A Single-center, Open-label, Fixed-sequence Trial to Investigate the Effect of Multiple-dose Aprocitentan on the Single-dose Pharmacokinetics of Combined Oral Contraceptives in Healthy Female Participants

The goal of this clinical trial is to learn if drug aprocitentan has an effect on hormonal contraceptives in healthy female volunteers. The main question it aims to answer is:
Does aprocitentan modify the fate of hormonal contraceptives in the body?
Trial participants will:
* Take a single dose of hormonal contraceptives (fixed combination) alone
* Take aprocitentan every day for 2 weeks
* Take a single dose of the same hormonal contraceptives at the same time as the 10th administration of aprocitentan.

Start Date18 Jan 2025

Sponsor / Collaborator

Idorsia Pharmaceuticals Ltd.

NCT05196399

/ CompletedPhase 1

A Single-center, Open-label, Randomized, Two-way Crossover Phase 1 Study to Compare the Single-dose Pharmacokinetics of Different Tablet Formulations of Aprocitentan in Healthy Subjects

The main purpose is to study the pharmacokinetics of aprocitentan (ACT-132577) using 2 different tablet formulations. The clinical pharmacology data will be used to determine bioequivalence of 2 different tablet formulations.

Start Date02 Feb 2022

Sponsor / Collaborator

Idorsia Pharmaceuticals Ltd.

NCT04252495

/ CompletedPhase 1

An Open-label Phase 1 Study to Investigate the Effect of Moderate Hepatic Impairment Due to Liver Cirrhosis on the Pharmacokinetics of a Single Dose of 25 mg Aprocitentan

This is a prospective, open-label, single-dose, Phase 1 study, to assess the effect of moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of aprocitentan (ACT-132577).

Start Date26 Jun 2020

Sponsor / Collaborator

Idorsia Pharmaceuticals Ltd.

100 Clinical Results associated with Aprocitentan

100 Translational Medicine associated with Aprocitentan

100 Patents (Medical) associated with Aprocitentan

Literatures (Medical) associated with Aprocitentan

01 Dec 2025·Current Cardiology Reports

Endothelin Receptor Antagonists for the Treatment of Hypertension: Recent Data from Clinical Trials and Implementation Approach

Review

Author: Krishnan, Anoushka ; Schlaich, Markus P ; Manickavasagar, Revathy ; Azzam, Omar

Abstract:

Purpose of Review:

The endothelin system is a highly relevant component of the pathophysiology of hypertension, which is currently unopposed by existing treatment approaches. We examined the role of dual endothelin receptor antagonists in the treatment of resistant hypertension.

Recent Findings:

The recent PRECISION trial demonstrated significant blood pressure lowering effect with the use of the dual endothelin receptor antagonist aprocitentan in the treatment of resistant hypertension. Aprocitentan was shown to be particularly effective in patients over 75 years of age, African-American patients, and patients with diabetes and advanced CKD. There was also a decrease in proteinuria. Aprocitentan was well tolerated and the risk of fluid retention can be mitigated by close clinical monitoring and titration of diuretic therapy.

Summary:

Aprocitentan presents a novel treatment option for resistant hypertension, with particular efficacy noted in patient cohorts who have historically been challenging to achieve blood pressure targets in.

01 Sep 2025·Nature Reviews Cardiology

Novel pharmacological approaches to lowering blood pressure and managing hypertension

Review

Author: Sayer, Matthew ; Dhaun, Neeraj ; Webb, David J

Hypertension is the leading cause of death globally, primarily due to its strong association with cardiovascular disease. The global prevalence of hypertension has surged over the past three decades, driven by rising rates of diabetes mellitus and obesity. Despite current antihypertensive therapies, only a small proportion of patients with hypertension achieve adequate blood pressure control, necessitating novel therapeutic strategies. In this Review we explore the challenges and emerging opportunities in hypertension management. Aprocitentan, a dual endothelin receptor antagonist, is the first agent from a novel class of antihypertensive drug to be licensed since 2007 and exemplifies innovative treatments on the horizon. Here we also address the complex factors contributing to poor hypertension control, including genetic influences, lifestyle factors, therapeutic inertia and poor patient adherence. We discuss the limitations of existing therapies and highlight promising new pharmacological approaches to hypertension management. Integrating these novel treatments alongside current pharmaceuticals combined with improved diagnostic and management strategies could substantially reduce the global burden of hypertension and associated cardiovascular disease.

