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Last update 25 Jun 2026

Budesonide

Last update 25 Jun 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryBudesonide, a small molecule drug with a strong ability to bind to the glucocorticoid receptor (GR) as an agonist, was approved as early as 1981 and has been on the market for more than 40 years. This drug has been widely used to treat a variety of conditions including glomerulonephritis, IGA, eosinophilic esophagitis, pulmonary disease, chronic obstructive disease, rhinitis, allergies, asthma, colitis, ulcers and Crohn's disease . Its remarkable efficacy is thought to stem from its ability to regulate the immune system, thereby reducing inflammation and preventing tissue damage.

Drug Type

Small molecule drug

Synonyms

Budenofalk Granules, Budesolv, Budesonide gastro-resistant granules

+ [74]

Target

Action

agonists

Mechanism

GR agonists(Glucocorticoid receptor agonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesDigestive System Disorders+ [6]

Active Indication

Glomerulonephritis, IGAEosinophilic EsophagitisColitis, Ulcerative+ [15]

Inactive Indication

Acute asthmaAcute Graft Versus Host DiseaseAnaphylaxis+ [18]

Originator Organization

AstraZeneca Pharmaceuticals Co. Ltd.

Active Organization

Zeria Pharmaceutical Co., Ltd.

STADA Arzneimittel AGEverest Medicines (Singapore) Pte Ltd.

+ [28]

Inactive Organization

Pearl Therapeutics, Inc.

Takeda Pharmaceutical Co., Ltd.Everstar Medicines (Shanghai) Limited

+ [7]

License Organization

Kissei Pharmaceutical Co., Ltd.Ferring Holding SA

Calliditas Therapeutics AB

+ [30]

Drug Highest PhaseApproved

First Approval Date-

RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (European Union), Conditional marketing approval (United Kingdom), Fast Track (South Korea), Accelerated Approval (Taiwan Province), Priority Review (United States), Breakthrough Therapy (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC25H34O6

InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N

CAS Registry51333-22-3

810

Clinical Trials associated with Budesonide

NCT05976802

/ Not yet recruitingPhase 4

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam BID for 2 Weeks, Followed by QD for 4 Weeks, in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis

The primary objective of this study is to evaluate the efficacy (as measured by induction of remission) of two dose levels (low and high) per age group (5 to <12 and 12 to ≤17 years) of budesonide rectal foam as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in pediatric subjects with active, mild to moderate distal ulcerative colitis (UC).

Start Date01 Jun 2027

Sponsor / Collaborator

Bausch Health Americas, Inc.

NCT06855043

/ Not yet recruitingPhase 1/2IIT

Pilot Randomized Controlled Trial of Late Surfactant Therapy With Budesonide for Prevention of Bronchopulmonary Dysplasia

This clinical trial is being done to evaluate the safety and clinical response of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age.

Start Date01 Sep 2026

Sponsor / Collaborator

University of Wisconsin-Madison

NCT07528820

/ Not yet recruitingNot ApplicableIIT

Investigating Sinonasal Inflammatory Profiles, Histopathological Features, and Remodeling Factors in Chronic Rhinosinusitis Patients With Nasal Polyposis

This study aims to examine three key aspects of chronic rhinosinusitis with nasal polyps (CRSwNP): inflammation, tissue structure (histopathology), and remodeling.

Start Date01 Jul 2026

Sponsor / Collaborator

St. Paul's Hospital

100 Clinical Results associated with Budesonide

100 Translational Medicine associated with Budesonide

100 Patents (Medical) associated with Budesonide

7,206

Literatures (Medical) associated with Budesonide

31 Dec 2026·RENAL FAILURE

The mediating effect role of methylmalonic acid on the association between oxidative balance score and diabetic kidney disease: a cross-sectional study from NHANES 2011–2014

Article

Author: Shen, Yan ; Ma, Lulu ; Huang, Huaxing ; Yao, Wubin ; Shen, Lianglan ; Yang, Hongli

Diabetic kidney disease (DKD) is a prevalent complication of diabetes. Methylmalonic acid (MMA) reflects mitochondrial dysfunction. Oxidative balance score (OBS) assesses the pro-oxidant/anti-oxidant propensity of lifestyle. This study explored the associations of OBS and MMA with the risk of DKD. In this cross-sectional study, diabetes patients aged ≥ 20 years were identified from National Health and Nutrition Examination Survey (NHANES) 2011-2014. Dialysis patients, those without serum and urine creatinine/albumin/education/serum vitamin B12/MMA/OBS data were excluded. The weighted logistic analysis evaluated the associations of OBS and MMA with the risk of DKD. Odds ratio (OR) and confidence interval were estimated. In total, 1618 patients were included. The percentage of participants with OBS <20 in the DKD group was higher than the non-DKD group (53.35% vs 44.98%). The percentage of patients with MMA ≥ 151 in the DKD group was higher than the non-DKD group (67.88% vs 42.36%). The risk of DKD was elevated in those with OBS <20 (OR = 1.42, 95% CI: 1.06-1.91). Elevated risk of DKD was observed in patients with MMA ≥ 151 (OR = 2.13, 95% CI: 1.45-3.14). The total effect of OBS on DKD was 1.42 (95% CI: 1.06-1.91). The direct effect of OBS on DKD was 1.38 (95% CI: 1.03-1.85). The percentage of excess risk mediated of MMA on the association between OBS and DKD was 9.52%. In conclusion, MMA potentially played a mediating role in the association between OBS and DKD. The findings may offer an insight for future screening and prevention of DKD.

