses include: In DUPLEX, significantly more patients treated with FILSPARI achieved UPCR below 0.7 g/g earlier and more often than those treated with irbesartan at any time (37.5% vs. 21.4% relative risk [RR], 1.8 [95% CI, 1.3-2.4]) and at week 108 (19% vs. 11.2% (RR, 1.7 [95% CI, 1.03-2.8]). Irrespective of treatment with FILSPARI or irbesartan, patients who achieved UPCR below 0.7 g/g at any time were less likely to reach kidney failure than those who did not (3.6% vs. 11.2% (RR, 0.52 [95% CI, 0.2-1.8]). In the DUPLEX-aligned RaDaR cohort, achieving UPCR below 0.7 g/g at 24-months was associated with lower risk of kidney failure over an additional 60-months of follow up (hazard ratio [HR], 0.14 [95% CI, 0.05-0.38]). A similar lower risk was observed for those who achieved UPCR below 0.7 g/g at any time over 24-months (HR, 0.27 [95% CI, 0.16-0.45]). In a separate oral presentation, the Company shared an analysis predicting the reduction in risk of kidney failure events at five-years for patients treated with FILSPARI based on the relative reduction in proteinuria from the DUPLEX Study. As previously published in the New England Journal of Medicine, the DUPLEX Study demonstrated that treatment with FILSPARI resulted in a clinically meaningful and durable reduction in proteinuria, with FSGS patients achieving a 50% reduction from baseline UPCR, compared to a 32% reduction with the maximum labeled dose of irbesartan. This translates to a 26% relative reduction in UPCR for FILSPARI-treated patients compared to the maximum labeled dose of irbesartan at 24 months. The analysis uses a DUPLEX-aligned cohort of patients from RaDaR to examine the correlation between reduction in proteinuria and the long-term risk of kidney failure. Key findings from the RaDaR analysis include: Within the RaDaR cohort, robust reductions in the risk of kidney failure were observed for patients achieving complete remission (UPCR below 0.3 g/g) and proteinuria below 0.7 g/g at 24-months. These findings support the overall conclusions of the PARASOL Project. Any reduction in UPCR correlated to a reduction in risk of kidney failure events at 5-years (1-unit reduction of log-transformed UPCR HR, 0.41 [95% CI, 0.29-0.58]). When applied to the DUPLEX Study, the 26% relative reduction in UPCR for patients treated with FILSPARI compared to irbesartan, correlates to a significant and clinically meaningful reduction in 5-year risk of kidney failure of 24% (HR, 0.76 [95% CI, 0.69-0.85]). More information on Travere’s presence at ASN can be found here. About the DUPLEX Study The Phase 3 DUPLEX Study is the largest interventional study to date in FSGS, and the only study in FSGS against a maximally dosed active comparator. While DUPLEX achieved its pre-specified interim FSGS partial remission of proteinuria (FPRE) endpoint with statistical significance at 36 weeks, it did not achieve the primary efficacy eGFR slope endpoint over 108 weeks of treatment. The two-year results from the study were published in the New England Journal of Medicine and showed that FILSPARI delivered clinically meaningful benefit at 108 weeks with significant proteinuria reduction, higher rates of partial and complete remission, and a lower rate of end-stage kidney disease compared to active control. FILSPARI was well-tolerated with a safety profile that was consistent across all clinical trials conducted to date and comparable to the maximally dosed active control, irbesartan, including no drug-induced liver injury and no fluid overload. Patients who completed the DUPLEX double-blind portion of the study on treatment were eligible to participate in the open-label extension of the trial. About Focal Segmental Glomerulosclerosis Focal segmental glomerulosclerosis (FSGS) is a rare proteinuric kidney disorder in both children and adults that is estimated to affect more than 40,000 patients in the U.S. with similar prevalence in Europe. The disorder is defined by progressive scarring of the kidney and often leads to kidney failure. FSGS is characterized by proteinuria, where protein leaks into the urine due to a breakdown of the normal filtration mechanism in the kidney. Once in the urine, protein is considered to be toxic to other parts of the kidney, especially the tubules, and is believed to contribute to further disease progression. Other common symptoms include swelling in parts of the body, known as edema, as well as low blood albumin levels, abnormal lipid profiles and hypertension. FILSPARI is not approved for use in FSGS. There are currently no FDA-approved pharmacologic therapies for FSGS. About Travere Therapeutics At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com FILSPARI® (sparsentan) U.S. Indication FILSPARI (sparsentan) is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. IMPORTANT SAFETY INFORMATION BOXED WARNING: HEPATOTOXICITY AND EMBRYO-FETAL TOXICITY Because of the risk of hepatotoxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Under the FILSPARI REMS, prescribers, patients and pharmacies must enroll in the program. Hepatotoxicity Some Endothelin Receptor Antagonists (ERAs) have caused elevations of aminotransferases, hepatotoxicity, and liver failure. In clinical studies, elevations in aminotransferases (ALT or AST) of at least 3-times the Upper Limit of Normal (ULN) have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge. Measure transaminases and bilirubin before initiating treatment and then every 3 months during treatment. Interrupt treatment and closely monitor patients who develop aminotransferase elevations more than 3x ULN. FILSPARI should generally be avoided in patients with elevated aminotransferases (>3x ULN) at baseline because monitoring for hepatotoxicity may be more difficult and these patients may be at increased risk for serious hepatotoxicity. Embryo-Fetal Toxicity FILSPARI is contraindicated for use during pregnancy because it may cause fetal harm if used by pregnant patients. Therefore, in patients who can become pregnant, exclude pregnancy prior to initiation of FILSPARI. Advise use of effective contraception before the initiation of treatment, during treatment, and for two weeks after discontinuation of treatment with FILSPARI. When pregnancy is detected, discontinue FILSPARI as soon as possible. Contraindications FILSPARI