01 Sep 2025·JOURNAL OF CARDIOVASCULAR PHARMACOLOGY AND THERAPEUTICS

Clinical Evaluation of QTc Interval Prolongation With the Dual Endothelin Receptor Antagonist Aprocitentan

Article

Author: Sidharta, P.N. ; Brussee, J.M. ; Schultz, A. ; Wierdak, J. ; Dingemanse, J.

Introduction:

Aprocitentan, is an orally active, once-daily administered, dual endothelin receptor antagonist that was recently approved for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs.

Methods:

The potential of aprocitentan to affect the QT interval was investigated in this thorough QT/QTc study that was performed as a multiple-dose, randomized, double-blind, placebo- and moxifloxacin-controlled (open-label), crossover study in healthy male and female subjects. Concentration-QT modeling, using a linear mixed-effects model, was performed on data extracted from continuous Holter electrocardiogram recordings.

Results:

Of the 48 subjects enrolled in the study, 32 subjects completed study treatment. The main reasons for stopping study treatment were the occurrence of adverse events and withdrawal of consent. The dosing regimen of 25 mg aprocitentan o.d. (the highest approved therapeutic dose in the European Union; C max = 3.68 µg/mL) was safe and well tolerated; the supratherapeutic dosing regimen of 100 mg aprocitentan o.d. showed limited tolerability. Results indicated that ΔΔQTcF increased with increasing aprocitentan concentrations. The predicted upper bound of the 2-sided 90% ΔΔQTcF confidence interval exceeded the 10 ms threshold of regulatory concern at 16.10 µg/mL, which was close to the geometric mean maximum concentration (ie, 16.77 µg/mL) obtained with a 100 mg supratherapeutic dose.

Conclusions:

At the highest therapeutic dose of 25 mg, there was no clinically significant prolongation of QTc. The risk of QT prolongation with therapeutic doses of aprocitentan is considered low.

News (Medical) associated with Aprocitentan

19 Sep 2025

·www.idorsia.com

Idorsia’s JERAYGO (aprocitentan) approved in Switzerland for the treatment of resistant hypertension