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Indirect treatment comparison of DVRd plus DR maintenance (PERSEUS study) versus DVTd or VTd with or without lenalidomide maintenance in transplant-eligible patients with previously untreated multiple myeloma

Article

Author: Einsele, Hermann ; Facon, Thierry ; Nair, Sandhya ; Dimopoulos, Meletios A. ; He, Jianming ; Caillot, Denis ; Sonneveld, Pieter ; Zweegman, Sonja ; Ammann, Eric ; Spencer, Andrew ; Nobrega, Marjorie ; Broijl, Annemiek ; Perrot, Aurore ; Schjesvold, Fredrik ; Gay, Francesca ; Boccadoro, Mario ; Hajek, Roman ; Rodriguez-Otero, Paula ; Hulin, Cyrille ; Sitthi-Amorn, Anna ; Rowe, Melissa ; Leleu, Xavier ; Mina, Roberto

AIMS:

To compare the effectiveness of induction and consolidation with daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd) plus maintenance therapy with daratumumab and lenalidomide (DR) with 2 treatment regimens that are widely used for transplant-eligible newly diagnosed multiple myeloma (TE NDMM): bortezomib, thalidomide, and dexamethasone (VTd) or daratumumab-VTd (DVTd) followed by observation (Obs) or lenalidomide maintenance.

MATERIALS AND METHODS:

Individual patient-level data from the PERSEUS (NCT03710603) and CASSIOPEIA (NCT02541383) trials were used to compare DVRd + DR with VTd + Obs and with DVTd + Obs. Inverse probability of treatment weighting was used to adjust for differences in baseline patient characteristics between the two trials; inverse probability of censoring weighting was used to adjust for the second randomization of CASSIOPEIA. Data from the CASSIOPEIA and Myeloma XI (EudraCT 2009-010956-93) trials were combined to model outcomes associated with lenalidomide (R) maintenance following induction with DVTd or VTd.

RESULTS:

DVRd + DR showed superior progression-free survival compared with DVTd + Obs (hazard ratio, 0.39 [95% CI = 0.26-0.59]), VTd + Obs (0.17 [95% CI = 0.12-0.25]), DVTd + R (0.62 [95% CI = 0.41-0.92]), and VTd + R (0.29 [95% CI = 0.18-0.43]). Sensitivity analyses showed results were consistent with the base case.

LIMITATIONS:

The indirect treatment comparison was unanchored due to a lack of common comparators and relied on external data from the Myeloma XI trial to model outcomes associated with DVTd or VTd followed by R maintenance. Despite best efforts to identify and adjust for important treatment effect modifiers, there is a potential for residual confounding.

CONCLUSIONS:

Findings from this study suggest that DVRd followed by DR maintenance offers superior survival outcomes compared with current standards of care in TE patients with NDMM.

01 Sep 2026·COLLOIDS AND SURFACES B-BIOINTERFACES

Cellulose nanocrystal stabilised Pickering emulgels for sustained colonic delivery of budesonide

Article

Author: Abdillah Akbar, Bambang V E B ; da Silva, Marcelo ; Dreiss, Cécile A ; Vllasaliu, Driton ; Akapan, Pornpilat ; Alhnan, Mohamed A

Inflammatory Bowel Disease (IBD) is a chronic gastrointestinal condition that could benefit from targeted drug delivery strategies to minimise systemic side effects. Conventional therapies often lack site specificity, limiting their effectiveness. Here, emulgels stabilised by cellulose nanocrystals (CNC) and reinforced with α-cyclodextrin/polyethylene glycol (α-CD/PEG) supramolecular gels were explored as a novel platform for the local delivery of budesonide to the gastrointestinal tract. CNC-stabilised Pickering emulsions (40-70% v/v oil, 0.5-2 mg·mL⁻¹ CNC) were characterised for droplet size, zeta potential, stability, and rheology. Emulgels were obtained by incorporating α-CD (6-10% w/v) and PEG (5-10% w/v, 10 and 20 kg/mol) in the aqueous phase. These systems were assessed for long-term stability, rheological properties, drug release, mucoadhesion, cytocompatibility, and drug permeability in Caco-2 cell monolayers. Emulsions showed enhanced stability with increasing CNC concentration and oil fraction. Incorporating a gel phase of α-CD/PEG markedly increased the storage modulus, G' up to 1.53 × 10⁵ Pa without phase separation over 30 days. The emulgels shear-thinned and quickly recovered after release of the strain, equally after injection through a synringe, and displayed mucoadhesiveness to porcine intestinal tissue. Budesonide was efficiently loaded (86-98%) and released in a sustained manner over 72 h. Permeation studies confirmed epithelial drug transport, which was reduced compared to solution, consistent with controlled release. The emulgels did not compromise epithelial barrier integrity and were non-toxic to Caco-2 cells. Overall, CNC-stabilised α-CD/PEG emulgels demonstrate high stability, biocompatibility, and tunable release, making them promising candidates for localised IBD therapy.

