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Last update 23 Oct 2026

Leflunomide

Last update 23 Oct 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

5-Methyl-N-(4-(trifluoromethyl)phenyl)-4-isoxazolecarboxamide, 5-Methylisoxazole-4-carboxylic acid (4-trifluoromethyl)anilide, alpha,alpha,alpha-Trifluoro-5-methyl-4-isoxazolecarboxy-p-toluidide

+ [17]

Target

DHODH

Action

inhibitors

Mechanism

DHODH inhibitors(Dihydroorotate dehydrogenase inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesSkin and Musculoskeletal Diseases

Active Indication

Arthritis, PsoriaticRheumatoid Arthritis

Inactive Indication

Renal transplant rejectionSystemic Lupus ErythematosusViremia

Originator Organization

Sanofi

Active Organization

ratiopharm GmbH

Sanofi-Aventis Deutschland GmbH

Suzhou Changzheng Cinkate Pharmaceutical Co., Ltd.

+ [7]

Inactive Organization

SanofiTeva Pharmaceuticals Europe BVTeva Pharmaceuticals USA, Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (10 Sep 1998),

Rheumatoid Arthritis

Regulation-

Structure/Sequence

Molecular FormulaC12H9F3N2O2

InChIKeyVHOGYURTWQBHIL-UHFFFAOYSA-N

CAS Registry75706-12-6

159

Clinical Trials associated with Leflunomide

CTIS2026-525221-21-01

/ Not yet recruitingPhase 4IIT

Optimising Arthritis Strategies in Elderly patients (≥70 years) with rheumatoid arthritis in sustained low disease activity (the OASE study): A Prospective Target Trial Emulation Study Evaluating Tapering of Disease-Modifying Anti-Rheumatic Drugs vs. Usual Care Based on Patient Preference

Start Date01 Oct 2026

Sponsor / Collaborator

Aalborg University Hospital

TCTR20260317002

/ Not yet recruitingPhase 1

A Single Dose, Randomized, Open-label, One-period Parallel Bioequivalence Study of Generic Leflunomide 20 mg Film-coated Tablets and Reference Product (ARAVA 20 MG TABLET) in Healthy Thai Male Volunteers under Fasting Conditions

Start Date08 Jun 2026

Sponsor / Collaborator-

NCT07138898

/ RecruitingPhase 2IIT

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

The purpose of this study is to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.

Start Date12 Dec 2025

Sponsor / Collaborator

NYU Langone Health

100 Clinical Results associated with Leflunomide

100 Translational Medicine associated with Leflunomide

100 Patents (Medical) associated with Leflunomide

3,609

Literatures (Medical) associated with Leflunomide

31 Dec 2026·RENAL FAILURE

Regulatory effects of leflunomide on gut microecology during IgA nephropathy treatment

Article

Author: Jiang, Hong ; Ren, Pingping ; Chen, Jianghua ; Xu, Gaosi ; Zhao, Wenjun ; Lin, Xiaoli ; Wen, Xiaoli

Growing evidence suggests that the gut-kidney axis may contribute to the pathogenesis of IgA nephropathy (IgAN). However, the effects of immunosuppressants on the intestinal microbiome remain unclear. We investigated how different therapeutic strategies influence gut microbial composition in IgAN patients. We enrolled 46 patients with IgAN and 37 healthy controls (HC). Patients were stratified by treatment regimen into a supportive care group or an immunosuppressive therapy group, with subgroups defined by the use of leflunomide and systemic glucocorticoids. Fecal samples from patients in clinical remission were analyzed and 16S rRNA gene sequencing was performed. We examined microbial α- and β-diversity, taxonomic differences, and predicted functional pathways using Linear Discriminant Analysis Effect Size and Kyoto Encyclopedia of Genes and Genomes (KEGG)-based annotation. Compared with HCs, IgAN patients showed significantly reduced microbial α-diversity, depletion of beneficial taxa such as Faecalibacterium, and enrichment of potential pathogens, including Enterobacteriaceae. Neither supportive care and systemic glucocorticoid therapy were not associated with an apparent restoration of overall microbial diversity or community structure. Conversely, leflunomide treatment was associated with higher microbial diversity and a taxonomic profile that showed a trend toward similarity with healthy controls. Notably, anti-inflammatory bacteria, including Dysosmobacter welbionis, Ruthenibacterium lactatiformans, and Intestinimonas butyriciproducens were significantly enriched (all p < 0.01). KEGG-based predictions revealed downregulation of pro-inflammatory pathways, accompanied by reduced levels of inflammatory markers (p < 0.05). Overall, the therapeutic efficacy of leflunomide in IgA nephropathy is associated with specific characteristics of the patients' gut microbiota, which may be linked to its potential to reverse dysbiosis and enhance anti-inflammatory effects.

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

Progressive alopecia areata during TNF-α inhibition with intralesional corticosteroid failure and subsequent improvement following JAK1 inhibition

Article

Author: Nkala, Mandisi Brendon ; Niakosari, Firouzeh

OBJECTIVES:

To report a case of AA developing during golimumab and leflunomide treatment for seropositive rheumatoid arthritis, with subsequent improvement following initiation of selective Janus kinase 1 (JAK1) inhibition.