Idorsia receives approval from Swissmedic for JERAYGO™ (aprocitentan) as the first and only endothelin receptor antagonist (ERA) for the treatment of resistant hypertension. JERAYGO is a new oral antihypertensive therapy – the first systemic hypertension treatment to target a new pathway in over 30 years. Allschwil, Switzerland – September 19, 2025Idorsia Ltd (SIX: IDIA) announces that Swissmedic has granted marketing authorization for JERAYGO™ (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products.1 The recommended dose is 12.5 mg orally once daily. The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure (BP) control.1 Hypertension remains a leading global health challenge and the number one modifiable risk factor for early morbidity and mortality. Despite advances in treatment, many patients still struggle with uncontrolled blood pressure, leaving them at significantly higher risk of heart attack, stroke, kidney failure, and premature death. Approximately 10% of hypertensive patients have resistant hypertension3,4 – defined by uncontrolled blood pressure despite receiving at least three antihypertensive medications from different classes, at optimal doses – underscoring the urgent need for more effective therapies. Srishti Gupta, MD, Chief Executive Officer of Idorsia, commented:“JERAYGO is the first and only hypertension treatment to target the endothelin pathway, a fundamental yet previously unaddressed driver of disease onset, progression, and complications. This breakthrough reflects nearly 30 years of research at our Swiss laboratories and represents Idorsia’s second product approval in our home country. JERAYGO has demonstrated rapid, durable, and clinically significant double-digit blood pressure reduction across a broad spectrum of challenging patient populations, including those with obesity, chronic kidney disease, or type 2 diabetes. I am incredibly proud of our team for achieving this milestone.” Idorsia is engaged in discussions with potential partners to make JERAYGO available to patients across Switzerland and Europe. For more information on the marketing authorization of JERAYGO in Switzerland, please refer to the Patient Information and Information for Healthcare Professionals. Notes to the editor About the Phase 3 PRECISION study1,5The efficacy of aprocitentan was evaluated in one randomized, double-blind (DB), placebo-controlled Phase 3 multicenter study. Patients with uncontrolled blood pressure (systolic blood pressure [SBP] ≥140 mmHg) despite the use of at least three antihypertensive medicinal products and following exclusion of pseudo-resistant hypertension (e.g., white coat effect, inappropriate blood pressure measurement, secondary causes of hypertension) were considered to have resistant hypertension. The patients were switched to standardized background antihypertensive therapy consisting of an angiotensin receptor blocker (valsartan 160 mg), a calcium channel blocker (amlodipine 5 or 10 mg), and a diuretic (hydrochlorothiazide 25 mg) throughout the study. Patients with concomitant use of beta-blockers continued this treatment throughout the study, in addition to the standardized background antihypertensive therapy and study treatment. A total of 730 patients received either aprocitentan 12.5 mg, aprocitentan 25 mg, or placebo once daily during the initial 4-week DB treatment (part 1). Thereafter, patients received aprocitentan 25 mg once daily during the 32-week single-blind treatment (part 2). At the end of the 32 weeks, patients were re-randomized to receive either aprocitentan 25 mg or placebo, once daily, during the 12-week double-blind withdrawal (DB-WD) treatment (part 3). The primary efficacy endpoint was the change in sitting SBP (SiSBP) from baseline to Week 4 during DB treatment (part 1), measured at trough by unattended automated office blood pressure (uAOBP). The key secondary endpoint was the change in SiSBP measured at trough by uAOBP from DB-WD baseline (Week 36) to Week 40 (part 3). Patients had a mean age of 61.7 years (range 24 to 84 years; 34.1% were ≥ 65 and < 75 years; 9.9% were ≥ 75 years) and 59.5% were male. Patients were White (82.9%), African American (11.2%) or Asian (5.2%). The mean body weight was 97.6 kg (range 46 to 196 kg) and mean BMI was 33.7 kg/m2 (range 18 to 64 kg/m2). Patients had a medical history of type 2 diabetes mellitus (54.1%), ischemic heart disease (30.8%), central nervous system vascular disorders (23.0%), chronic kidney disease stages 3 and 4 (22.2%; 19.3% of patients had eGFR 30–59 mL/min/1.73 m2 and 2.9% had eGFR 15–29 mL/min/1.73 m2), congestive heart failure (19.6%), and sleep apnea syndrome (14.1%). 63.0% of patients had four or more antihypertensive medicinal products. Key PRECISION findings1,5Doses of aprocitentan 12.5 and 25 mg showed a statistically significant reduction vs placebo on SiSBP at Week 4. The treatment effect was consistent for sitting diastolic blood pressure (SiDBP). The persistence of the BP-lowering effect of aprocitentan was shown in DB-WD treatment (part 3). In patients re-randomized to placebo, the mean SiSBP increased, whereas in patients re-randomized to aprocitentan 25 mg the mean effect on SiSBP was stable, resulting in a statistically significant difference. The treatment effect was consistent for SiDBP. The effect was also consistent across SBP and DBP measured by ambulatory BP monitoring (ABPM) and assessed as daytime, night-time, and 24h periods at Week 4 and Week 40. A substantial proportion (i.e., at least 90%) of the BP-lowering effect was observed within the first two weeks of treatment with aprocitentan. The effect of aprocitentan was consistent across subgroups of age (including patients ≥ 75 years), sex, race (including patients with Black or African American origin), BMI, baseline urine albumin-to-creatinine ratio (UACR), baseline eGFR and medical history of diabetes. The most frequently reported adverse reactions with aprocitentan were edema/fluid retention (mostly peripheral edema) (9.1%, 12.5 mg; 18.4%, 25 mg) and hemoglobin decreased (3.7%, 12.5 mg; 1.2%, 25 mg). JERAYGO is contraindicated for use in women who are pregnant, breast-feeding, in women of childbearing potential who are not using reliable contraception, patients with severe hepatic impairment, and in patients with hypersensitivity to the active substance or to any of the excipients. About aprocitentanAprocitentan is Idorsia’s once-daily, orally active, dual endothelin receptor antagonist, which inhibits the binding of ET-1 to ETA and ETB receptors. Aprocitentan is approved as TRYVIO™ in the US for the treatment of systemic hypertension in combination with other antihypertensives and has been commercially available since October 2024. Aprocitentan is approved as JERAYGO™ for the treatment of resistant hypertension in combination with at least three antihypertensives in the European Union, the UK, and Switzerland, and a marketing authorization application is under review in Canada. Idorsia Pharmaceuticals Ltd has transferred its rights for aprocitentan (including JERAYGO™) to Idorsia Investments SARL to allow the repayment of newly created notes issued in connection with the repurchase offer completed in August 2025. More details on the transfer can be found in the press release issued on May 21, 2025 and on the exchange offer in the press release issued on August 27, 2025. References About IdorsiaThe purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact:Investor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as “intend”, "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF

Clinical ResultPhase 3Drug ApprovalLicense out/in

05 Sep 2025

·www.prnewswire.com

Idorsia to collaborate with two leading academic medical centers to launch IMPACT-HTN - a US initiative to transform care for patients with difficult-to-control hypertension

Multi-phase program to standardize treatment, generate real-world evidence, and explore AI-powered tools to improve outcomes for hypertension patients ALLSCHWIL, Switzerland and RADNOR, Pa., Sept. 5, 2025 /PRNewswire/ -- Idorsia Ltd (SIX: IDIA) announces a first-of-its-kind initiative with the Stanford Hypertension Center and Duke Heart Center to launch IMPACT-HTN, a new three-phase program to transform and modernize the management of difficult-to-control hypertension. Patients requiring multiple medications for difficult-to-control hypertension face increasing challenges with care coordination, evaluation of underlying causes, and worsening outcomes. The initiative, led by Dr. Vivek Bhalla of the Stanford University School of Medicine and Dr. Sreekanth Vemulapalli of Duke University School of Medicine, is expected to generate real-world evidence, standardize clinical decision-making, and deliver scalable tools that leverage AI technology to help identify patients with difficult-to-control hypertension who may benefit from innovative therapies that utilize new pathways, including Idorsia's once-daily TRYVIO™ (aprocitentan), the first systemic hypertension treatment to target a new pathway in over 30 years. Sreekanth Vemulapalli, MD, Associate Professor of Medicine, Duke Heart Center, commented: "With novel therapies emerging to improve hypertension control, we are thrilled to work with our esteemed colleagues at Stanford and other hypertension centers to standardize the evaluation, management, and access to innovative therapies for our patients with difficult-to-control hypertension. We'll be collaborating with companies to develop high-touch AI tools aimed at supporting the care of our patients to meet people where they are. This is a cross-institutional collaboration which we hope to expand to improve the outcomes of our patients." Despite progress in improving patient outcomes, hypertension remains a major global health issue, affecting an estimated 50% of adults in the US. Patients whose blood pressure remains above target despite the use of appropriate therapy face significantly higher risks of cardiovascular events, including heart attack, stroke, and kidney failure, and are nearly twice as likely to experience premature mortality compared to those with controlled blood pressure. Difficult-to-control hypertension is defined as above-goal elevated blood pressure in a patient despite the concurrent use of multiple antihypertensive drug classes. Vivek Bhalla, MD, Associate Professor of Medicine/Nephrology, Founding Director of the Stanford Hypertension Center, commented: "The IMPACT-HTN program challenges the boundaries of the standard care model for hypertension treatment by building a platform to fundamentally shift how we approach difficult-to-control hypertension. I'm proud to collaborate with Idorsia and Dr. Vemulapalli as well as Dr. Kenneth Mahaffey, the Founding Director of the Stanford Center for Clinical Research, for this initiative. By developing and publishing best practices, analyzing real-world data, and harnessing emerging technologies, we're working to deliver impactful solutions that can transform hypertension care and improve lives." The multi-phased IMPACT-HTN program is expected to deliver actionable tools, data, and insights to improve care for those with difficult-to-control hypertension, including: A digital care algorithm to standardize how difficult-to-control hypertension is assessed and managed. Through interactive tools such as patient-facing algorithms, AI chatbots, and a program portal, this initiative aims to transform protocols to improve patient care. A personalized hypertension risk score that will build on existing risk scores for prevention to better identify difficult-to-control hypertension patients at risk for negative cardiovascular outcomes so appropriate treatment protocols can be implemented sooner. A prospective early patient experience initiative that will enroll patients from hypertension specialty centers to better understand the treatment obstacles for patients with difficult-to-control hypertension and how newer treatments, like Idorsia's TRYVIO, are impacting the treatment paradigm. Srishti Gupta, MD, CEO of Idorsia, commented: "We are proud to have pioneered the first treatment tackling a new pathway in hypertension in over three decades and as a leader in this area, we understand that our commitment to improving patient outcomes goes beyond the medicine. We are proud to collaborate with two of the world's leading research institutions on this exciting new program and believe IMPACT-HTN will help reimagine the pathways of care for hypertension patients who need additional options." TRYVIO, a dual endothelin receptor antagonist (ERA), is now available