441

News (Medical) associated with Budesonide

17 Jun 2026

·www.globenewswire.com

Cosmos Health Signs 2.86 Million-Unit Contract Manufacturing Agreement With Pharmex S.A. Across Three Dermatological Products

CHICAGO, June 17, 2026 (GLOBE NEWSWIRE) -- Cosmos Health Inc. ("Cosmos Health" or the “Company”) (NASDAQ:COSM), a diversified, vertically integrated global healthcare group, today announced that, through its wholly owned subsidiary Cana Laboratories S.A. ("Cana"), it has entered into a five-year contract manufacturing agreement with Pharmex S.A. ("Pharmex") to produce three pharmaceutical products. Under the agreement, Cana will manufacture the following products for Pharmex at its EU-GMP-licensed, EMA-certified facility, with combined volumes of approximately 2.86 million units over the five-year term. ProductActive IngredientPharmaceutical FormAnnual UnitsFive-Year TotalBETAFUSIN®Betamethasone, Fusidic AcidCream450,0002,250,000BOTAFEX®MinoxidilCutaneous Solution65,000325,000BUDESODERM®BudesonideCream / Cutaneous Solution57,000285,000Total 572,0002,860,000 The agreement reinforces Cosmos Health's role as a contract manufacturer of pharmaceutical products and supports higher utilization of its EU manufacturing capacity. By leveraging Cana's licensed production capabilities, the Company aims to deepen its long-term manufacturing partnerships and strengthen recurring revenue from its higher-margin contract manufacturing activities. Founded in 1981, Pharmex is a Greek pharmaceutical company with over 40 years in medicinal products and dermocosmetics. It develops and produces its own products and serves as the exclusive local distributor for international partners. Pharmex products are available in more than 20 countries across Europe, the Middle East, Asia, Africa and Latin America. Greg Siokas, CEO of Cosmos Health, stated: "This five-year agreement with Pharmex reflects the strength of our manufacturing platform and the trust that pharmaceutical partners place in Cana Laboratories. Contract manufacturing is an important pillar of our vertically integrated model, allowing us to maximize the value of our EU-licensed facilities while building stable, long-term relationships. We look forward to delivering for Pharmex and to expanding these partnerships over time.” About Cosmos Health Inc. Cosmos Health Inc. (Nasdaq:COSM), incorporated in 2009 in Nevada, is a diversified, vertically integrated global healthcare group. The Company owns a portfolio of proprietary pharmaceutical and nutraceutical brands, including Sky Premium Life®, Mediterranation®, bio-bebe®, C-Sept® and C-Scrub®. Through its subsidiary Cana Laboratories S.A., licensed under European Good Manufacturing Practices (GMP) and certified by the European Medicines Agency (EMA), it manufactures pharmaceuticals, food supplements, cosmetics, biocides, and medical devices within the European Union. Cosmos Health also distributes a broad line of pharmaceuticals and parapharmaceuticals, including branded generics and OTC medications, to retail pharmacies and wholesale distributors through its subsidiaries in Greece and the UK. Furthermore, the Company has established R&D partnerships targeting major health disorders such as obesity, diabetes, and cancer, enhanced by artificial intelligence drug repurposing technologies, and focuses on the R&D of novel patented nutraceuticals, specialized root extracts, proprietary complex generics, and innovative OTC products. Cosmos Health has also entered the telehealth space through the acquisition of ZipDoctor, Inc., based in Texas, USA. With a global distribution platform, the Company is currently expanding throughout Europe, Asia, and North America, and has offices and distribution centers in Thessaloniki and Athens, Greece, and in Harlow, UK. More information is available at www.cosmoshealthinc.com, www.skypremiumlife.com, www.cana.gr, www.zipdoctor.co, www.cloudscreen.gr, as well as LinkedIn and X. Forward-Looking StatementsWith the exception of the historical information contained in this news release, the matters described herein may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Words such as “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans,” and similar expressions, or future or conditional verbs such as “will,” “should,” “would,” “may,” and “could,” generally identify forward-looking statements, although not all forward-looking statements contain these words. These statements involve risks and uncertainties that may individually or materially affect the matters discussed herein for a variety of reasons outside the Company’s control, including, but not limited to: the Company’s ability to raise sufficient financing to implement its business plan; the effectiveness of its digital asset strategies, including accumulation and yield-generating activities; the impact of the war in Ukraine and ongoing conflicts in the Middle East and other regions on the Company’s business, operations, and the economy in general; the Company’s ability to successfully develop and commercialize its proprietary products and technologies; changes in interest rates; changes in foreign currency exchange rates, commodity or other price inflation and deflation; our ability to issue debt on terms and at rates acceptable to us; the impact and expected outcome of investigations, inquiries, claims, and litigation; the challenges of operating in international markets; the adequacy of insurance coverage; the effect of accounting charges and of adopting certain accounting standards; the impact of legal and regulatory changes, including changes to tax laws and regulations; guidance for fiscal 2026 and beyond and financial outlook. Forward-looking statements are based on currently available information and our current assumptions, expectations and projections about future events. You should not rely on our forward-looking statements. These statements are not guarantees of future performance and are subject to future events, risks and uncertainties – many of which are beyond our control, dependent on the actions of third parties, or currently unknown to us – as well as potentially inaccurate assumptions that could cause actual results to differ materially from our historical experience and our expectations and projections. These risks and uncertainties include, but are not limited to, those described from time to time in our periodic reports filed with the SEC and available at the SEC’s website (www.sec.gov). There also may be other factors that we cannot anticipate or that are not described herein, generally because we do not currently perceive them to be material. Such factors could cause results to differ materially from our expectations. Forward-looking statements speak only as of the date they are made, and we do not undertake to update these statements other than as required by law. You are advised, however, to review any further disclosures we make on related subjects in our filings with the Securities and Exchange Commission and in our other public statements. Investor Relations Contact:BDG Communicationscosm@bdgcommunications.com