is contraindicated in patients who are pregnant. Do not coadminister FILSPARI with angiotensin receptor blockers (ARBs), ERAs, or aliskiren. Warnings and Precautions Hepatotoxicity: Elevations in ALT or AST of at least 3-fold ULN have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge. While no concurrent elevations in bilirubin >2-times ULN or cases of liver failure were observed in FILSPARI-treated patients in clinical trials, some ERAs have caused elevations of aminotransferases, hepatotoxicity, and liver failure. To reduce the risk of potential serious hepatotoxicity, measure serum aminotransferase levels and total bilirubin prior to initiation of treatment and then every 3 months during treatment. Advise patients with symptoms suggesting hepatotoxicity (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching) to immediately stop treatment with FILSPARI and seek medical attention. If aminotransferase levels are abnormal at any time during treatment, interrupt FILSPARI and monitor as recommended. Consider re-initiation of FILSPARI only when hepatic enzyme levels and bilirubin return to pretreatment values and only in patients who have not experienced clinical symptoms of hepatotoxicity. Avoid initiation of FILSPARI in patients with elevated aminotransferases (>3x ULN) because monitoring hepatotoxicity in these patients may be more difficult and these patients may be at increased risk for serious hepatotoxicity. FILSPARI REMS: Due to the risk of hepatotoxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Prescribers, patients, and pharmacies must be enrolled in the REMS program and comply with all requirements ( www.filsparirems.com ). Embryo-Fetal Toxicity: Based on data from animal reproduction studies, FILSPARI may cause fetal harm when administered to a pregnant patient and is contraindicated during pregnancy. The available human data for ERAs do not establish the presence or absence of fetal harm related to the use of FILSPARI. Counsel patients who can become pregnant of the potential risk to a fetus. Exclude pregnancy before initiating treatment with FILSPARI. Advise patients who can become pregnant to use effective contraception prior to initiation of treatment, during treatment, and for two weeks after discontinuation of treatment with FILSPARI. When pregnancy is detected, discontinue FILSPARI as soon as possible. Hypotension: Hypotension has been observed in patients treated with ARBs and ERAs. There was a greater incidence of hypotension-associated adverse events, some serious, including dizziness, in patients treated with FILSPARI compared to irbesartan. In patients at risk for hypotension, consider eliminating or adjusting other antihypertensive medications and maintaining appropriate volume status. If hypotension develops, despite elimination or reduction of other antihypertensive medications, consider a dose reduction or dose interruption of FILSPARI. A transient hypotensive response is not a contraindication to further dosing of FILSPARI, which can be given once blood pressure has stabilized. Acute Kidney Injury: Monitor kidney function periodically. Drugs that inhibit the renin-angiotensin system (RAS) can cause kidney injury. Patients whose kidney function may depend in part on the activity of the RAS (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute kidney injury on FILSPARI. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in kidney function while on FILSPARI. Hyperkalemia: Monitor serum potassium periodically and treat appropriately. Patients with advanced kidney disease, taking concomitant potassium-increasing drugs (e.g., potassium supplements, potassium-sparing diuretics), or using potassium-containing salt substitutes are at increased risk for developing hyperkalemia. Dosage reduction or discontinuation of FILSPARI may be required. Fluid Retention: Fluid retention may occur with ERAs, and has been observed in clinical studies with FILSPARI. FILSPARI has not been evaluated in patients with heart failure. If clinically significant fluid retention develops, evaluate the patient to determine the cause and the potential need to initiate or modify the dose of diuretic treatment then consider modifying the dose of FILSPARI. Most common adverse reactions The most common adverse reactions (≥5%) are hyperkalemia, hypotension (including orthostatic hypotension), peripheral edema, dizziness, anemia, and acute kidney injury. Drug interactions Renin-Angiotensin System (RAS) Inhibitors and ERAs: Do not coadminister FILSPARI with ARBs, ERAs, or aliskiren due to increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure). Strong and Moderate CYP3A Inhibitors: Avoid concomitant use of FILSPARI with strong CYP3A inhibitors. If a strong CYP3A inhibitor cannot be avoided, interrupt FILSPARI treatment. When resuming treatment with FILSPARI, consider dose titration. Monitor blood pressure, serum potassium, edema, and kidney function regularly when used concomitantly with moderate CYP3A inhibitors. Concomitant use with a strong CYP3A inhibitor increases sparsentan exposure which may increase the risk of FILSPARI adverse reactions. Strong CYP3A Inducers: Avoid concomitant use with a strong CYP3A inducer. Concomitant use with a strong CYP3A inducer decreases sparsentan exposure which may reduce FILSPARI efficacy. Antacids and Acid Reducing Agents: Administer FILSPARI 2 hours before or after administration of antacids. Avoid concomitant use of acid reducing agents (histamine H2 receptor antagonist and PPI proton pump inhibitor) with FILSPARI. Sparsentan exhibits pH-dependent solubility. Antacids or acid reducing agents may decrease sparsentan exposure which may reduce FILSPARI efficacy. Non-Steroidal Anti-Inflammatory Agents (NSAIDs), Including Selective Cyclooxygenase-2 (COX-2) Inhibitors: Monitor for signs of worsening renal function with concomitant use with NSAIDs (including selective COX-2 inhibitors). In patients with volume depletion (including those on diuretic therapy) or with impaired kidney function, concomitant use of NSAIDs (including selective COX-2 inhibitors) with drugs that antagonize the angiotensin II receptor may result in deterioration of kidney function, including possible kidney failure. CYP2B6, 2C9, and 2C19 Substrates: Monitor for efficacy of concurrently administered