to prescribe. It is indicated for the treatment of hypertension in combination with other antihypertensive drugs to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. TRYVIO is now included in the American College of Cardiology's (ACC) and the American Heart Association's (AHA) new comprehensive clinical practice guidelines for the management of high blood pressure, but many patients remain undiagnosed and undertreated. Important Safety Information TRYVIO may cause serious side effects, including: TRYVIO can cause major birth defects if used by pregnant patients and has a BOXED Warning for embryo-fetal toxicity. People who can become pregnant must not be pregnant when they start taking TRYVIO or become pregnant during treatment with TRYVIO or for 1 month after stopping treatment with TRYVIO. People who can become pregnant should have a negative pregnancy test before starting treatment with TRYVIO, each month during treatment with TRYVIO, and 1 month after stopping TRYVIO. People who can become pregnant should use acceptable birth control before starting treatment with TRYVIO, during treatment with TRYVIO, and for 1 month after stopping TRYVIO because the medicine may still be in your body. If you are a person who can become pregnant, your healthcare provider will talk to you about pregnancy testing recommendations and the need to use acceptable birth control, the benefits and risks of TRYVIO, and the need to report suspected pregnancy right away to your healthcare provider. What is TRYVIO? TRYVIO is a prescription medicine used to treat high blood pressure (hypertension) in adults who are taking other high blood pressure medicines and whose blood pressure is not well controlled. Do not take TRYVIO if you are pregnant or currently trying to become pregnant. allergic to aprocitentan or any of the ingredients in TRYVIO. Before taking TRYVIO, tell your healthcare provider about all of your medical conditions, including if you: have liver problems have heart failure have anemia have kidney problems or get dialysis are pregnant or plan to become pregnant during treatment with TRYVIO. TRYVIO can cause serious birth defects. are breastfeeding or plan to breastfeed. It is not known if TRYVIO passes into your breastmilk. Do not breastfeed if you take TRYVIO. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRYVIO may cause other serious side effects, including: Liver problems. TRYVIO may cause liver problems. Your healthcare provider should do blood tests to check your liver before starting treatment and as needed during treatment with TRYVIO. Tell your healthcare provider if you have any of the following symptoms of liver problems during treatment with TRYVIO: Fluid retention. Fluid retention and swelling are common during treatment with TRYVIO and can be serious. Tell your healthcare provider right away if you have any unusual weight gain, trouble breathing, or swelling of your ankles or legs. Your healthcare provider may treat you with other medicines (diuretics) if you develop fluid retention or swelling. Low red blood cell levels (anemia). Anemia is common during treatment with TRYVIO and can be serious. Your healthcare provider will do blood tests to check your red blood cells before starting and as needed during treatment with TRYVIO. Decreased sperm count. TRYVIO may cause decreased sperm counts in males and may affect the ability to father a child. Tell your healthcare provider if being able to have children is important to you. Your healthcare provider may stop treatment with TRYVIO if you develop certain side effects. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TRYVIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information see the Full Prescribing Information including BOXED Warning (PI and Medication Guide). Notes to the editor About aprocitentan Aprocitentan is Idorsia's once-daily, orally active, dual endothelin receptor antagonist, which inhibits the binding of ET-1 to ETA and ETB receptors. Aprocitentan is approved as TRYVIO® in the US for the treatment of systemic hypertension in combination with other antihypertensives and has been commercially available since October 2024. Aprocitentan is approved as JERAYGO® for the treatment of resistant hypertension in combination with other antihypertensives in the European Union and the UK and marketing authorization applications are under review in Canada, and Switzerland. About Idorsia The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact: Investor & Media Relations Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil +41 58 844 10 10 [email protected] – [email protected] – The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "intend", "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. SOURCE Idorsia Pharmaceuticals Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalAHA

05 Sep 2025

·www.idorsia.com

Idorsia to collaborate with two leading academic medical centers to launch IMPACT-HTN – a US initiative to transform care for patients with difficult-to-control hypertension