Acquisition

08 Jun 2026

·www.biospace.com

Lyell Immunopharma Provides Update on Safety Profile of LYL273 in Relapsed or Refractory Metastatic Colorectal Cancer and Amends Phase 1 Trial to Phase 1/2 Expansion

Gastrointestinal prophylaxis reduced Grade ≥ 2 diarrhea/colitis from 55% without prophylaxis to 10% with prophylaxis The maximum tolerated dose has not yet been determined No difference is observed in GCC CAR T-cell expansion kinetics in patients with or without GI prophylaxis Ongoing U.S. Phase 1 trial amended to enable seamless expansion into a potential pivotal single-arm Phase 2 trial pending regulatory alignment Amendment of ongoing U.S. Phase 1 trial adds new cohorts, including a second-line cohort and a cohort evaluating a combination strategy with radiotherapy Additional Phase 1 clinical data, including clinical outcomes, and End-of-Phase 1 FDA meeting expected in second half of 2026 SOUTH SAN FRANCISCO, Calif., June 08, 2026 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today provided an update on the safety pro LYL273 in its ongoing U.S. Phase 1 clinical trial in patients with relapsed or refractory metastatic colorectal cancer (mCRC), and announced the Phase 1 trial has been amended to enable seamless expansion into a potential pivotal single-arm Phase 2 trial pending regulatory alignment. LYL273 is a guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile solid tumor microenvironment. A 50% overall response rate across Dose Levels 1 and 2 has been previously reported (data cutoff date of October 28, 2025) in third- or later-line (3L+) relapsed or refractory mCRC patients in the U.S. Phase 1 clinical trial. The FDA has granted LYL273 Fast Track designation for the treatment of mCRC. “The substantial reduction of Grade 2 or higher diarrhea or colitis, and absence of Grade 3 or higher CRS and ICANS in patients treated under our gastrointestinal prophylaxis and standardized safety management plan suggest we can manage the safety pro LYL273 in patients with relapsed or refractory metastatic colorectal cancer,” said Lynn Seely, M.D., President and Chief Executive Officer of Lyell. “We are continuing to move forward to selection of the recommended Phase 2 dose and are on track for an End-of-Phase 1 meeting with the FDA by the end of the year.” Updated Safety Data from U.S. Phase 1 Clinical Trial Evaluating LYL273 in Patients with Relapsed or Refractory Third- or Later-Line mCRC Nineteen patients have been enrolled in the U.S. Phase 1 clinical trial across Dose Levels 1 and 2 (1 and 2 x 10 6 CAR+ cells/kg) as of the data cutoff date of May 5, 2026. Ten of these patients were enrolled under the new gastrointestinal (GI) prophylaxis regimen including infliximab, vedolizumab and budesonide, along with a standardized safety management plan. Notably, the GI prophylaxis and standardized safety management plan reduced Grade > 2 diarrhea or colitis from 55% to 10% in patients without (N = 9) and with (N = 10) GI prophylaxis, respectively. These ten patients did not experience Grade ≥ 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). No additional adverse events of interest have been identified. There was no difference observed in GCC-CAR+ cell expansion either in terms of maximum cell expansion or area under the curve in those patients who received GI prophylaxis and those who did not. Dose escalation continues in the U.S. Phase 1 clinical trial; the maximum tolerated dose has not been determined. Phase 1 Clinical Trial Amended to Phase 1/2 Design The U.S. Phase 1 clinical trial evaluating LYL273 in relapsed or refractory 3L+ mCRC has been amended to a Phase 1/2 design (CARABINER). The amended design enables seamless expansion into a potential pivotal single-arm Phase 2 trial once the recommended Phase 2 dose has been determined, subject to discussions with the U.S. Food and Drug Administration (FDA). New centers are being added to the trial in preparation for initiating the dose expansion portion of the Phase 1/2 trial. The Phase 1 portion of the clinical trial includes four dose-escalation cohorts at Dose Levels 1 through 4 (1, 2, 3, 4 x 10 6 CAR+ cells/kg). Each dose-escalation cohort is designed to include three or six patients, with up to twenty-four patients across the four dose-escalation cohorts. In addition to the existing 3L+ cohorts, the amendment adds new cohorts, including a second-line cohort and a cohort evaluating a combination strategy with radiotherapy. Up to sixty patients are expected to be enrolled across the new cohorts. The Phase 2 portion will expand enrollment at the recommended Phase 2 dose in an open-label, single-arm cohort. Upcoming LYL273 Milestones In the second half of 2026, additional Phase 1 clinical data, including clinical outcomes, and an End-of-Phase 1 meeting with the FDA are expected. About Lyell Immunopharma, Inc. Lyell is a late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies for patients with hematologic malignancies and solid tumors. To realize the potential of cell therapy for cancer, Lyell utilizes a suite of technologies to arm CAR T cells with enhancements needed to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical responses, including the ability to resist exhaustion, maintain qualities of durable stemness and function in the hostile tumor microenvironment. LyFE has commercial launch capability and is expected to have the capacity to manufacture more than 1,200 CAR T-cell doses per year. To learn more, please visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: Lyell’s intention for the amended ongoing U.S. Phase 1 trial to enable seamless expansion into a potential pivotal single-arm Phase 2 trial pending regulatory alignment; the potential clinical benefits and therapeutic potential of Lyell’s product candidates; Lyell’s expected timing for an End-of-Phase 1 meeting with the FDA and for reporting additional Phase 1 data, including clinical outcomes; the number of patients expected to be enrolled across the new cohorts of the amended ongoing U.S. Phase 1 trial; and the sufficiency of the capacity of LyFE to manufacture drug supply through potential commercial launch. These statements are based on Lyell’s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: Lyell’s ability to successfully develop, manufacture and commercialize product candidates or its experiencing significant delays in doing so; Lyell’s dependence on the enrollment and retention of patients in its current and planned clinical trials for its product candidates; the potential for results of Lyell’s research, nonclinical studies or earlier clinical trials to not be predictive of future results; clinical development involving a lengthy and expensive process with uncertain outcomes; Lyell’s product candidates and technologies being based on novel technologies that are unproven and may not result in approvable or marketable products; significant adverse events, toxicities or other undesirable side effects associated with Lyell’s product candidates; Lyell facing substantial competition in a rapidly changing industry, which may result in others discovering, developing or commercializing products before or more successfully than it does; the complexity of manufacturing cellular therapies; Lyell’s ability to manufacture drug products for its clinical trials itself and any potential delays in further qualifying or in receiving regulatory approvals for any manufacturing facility or product candidates or in expanding its manufacturing capacity; Lyell’s reliance on third parties; implementation of Lyell’s strategic plans for its business and product candidates and Lyell’s realization of the expected benefits of such plans; RMAT and Fast Track designations may not actually lead to faster development, regulatory review or approval process, and do not assure ultimate FDA approval; the sufficiency of Lyell’s capital resources and need for additional capital to achieve its goals; and other risks, including those described under the heading “Risk Factors” in Lyell’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the Securities and Exchange Commission on May 6, 2026. Forward-looking statements contained in this press release are made as of this date, and Lyell undertakes no duty to update such information except as required under applicable law. Contact: Pablo Fenton Associate Director, Investor Relations and Corporate Communications pfenton@lyell.com

Phase 1ImmunotherapyFast TrackCell TherapyClinical Result

29 May 2026

·www.everestmedicines.com

23 Abstracts on NEFECON® to Be Presented at the 63rd ERA Congress

Shanghai, China – May 29, 2026 – Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that 23 abstracts on NEFECON® (budesonide delayed-release capsules) have been accepted for presentation at the 63rd European Renal Association (ERA) Congress, including 11 oral presentations and 12 e-posters. The congress will take place in Glasgow, United Kingdom, from June 3 to 6, 2026. The newly released results from 21 real-world studies conducted in China further validate the efficacy and safety of NEFECON® in clinical practice and reinforce its position as a cornerstone of first-line treatment for patients with IgA nephropathy. Oral Presentation 01 Title：Real-World Impact of Nefecon Combined with Other lmmunosuppressants in Chinese IgAN Patients Main Author and Institution：Ying Fan, Shuling Chen，Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiaotong University School of Medicine Time：June 4, 2026，09:39-09:45 BST Location：Focussed Oral Room 5 02 Title：A Real-World Study of Efficacy and Safety of Nefecon in IgA Nephropathy Patients with Different Renal Function Stratifications Main Author and Institution：Ying Yang，The Second Hospital of Shanxi Medical University Time：June 4, 2026，11:33-11:39 BST Location：Focussed Oral Room 2 03 Title：Nefecon as Add-On Therapy in Refractory IgA Nephropathy: A Real-World Case Series Main Author and Institution：Sha Chen, Tianjin Hospital Time：June 4, 2026，16:06-16:12 BST Location：Focussed Oral Room 2 04 Title：Differential Renal Response to Nefecon in IgA Nephropathy: A Retrospective Study Stratified by Baseline eGFR Main Author and Institution：Fanna Liu，The First Affiliated Hospital of Jinan University Time：June 4, 2026，16:54-17:00 BST Location：Focussed Oral Room 3 05 Title：Real-World Analysis of Efficacy and Safety of Nefecon Combined with Low Dose Corticosteroids in High-Risk Progressive IgA Nephropathy Main Author and Institution：Xiaoling Zhou，General Hospital of Ningxia Medical University Time：June 4, 2026，17:21-17:27 BST Location：Focussed Oral Room 7 06 Title：Real-World Study on Efficacy and Safety of Nefecon in IgA Nephropathy Main Author and Institution：Xin Wei，Honghui Zeng，The First Affiliated Hospital of Nanchang University Time：June 4, 2026，09:21-09:27 BST Location：Focussed Oral Room 3 07 Title：Budesonide Combined with Mycophenolate Mofetil Enhances Response Rates in IgA Nephropathy: A Real-World Study Main Author and Institution：Xue Jiang, Hangzhou Traditional Chinese Medicine Hospital Time：June 4, 2026，09:21-09:27 BST Location：Focussed Oral Room 5 08 Title：Podocyte Hypertrophy Predicts Treatment Response to Targeted-Release Budesonide ± Tacrolimus in IgA Nephropathy: A Real-World Retrospective Study Main Author and Institution：Guiqing Tian，Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Time：June 4, 2026，16:06-16:12 BST Location：Focussed Oral Room 3 09 Title：A 15-Month Nefecon Therapy in IgA Nephropathy: A Propensity Score-Matched Study Main Author and Institution：Xiu Yang，The First People's Hospital of Hangzhou Time：June 4, 2026，11:21-11:27 BST Location：Focussed Oral Room 5 10 Title：NefIgArd: Efficacy of Nefecon in Immunoglobulin A Nephropathy Patients With a Baseline Urine Protein-Creatinine Ratio of 0.5 to 1g/gram Main Author and Institution：Jonathan Barratt，University of Leicester Time：June 4, 2026，11:27-11:39 BST Location：Lomond Auditorium 11 Title：NefIgArd: Assessment of Kidney Function With Nefecon Versus Placebo in Patients With Proteinuria or Hematuria Non-Response Main Author and Institution：Richard Lafayette，Stanford University Time：June 4, 2026，11:57-12:09 BST Location：Lomond Auditorium E-Poster 01 Title：Efficacy and Safety of Oral Budesonide Targeted-Release Formulation Combined with Ambrisentan in the Treatment of IgA Nephropathy Main Author and Institution：Weixia Sun，the First Hospital of Jilin University Changchun Location：Research Zone 02 Title：Real-World Study on the Efficacy and Safety of Combination Therapy of Nefecon and Hydroxychloroquine in the Treatment of IgA Nephropathy Main Author and Institution：Xin Wei，The First Affiliated Hospital of Nanchang University Location：Research Zone 03 Title：Efficacy and Safety of Nefecon Combined with Mycophenolate Mofetil in the Treatment of IgA Nephropathy: Real-World Data Main Author and Institution：Xin Wei，The First Affiliated Hospital of Nanchang University Location：Research Zone 04 Title：More treatment options: Real-world efficacy and safety of Nefecon with or without immunosuppression in patients with IgA nephropathy Main Author and Institution：Jing Li，The First Affiliated Hospital of Xinjiang Medical University Location：Research Zone 05 Title：Effectiveness and Safety of Nefecon Beyond Pivotal Trial Populations in IgA Nephropathy: 6-Month Real-World Main Author and Institution：Xingyang Zhao，Tongji Hospital, Huazhong University of Science and Technology Location：Research Zone 06 Title：Comparative Efficacy of Budesonide Enteric-Coated Capsules (Nefecon) in the Management of IgA Nephropathy Stratified by Baseline Proteinuria Levels Main Author and Institution：Jia Lv，The First Affliated Hospital of Xi’an Jiaotong University Location：Research Zone 07 Title：Efficacy of Nefecon in IgA Nephropathy Patients with 24-Hour Urine Protein Excretion of 0.5–1.0 g: A 9-Month Retrospective Study Main Author and Institution：Jun Cheng, The First Affiliated Hospital of Zhejiang University School of Medicine Location：Research Zone 08 Title：Real-World Data on Early Treatment of IgA Nephropathy Patients with Baseline Proteinuria of 0.5-1g/d Using Nefecon for 9 Months Main Author and Institution：Jing Li, First Affiliated Hospital of Xinjiang Medical University Location：Research Zone 09 Title：Impact of Early Diagnosis and Treatment on the Efficacy of Nefecon in Patients with IgA Nephropathy: A Single-Center Follow-Up Study Main Author and Institution：Yi Ren，Longhua Hospital Affiliated to Southern University of Science and Technology Location：Research Zone 10 Title：Early Initiation of Targeted-Release Budesonide in IgA Nephropathy: A Multi-Center Prospective Study Design and Baseline Characteristics Main Author and Institution：Yunlin Feng, Sichuan Provincial People’s Hospital Location：Research Zone 11 Title：Early Initiation of targeted-release budesonide in primary IgA nephropathy: a multicenter prospective study's baseline and interim analysis Main Author and Institution：Yunlin Feng, Sichuan Provincial People’s Hospital Location：Research Zone 12 Title：Beyond Twelve Months: Real-World Efficacy and Safety of Nefecon in Patients With Newly Diagnosed IgA Nephropathy Main Author and Institution：Wenjing Zhang，The First Affiliated Hospital of Xi’an Jiao Tong University Location：Research Zone About NEFECON® NEFECON® is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. NEFECON® was designed as a 4 mg delayed release capsule and is enteric coated so that it would remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer’s patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-IgA1) causing IgA nephropathy. NEFECON® was approved in November 2023 through National Medical Products Administration (NMPA)’s priority review for the treatment of primary IgA nephropathy in adults at risk of disease progression. It was subsequently included in the National Reimbursement Drug List in November 2024, and received full approval from the NMPA in April 2025, irrespective of proteinuria levels, benefiting most individuals living with IgA nephropathy. It has been approved across all Everest Medicines’ territories, including mainland China, Hong Kong SAR, Macau SAR, Taiwan region, China, as well as Singapore and South Korea. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative pharmaceutical products that address critical unmet medical needs for patients in global markets. The management team of Everest Medicines has deep expertise and an extensive track record both in China and with leading global pharmaceutical companies. he Company’s therapeutic areas of focus include CKM (cardiovascular, kidney, and metabolic), autoimmune, ophthalmology and critical care. Everest Medicines has developed a fully integrated commercialization platform that combines omnichannel commercial capabilities with end-to-end product lifecycle management. Leveraging its proprietary mRNA platform, the Company is advancing its existing pipeline, including mRNA in vivo CAR-T and mRNA cancer vaccines, while selectively expanding into additional high-value therapeutic areas with blockbuster potential, and accelerating its global expansion. For more information, please visit the Company’s website: www.everestmedicines.com. Forward-Looking Statements This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. References 1.Lafayette R,et al. Lancet. 2023 Sep 9;402(10405):859-870. 2. Zhang H, et al. Kidney360. 2024 Dec 1;5(12):1881-1892. 3.Jonathan Barratt,et al. 2023 ASN. Poster no. SA-PO886. 4.Edsbäcker S,et al. Aliment Pharmacol Ther. 1999 Feb;13(2):219-24.

Drug ApprovalClinical Study

100 Deals associated with Budesonide

External Link

KEGG	Wiki	ATC	Drug Bank
D00246	Budesonide	A07EA06 D07AC09 R01AD05	DB01222

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Glomerulonephritis, IGA	United States	Calliditas Therapeutics AB	15 Dec 2021
Eosinophilic Esophagitis	European Union	Dr. Falk Pharma GmbH	08 Jan 2018
Eosinophilic Esophagitis	Iceland	Dr. Falk Pharma GmbH	08 Jan 2018
Eosinophilic Esophagitis	Liechtenstein	Dr. Falk Pharma GmbH	08 Jan 2018
Eosinophilic Esophagitis	Norway	Dr. Falk Pharma GmbH	08 Jan 2018
Colitis, Ulcerative	United States	Salix Pharmaceuticals, Inc.	14 Jan 2013
Crohn Disease	United States	Padagis US LLC	02 Oct 2001
Perennial allergic rhinitis with seasonal variation	United States	Johnson & Johnson de Colombia SA	01 Oct 1999
Asthma	South Korea	AstraZeneca Korea Co. Ltd.	17 Dec 1993

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Conjunctivitis, Allergic	Phase 3	Austria	Marinomed Biotech AG	19 Nov 2018
Kidney Failure, Chronic	Phase 3	United States	Everstar Medicines (Shanghai) Limited	05 Sep 2018
Kidney Failure, Chronic	Phase 3	United States	Calliditas Therapeutics AB	05 Sep 2018
Kidney Failure, Chronic	Phase 3	Argentina	Calliditas Therapeutics AB	05 Sep 2018
Kidney Failure, Chronic	Phase 3	Argentina	Everstar Medicines (Shanghai) Limited	05 Sep 2018
Kidney Failure, Chronic	Phase 3	Australia	Calliditas Therapeutics AB	05 Sep 2018
Kidney Failure, Chronic	Phase 3	Australia	Everstar Medicines (Shanghai) Limited	05 Sep 2018
Kidney Failure, Chronic	Phase 3	Belarus	Everstar Medicines (Shanghai) Limited	05 Sep 2018
Kidney Failure, Chronic	Phase 3	Belarus	Calliditas Therapeutics AB	05 Sep 2018
Kidney Failure, Chronic	Phase 3	Belgium	Calliditas Therapeutics AB	05 Sep 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05202262 (VATHOS, CTgov)	Phase 3	Asthma	645	BFF MDI 160/9.6 μg (BFF MDI 160/9.6 μg)	takrsdxhij(vtyvnwdlsb) = iuznmmrslj eyhnypmpyx (bisqfytawl, 0.0300) View more	-	28 Jan 2026
				BFF MDI 320/9.6 μg (BFF MDI 320/9.6 μg)	takrsdxhij(vtyvnwdlsb) = nenweqvvpq eyhnypmpyx (bisqfytawl, 0.0219) View more
NCT03952286 (EDSAMS, CTgov)	Phase 4	Childhood asthma	13	budesonide+prednisolone+albuterol sulfate (ED-Dispensing With Home and School Supervision)	lxzvnjwfgi = bzgvcjugjd oaqaxvrwgq (xoxiovmjaf, daczreikye - gmkuueanml) View more	-	19 Nov 2025
				budesonide+prednisolone+albuterol sulfate (ED-Dispensing With Home Supervision)	lxzvnjwfgi = dikkjzjknj oaqaxvrwgq (xoxiovmjaf, gfknwjitoh - damovordmf) View more
NCT04545866 (BiB, CTgov)	Phase 3	Bronchopulmonary Dysplasia \| Respiratory Distress Syndrome \| Obstetric Labor, Premature	642	poractant alfa+Curosurf+Budesonide (BUDE)	yvpewcrqua = yipfzkgecu bhtlywakao (jbmmaoonfi, yxouqdosux - vohjmpykra) View more	-	10 Nov 2025
				Curosurf (SURF)	yvpewcrqua = afiyrwmlkm bhtlywakao (jbmmaoonfi, hyggltejms - rfyruvkabw) View more
NCT02493335 (Pubmed \| Clin Gastroenterol Hepatol)	Phase 3	Eosinophilic Esophagitis Maintenance	186	Budesonide Orodispersible Tablets 0.5 mg	wxwflglyuz(ngejceqrpz) = occurred at similar rates to prior BOT studies, and was predominantly mild and resolved with treatment ypidoetrsk (jfveblwrvz )	Positive	01 Nov 2025
				Budesonide Orodispersible Tablets 1.0 mg
NCT03245840 (SHP621-303, Pubmed \| Clin Gastroenterol Hepatol)	Phase 3	Eosinophilic Esophagitis	131	Budesonide Oral Suspension 2.0 mg twice daily	oaqsvranlv(limevtungw) = 3.1% (4/131) iwqjpzzowg (bcoibkhiaw ) View more	Positive	01 Nov 2025
				Placebo-Budesonide Oral Suspension 2.0 mg twice daily
NCT04545866 (Pubmed \| JAMA)	Phase 3	Bronchopulmonary Dysplasia	641	Budesonide + Surfactant	ldsarkmopp(gjbqrdolwa) = okzxgwkelo slzintqety (yqivgtzzjb ) View more	Negative	28 Oct 2025
				Surfactant alone	ldsarkmopp(gjbqrdolwa) = esnraaemik slzintqety (yqivgtzzjb ) View more
NCT01738035 (NefIgArd \| NEFIGAN, Company_Website) Manual	Phase 3	Glomerulonephritis, IGA	-	NEFECON	tvoapjbabv(hcjayemedc) = hzggsvpqez ngvqvaeoxg (waotffgzqo ) View more	Positive	04 Aug 2025
ERA2025	Not Applicable	Glomerulonephritis, IGA	918	Renin-angiotensin-aldosterone system inhibitors (RAASi)	qlfimibyfw(pbezjlnnqc) = xmaikonesc nyxjzlzzhp (cgwjodsqqp ) View more	Positive	04 Jun 2025
				Immunosuppressants (IS)	qlfimibyfw(pbezjlnnqc) = ybctwjtzvt nyxjzlzzhp (cgwjodsqqp )
NCT06712407 (NefXtend, ERA2025)	Phase 4	Glomerulonephritis, IGA	60	nefecon	boijluxdtb(nzeopskfpe) = uejetfjrsh ajpkirznby (cicwkkipkq ) View more	Positive	04 Jun 2025
IgANEF (ERA2025)	Not Applicable	Glomerulonephritis, IGA	55	Budesonide 9 mg (eGFR <35)	lyefhesmju(yjdhzgcjdx) = lcwtjfaopj hghcpikjgp (rretxgvkft, 38 - 68) View more	Positive	04 Jun 2025
				Budesonide 9 mg (UACR <800 mg/g creatinine)	lyefhesmju(yjdhzgcjdx) = wvooyigjuc hghcpikjgp (rretxgvkft, 36 - 61) View more

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