METHODS:

A 55-year-old woman developed progressive, non-scarring alopecia while rheumatoid arthritis disease activity remained well controlled. Clinical and trichoscopic findings were consistent with AA, and laboratory investigations were unremarkable. The patient received serial intralesional triamcinolone at approximately 4-8 week intervals over a 14-month period, with progression in Severity of Alopecia Tool (SALT) score from approximately 20 to 50. Alopecia developed and progressed despite ongoing TNF-α inhibitor therapy and serial intralesional corticosteroids. Upadacitinib was initiated for rheumatoid arthritis management and escalated from 15 mg to 30 mg.

RESULTS:

Hair regrowth was observed within six weeks, with SALT improving to approximately 15 by three months.

CONCLUSIONS:

Although spontaneous remission and delayed corticosteroid effects cannot be excluded, the timing and magnitude of improvement support a temporal association with JAK1 inhibition. This case highlights a pragmatic therapeutic consideration when alopecia arises during TNF-α inhibitor therapy.

13 Oct 2026·JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Rheumatoid Arthritis in Adults

Review

Author: Kerschbaumer, Andreas ; Smolen, Josef S. ; Robinson, William H. ; Aletaha, Daniel

Importance:

Rheumatoid arthritis (RA) is a chronic autoimmune disease that causes inflammation and destruction of cartilage and adjacent bone and can lead to irreversible disability. Rheumatoid arthritis affects 0.53% of adults worldwide and 0.74% of US adults.

Observations:

Rheumatoid arthritis is more common among females than males (2:1) and has a peak incidence at ages 55 to 75 years. Rheumatoid arthritis can affect all synovial joints, and extra-articular involvement may include rheumatoid nodules, vasculitis, and rheumatoid lung disease. At diagnosis, approximately 40% to 60% of patients have autoantibodies (eg, rheumatoid factor and/or anticitrullinated peptide antibodies). There are no formal diagnostic criteria for RA, so the diagnosis is based on clinical history, characteristic joint swelling in proximal interphalangeal, metacarpophalangeal, and/or wrist joints and often presence of autoantibodies and elevated C-reactive protein levels. Early diagnosis, ideally within 6 weeks of symptom onset, allows rapid initiation of therapy with disease-modifying antirheumatic drugs (DMARDs), which inhibit inflammation and decrease the risk of joint destruction. The goal of treatment is to achieve at least 50% improvement in disease activity by 3 months and remission or low disease activity at 6 months, measured by validated indexes such as the Clinical Disease Activity Index (CDAI). The European Alliance of Associations for Rheumatology recommends starting treatment with methotrexate, 7.5 mg to 10 mg orally weekly, increasing to 20 mg to 25 mg weekly within 4 to 8 weeks, and considering addition of short-term glucocorticoids (eg, prednisone, 5-7.5 mg/d), tapered and discontinued within 3 months, or 1 intramuscular injection of 80 mg to 160 mg depot methylprednisolone. For patients with contraindications to methotrexate, sulfasalazine (2-4 g/d) or leflunomide (20 mg/d) is recommended. With treatment, about 40% of patients with newly diagnosed RA achieve CDAI remission within 6 months. Patients who do not achieve remission with first-line DMARDs should be prescribed biological DMARDs (eg, tumor necrosis factor α inhibitors, costimulation inhibitors, interleukin 6 receptor inhibitors, anti-CD20–targeting B cells), or Janus kinase (JAK) inhibitors (in patients not at high risk of thromboembolism, cardiovascular disease, or malignancy). With addition of biological DMARDs or JAK inhibitors to first-line DMARDs, overall remission or low disease activity rates increase to approximately 80%.

Conclusions and Relevance:

Rheumatoid arthritis is a chronic autoimmune disease that causes joint destruction. First-line initial therapy is methotrexate, with consideration of glucocorticoids as additive therapy. For patients who do not achieve remission with this initial treatment, adding biological DMARDs or JAK inhibitors increases overall remission or low disease activity rates to 80%.