Multi-phase program to standardize treatment, generate real-world evidence and explore AI-powered tools to improve outcomes for hypertension patients Allschwil, Switzerland & Radnor, Philadelphia – September 5, 2025Idorsia Ltd (SIX: IDIA) announces a first-of-its-kind initiative with the Stanford Hypertension Center and Duke Heart Center to launch IMPACT-HTN, a new three-phase program to transform and modernize the management of difficult-to-control hypertension. Patients requiring multiple medications for difficult-to-control hypertension face increasing challenges with care coordination, evaluation of underlying causes, and worsening outcomes. The initiative, led by Dr. Vivek Bhalla of the Stanford University School of Medicine and Dr. Sreekanth Vemulapalli of Duke University School of Medicine, is expected to generate real-world evidence, standardize clinical decision-making and deliver scalable tools that leverage AI technology to help identify patients with difficult-to-control hypertension who may benefit from innovative therapies that utilize new pathways, including Idorsia's once-daily TRYVIO™ (aprocitentan), the first systemic hypertension treatment to target a new pathway in over 30 years. Sreekanth Vemulapalli, MD, Associate Professor of Medicine, Duke Heart Center, commented:“With novel therapies emerging to improve hypertension control, we are thrilled to work with our esteemed colleagues at Stanford and other hypertension centers to standardize the evaluation, management and access to innovative therapies for our patients with difficult-to-control hypertension. We'll be collaborating with companies to develop high-touch AI tools aimed at supporting the care of our patients to meet people where they are. This is a cross-institutional collaboration which we hope to expand to improve the outcomes of our patients.” Despite progress in improving patient outcomes, hypertension remains a major global health issue, affecting an estimated 50% of adults in the U.S. Patients whose blood pressure that remains above target despite the use of appropriate therapy face significantly higher risks of cardiovascular events, including heart attack, stroke and kidney failure, and are nearly twice as likely to experience premature mortality compared to those with controlled blood pressure. Difficult-to-control hypertension is defined as above-goal elevated blood pressure in a patient despite the concurrent use of multiple antihypertensive drug classes. Vivek Bhalla, MD, Associate Professor of Medicine/Nephrology, Founding Director of the Stanford Hypertension Center, commented: “The IMPACT-HTN program challenges the boundaries of the standard care model for hypertension treatment by building a platform to fundamentally shift how we approach difficult-to-control hypertension. I’m proud to collaborate with Idorsia and Dr. Vemulapalli as well as Dr. Kenneth Mahaffey, the Founding Director of the Stanford Center for Clinical Research for this initiative. By developing and publishing best practices, analyzing real-world data and harnessing emerging technologies, we’re working to deliver impactful solutions that can transform hypertension care and improve lives.”The multi-phased IMPACT-HTN program is expected to deliver actionable tools, data and insights to improve care for those with difficult-to-control hypertension, including: A digital care algorithm to standardize how difficult-to-control hypertension is assessed and managed. Through interactive tools such as patient-facing algorithms, AI chatbots and a program portal, this initiative aims to transform protocols to improve patient care. A personalized hypertension risk score that will build on existing risk scores for prevention to better identify difficult-to-control hypertension patients at risk for negative cardiovascular outcomes so appropriate treatment protocols can be implemented sooner. A prospective early patient experience initiative that will enroll patients from hypertension specialty centers to better understand the treatment obstacles for patients with difficult-to-control hypertension and how newer treatments, like Idorsia's TRYVIO, are impacting the treatment paradigm. Srishti Gupta, MD, CEO of Idorsia, commented: “We are proud to have pioneered the first treatment tackling a new pathway in hypertension in over three decades and as a leader in this area, we understand that our commitment to improving patient outcomes goes beyond the medicine. We are proud to collaborate with two of the world’s leading research institutions, on this exciting new program and believe IMPACT-HTN will help reimagine the pathways of care for hypertension patients who need additional options.” TRYVIO, a dual endothelin receptor antagonist (ERA) is now available to prescribe. It