CYP2B6, 2C9, and 2C19 substrates and consider dosage adjustment in accordance with the Prescribing Information. Sparsentan decreases exposure of these substrates, which may reduce efficacy related to these substrates. P-gp and BCRP Substrates: Avoid concomitant use of sensitive substrates of P-gp and BCRP with FILSPARI. Sparsentan may increase exposure of these transporter substrates which may increase the risk of adverse reactions related to these substrates. Agents Increasing Serum Potassium: Monitor serum potassium frequently in patients treated with FILSPARI and other agents that increase serum potassium. Concomitant use of FILSPARI with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other drugs that raise serum potassium levels may result in hyperkalemia. Please see the full Prescribing Information, including BOXED WARNING, for additional Important Safety Information. Forward Looking Statements This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are often identified by the words “on-track,” “positioned,” “look forward to,” “will,” “would,” “may,” “might,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “potential,” or similar expressions. In addition, expressions of strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to: statements relating to the clinical studies, models and data described herein; statements regarding the potential of FILSPARI to reduce long-term kidney failure events; statements regarding FILSPARI as a potential treatment for FSGS; and statements related to the estimated sizes of patient populations. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties related to the Company’s sNDA for FILSPARI in FSGS, including the timing and outcome thereof. There is no guarantee that the FDA will grant approval of FILSPARI for FSGS on the anticipated timeline, or at all. The Company also faces risks and uncertainties related to its business and finances in general, the success of its commercial products, risks and uncertainties associated with its preclinical and clinical stage pipeline, risks and uncertainties associated with the regulatory review and approval process, risks and uncertainties associated with enrollment of clinical trials for rare diseases, and risks that ongoing or planned clinical trials may not succeed or may be delayed for safety, regulatory or other reasons. Specifically, the Company faces risks associated with the ongoing commercial launch of FILSPARI in IgAN, the timing and potential outcome of its and its partners’ clinical studies, market acceptance of its commercial products including efficacy, safety, price, reimbursement, and benefit over competing therapies, risks related to the challenges of manufacturing scale-up, risks associated with the successful development and execution of commercial strategies for such products, including FILSPARI, and risks and uncertainties related to the new administration, including but not limited to risks and uncertainties related to tariffs and the funding, staffing and prioritization of resources at government agencies including the FDA. The Company also faces the risk that it will be unable to raise additional funding that may be required to complete development of any or all of its product candidates, including as a result of macroeconomic conditions; risks relating to the Company’s dependence on contractors for clinical drug supply and commercial manufacturing; uncertainties relating to patent protection and exclusivity periods and intellectual property rights of third parties; risks associated with regulatory interactions; and risks and uncertainties relating to competitive products, including current and potential future generic competition with certain of the Company’s products, and technological changes that may limit demand for the Company’s products. The Company also faces additional risks associated with global and macroeconomic conditions, including health epidemics and pandemics, including risks related to potential disruptions to clinical trials, commercialization activity, supply chain, and manufacturing operations. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties, including under the heading “Risk Factors,” as included in the Company’s most recent Form 10-K, Form 10-Q and other filings with the Securities and Exchange Commission.

Clinical ResultPhase 3

24 Oct 2025

·www.prnewswire.com

Renalys Pharma to be Acquired by Chugai Pharmaceutical

TOKYO, Oct. 24, 2025 /PRNewswire/ -- Renalys Pharma, Inc. (Headquarters: Tokyo; Representative Director Chaiman & CEO; BT Slingsby; "Renalys") and Chugai Pharmaceutical Co., Ltd. (Headquarters: Tokyo; President & CEO: Osamu Okuda; "Chugai") today announced a definitive stock purchase agreement, under which Chugai will acquire Renalys (the "Transaction"). Renalys is advancing sparsentan in Japan; the medicine was initially developed by Travere Therapeutics, Inc. ("Travere") and is approved in the United States and Europe for the treatment of IgA nephropathy. As part of the Transaction, Chugai will gain exclusive rights to develop and commercialize sparsentan in Japan, South Korea, and Taiwan. Founded to close Asia's persistent "drug lag," Renalys develops innovative therapies for chronic kidney disease across Japan and the region. The company has completed primary endpoint data collection in its Japan Phase III clinical trial of sparsentan for IgA nephropathy, with topline results expected in Q4 2025. Renalys has also reached agreements with the Pharmaceuticals and Medical Devices Agency (PMDA) on registrational trial plans for focal segmental glomerulosclerosis (FSGS) and Alport syndrome in Japan. Renalys believes that transferring sparsentan to Chugai, a company recognized for its rare-disease and nephrology expertise, will accelerate access for patients across Asia. BT Slingsby, MD, PhD, MPH, Representative Director, Chairman & CEO, and Co-Founder of Renalys, stated: "Renalys was built to close Asia's drug lag with a simple promise: patients should not have to wait years for proven therapies. By advancing sparsentan in Japan, we proved that the model works. Partnering with Chugai now scales it—accelerating access across Japan and the region and setting a new standard for how innovative renal medicines reach patients." Ryutaro Shimazaki, Chief Development