News (Medical) associated with Leflunomide

04 Jul 2026

·www.sciencedaily.com

A hidden weakness in deadly cancers could lead to powerful new treatments

A UCLA study has identified a hidden Achilles' heel in aggressive small cell cancers that have resisted new treatments for decades. Scientists found that tumors lacking the RB gene become critically dependent on the protein E2F3 for survival. Blocking E2F3 shut down tumor growth in laboratory models, and existing FDA-approved drugs may be able to exploit this vulnerability. The discovery could pave the way for faster development of more effective therapies.Researchers at UCLA have identified a hidden weakness in some of the most aggressive and difficult-to-treat cancers, raising hopes for a new way to attack tumors that have resisted treatment for decades. Small cell neuroendocrine cancers can develop in the lung, prostate, and ovary. These fast-growing tumors tend to spread early and have remained among the hardest cancers to treat successfully. A key feature of these cancers is the loss of a gene called RB. Under normal conditions, RB helps keep cell growth under control. When the gene is missing, cancer cells multiply rapidly and become resistant to many targeted therapies. Now, a new study published in Proceedings of the National Academy of Sciences suggests that losing RB also creates an unexpected vulnerability that researchers believe could become a powerful treatment target. A Hidden Dependency in Deadly Cancers The UCLA team discovered that cancer cells lacking RB become heavily dependent on a protein called E2F3 to survive. In laboratory experiments, blocking E2F3 prevented tumor growth through a process known as "synthetic lethality." In simple terms, cancer cells can survive without RB, but they cannot survive when both RB and E2F3 are lost. Removing E2F3 alongside the missing RB exposes a critical weakness that researchers believe could be exploited with future therapies. "Discovering a vulnerability like this opens the door to thinking about entirely new treatment strategies," said study senior author Dr. Owen N. Witte, who holds the Presidential Chair in Developmental Immunology in the Department of Microbiology, Immunology, and Molecular Genetics and is a member of the UCLA Health Jonsson Comprehensive Cancer Center. "That's especially important because there has not been a major change in how we treat these cancers for decades. When I first encountered these tumors as a medical student more than 50 years ago, the survival statistics were essentially the same as they are today." Building Better Models To Study Small Cell Cancer Progress against small cell neuroendocrine cancers, especially those that develop in the prostate, has been slowed by the lack of realistic laboratory models. Without them, scientists have struggled to identify the genes these tumors rely on and uncover their biological weaknesses. To overcome that challenge, the UCLA researchers engineered normal human prostate cells with five major cancer-causing genetic changes, including the loss of RB and TP53. The cells were grown into organoids and then used to produce tumors in mice, creating models that closely resemble human small cell prostate cancer. The work builds on more than a decade of research by Witte's laboratory to develop specialized models of small cell neuroendocrine prostate cancer. CRISPR Screens Reveal a Shared Weakness Using these models, the team performed genome-wide CRISPR screens that examined thousands of genes to determine which ones were essential for cancer cell survival. The researchers identified nearly 1,400 genes that play important roles in keeping the cancer cells alive. Among the most significant discoveries was that small cell cancers from different organs all shared a strong dependence on E2F3. When the scientists reduced E2F3 levels in RB-deficient cancer cells, the tumors stopped dividing, could no longer form clusters, and in some cases died completely. "It's not that the two genes do the same thing," said Witte, who is also the founding director emeritus of the UCLA Broad Stem Cell Research Center and co-director of the Parker Institute of Cancer Immunotherapy Center at UCLA. "But the combination of what they do together becomes essential for the cancer cell. Losing one gene may not matter much, but losing both has a dramatic effect on tumor growth." "These new model systems allowed us to uncover a genetic vulnerability that would have been very difficult to find otherwise," added first author Dr. Evan Abt, an assistant professor of Molecular and Medical Pharmacology at the David Geffen School of Medicine at UCLA. Existing FDA-Approved Drugs May Offer a Shortcut Because no medicines currently target E2F3 directly, the researchers looked for another way to exploit the cancer's weakness. They found that blocking a metabolic pathway involved in producing DNA building blocks by inhibiting an enzyme called DHODH lowered E2F3 levels and slowed tumor growth. That finding is especially intriguing because DHODH inhibitors, including leflunomide and teriflunomide, are already FDA-approved to treat autoimmune diseases. Repurposing existing medications could potentially speed the development of new therapies for patients with these cancers. "What's exciting is that our findings open the door to applying existing drugs in a new way," Abt said. "By understanding how these cancers depend on E2F3, we can start to think about strategies that might work much more quickly in patients." Although the research remains in its early stages, the findings provide important new insight into how these aggressive cancers survive and point toward a promising new direction for future treatments. Other UCLA authors are Liang Wang, Grigor Varuzhanyan, Jack Freeland, Tian He, Guadalupe M. Peña-Garcia, Lauryn Ruegg, Jami McLaughlin, Donghui Cheng, Nikolas G. Balanis, Chia-Chun Chen, Sanaz Memarzadeh, Caius G. Radu and Thomas G. Graeber.

Immunotherapy

30 Jun 2026

·www.biospace.com

Quince Therapeutics Appoints Recognized Leaders in Pulmonary Medicine to Scientific Advisory Board