is indicated for the treatment of hypertension in combination with other antihypertensive drugs to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. TRYVIO is now included in the American College of Cardiology’s (ACC) and the American Heart Association’s (AHA) new comprehensive clinical practice guidelines for the management of high blood pressure, but many patients remain undiagnosed and undertreated. Important Safety InformationTRYVIO may cause serious side effects, including:TRYVIO can cause major birth defects if used by pregnant patients and has a BOXED Warning for embryo-fetal toxicity. People who can become pregnant must not be pregnant when they start taking TRYVIO or become pregnant during treatment with TRYVIO or for 1 month after stopping treatment with TRYVIO. People who can become pregnant should have a negative pregnancy test before starting treatment with TRYVIO, each month during treatment with TRYVIO, and 1 month after stopping TRYVIO. People who can become pregnant should use acceptable birth control before starting treatment with TRYVIO, during treatment with TRYVIO, and for 1 month after stopping TRYVIO because the medicine may still be in your body. If you are a person who can become pregnant, your healthcare provider will talk to you about pregnancy testing recommendations and the need to use acceptable birth control, the benefits and risks of TRYVIO, and the need to report suspected pregnancy right away to your healthcare provider. What is TRYVIO?TRYVIO is a prescription medicine used to treat high blood pressure (hypertension) in adults who are taking other high blood pressure medicines and whose blood pressure is not well controlled.Do not take TRYVIO if you are pregnant or currently trying to become pregnant. allergic to aprocitentan or any of the ingredients in TRYVIO. Before taking TRYVIO, tell your healthcare provider about all of your medical conditions, including if you: have liver problems have heart failure have anemia have kidney problems or get dialysis are pregnant or plan to become pregnant during treatment with TRYVIO. TRYVIO can cause serious birth defects. are breastfeeding or plan to breastfeed. It is not known if TRYVIO passes into your breastmilk. Do not breastfeed if you take TRYVIO. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.TRYVIO may cause other serious side effects, including: Liver problems. TRYVIO may cause liver problems. Your healthcare provider should do blood tests to check your liver before starting treatment and as needed during treatment with TRYVIO. Tell your healthcare provider if you have any of the following symptoms of liver problems during treatment with TRYVIO: nausea or vomiting yellowing of your skin or whites of your eyes pain in the upper right stomach dark urine tiredness fever loss of appetite itching Fluid retention. Fluid retention and swelling are common during treatment with TRYVIO and can be serious. Tell your healthcare provider right away if you have any unusual weight gain, trouble breathing, or swelling of your ankles or legs. Your healthcare provider may treat you with other medicines (diuretics) if you develop fluid retention or swelling. Low red blood cell levels (anemia). Anemia is common during treatment with TRYVIO and can be serious. Your healthcare provider will do blood tests to check your red blood cells before starting and as needed during treatment with TRYVIO. Decreased sperm count. TRYVIO may cause decreased sperm counts in males and may affect the ability to father a child. Tell your healthcare provider if being able to have children is important to you. Your healthcare provider may stop treatment with TRYVIO if you develop certain side effects. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of TRYVIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.For more information see the Full Prescribing Information including BOXED Warning (PI and Medication Guide). Notes to the editor About aprocitentanAprocitentan is Idorsia’s once-daily, orally active, dual endothelin receptor antagonist, which inhibits the binding of ET-1 to ETA and ETB receptors. Aprocitentan is approved as TRYVIO® in the US for the treatment of systemic hypertension in combination with other antihypertensives and has been commercially available since October 2024. Aprocitentan is approved as JERAYGO® for the treatment of resistant hypertension in combination with other antihypertensives in the European Union and the UK and marketing authorization applications are under review in Canada, and Switzerland. About IdorsiaThe purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact:Investor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as “intend”, "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF Press Release PDF