Officer of Renalys, added: "Chugai brings scale, speed, and deep know-how in renal disease. Together, we will align development with PMDA expectations, prepare clinicians for adoption, and focus on the practical steps that get sparsentan to patients sooner. Our goal is simple and urgent: convert strong data into real access for people living with IgA nephropathy, FSGS, and Alport syndrome." Financial Terms Upfront payment: Upon execution of the Share Acquisition, Chugai will pay Renalys JPY 15.0 billion in cash, subject to customary purchase-price adjustments. Earn-outs: Chugai will pay up to JPY 16.0 billion in cash tied to regulatory milestone achievements for sparsentan and to net sales in Japan, South Korea, and Taiwan. About sparsentan Sparsentan is an oral dual endothelin and angiotensin II receptor antagonist developed by Travere Therapeutics, Inc. ("Travere"). Renalys has an exclusive license for development and commercialization of sparsentan in Japan and several Asian territories. In Japan, data collection for the primary endpoint has been completed for all evaluable patients in the Phase III clinical trial of IgA nephropathy, with topline results expected in Q4 2025. In 2024, Travere received full FDA approval for sparsentan (U.S. brand name: FILSPARI®) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression*. Full approval is based on positive long-term confirmatory results from the PROTECT Study demonstrating that FILSPARI® significantly slowed kidney function decline over two years compared to irbesartan. In the PROTECT Study, the only head-to-head study in IgA nephropathy versus an active comparator, FILSPARI® demonstrated a significant reduction in proteinuria, preservation of kidney function and a well-tolerated safety profile compared with active control irbesartan. In Europe, FILSPARI® received standard EU approval for the IgA nephropathy indication in 2025. In 2025, the FDA accepted for review Travere's supplemental new drug application (sNDA) for FILSPARI® for the treatment of focal segmental glomerulosclerosis (FSGS). *FILSPARI® (sparsentan) U.S. Indication: FILSPARI is an endothelin and angiotensin II receptor antagonist indicated to slow kidney function decline in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression. About IgA Nephropathy The management of patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD) has become a social issue that places a heavy burden on the Japanese healthcare system. IgA nephropathy is widely known as one of the main causes of kidney failure and is considered to develop when abnormal IgA proteins are deposited in kidney tissue, inhibiting kidney function and causing inflammation. IgA nephropathy is a rare intractable disease (designated as an intractable disease 66) with many unresolved mechanisms of onset and severity. Currently, there is significant unmet need for approved treatment for IgA nephropathy in Japan. About Focal Segmental Glomerulosclerosis (FSGS) Chronic kidney disease (CKD) and end-stage renal disease (ESRD) impose a significant burden on Japan's healthcare system and represent a major social issue. FSGS is recognized as an important cause of kidney failure, with many patients progressing to ESRD requiring dialysis. The disease is characterized by focal and segmental sclerosis of glomeruli, which impairs renal filtration function. FSGS is classified as one of the designated intractable nephrotic syndromes (designated intractable disease No. 222) in Japan. Because the precise mechanisms underlying disease onset and progression remain unclear and steroid-resistant cases exist, treatment can be challenging. Currently, therapeutic options for FSGS in Japan are limited, creating a significant unmet medical need. About Alport Syndrome Alport syndrome is a hereditary kidney disorder characterized by hematuria and proteinuria that begin in childhood and progressively lead to renal impairment. The disease results from mutations in genes encoding type IV collagen, causing structural defects in the glomerular basement membrane and consequent renal dysfunction. Severe cases often progress to end-stage renal disease in male patients during late adolescence or early adulthood and may also present with hearing loss or ocular symptoms. As a rare disease (designated intractable disease No. 218), Alport syndrome remains without an established curative treatment, and effective therapeutic options are urgently needed. About Renalys Pharma, Inc. Renalys Pharma, a privately held late-stage clinical biopharmaceutical company based in Japan, is committed to the development of innovative therapeutics targeting unmet needs in the management of renal disease for Japanese and Asian patients. Founded by Catalys Pacific and SR One, the company aims to address the growing "drug loss" in the region by catalyzing access to new treatments for kidney disease patients. About Chugai Pharmaceutical, Co. Chugai Pharmaceutical Co., Ltd., headquartered in Tokyo, is a research-based pharmaceutical company with world-class drug discovery capabilities, including proprietary antibody engineering technologies. Chugai is committed to creating innovative pharmaceutical products that may satisfy unmet medical needs. Chugai is listed on the Prime Market of the Tokyo Stock Exchange. While maintaining autonomy and management independence, Chugai is an important member of the Roche Group. Additional information is available at . Company Name: Renalys Pharma, Inc. Address: 3-11, Nihonbashi-honcho 2-chome, Chuo-ku, Tokyo, Japan Representative: BT Slingsby, MD, PhD, MPH URL: [Disclaimer] Information concerning pharmaceutical products (compound under development) contained herein is not intended as advertising or as medical advice, but intended for disclosure of management information. SOURCE Renalys Pharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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17 Oct 2025

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Travere Therapeutics to Present Abstracts at American Society of Nephrology (ASN) Kidney Week 2025

SAN DIEGO--(BUSINESS WIRE)--Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced that the Company will present 11 abstracts, including a late-breaking poster, at the upcoming American Society of Nephrology (ASN) Kidney Week 2025 in Houston, TX, November 6-9. We look forward to presenting new clinical and real-world data further reinforcing the role of our medicine as foundational treatment for people living with IgAN and as a potential treatment for FSGS. In focal segmental glomerulosclerosis (FSGS), the Company will present: A late-breaking analysis from the DUPLEX Study demonstrating that patients treated with FILSPARI ® (sparsentan) were more likely to reach proteinuria levels under 0.7 g/g when compared with the maximum labeled dose of irbesartan, and achievement of this threshold correlated with reduced risk of kidney failure irrespective of treatment arm. An analysis evaluating the relationship between the magnitude of proteinuria reduction at two years with FILSPARI compared to the maximum labeled dose of irbesartan and long-term kidney outcomes in a subset of DUPLEX aligned participants in the UK National Registry of Rare Kidney Diseases (RaDaR). Data showing that FILSPARI-treated children and FILSPARI-treated individuals with COL4A3-5 mutations achieved rapid and sustained reductions in proteinuria compared with the maximum labeled dose of irbesartan in the DUPLEX Study. Presentations in IgA nephropathy (IgAN) will include: New data from SPARTAN demonstrating that among RASI-naïve patients, FILSPARI induced anti-inflammatory and anti-fibrotic effects, regardless of disease severity, as well as favorable effects on cardiovascular risk factors. Real-world data reinforcing FILSPARI’s ability to consistently lower proteinuria and preserve kidney function. Two new analyses from PROTECT showing that, irrespective of time from diagnosis or severity of disease based on kidney biopsy, FILSPARI demonstrated consistent, superior and sustained proteinuria reduction compared to maximum dose irbesartan. “We look forward to presenting new clinical and real-world data further reinforcing FILSPARI as a foundational treatment for people living with IgA nephropathy and as a potential treatment for FSGS,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics. “Analyses from the DUPLEX Study in FSGS consistently show that FILSPARI achieves clinically meaningful reductions in proteinuria across the FSGS population, including children and genetically mutated forms of the disease. These data support FILSPARI’s potential to preserve kidney function and are in alignment with findings from the PARASOL Project, which examined proteinuria as a key predictor of long-term outcomes in FSGS. In IgAN, biomarker data from the SPARTAN Study highlight FILSPARI’s potential disease-modifying effect, underscoring its position as foundational therapy and highlighting the importance of early intervention.” More information on Travere’s presence at ASN can be found here. Late-Breaking Poster Presentation Patients with Focal Segmental Glomerulosclerosis (FSGS) Reach Proteinuria <0.7 g/g More Often with Sparsentan vs. Irbesartan in DUPLEX: Implications for Kidney Failure Risk Poster: TH-PO1219 Session: Late-Breaking Science Posters Exhibit Hall; November 6, 2025, 10:00 a.m.–12:00 p.m. CT Oral Presentations Estimating the Benefits of Proteinuria Reduction on Kidney Failure Risk in the DUPLEX Study Using an Aligned FSGS Cohort from the UK RaDaR Registry Oral: FR-OR031 Oral Abstract Session: Glomerular Disease Outcomes: Measuring What Matters Room 310A; November 7, 2025, 5:00–5:10 p.m. CT Impact of Histology on Efficacy of Sparsentan Therapy in IgA Nephropathy (IgAN): Central Biopsy Review of Patients in the PROTECT Trial Oral: FR-OR032 Oral Abstract Session: Glomerular Disease Outcomes: Measuring What Matters Room 310A; November 7, 2025, 5:10–5:20 p.m. CT Outcomes of Renal Transplantation in Primary Glomerulonephritis Mapped to Post-Transplant Proteinuria in the UK RaDaR Registry Oral: SA-OR080 Oral Abstract Session: Transplantation: Clinical Controversies in Donation, Access, Monitoring, and Treatment Room 370A; November 8, 2025, 5:40–5:50 p.m. CT Poster Presentations Sparsentan vs. Irbesartan in Pediatric Patients with Focal Segmental Glomerulosclerosis (FSGS) in the Phase 3 DUPLEX Trial Poster: FR-PO0746 Poster Session: Pediatric Nephrology: CKD, ESKD, and Glomerular Diseases Exhibit Hall; November 7, 2025, 10:00 a.m.–12:00 p.m. CT Sparsentan in Participants with Focal Segmental Glomerulosclerosis (FSGS) and Collagen Type IV Alpha 3-5 Chain (COL4A3-5) Variants Poster: FR-PO0839 Poster Session: Glomerular Clinical Trials: From Data to Impact Exhibit Hall; November 7, 2025, 10:00 a.m.–12:00 p.m. CT Efficacy of Sparsentan vs. Irbesartan in Patients with IgA Nephropathy (IgAN) ≤12 mo vs. >12 mo From Kidney Biopsy Poster: FR-PO0807 Poster Session: Glomerular Clinical Trials: From Data to Impact Exhibit Hall; November 7, 2025, 10:00 a.m.–12:00 p.m. CT The Effect of Sparsentan on Proteinuria and Urinary Inflammatory and Profibrotic Biomarkers by Baseline Proteinuria Strata in SPARTAN Study Participants with IgA Nephropathy (IgAN) Poster: FR-PO0809 Poster Session: Glomerular Clinical Trials: From Data to Impact Exhibit Hall; November 7, 2025, 10:00 a.m.–12:00 p.m. CT Evaluation of Cardiovascular Risk Factors, Structure and Function in an Interim Analysis of the SPARTAN Study: Sparsentan as First-Line Treatment of Incident Patients with IgA Nephropathy (IgAN) Poster: FR-PO0810 Poster Session: Glomerular Clinical Trials: From Data to Impact Exhibit Hall; November 7, 2025, 10:00 a.m.–12:00 p.m. CT Proteinuria Reductions with Sparsentan Combined with Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2is) in Adults with IgA Nephropathy (IgAN) at a Single Site Poster: SA-PO0888 Poster Session: Glomerular Case Reports: ANCA, IgA, IgG, and More Exhibit Hall; November 8, 2025, 10:00 a.m.–12:00 p.m. CT Real-World Data on Low Proteinuria with Sparsentan in Patients with IgA Nephropathy (IgAN): A Case Series Poster: SA-PO0889 Poster Session: Glomerular Case Reports: ANCA, IgA, IgG, and More Exhibit Hall; November 8, 2025, 10:00 a.m.–12:00 p.m. CT About IgA Nephropathy IgA nephropathy (IgAN), also called Berger's disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA), a protein that helps the body fight infections, in the kidneys. The deposits of IgA cause a breakdown of the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), protein in the urine (proteinuria) and a progressive loss of kidney function. Other symptoms of IgAN may include swelling (edema) and high blood pressure. IgAN is the most common type of primary glomerulonephritis worldwide and a leading cause of kidney failure due to glomerular disease. IgAN is estimated to affect up to 150,000 people in the U.S. and is one of the most common glomerular diseases in Europe and Japan. About Focal Segmental Glomerulosclerosis Focal segmental glomerulosclerosis (FSGS) is a rare proteinuric kidney disorder in both children and adults that is estimated to affect more than 40,000 patients in the U.S. with similar prevalence in Europe. The disorder is defined by progressive scarring of the kidney and often leads to kidney failure. FSGS is characterized by proteinuria, where protein leaks into the urine due to a breakdown of the normal filtration mechanism in the kidney. Once in the urine, protein is considered to be toxic to other parts of the kidney, especially the tubules, and is believed to contribute to further disease progression. Other common symptoms include swelling in parts of the body, known as edema, as well as low blood albumin levels, abnormal lipid profiles and hypertension. Sparsentan is not approved for use in FSGS. There is currently no approved pharmacologic indicated for the treatment of FSGS. About Travere Therapeutics At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com. FILSPARI® (sparsentan) U.S. Indication FILSPARI (sparsentan) is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. IMPORTANT SAFETY INFORMATION BOXED WARNING: HEPATOTOXICITY AND EMBRYO-FETAL TOXICITY Because of the risk of hepatotoxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Under the FILSPARI REMS, prescribers, patients and pharmacies must enroll in the program. Hepatotoxicity Some Endothelin Receptor Antagonists (ERAs) have caused elevations of aminotransferases, hepatotoxicity, and liver failure. In clinical studies, elevations in aminotransferases (ALT or AST) of at least 3-times the Upper Limit of Normal (ULN) have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge. Measure transaminases and bilirubin before initiating treatment and then every 3 months during treatment. Interrupt treatment and closely monitor patients who develop aminotransferase elevations more than 3x ULN. FILSPARI should generally be avoided in patients with elevated aminotransferases (>3x ULN) at baseline because monitoring for hepatotoxicity may be more difficult and these patients may be at increased risk for serious hepatotoxicity. Embryo-Fetal Toxicity FILSPARI is contraindicated for use during pregnancy because it may cause fetal harm if used by pregnant patients. Therefore, in patients who can become pregnant, exclude pregnancy prior to initiation of FILSPARI. Advise use of effective contraception before the initiation of treatment, during treatment, and for two weeks after discontinuation of treatment with FILSPARI. When pregnancy is detected, discontinue FILSPARI as soon as possible. Contraindications FILSPARI is contraindicated in patients who are pregnant. Do not coadminister FILSPARI with angiotensin receptor blockers (ARBs), ERAs, or aliskiren. Warnings and Precautions Hepatotoxicity: Elevations in ALT or AST of at least 3-fold ULN have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge. While no concurrent elevations in bilirubin >2-times ULN or cases of liver failure were observed in FILSPARI-treated patients in clinical trials, some ERAs have caused elevations of aminotransferases, hepatotoxicity, and liver failure. To reduce the risk of potential serious hepatotoxicity, measure serum aminotransferase levels and total bilirubin prior to initiation of treatment and then every 3 months during treatment. Advise patients with symptoms suggesting hepatotoxicity (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching) to immediately stop treatment with FILSPARI and seek medical attention. If aminotransferase levels are abnormal at any time during treatment, interrupt FILSPARI and monitor as recommended. Consider re-initiation of FILSPARI only when hepatic enzyme levels and bilirubin return to pretreatment values and only in patients who have not experienced clinical symptoms of hepatotoxicity. Avoid initiation of FILSPARI in patients with elevated aminotransferases (>3x ULN) because monitoring hepatotoxicity in these patients may be more difficult and these patients may be at increased risk for serious hepatotoxicity. FILSPARI REMS: Due to the risk of hepatotoxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Prescribers, patients, and pharmacies must be enrolled in the REMS program and comply with all requirements ( www.filsparirems.com ). Embryo-Fetal Toxicity: Based on data from animal reproduction studies, FILSPARI may cause fetal harm when administered to a pregnant patient and is contraindicated during pregnancy. The available human data for ERAs do not establish the presence or absence of fetal harm related to the use of FILSPARI. Counsel patients who can become pregnant of the potential risk to a fetus. Exclude pregnancy before initiating treatment with FILSPARI. Advise patients who can become pregnant to use effective contraception prior to initiation of treatment, during treatment, and for two weeks after discontinuation of treatment with FILSPARI. When pregnancy is detected, discontinue FILSPARI as soon as possible. Hypotension: Hypotension has been observed in patients treated with ARBs and ERAs. There was a greater incidence of hypotension-associated adverse events, some serious, including dizziness, in patients treated with FILSPARI compared to irbesartan. In patients at risk for hypotension, consider eliminating or adjusting other antihypertensive medications and maintaining appropriate volume status. If hypotension develops, despite elimination or reduction of other antihypertensive medications, consider a dose reduction or dose interruption of FILSPARI. A transient hypotensive response is not a contraindication to further dosing of FILSPARI, which can be given once blood pressure has stabilized. Acute Kidney Injury: Monitor kidney function periodically. Drugs that inhibit the renin-angiotensin system (RAS) can cause kidney injury. Patients whose kidney function may depend in part on the activity of the RAS (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute kidney injury on FILSPARI. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in kidney function while on FILSPARI. Hyperkalemia: Monitor serum potassium periodically and treat appropriately. Patients with advanced kidney disease, taking concomitant potassium-increasing drugs (e.g., potassium supplements, potassium-sparing diuretics), or using potassium-containing salt substitutes are at increased risk for developing hyperkalemia. Dosage reduction or discontinuation of FILSPARI may be required. Fluid Retention: Fluid retention may occur with ERAs, and has been observed in clinical studies with FILSPARI. FILSPARI has not been evaluated in patients with heart failure. If clinically significant fluid retention develops, evaluate the patient to determine the cause and the potential need to initiate or modify the dose of diuretic treatment then consider modifying the dose of FILSPARI. Most common adverse reactions The most common adverse reactions (≥5%) are hyperkalemia, hypotension (including orthostatic hypotension), peripheral edema, dizziness, anemia, and acute kidney injury. Drug interactions Renin-Angiotensin System (RAS) Inhibitors and ERAs: Do not coadminister FILSPARI with ARBs, ERAs, or aliskiren due to increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure). Strong and Moderate CYP3A Inhibitors: Avoid concomitant use of FILSPARI with strong CYP3A inhibitors. If a strong CYP3A inhibitor cannot be avoided, interrupt FILSPARI treatment. When resuming treatment with FILSPARI, consider dose titration. Monitor blood pressure, serum potassium, edema, and kidney function regularly when used concomitantly with moderate CYP3A inhibitors. Concomitant use with a strong CYP3A inhibitor increases sparsentan exposure which may increase the risk of FILSPARI adverse reactions. Strong CYP3A Inducers: Avoid concomitant use with a strong CYP3A inducer. Concomitant use with a strong CYP3A inducer decreases sparsentan exposure which may reduce FILSPARI efficacy. Antacids and Acid Reducing Agents: Administer FILSPARI 2 hours before or after administration of antacids. Avoid concomitant use of acid reducing agents (histamine H2 receptor antagonist and PPI proton pump inhibitor) with FILSPARI. Sparsentan exhibits pH-dependent solubility. Antacids or acid reducing agents may decrease sparsentan exposure which may reduce FILSPARI efficacy. Non-Steroidal Anti-Inflammatory Agents (NSAIDs), Including Selective Cyclooxygenase-2 (COX-2) Inhibitors: Monitor for signs of worsening renal function with concomitant use with NSAIDs (including selective COX-2 inhibitors). In patients with volume depletion (including those on diuretic therapy) or with impaired kidney function, concomitant use of NSAIDs (including selective COX-2 inhibitors) with drugs that antagonize the angiotensin II receptor may result in deterioration of kidney function, including possible kidney failure. CYP2B6, 2C9, and 2C19 Substrates: Monitor for efficacy of concurrently administered CYP2B6, 2C9, and 2C19 substrates and consider dosage adjustment in accordance with the Prescribing Information. Sparsentan decreases exposure of these substrates, which may reduce efficacy related to these substrates. P-gp and BCRP Substrates: Avoid concomitant use of sensitive substrates of P-gp and BCRP with FILSPARI. Sparsentan may increase exposure of these transporter substrates which may increase the risk of adverse reactions related to these substrates. Agents Increasing Serum Potassium: Monitor serum potassium frequently in patients treated with FILSPARI and other agents that increase serum potassium. Concomitant use of FILSPARI with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other drugs that raise serum potassium levels may result in hyperkalemia. Please see the full Prescribing Information, including BOXED WARNING, for additional Important Safety Information. Forward-Looking Statements This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are often identified by the words “on-track,” “positioned,” “look forward to,” “will,” “would,” “may,” “might,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “potential,” or similar expressions. In addition, expressions of strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to: statements relating to the clinical studies and data described herein; statements and expectations regarding FILSPARI’s role as a foundational treatment in IgAN, its potential disease-modifying effect, and the potential to preserve kidney function; statements regarding FILSPARI as a potential treatment for FSGS; and statements related to the estimated sizes of patient populations. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties related to the Company’s sNDA for FILSPARI in FSGS, including the timing and outcome thereof. There is no guarantee that the FDA will grant approval of FILSPARI for FSGS on the anticipated timeline, or at all. The Company also faces risks and uncertainties related to its business and finances in general, the success of its commercial products, risks and uncertainties associated with its preclinical and clinical stage pipeline, risks and uncertainties associated with the regulatory review and approval process, risks and uncertainties associated with enrollment of clinical trials for rare diseases, and risks that ongoing or planned clinical trials may not succeed or may be delayed for safety, regulatory or other reasons. Specifically, the Company faces risks associated with the ongoing commercial launch of FILSPARI in IgAN, the timing and potential outcome of its and its partners’ clinical studies, market acceptance of its commercial products including efficacy, safety, price, reimbursement, and benefit over competing therapies, risks related to the challenges of manufacturing scale-up, risks associated with the successful development and execution of commercial strategies for such products, including FILSPARI, and risks and uncertainties related to the new administration, including but not limited to risks and uncertainties related to tariffs and the funding, staffing and prioritization of resources at government agencies including the FDA. The Company also faces the risk that it will be unable to raise additional funding that may be required to complete development of any or all of its product candidates, including as a result of macroeconomic conditions; risks relating to the Company’s dependence on contractors for clinical drug supply and commercial manufacturing; uncertainties relating to patent protection and exclusivity periods and intellectual property rights of third parties; risks associated with regulatory interactions; and risks and uncertainties relating to competitive products, including current and potential future generic competition with certain of the Company’s products, and technological changes that may limit demand for the Company’s products. The Company also faces additional risks associated with global and macroeconomic conditions, including health epidemics and pandemics, including risks related to potential disruptions to clinical trials, commercialization activity, supply chain, and manufacturing operations. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties, including under the heading “Risk Factors,” as included in the Company’s most recent Form 10-K, Form 10-Q and other filings with the Securities and Exchange Commission.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Irbesartan

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KEGG	Wiki	ATC	Drug Bank
D00523	Irbesartan	C09CA04	DB01029

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Australia	Sanofi-Aventis Australia Pty Ltd.	18 May 2005
Hypertension	United States	Sanofi-Aventis U.S. LLC	30 Sep 1997
Type 2 diabetes mellitus with established diabetic nephropathy	United States	Sanofi-Aventis U.S. LLC	30 Sep 1997
Essential Hypertension	European Union	Sanofi Winthrop Industrie SA	26 Aug 1997
Essential Hypertension	Iceland	Sanofi Winthrop Industrie SA	26 Aug 1997
Essential Hypertension	Liechtenstein	Sanofi Winthrop Industrie SA	26 Aug 1997
Essential Hypertension	Norway	Sanofi Winthrop Industrie SA	26 Aug 1997
Kidney Diseases	European Union	Sanofi Winthrop Industrie SA	26 Aug 1997
Kidney Diseases	Iceland	Sanofi Winthrop Industrie SA	26 Aug 1997
Kidney Diseases	Liechtenstein	Sanofi Winthrop Industrie SA	26 Aug 1997
Kidney Diseases	Norway	Sanofi Winthrop Industrie SA	26 Aug 1997

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Hypercholesterolemia	Phase 3	Germany	Bristol Myers Squibb Co.	01 Nov 2009
Fibrosis, Liver	Phase 3	France	Sanofi	01 Oct 2006
Hepatitis C, Chronic	Phase 3	France	Sanofi	01 Oct 2006
Acute Coronary Syndrome	Phase 3	United States	Bristol Myers Squibb Co.	01 Feb 2006
Acute Coronary Syndrome	Phase 3	United States	Sanofi	01 Feb 2006
Acute Coronary Syndrome	Phase 3	Belgium	Sanofi	01 Feb 2006
Acute Coronary Syndrome	Phase 3	Belgium	Bristol Myers Squibb Co.	01 Feb 2006
Acute Coronary Syndrome	Phase 3	Canada	Bristol Myers Squibb Co.	01 Feb 2006
Acute Coronary Syndrome	Phase 3	Canada	Sanofi	01 Feb 2006
Acute Coronary Syndrome	Phase 3	France	Sanofi	01 Feb 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02597361 (Pubmed \| Circulation)	Phase 3	Ehlers-Danlos Syndrome defective type III collagen	-	Irbesartan 150 mg/day titrated to 300 mg/day	wijmkxkqcy(djjgspuvqs) = Eleven episodes of irbesartan-related hypotension were recorded, leading to a downtitration in 4 patients qefurfyccc (btpvgsfqyc ) View more	Positive	11 Mar 2025
				Placebo
NCT00933231 (Phase 3b trial, Pubmed \| Clin Transplant)	Phase 3	Renal transplant rejection	281	Standard-Dose Prolonged-Release Tacrolimus + ACEi/ARB	fblsfkdekt(jhzkroflsn) = zbmodfbnks wefnglrybn (hvszycajkd ) View more	Positive	01 Jan 2025
				Standard-Dose Prolonged-Release Tacrolimus + Other Antihypertensive Therapy	fblsfkdekt(jhzkroflsn) = chobsvregm wefnglrybn (hvszycajkd ) View more
NCT05476354 \| NCT05475665 (I-DUO 301;I-DUO 302, Pubmed \| Clin Ther)	Phase 3	Essential Hypertension	428	Irbesartan/Amlodipine 150/5 mg	okfqdtvape(qmwzggfjxj) = wivcrioled twvuthfnww (gzvjdwuvxd, 12.35)	Positive	01 Jun 2024
				Irbesartan/Amlodipine 150/10 mg	okfqdtvape(qmwzggfjxj) = oiljidwcjk twvuthfnww (gzvjdwuvxd, 12.78)
NCT03762850 (PROTECT, ISN WCN2024) Manual	Phase 3	Glomerulonephritis, IGA	404	Sparsentan 400 mg/day	ruvfymzkcm(mkxaqfmzzv) = ekvcrpsarb hqhackocsk (xuadphukkz ) View more	Positive	01 Apr 2024
				irbesartanirbesartan 300 mg/day	ruvfymzkcm(mkxaqfmzzv) = swqipshvmn hqhackocsk (xuadphukkz ) View more
NCT00791830 (Pubmed \| BMC Nephrol)	Phase 3	Hemodialysis complication	81	Placebo	ahuzpxrdzq(mjsobctuje) = ennocpeoqo siizbgeanv (snixpsshrb ) View more	-	28 Oct 2020
				Angiotensin II receptor blocker (ARB)	ahuzpxrdzq(mjsobctuje) = aaylcsehch siizbgeanv (snixpsshrb ) View more
PARCERIA STUDY (ESH2018)	Not Applicable	Hypertension	509	Amlodipine/Irbesartan fixed combination	mikwqsvkeo(icfuyfsnaz) = There were 124 Treatment Emergent Adverse Events (TEAEs) experienced by 89 (17.5%) patients, including 7 serious TEAEs by 5 (1.0%) patients. TEAEs were not related to A/I (76.6%) nfdtsqimzm (niqswnecdp )	Positive	01 Jun 2018
NCT00095238 (I-Preserve, Pubmed \| Circulation)	Phase 3	Heart failure with normal ejection fraction	4,128	Irbesartan (Patients with diabetes mellitus)	nubadrukoc(gvhhecoxpq) = zxnnepynkz rdtpobhelt (kdzpnsmytj ) View more	-	21 Feb 2017
				Irbesartan (Patients without diabetes mellitus)	nubadrukoc(gvhhecoxpq) = lxclmwfzkj rdtpobhelt (kdzpnsmytj ) View more
NCT01442987 (Pubmed \| Clin Ther)	Phase 3	Hypertension \| Hypercholesterolemia	230	Irbesartan 300 mg + Atorvastatin 40 mg	thlaipgshz(izjkqxtiuz) = rtogxsuqrn chplvbdlhj (vhammfbgcr, 2.06) View more	-	01 Oct 2016
				Irbesartan 300 mg + Atorvastatin 80 mg	thlaipgshz(izjkqxtiuz) = srvfmtxsrj chplvbdlhj (vhammfbgcr, 2.12) View more
NCT00389168 (SILVHIA, CTgov)	Phase 2/3	Hypertrophy, Left Ventricular \| Hypertension	115	Atenolol (Atenolol)	maamuuhflr(geivjgeizu) = tafgdzmkkt apschnkllf (iqlxtbouih, artbjgrgkz - gwnrjpohln) View more	-	05 May 2015
				Irbesartan (Irbesartan)	maamuuhflr(geivjgeizu) = sdkfhmxcda apschnkllf (iqlxtbouih, jkxtbwwfmk - mymxdgoflp) View more
NCT00353652 (CTgov)	Phase 4	Hypertension \| Essential Hypertension	166	Chlorthalidone (CTD) (Study#1: Chlorthalidone (CTD), Titrated Dose)	zxqpunosqw(uhbbhvaysq) = doqfnttjol igepnmwwjg (hkihteiiyd, 4) View more	-	29 Dec 2014
				Spironolactone (SP) (Study #1: Spironolactone (SP), Titrated Dose)	zxqpunosqw(uhbbhvaysq) = avmxvpaymv igepnmwwjg (hkihteiiyd, 3) View more

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