SOUTH SAN FRANCISCO, Calif., June 30, 2026 (GLOBE NEWSWIRE) -- Quince Therapeutics, Inc. (Nasdaq: QNCX), a clinical stage biopharmaceutical company focused on the development of novel, disease modifying therapies for serious underserved diseases, today announced the formation of a Scientific Advisory Board (SAB) of leading clinicians to support the advancement of LAM-001, an inhaled formulation of rapamycin (mTOR inhibitor) designed to enhance pulmonary delivery and reduce systemic exposure. Comprised of internationally recognized experts in pulmonary medicine, the SAB will be instrumental in progressing the development of LAM-001 across multiple pulmonary indications including pulmonary hypertension associated with interstitial lung disease (PH-ILD), bronchiolitis obliterans syndrome post lung transplant (BOS), and sarcoidosis associated pulmonary hypertension (SAPH). “I am honored to serve as the Chairman of Quince’s Scientific Advisory Board to help guide the development of LAM-001 across a range of pulmonary conditions where evidence strongly suggests it has a direct effect on the underlying disease pathophysiology,” commented Paul Yu, M.D., Ph.D., Director, Cardiovascular Research Center, Massachusetts General Hospital. “On behalf of the SAB, we are encouraged by the clinically relevant improvement seen in measures of lung function in patients with functional class III pulmonary hypertension treated with LAM-001. With continued development, we believe LAM-001 has the potential to provide patients with a much needed treatment option that, importantly, may be utilized in conjunction with currently available therapies to achieve better health outcomes.” Scientific Advisory Board members: Paul Yu, M.D., Ph.D. (Chairman of SAB) Dr. Paul Yu is Director of the Cardiovascular Research Center at Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School, where he holds the Charles and Elizabeth Sanders Endowed Chair. A physician-scientist trained in immunology and cardiovascular medicine, Dr. Yu’s research focuses on BMP and TGF-β signaling in cardiovascular homeostasis, repair, and disease. His work spans pulmonary vascular disease, cardiovascular rheumatology, and rare disorders such as fibrodysplasia ossificans progressiva. Dr. Yu has translated several scientific discoveries into therapeutics, including contributions to sotatercept for pulmonary arterial hypertension and the clinical repositioning of saracatinib for fibrodysplasia ossificans progressiva (FOP). He has published over 120 peer-reviewed studies and has been elected to the American Society for Clinical Investigation. Aaron Waxman, M.D., Ph.D. Dr. Aaron Waxman is Director of the Pulmonary Vascular Disease Program at Brigham and Women's Hospital and Associate Professor of Medicine at Harvard Medical School. Dr. Waxman’s clinical practice and research programs center on pulmonary arterial hypertension (PAH), right heart failure, thromboembolic disease, and the broader spectrum of pulmonary vascular disease. Across local and national efforts, Dr. Waxman has served as Principal Investigator on more than 15 clinical trials in pulmonary hypertension. These include the Phase 2 SPECTRA trial of sotatercept, which helped establish activin signaling inhibition as a novel therapeutic pathway in PAH, and the INCREASE trial of inhaled treprostinil in pulmonary hypertension associated with interstitial lung disease—a study that defined a new treatment standard for a previously underserved patient population. He has authored more than 180 peer-reviewed publications, and his research has been supported by the National Institutes of Health, including the National Heart, Lung, and Blood Institute. Steven Nathan, M.D., F.C.C.P. Dr. Steven Nathan is Schar Chair of the Advanced Lung Disease and Lung Transplant Program, Inova Health System and Professor of Education at the University of Virginia. The author of more than 500 publications and co-editor of two books on idiopathic pulmonary fibrosis, Dr. Nathan is internationally recognized for his expertise in advanced lung diseases. Dr. Nathan is a reviewer for multiple journals and is on the editorial board for the journal, Thorax. He has served on multiple committees, including U.S. Food and Drug Administration advisory boards as well as steering committees for clinical trials in IPF and pulmonary hypertension, where he has also served as chair. Dr. Nathan is the recipient of the 2023 American College of Chest Physicians’ 2023 College Medalist Award, and is a member of several professional medical associations, including the American Thoracic Society, the American College of Chest Physicians, and the International Society for Heart and Lung Transplantation. Steve Hays, M.D. Dr. Steven R. Hays is Medical Director of the UCSF Advanced Lung Disease and Lung Transplant Program and Professor of Medicine at the University of California, San Francisco. Under his leadership, the program has grown to one of the nation’s largest transplant centers while consistently achieving superior outcomes, receiving INTERLINK’s Chairman’s Award for Transplant Excellence for three consecutive years. Dr. Hays brings deep clinical expertise across the full spectrum of advanced lung disease, including cystic fibrosis, alpha-1 antitrypsin deficiency, interstitial lung disease, and emphysema. A dedicated clinical investigator, Dr. Hays has served as principal investigator on NIH-funded, industry-sponsored, and investigator-initiated trials. His research portfolio spans lung transplant immunology, chronic lung allograft dysfunction, infectious disease, and transplant digital health. He has authored more than 110 peer-reviewed publications and has been an invited speaker at the American Thoracic Society, the International Society of Heart and Lung Transplantation, and the American Society of Transplantation, among others. He is a Fellow of the American College of Chest Physicians, and a member of the American Thoracic Society and the International Society of Heart and Lung Transplantation, where he serves on the Pulmonary and Infectious Disease Councils. He is a recipient of the American Thoracic Society’s Outstanding Clinician Award and a member of the prestigious UCSF Council of Master Clinicians. Robert Baughman, M.D. Dr. Baughman is Professor Emeritus at the University of Cincinnati. Along with his longtime collaborator Dr. Elyse Lower, he has performed numerous investigator initiated trials of novel treatments for sarcoidosis, including methotrexate, thalidomide, leflunomide, infliximab, rituximab, repository corticotropin injection, pirfenidone, roflumilast, and armodafinil. For sarcoidosis associated pulmonary hypertension, he has conducted trials on bosentan, iloprost, riociguat, tadalafil, selexipag, and inhaled nitric oxide. His publications include over 350 original papers and over 70 review articles and/or book chapters. Additionally, Dr. Baughman has edited multiple books on sarcoidosis and interstitial lung disease. A recognized leader in his field, Dr. Baughman led a multi-national registry of sarcoidosis associated pulmonary hypertension (ReSAPH) and is past president of the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG). About LAM-001 LAM-001 is a proprietary, investigational, once-daily inhaled formulation of sirolimus, also known as rapamycin. LAM-001’s potential as a disease-modifying agent in pulmonary hypertension stems from its ability to inhibit mTOR-mediated pulmonary arterial smooth muscle cell proliferation. The mTOR pathway has been shown to be activated in the pulmonary arterial smooth muscle cells of patients with pulmonary hypertension, and mTOR inhibition with rapamycin has been shown to reverse smooth muscle cell hyperproliferation and attenuate pulmonary vascular remodeling and cardiopulmonary dysfunction in multiple nonclinical models. Additionally, mTOR signaling promotes fibroblast activation, myofibroblast differentiation, and extracellular matrix deposition in injured or inflamed lung tissue, and mTOR inhibition has been shown to exert direct anti-fibrotic activity, reducing collagen accumulation, suppressing profibrotic cytokine signaling, and attenuating parenchymal fibrosis. These effects are particularly relevant in PH-ILD, where vascular remodeling and progressive fibrosis evolve in parallel and amplify pulmonary vascular load. LAM-001 is designed to enhance pulmonary delivery and reduce systemic exposure, offering a promising potential disease-modifying therapy for pulmonary disease. LAM-001 is currently being studied in multiple indications including PH-ILD, a serious and progressive condition affecting an estimated ~86K patients in the U.S. and ~120K in Europe. Based on compelling Phase 2a data presented at the American Thoracic Society (ATS) in May 2026, the company is advancing LAM-001 into a Phase 2b trial in PH-ILD, with initiation planned for mid-2026 and data anticipated in the first quarter of 2028. LAM-001 is also being evaluated in a Phase 2 study in BOS, a serious complication following lung transplantation affecting an estimated ~17K patients in the U.S. and ~11K in Europe. The trial is fully enrolled, with data anticipated in the first quarter of 2027. In late 2026, the company also plans to initiate a Phase 2 study of LAM-001 in SAPH, a severe complication of sarcoidosis with no approved therapy affecting an estimated ~60K patients in the U.S. and Europe. About Quince Therapeutics, Inc. Quince Therapeutics, Inc. is committed to transforming the lives of patients facing serious, underserved diseases by developing disease-modifying therapies to treat their conditions. The company is currently developing LAM-001 for the treatment of PH-ILD, BOS, and SAPH. A Phase 2a study in PH patients has been completed, a Phase 2 clinical study in BOS patients is ongoing, a Phase 2b study in PH-ILD is anticipated to begin in mid-2026, and a Phase 2 study in SAPH is anticipated to begin in late-2026. By pioneering innovative approaches, the company aims to offer new hope and improved quality of life to patients worldwide. Forward Looking Statements Statements in this news release contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as “believe,” “may,” “should,” “expect,” “aim,” “anticipate,” “plan,” “believe,” “estimated,” “potential,” “intend,” “will,” “can,” “seek,” or other similar words. Examples of forward-looking statements include, among others, statements relating to expectations that the SAB will be instrumental in progressing the development of LAM-001 across multiple pulmonary indications; the design and potential benefits of LAM-001, including as a disease-modifying therapy for pulmonary disease and as a treatment option that may be utilized in conjunction with currently available therapies to achieve better health outcomes; anticipated regulatory and development processes and timelines, including the expected timing to initiate the planned Phase 2b trial of LAM-001 in PH-ILD and the planned Phase 2 trial of LAM-001 in SAPH, the expected timing for data readouts from the ongoing Phase 2 trial of LAM-001 in BOS and the planned Phase 2b trial of LAM-001 in PH-ILD; the Phase 2a data of LAM-001 in PAH and PH-ILD supporting continued development of LAM-001 in PH-ILD and the potential benefit across exercise capacity, pulmonary hemodynamics, cardiac stress and lung function; observed improvements in 6MWD and PVR in the Phase 2a trial potentially suggesting broader effects on cardiopulmonary physiology; the estimated patient populations in the U.S. and Europe for PH-ILD, BOS and SAPH; and the potential advantages of mTOR inhibitors in PH-ILD. Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, clinical results may not be indicative of results that may be observed in the future, including in larger populations; potential safety and other complications related to LAM-001; the ability to obtain and maintain regulatory approval; competition in the company’s industry; the scope, progress and expansion of developing LAM-001; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the company’s ability to attract or retain key management, members of the board of directors and other personnel; the impacts of general macroeconomic and geopolitical conditions on the company’s business and financial position; and other risks and uncertainties described in the section titled “Risk Factors” in the company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on April 10, 2026, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law. Contacts Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com 212-915-2577

Phase 2

12 Mar 2025

·www.prnewswire.com

Psoriatic Arthritis Market Sees Major Shift with Growing Biosimilar Adoption | DelveInsight

The arrival of biosimilars like Celltrion's STEQEYMA and Biocon's YESINTEK is shaking up the psoriatic arthritis market, challenging blockbuster biologics with cost-effective alternatives. As competition intensifies, these biosimilars are reshaping treatment choices and driving a shift in the market landscape. LAS VEGAS, March 12, 2025 /PRNewswire/ -- Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects approximately 112 per 100,000 adults worldwide. It is more prevalent in Europe and North America than in Asia and South America. In patients with psoriasis, the prevalence of psoriatic arthritis can range from 6% to 34% in Western populations. Despite its impact, many individuals with psoriatic arthritis remain undiagnosed or receive inadequate treatment, highlighting the need for increased awareness and access to specialized care. As per DelveInsight analysis, among the 7MM, the United States accounted for the highest number of prevalent cases of psoriatic arthritis in 2023, and these cases are expected to increase by the end of 2034 due to several key factors such as an increase in awareness and diagnosis, as well as the rapid prevalence of PsA. Psoriatic arthritis, occurring in approximately 20% of individuals with psoriasis, is a chronic inflammatory arthritis intricately linked to psoriatic arthritis. This aggressive condition is characterized by potential significant morbidity and compromised quality of life. Treatment approaches for psoriatic arthritis encompass a variety of strategies aimed at managing symptoms, slowing disease progression, and improving the overall quality of life. These approaches typically involve a combination of pharmacological therapies, lifestyle modifications, and, in severe cases, surgical interventions. Psoriatic arthritis treatment is highly individualized based on disease severity, response to therapy, and patient preferences, with multidisciplinary care from rheumatologists, dermatologists, and physical therapists playing a key role. Pharmacological treatment for psoriatic arthritis primarily targets inflammation and pain relief. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, are often the first line of defense, helping to reduce pain and inflammation. Disease-modifying antirheumatic drugs (DMARDs) like methotrexate, sulfasalazine, and leflunomide are commonly prescribed to prevent joint damage and suppress the inflammatory process. For individuals with mild-to-moderate psoriatic arthritis, oral small molecules (OSMs) like OTEZLA (apremilast) offer a convenient, non-injectable option by modulating inflammatory pathways. Biologic agents have revolutionized the treatment landscape for psoriatic arthritis. These medications specifically inhibit key molecules in the inflammatory cascade. TNF inhibitors like HUMIRA (adalimumab), ENBREL (etanercept), and REMICADE (infliximab) are frontline biologics that target tumor necrosis factor, a crucial driver of inflammation. Patients who do not respond to TNF inhibitors may benefit from IL-17 inhibitors like COSENTYX (secukinumab) and TALTZ (ixekizumab) or IL-12/23 inhibitors such as STELARA (ustekinumab). Learn more about the FDA-approved psoriatic arthritis drugs @ Drugs for Psoriatic Arthritis Treatment SKYRIZI (risankizumab), developed by AbbVie, is a humanized IgG1 monoclonal antibody that acts as an interleukin-23 (IL-23) antagonist. It can be used on its own or in conjunction with non-biologic DMARDs. In June 2022, the FDA approved SKYRIZI as the first and only targeted IL-23 inhibitor for adults with active psoriatic arthritis. Another biologic, TREMFYA (guselkumab by Janssen), was approved by the FDA in July 2020 as the first monoclonal antibody that selectively binds to the p19 subunit of IL-23, further expanding treatment options for psoriatic arthritis patients. BIMZELX (bimekizumab), developed by UCB Biopharma, is a humanized monoclonal antibody that targets IL-17A and IL-17F. It received European Commission approval in June 2023 for adults with active psoriatic arthritis and axial spondyloarthritis. On September 23, 2024, the FDA approved BIMZELX for treating adults with active psoriatic arthritis, non-radiographic axial spondyloarthritis (nr-axSpA) with objective inflammation, and active ankylosing spondylitis. In Phase III studies, BIMZELX showed meaningful responses in patients with inadequate TNF inhibitor responses and those new to biologics, indicating its potential as an important treatment option for psoriatic arthritis. In cases where joint damage becomes severe and unresponsive to medical therapies, surgical interventions like joint replacement surgery may be necessary to restore function and alleviate pain. Lifestyle changes, such as regular exercise, joint protection techniques, and weight management, are also critical in managing psoriatic arthritis, as excess weight can worsen symptoms and increase disease severity. The treatment landscape for psoriatic arthritis continues to evolve, offering hope to patients with more targeted therapies and improved outcomes. As companies like UCB Biopharma, AbbVie, and Janssen advance their biologic portfolios, the future looks promising for psoriatic arthritis management. The competition in the biosimilar market is intensifying as companies introduce cost-effective alternatives to blockbuster biologics. In December 2024, Celltrion announced FDA approval for STEQEYMA (ustekinumab-stba), a biosimilar to STELARA, for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. Simultaneously, Biocon Biologics Ltd. is strengthening its position with positive Phase III results for YESINTEK, its biosimilar to ustekinumab, in adult patients with moderate to severe chronic plaque psoriasis. The pivotal randomized, double-blind, parallel-group study demonstrated comparable efficacy and safety to the reference biologic, STELARA, and the findings are being presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida. With the approval of STEQEYMA and the promising clinical outcomes for YESINTEK, these biosimilars are poised to challenge STELARA by offering cost-effective alternatives in key immunology indications. As pricing pressures and healthcare sustainability concerns drive the demand for biosimilars, these developments mark a significant shift in the treatment landscape, providing greater accessibility and affordability for patients while increasing competition in the immunology market. To know more about psoriatic arthritis treatment options, visit @ New Treatment for Psoriatic Arthritis The psoriatic arthritis market is buzzing with numerous companies advancing treatments to cater to the growing patient base. Several therapies are expected to enter the market during the forecast period, providing new hope for patients. Some of these potential therapies include ACELYRIN Inc.'s Izokibep, Novartis Pharmaceuticals' Secukinumab, UCB Biopharma SRL's Bimekizumab, and Bristol-Myers Squibb's Deucravacitinib. Additionally, AbbVie's Upadacitinib and Risankizumab, as well as Eli Lilly and Company's Ixekizumab, are also part of the promising pipeline. Other noteworthy therapies include Sun Pharma's ILUMYA/ILUMETRI, Bristol-Myers Squibb's SOTYKTU, and Affibody's Izokibep in collaboration with Acelyrin and Inmagene. With these advancements, the psoriatic arthritis treatment landscape is set for a major shift, offering patients more tailored and effective options. The companies involved in developing biosimilars include Alvotech, Teva, Biocon Biologics, Celltrion, Fresenius Kabi, and others. Discover which therapies are expected to grab major psoriatic arthritis market share @ Psoriatic Arthritis Market Report ILUMYA/ILUMETRI by Sun Pharma is an interleukin-23 (IL-23) inhibitor classified as a humanized, anti-IL-23p19 monoclonal antibody. It works by blocking inflammatory proteins (cytokines and chemokines) in the body. By inhibiting the effects of IL-23, ILUMYA helps control the release of other inflammatory proteins, including IL-17 and TNF-α. This mechanism reduces inflammation, decreases the number of inflammatory cells in psoriatic lesions, helps prevent plaque formation, and resolves tissue damage. The drug is currently undergoing evaluation in Phase III clinical development, actively recruiting subjects with active psoriatic arthritis who have prior exposure to anti-TNF agents, as well as those who are anti-TNF naïve. SOTYKTU, developed by Bristol-Myers Squibb, is the first and only novel oral selective tyrosine kinase 2 (TYK2) inhibitor being studied across multiple immune-mediated diseases. Deucravacitinib binds to the regulatory domain of the TYK2 enzyme, inhibiting its activation. This selective inhibition reduces the release of proinflammatory cytokines and chemokines, helping to control the inflammation associated with psoriatic arthritis and alleviating its signs and symptoms. Currently, the drug is being investigated for the treatment of psoriatic arthritis in a Phase III clinical trial. Izokibep, developed by Affibody in partnership with Acelyrin and Inmagene, is a unique antibody mimetic and a novel bispecific agent that potentially targets both subunits of the IL-17A homo-dimer and serum albumin. Affibody has entered into a partnership agreement with Acelyrin for the development and commercialization of izokibep and has completed a Phase II trial. As part of this agreement, Acelyrin obtained worldwide rights to izokibep, excluding selected Asian countries, where rights have been granted to Inmagene Biopharmaceuticals. In March 2024, Acelyrin announced the release of positive top-line results from the Phase IIb/III trial, indicating that izokibep was well-tolerated with a favorable safety profile. This drug is currently in Phase III clinical trial. Discover more about drugs for psoriatic arthritis in development @ Psoriatic Arthritis Clinical Trials The anticipated launch of these emerging therapies for psoriatic arthritis is poised to transform the market landscape in the coming years. As these cutting-edge treatments continue to mature and gain regulatory approval, they are expected to reshape the psoriatic arthritis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the psoriatic arthritis market size was USD 9 billion in 2021 and is expected to grow significantly in the coming years. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the condition. The anticipated launch of these therapies is also expected to attract new entrants to the psoriatic arthritis market, resulting in increased competition and innovation. DelveInsight's latest published market report titled " Psoriatic Arthritis Market Insight, Epidemiology, and Market Forecast – 2034" will help you discover which market leader is set to capture the largest market share. The report provides comprehensive insights into country-specific treatment guidelines, patient pool analysis, and epidemiology forecasts to help understand key opportunities and assess the market's underlying potential. The psoriatic arthritis market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Prevalent Cases of Psoriatic Arthritis Total Diagnosed Prevalent Cases of Psoriatic Arthritis Gender-specific Diagnosed Prevalent Cases of Psoriatic Arthritis Severity-specific Diagnosed Prevalent Cases of Psoriatic Arthritis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM Psoriatic Arthritis market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this psoriatic arthritis market report to assess the epidemiology forecasts, understand patient journeys, gain insights into KOLs' opinions about upcoming treatment paradigms, and identify the factors contributing to changes in the psoriatic arthritis market. Additionally, stay informed about the mitigating factors that can enhance your market position in the psoriatic arthritis therapeutic space. Related Reports Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key schizophrenia companies, including Affibody, Kymera, Selection Therapeutics GmbH, Jiangsu HengRui Medicine Co., Ltd., Nimbus Lakshmi, Inc., Hansoh BioMedical R&D Company, Bio-Thera Solutions, ACELYRIN Inc., among others. Psoriatic Arthritis Epidemiology Forecast Psoriatic Arthritis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and Psoriatic Arthritis epidemiology trends. Ankylosing Spondylitis Market Ankylosing Spondylitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Ankylosing Spondylitis companies, including UCB, AbbVie, Pfizer, Astella, Amgen, Janssen Biotech, Pozen, Novartis, Iroko Pharmaceuticals, Syntex Pharmaceuticals, Horizon Pharma, Eli Lilly and Company, among others. Psoriasis Market Psoriasis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Psoriasis companies, including Amgen, Janssen, Abbvie, Novartis, AstraZeneca, Bausch Health, Eli Lilly, Sun Pharmaceutical, Janssen Biotech, UCB Inc., LEO Pharma, Promius Pharma, Mayne Pharma, Bausch Health Companies, MC2 Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalClinical ResultPhase 2

100 Deals associated with Leflunomide

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KEGG	Wiki	ATC	Drug Bank
D00749	Leflunomide	L04AK01	DB01097

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Arthritis, Psoriatic	European Union	Sanofi-Aventis Deutschland GmbH	02 Sep 1999
Arthritis, Psoriatic	Iceland	Sanofi-Aventis Deutschland GmbH	02 Sep 1999
Arthritis, Psoriatic	Liechtenstein	Sanofi-Aventis Deutschland GmbH	02 Sep 1999
Arthritis, Psoriatic	Norway	Sanofi-Aventis Deutschland GmbH	02 Sep 1999
Rheumatoid Arthritis	United States	Sanofi-Aventis U.S. LLC	10 Sep 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Renal transplant rejection	Phase 2	United States	Suzhou Changzheng Cinkate Pharmaceutical Co., Ltd.	01 Jul 2012
Viremia	Phase 2	United States	Suzhou Changzheng Cinkate Pharmaceutical Co., Ltd.	01 Jul 2012
Systemic Lupus Erythematosus	Phase 2	Hong Kong	Sanofi	01 Jan 2003

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACR2026	Not Applicable	Sjogren's Syndrome	29	abatacept	fzuqeoviqb(jeidjpivxc) = rgpkyxedqo yopdrskneo (sjrmvnldvd ) View more	Positive	06 Nov 2026
ACR2026	Not Applicable	Rheumatoid Arthritis	16,386	Methotrexate (MTX)	kzbvwxvyag(bacehlenns) = aamnecaspt gajcohbjfr (vighjewyvr ) View more	Positive	06 Nov 2026
				Leflunomide (LEF)	kzbvwxvyag(bacehlenns) = dsemgevjmk gajcohbjfr (vighjewyvr ) View more
ACR2026	Not Applicable	Sarcoidosis	1,774	Systemic corticosteroid	vloidogejy(ltplclwkce) = rvagoiuffv ssmuddizde (rfasynoqze ) View more	Positive	06 Nov 2026
				Any steroid-sparing therapy	vcngiihunq(pisplhmefd) = qxrsluorri bamcewukig (ukkvigokvz ) View more
NCT02981979 (Pubmed \| BMC Med)	Phase 3	Takayasu Arteritis	116	PrednisoneLeflunomide (LEF) 20 mg/d + PrednisoneLeflunomide (LEF) 20 mg/d	rmbuucvwtz(xglxenvbdw) = imylooxvwf mwbtetkiok (gbahqsjqkw ) View more	Negative	03 Jul 2026
				Prednisone + Prednisone	rmbuucvwtz(xglxenvbdw) = nvsczxkzxy mwbtetkiok (gbahqsjqkw ) View more
NCT03739853 (SPEED, CTgov)	Phase 4	Arthritis, Psoriatic	192	Methotrexate+Sulfasalazine+Leflunomide (Standard Care)	ullfnvecva(xvzbwpqbat) = ibcvifzezn vqvhiqeeor (cwulzncyyd, 1.5) View more	-	26 Nov 2025
				Methotrexate+Sulfasalazine+Leflunomide (Combination csDMARD)	ullfnvecva(xvzbwpqbat) = mvegiwjbpz vqvhiqeeor (cwulzncyyd, 1.5) View more
EULAR2025	Not Applicable	Rheumatoid Arthritis	83	Methotrexate + Leflunomide	vjzlrnpobw(qwagcgivbm): P-Value = 0.0001 View more	Positive	11 Jun 2025
				Methotrexate + Sulfasalazine
COMPLETE PsA (EULAR2025)	Not Applicable	Arthritis, Psoriatic	62	Methotrexate + Leflunomide	-	Negative	11 Jun 2025
				Methotrexate	nbwsqnexci(vlaeugpapc) = vyrryprsgc uhimamvlya (humuuzlcyw )
EULAR2025	Not Applicable	Rheumatoid Arthritis	100	Methotrexate-Sulfasalazine combination	fjlhhckkbn(puutuqltzs) = Frequency of Transaminitis was higher in MTX + LEF group. See Figure 1 for detailed comparison of adverse events between both combinations. fdtztheeth (irrtfnegmj )	Positive	11 Jun 2025
NCT02451748 (CTgov)	Phase 4	Rheumatoid Arthritis	32	Lab Work (DMARD's Responder and Non-Responder)	knqsrbhrcw(pzypxbqngi) = iukemtikvw rgnnhxrvrv (ppqwchtbgn, fvpjdcxtow - joaezugcvy) View more	-	10 Jul 2024
				Naproxen+Medrol+Hydroxychloroquine+humira+prednisone+Lab Work+Triamcinolone+Methotrexate+Sulfasalazine+CDP870+Leflunomide (DMARD's Plus Cimzia (Certolizumab Pegol))	ciudldbbqb(zdshwzpuql) = rtqbczsjtb amyexxknbd (ghugtegcqi, 0.132) View more
NCT04532372 (CTgov)	Phase 1/2	COVID-19 \| Malignant Solid Neoplasm \| Hematologic Neoplasms	2	Best Practice+Leflunomide	lhdhomozxo = baeylohpxl wdbsowegwi (npuuglvrrc, amlfvphvkf - hfajpsxcmm) View more	-	03 Jul 2024

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