Drug ApprovalAHA

100 Deals associated with Aprocitentan

External Link

KEGG	Wiki	ATC	Drug Bank
D11441	-	-	DB15059

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Resistant hypertension	European Union	IDORSIA LTD	01 Jul 2024
Resistant hypertension	Iceland	IDORSIA LTD	01 Jul 2024
Resistant hypertension	Liechtenstein	IDORSIA LTD	01 Jul 2024
Resistant hypertension	Norway	IDORSIA LTD	01 Jul 2024
Hypertension	United States	Idorsia Pharmaceuticals Ltd.	19 Mar 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	NDA/BLA	Canada	Idorsia Pharmaceuticals Ltd.	01 Jan 2025
Chronic Kidney Diseases	Phase 3	-	Idorsia Pharmaceuticals Ltd.	01 Jan 2020
Chronic Kidney Diseases	Phase 3	-	Janssen Biotech, Inc.	01 Jan 2020
Liver Cirrhosis	Phase 1	Germany	Idorsia Pharmaceuticals Ltd.	26 Jun 2020
Liver Cirrhosis	Phase 1	Poland	Idorsia Pharmaceuticals Ltd.	26 Jun 2020
Liver Injury	Phase 1	Germany	Idorsia Pharmaceuticals Ltd.	26 Jun 2020
Liver Injury	Phase 1	Poland	Idorsia Pharmaceuticals Ltd.	26 Jun 2020
Renal Insufficiency	Phase 1	Czechia	Idorsia Pharmaceuticals Ltd.	03 Jun 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03541174 (PRECISION, Pubmed \| Hypertension)	Phase 3	Hypotension	-	Aprocitentan 12.5 mg	lbpkaxicca(vdnldcmhcw) = mgbsmoguyx llsjoidtor (ovvgdqldbo )	Positive	01 Apr 2025
				Aprocitentan 25 mg	lbpkaxicca(vdnldcmhcw) = xidbdesthk llsjoidtor (ovvgdqldbo )
PRECISION (ESH2024)	Phase 3	Resistant hypertension	93	Aprocitentan 12.5 mg	zemonsmmql(olxzakylgs) = yxorxswyaq qqlokggqok (lkhxphdfpe ) View more	Positive	01 May 2024
				Aprocitentan 25 mg	zemonsmmql(olxzakylgs) = tscgmechkz qqlokggqok (lkhxphdfpe ) View more
PRECISION (ESH2024)	Phase 3	Resistant hypertension	-	Aprocitentan 12.5 mg	pseimttzvd(vlvrknvwmw) = nahgdkeols yaiafeueqs (qlfxgbxdep )	Positive	01 May 2024
				Aprocitentan 25 mg	pseimttzvd(vlvrknvwmw) = gmsltojymp yaiafeueqs (qlfxgbxdep ) View more
NCT03541174 (FDA) Manual	Phase 3	Hypertension	-	Aprocitentan (12.5 mg)	pflmiinzop(nibmkrateo) = bzrtyweafb mlqrfgfpvy (gjlsxehujx, −17.5 - −13.3) View more	Superior	19 Mar 2024
				Placebo	pflmiinzop(nibmkrateo) = jbrokzihww mlqrfgfpvy (gjlsxehujx, −13.7 - −9.5) View more
PRECISION (ESH2023)	Phase 3	Resistant hypertension	730	Aprocitentan 12.5 mg	auslpymoky(kezgnyjaxl) = xtbwtamews rmazcmnhbl (qxkcdfafjc )	Positive	01 Jun 2023
				Aprocitentan 25 mg	auslpymoky(kezgnyjaxl) = rfrkhdkxtt rmazcmnhbl (qxkcdfafjc )
NCT03541174 (PRECISION, CTgov)	Phase 3	Resistant hypertension	730	Aprocitentan 12.5 mg (Aprocitentan 12.5 mg in Part 1 (Double-blind))	ekcqxyzncx(lksikjdncj) = cmsuqwxkaj muotznuckl (aoaiiyoleq, vtvealrixw - xkjvpldvck) View more	-	21 Mar 2023
				Aprocitentan 25 mg (Aprocitentan 25 mg in Part 1 (Double-blind))	ekcqxyzncx(lksikjdncj) = suozlkekfy muotznuckl (aoaiiyoleq, revjrbrvcx - owlbwzzqvw) View more
NCT02603809 (CTgov)	Phase 2	Essential Hypertension	1,659	Placebo (Placebo)	scpsbardcw(ujdztcuaew) = wxjrburdbk msgiawwcjp (mobnizosjm, 5.4) View more	-	13 Apr 2020
				Aprocitentan 5 mg (Aprocitentan 5 mg)	scpsbardcw(ujdztcuaew) = pjirsdhlcr msgiawwcjp (mobnizosjm, 5.5) View more
NCT02603809 (ESC2019)	Phase 2	Hypertension	490	Aprocitentan 5 mg	coudvxstyd(mgnjdyxxdx) = nipgovbjwl bsrmnlachg (coccocdiri ) View more	-	31 Aug 2019
				Aprocitentan 10 mg	coudvxstyd(mgnjdyxxdx) = zuyajwrlqq bsrmnlachg (coccocdiri ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis