A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of Cenerimod in Adult Patients With Systemic Lupus Erythematosus and Active Lupus Nephritis in Combination With Background Therapy

The goal of this clinical trial is to learn if cenerimod, on top of regular treatment, works to treat active lupus nephritis in adults with systemic lupus erythematosus and active lupus nephritis. It will also learn about the safety of cenerimod. The main questions it aims to answer are:
* Does cenerimod improve kidney function in participants?
* What medical problems do participants have when taking cenerimod?
Researchers will compare cenerimod to a placebo (a look-alike substance that contains no drug) to see how well cenerimod works when it is added to regular treatment.
Participants will:
* Take cenerimod or a placebo every day for 76 weeks (approximately 1.5 years), on top of regular treatment.
* Visit the clinic every 1 to 3 months for checkups and tests.

Start Date09 Feb 2026

Sponsor / Collaborator

Viatris, Inc.

NCT07266090

/ Active, not recruitingPhase 2

A Multicenter,Open-label,Single Arm,Multiple-dose Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of Cenerimod in Adult Chinese Participants With Moderate-to-severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy

The goal of this clinical trial is to learn about the safety, how the body processes the drug, and its effects of a drug called cenerimod in adult Chinese participants (aged 18-75) with moderate to severe Systemic Lupus Erythematosus (SLE) who are already receiving standard background therapy.
The main questions it aims to answer are:
* What is the safety and tolerability of a daily 4 mg dose of cenerimod in Chinese participants with SLE?
* How is cenerimod processed by the body (pharmacokinetics) in this population?
* What is the effect of cenerimod on the level of lymphocytes in the blood (pharmacodynamics)? This is a single-arm study without a comparison group.
Participants will:
* Take one 4 mg cenerimod tablet by mouth once daily for up to 12 months.
* Continue their stable, pre-existing background SLE medications throughout the study.
* Attend regular clinic visits over a period of up to 22 months for tests and check-ups, including blood draws, heart monitoring (12-lead electrocardiogram), vital signs(blood pressure),and physical examinations.
* Undergo a final safety follow-up 6 months after their last dose of the study drug.

Start Date14 Jan 2026

Sponsor / Collaborator

Viatris Pharmaceuticals Co., Ltd.

NCT07301723

/ CompletedPhase 1

A Single-center, Open-label Trial to Determine the Absolute Bioavailability of Cenerimod Using an Intravenous 14C-radiolabeled Cenerimod Microtracer in Healthy Male Participants

The goal of this clinical trial is to learn about the absolute bioavailability of cenerimod in healthy participants. It will also provide information about the safety of cenerimod.
Participants will receive one tablet with cenerimod, followed by an intravenous (i.v.) infusion with a 14C-radiolabeled cenerimod microtracer (cenerimod with a very low dose of radioactivity) 6 hours later.
Participants will stay at the clinic for a total of 4 days, and will return to the clinic for further tests over the course of approximately 3 months.

Start Date11 Dec 2025

Sponsor / Collaborator

Viatris, Inc.

100 Clinical Results associated with Cenerimod

100 Translational Medicine associated with Cenerimod

100 Patents (Medical) associated with Cenerimod

Literatures (Medical) associated with Cenerimod

01 Feb 2025·ANNALS OF THE RHEUMATIC DISEASES

Pharmacodynamics of the S1P₁ receptor modulator cenerimod in a phase 2b randomised clinical trial in patients with moderate to severe SLE.

Article

Author: Murphy, Mark Joseph ; Suffiotti, Madeleine ; Keller, Marcel Peter ; Seifer, Gustavo ; Berkani, Ouali ; Strasser, Daniel Stefan ; Cornelisse, Peter ; Brazauskas, Pijus

BACKGROUND:

Systemic lupus erythematosus (SLE) is a complex autoimmune disease characterised by autoreactive T and B lymphocytes. Sphingosine-1- phosphate (S1P) is involved in lymphocyte egress from peripheral lymphoid organs into the circulation. In phase 2a clinical trial, the potent, selective S1P₁ receptor modulator cenerimod reduced circulating antibody-secreting cells and interferon (IFN)-associated biomarkers.

OBJECTIVES:

Pharmacodynamic effects of 2 and 4 mg cenerimod were evaluated in the phase 2b clinical trial (CARE) in moderate to severe patients with SLE (NCT03742037).

METHODS:

Blood samples were collected at baseline and after 6 months of treatment with cenerimod or placebo from CARE. The gene expression signatures for type 1 interferon (IFN-1), IFN-γ and plasma cells were used to assess dose-dependent pharmacodynamic effects of cenerimod. Cell-type deconvolution was performed to estimate cell abundance.

RESULTS:

Cenerimod 4 mg reduced IFN-associated protein and gene signature biomarkers after 6 months compared with placebo. A larger decrease of IFN proteins was evident in IFN-1 high patients compared with IFN-1 low patients. The median IFN-1 score in the IFN-1 high patients was reduced after 6 months of cenerimod 4 mg and the transition from IFN-1 low to high status compared with placebo was prevented. Cenerimod 4 mg exhibited a larger effect size on the pharmacodynamic biomarkers IFN-1, IFN-γ and plasma cells compared with cenerimod 2 mg.

CONCLUSIONS:

This study further characterised the mechanism of action of cenerimod in patients with SLE and substantiated the scientific rationale for cenerimod 4 mg in the phase 3 clinical trials in moderate to severe SLE (OPUS-1/-2).

01 Jan 2025·Lancet Rheumatology

Cenerimod, a sphingosine-1-phosphate receptor modulator, versus placebo in patients with moderate-to-severe systemic lupus erythematosus (CARE): an international, double-blind, randomised, placebo-controlled, phase 2 trial

Article

Author: Trokan, Luba ; Cahuzac, Clélia ; Merrill, Joan T ; Murphy, Mark J ; Kalunian, Kenneth ; Berkani, Ouali ; Navarra, Sandra V ; Askanase, Anca D ; D'Cruz, David ; Cornelisse, Peter ; Strasser, Daniel S

BACKGROUND:

Sphingosine-1-phosphate (S1P) is a signalling molecule that has an inhibitory role in atherosclerosis, inflammation, cell proliferation, and immunity. Cenerimod is a selective S1P₁ receptor modulator under investigation for the treatment of systemic lupus erythematosus (SLE). We aimed to determine the efficacy, safety, and tolerability of four doses of cenerimod in adults with moderate-to-severe SLE receiving standard of care background therapy.

METHODS:

CARE was a double-blind, randomised, placebo-controlled, phase 2 trial, in adults (aged 18-75 years) with moderate-to-severe SLE (a score of at least 6 out of 105 on the SLE disease activity index-2000, modified to exclude leukopenia [mSLEDAI-2K] score). Participants were recruited from 189 hospitals, specialist centres, and outpatient clinics in 22 countries in Asia Pacific, Latin America, Europe, and the USA. Participants were randomly assigned (1:1:1:1:1), using an interactive response technology via balanced block randomisation (block size of 5) and stratified by oral glucocorticoid dose at randomisation and disease activity at screening, to once-daily oral cenerimod at 0·5 mg, 1·0 mg, 2·0 mg, or 4·0 mg or placebo, in addition to stable background SLE therapy, and followed up for 12 months. After 6 months, participants assigned to cenerimod 4·0 mg were randomly assigned again (1:1) to either cenerimod 2.0 mg or placebo for a further 6 months. The primary endpoint was change from baseline to month 6 in mSLEDAI-2K score, assessed in all participants randomly assigned to treatment (full analysis set). To meet the primary endpoint, the doses had to show a significant improvement over placebo, when adjusting for multiplicity, considering the hierarchical testing strategy, per a prespecified plan. Safety analyses included all participants who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, NCT03742037, and is complete.

FINDINGS:

Between Dec 21, 2018, and Aug 25, 2022, 810 patients were screened and 427 were randomly assigned to 0·5 mg (n=85), 1·0 mg (n=85), 2·0 mg (n=86), and 4·0 mg (n=85) cenerimod or placebo (n=86). Median age was 42 years (IQR 33-51), 406 (95%) of 427 participants were women, 21 (5%) were men, and 337 (79%) were White. At month 6, the least squares mean change from baseline in mSLEDAI-2K score was -2·85 (95% CI -3·60 to -2·10) for the placebo group and -3·24 (-3·98 to -2·49; difference vs placebo -0·39 [95% CI -1·45 to 0·68]; p=0·47) for the cenerimod 0·5 mg group, -3·41 (-4·16 to -2·67; difference vs placebo -0·57 [-1·62 to 0·49]; p=0·29) for the 1·0 mg group, -2·84 (-3·58 to -2·09; difference vs placebo 0·01 [-1·05 to 1·08]; p=0·98) for the 2·0 mg group, and -4·04 (-4·79 to -3·28; difference vs placebo -1·19 [-2·25 to -0·12]; p=0·029) for the 4·0 mg group; hence, the primary endpoint was not met. Treatment-emergent adverse events up to 12 months had no clear treatment-related or dose-related pattern across the groups. At month 6, treatment-emergent lymphopenia was reported in one (1%) of 85 patients who received cenerimod 0·5 mg, five (6%) of 85 patients who received 1·0 mg, nine (10%) of 86 patients who received 2·0 mg, 12 (14%) of 84 patients who received 4·0 mg, and no patients who received placebo. Two deaths due to adverse events occurred (both in the cenerimod 1·0 mg group; one due to acute coronary syndrome and the other due to upper gastrointestinal haemorrhage), and were determined to be unrelated to study treatment.

INTERPRETATION:

The primary endpoint was not met. Cenerimod was well tolerated over 12 months. Cenerimod 4·0 mg is being investigated for the treatment of SLE in two ongoing phase 3 trials (NCT05648500, NCT05672576).

FUNDING:

Idorsia Pharmaceuticals.

03 Dec 2024·Cureus Journal of Medical Science

Evolving Treatment Strategies for Systemic Lupus Erythematosus in Clinical Practice: A Narrative Review

Review

Author: Upshaw, William C ; Varrassi, Giustino ; Burroughs, Caroline R ; Mosieri, Chizoba N ; Tassin, Joseph P ; Patel, Chandni R ; Kaye, Alan D ; Bembenick, Kristin Nicole ; Shekoohi, Sahar ; Kaye, Adam M ; Ahmadzadeh, Shahab ; Hawkins, Alison M

Systemic lupus erythematosus (SLE) is an autoimmune disease that more commonly affects African American people, although it is seen in people of all racial backgrounds. This condition is characterized by a dysregulated immune response resulting in widespread inflammation. Clinical manifestations caused by this inflammation include arthritis, anemia, cutaneous rashes, pleuritis, and nephritis. Treatment for SLE aims to reduce disease activity and maintain a state of low inflammation. In this regard, numerous treatments are used, such as hydroxychloroquine, glucocorticoids, and non-glucocorticoid immunosuppressants such as methotrexate. Related to these drugs resulting in significant adverse effects and being ineffective in controlling SLE symptoms in some patients, new biologic agents have been created in hopes of better treating SLE. This includes belimumab and anifrolumab, monoclonal antibodies directed against the cytokine, and type 1 interferon receptor, respectively. These agents are indicated in patients with SLE whose symptoms are inadequately controlled by standard therapy alone. Clinical trials have shown that these agents effectively reduce SLE symptoms as judged using standardized metrics of disease activity. These biological agents have also been shown to have generally mild side effects when taken by patients with SLE, making them safe for use. In addition to the above medications, new treatments are being developed for SLE patients, such as cenerimod, litifilimab, chimeric antigen receptor T cells, and DS-7011a (anti-toll-like receptor 7 monoclonal antibody). These new treatments have shown promise in clinical trials. However, more information regarding their safety and efficacy is needed before they are available for the treatment of SLE.

News (Medical) associated with Cenerimod

09 Jul 2026

·www.prnewswire.com

Systemic Lupus Erythematosus Market at a Turning Point as 6 Late-Stage Emerging Therapies Set to Redefine Treatment Landscape | DelveInsight

Companies like Biogen and Royalty Pharma (Litifilimab), Biogen and UCB (Dapirolizumab pegol), Idorsia Pharmaceuticals and Viatris (Cenerimod), Novartis (Ianalumab, YTB3231), Kyowa Kirin (KK-4277), and others are advancing late, mid, and early-stage drugs, showing promise in the systemic lupus erythematosus treatment market. LAS VEGAS, July 9, 2026 /PRNewswire/ -- Systemic lupus erythematosus (SLE) is a chronic, complex autoimmune disease that can affect multiple organ systems, with disease severity and clinical manifestations varying considerably among patients. Despite significant advances in understanding its pathophysiology, SLE remains incurable, and current treatment strategies primarily focus on controlling disease activity, achieving remission or low disease activity, preventing irreversible organ damage, minimizing flares, and improving patients' long-term quality of life. The therapeutic landscape for SLE remains limited, with only two therapies currently approved by the US FDA specifically for the disease: BENLYSTA (belimumab) from GlaxoSmithKline and SAPHNELO (anifrolumab) from AstraZeneca. Conventional treatment continues to rely on nonsteroidal anti-inflammatory drugs (NSAIDs), antimalarial agents, glucocorticoids, immunosuppressants, and other supportive therapies. While glucocorticoids remain a cornerstone of disease management, their well-documented long-term toxicities have intensified efforts to reduce steroid exposure through treat-to-target strategies. The persistent need for multiple lines of therapy and the limitations associated with existing treatments highlight the substantial unmet need for safer and more effective disease-modifying options. Discover what is the future of the systemic lupus erythematosus (SLE) drugs market @ The SLE pipeline is robust and increasingly diverse, with several late-stage and emerging therapies targeting novel immune pathways. Prominent investigational candidates include obinutuzumab (Roche), ianalumab (Novartis), dapirolizumab pegol (Biogen/UCB), upadacitinib (AbbVie), deucravacitinib (Bristol Myers Squibb), litifilimab (Biogen and Royalty Pharma), and other innovative agents that have the potential to improve disease control while reducing treatment-related toxicity. Aparna Thakur, Project Manager of Forecasting at DelveInsight, said that Oral small molecules such as cenerimod (S1P1 modulator), deucravacitinib (TYK2 inhibitor), and upadacitinib (JAK1 inhibitor) target multiple immune pathways in SLE, reflecting a shift toward oral multi-pathway immune modulation in treatment. In parallel, CAR T-cell therapies are emerging as a potentially transformative approach for patients with refractory SLE by enabling targeted B-cell depletion and immune system reprogramming that could deliver durable, treatment-free remission. Leading programs in this space include rapcabtagene autoleucel (YTB-323), zolacabtagene autoleucel, resecabtagene autoleucel (CABA-201), and obecabtagene autoleucel (obe-cel, AUCATZYL), signaling a potential shift from lifelong immunosuppression toward one-time disease-modifying interventions. As per Thakur, CD19-directed CAR-T therapies, including rapcabtagene autoleucel, zolacabtagene autoleucel, and resecabtagene autoleucel, show strong potential in SLE by inducing deep B-cell depletion and durable remission, though safety risks such as CRS and ICANS require intensive monitoring. Reflecting the growing innovation and expanding therapeutic opportunities in this space, DelveInsight estimates that the SLE market across the leading markets, including the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately USD 3 billion in 2025 and is projected to grow at a CAGR of 10.4% through 2036. Below, we highlight 6 emerging late-stage therapies poised to reshape the future of the systemic lupus erythematosus treatment market. Biogen and Royalty Pharma's Litifilimab CLEC4C protein inhibitors Litifilimab (BIIB059) is a humanized IgG1 monoclonal antibody designed to target BDCA2 (Blood Dendritic Cell Antigen 2) and is being developed as a potential therapy for systemic lupus erythematosus (SLE). BDCA2 is a receptor primarily found on plasmacytoid dendritic cells (pDCs), a specialized immune cell population involved in the production of inflammatory mediators. By binding to BDCA2, litifilimab suppresses pDC activation, thereby reducing the release of type I interferons (IFN-I) along with other proinflammatory cytokines and chemokines implicated in SLE pathogenesis. Biogen is currently evaluating litifilimab in two global Phase III clinical studies, TOPAZ-1 (NCT04895241) and TOPAZ-2 (NCT04961567), for patients with SLE, with topline results anticipated by the end of 2026. In October 2025, the company announced that patient enrollment had been completed for both Phase III trials and that the expected data readout timeline had been accelerated to the second half of 2026. Earlier, in February 2025, Biogen entered into a funding agreement with Royalty Pharma, under which it is eligible to receive up to USD 200 million in 2025 and an additional USD 50 million in 2026 to help support the ongoing development of the litifilimab program. Roche's Obinutuzumab (GAZYVA/GAZYVARO) TSLP inhibitor Obinutuzumab is a glycoengineered monoclonal antibody designed to target the CD20 protein expressed on the surface of lymphoma and leukemia cells. As a type II anti-CD20 antibody, it exhibits greater antibody-dependent cellular cytotoxicity and stronger direct cell-killing activity compared with conventional CD20 antibodies. After binding to CD20, obinutuzumab promotes B-cell destruction by engaging immune effector cells, directly triggering intracellular death-signaling pathways, and activating the complement cascade. In Europe, the therapy is marketed under the name GAZYVARO. In February 2026, Roche submitted regulatory applications in the United States and Europe seeking approval of obinutuzumab for the treatment of Systemic Lupus Erythematosus. Subsequently, in April 2026, Roche announced that the FDA had accepted its supplemental Biologics License Application (sBLA) for obinutuzumab in SLE. The filing is based on positive results from the Phase III ALLEGORY study, which showed a statistically significant and clinically meaningful improvement in the primary endpoint. The FDA is expected to issue a decision on the application by December 2026. Discover more about which pipeline drugs could transform systemic lupus erythematosus treatment @ Systemic Lupus Erythematosus Market Size Novartis' Ianalumab BAFF-R inhibitor, ADCC-mediated B-cell depletor Ianalumab, a novel monoclonal antibody developed by Novartis, targets the B-cell Activating Factor Receptor (BAFF-R). It is designed to inhibit BAFF-R signaling while simultaneously promoting B-cell depletion through antibody-dependent cellular cytotoxicity (ADCC). The therapy is currently being evaluated in two Phase III clinical studies for systemic lupus erythematosus (SLE): NCT05639114 (SIRIUS-SLE 1) and NCT05624749 (SIRIUS-SLE 2). According to Novartis' 2026 interim financial report, topline results from the Phase III SIRIUS-SLE 1 and SIRIUS-SLE 2 trials are expected in 2027. Pending positive outcomes, the company plans to submit Ianalumab for regulatory approval in SLE in 2028. Johnson & Johnson's Nipocalimab (IMAAVY) FcRn blockade Nipocalimab is an investigational immunoselective therapy engineered to selectively bind with high affinity to the neonatal Fc receptor (FcRn), blocking its activity and lowering circulating pathogenic IgG antibodies while maintaining essential immune functions. The therapy is being evaluated across three major autoantibody-driven disease areas: rheumatologic disorders, rare autoantibody-mediated conditions, and maternal-fetal diseases, where inhibiting IgG interaction with FcRn in the placenta is expected to reduce the transfer of harmful maternal alloantibodies to the fetus. In March 2026, Johnson & Johnson announced that the U.S. Food and Drug Administration granted Fast Track Designation (FTD) to nipocalimab for the treatment of Systemic Lupus Erythematosus. Explore systemic lupus erythematosus competitors Johnson & Johnson marketed products @ Systemic Lupus Erythematosus Marketed Drugs Idorsia Pharmaceuticals and Viatris' Cenerimod Sphingosine 1-phosphate receptor modulators Cenerimod is a highly selective Sphingosine-1-Phosphate Receptor 1 (S1P1) modulator administered as a once-daily oral tablet. Although the exact cause of systemic lupus erythematosus remains unclear, dysregulated T and B lymphocytes are recognized as central drivers of disease pathogenesis. By selectively targeting the S1P1 receptor, cenerimod is designed to modulate lymphocyte trafficking and reduce immune-mediated inflammation. The therapy is currently being evaluated in two Phase III clinical trials, OPUS-1 (NCT05648500) and OPUS-2 (NCT05672576), for the treatment of SLE. The US FDA has also granted Fast Track Designation (FTD) to cenerimod, underscoring its potential to address an unmet medical need in SLE. In February 2025, Idorsia Pharmaceuticals amended its collaboration agreement with Viatris for the development of cenerimod. Under the revised terms, Idorsia's contribution toward the drug's 2025 development costs was reduced by USD 100 million. In exchange, the company agreed to a USD 250 million reduction in future regulatory and commercial milestone payments while granting Viatris expanded territorial commercialization rights for cenerimod. AbbVie's RINVOQ (upadacitinib) JAK 1 inhibitor Upadacitinib (ABT-494) is a selective inhibitor of Janus kinase 1 (JAK1) that is approved for the treatment of several immune-mediated inflammatory diseases, including ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. In addition to its approved indications, the therapy is currently under clinical investigation for potential use in alopecia areata, hidradenitis suppurativa (HS), systemic lupus erythematosus (SLE), Takayasu arteritis, and vitiligo. AbbVie's RINVOQ (upadacitinib) continues to be an interesting lupus asset after its Phase 2 SLEek study showed meaningful activity in moderate to severe systemic lupus erythematosus, with the 30 mg monotherapy arm meeting the primary endpoint and achieving steroid-sparing benefit versus placebo. Updated data presented in 2023 also showed durability through 48 weeks, with fewer flares, longer time to first flare, and sustained improvements in disease-activity measures such as SRI-4, BICLA, and LLDAS, while no new safety signals were reported. The key development story is that AbbVie advanced RINVOQ into Phase 3 lupus testing after the positive Phase 2 readout, but it did not move forward with the ABBV-599 combination because elsubrutinib did not add enough efficacy to justify development. Find out more about top SLE CAR-T pipeline assets @ Systemic Lupus Erythematosus Clinical Trials Source: Systemic Lupus Erythematosus Market Report Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2036 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 SLE companies, including GlaxoSmithKline, AstraZeneca, Genentech (Roche), AbbVie, Bristol Myers Squibb, Novartis, MorphoSys, UCB Pharma, Biogen, Juno Therapeutics, Johnson & Johnson Innovative Medicine, Idorsia Pharmaceuticals, Viatris, Merck, and others. Related Reports Systemic Lupus Erythematosus Clinical Trial Analysis Complement 3 Glomerulopathy Pipeline Insight – 2026 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key SLE companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Therapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, and others. JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 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 JAK inhibitors companies, including Incyte Corporation, Aclaris Therapeutics, Sareum, Takeda, AstraZeneca, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Arcutis Biotherapeutics, Reistone Biopharma, and others. FcRn Inhibitors Market FcRn Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 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 FcRn inhibitors companies, including Immunovant, Viridian Therapeutics, argenx, and others. TSLP Inhibitors Market TSLP Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 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 TSLP inhibitors companies, including Sanofi, Uniquity Bio, Upstream Bio, Keymed Biosciences, Belenos Bioscience, Biosion, Pfizer, and 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 SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

Phase 3Phase 2Clinical ResultImmunotherapyFast Track

23 Mar 2026

·www.prnewswire.com

Viatris Advances Innovative Portfolio with Approval of Effexor® in Japan for Adults with Generalized Anxiety Disorder (GAD)

Addresses a Significant Unmet Need in Japan as First and Only Approved Treatment Option for GAD PITTSBURGH, March 23, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Effexor® SR 37.5 mg / 75 mg capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor (SNRI), for the treatment of adults with generalized anxiety disorder (GAD). Following the MHLW's decision, Effexor® becomes the first and only approved treatment option in Japan for adults living with GAD, addressing a long-standing unmet medical need in mental health and enabling new access to care. Effexor® is currently approved in Japan for the indication of major depressive disorder in adults, and with this approval, is now available to patients with GAD. GAD is among the most prevalent and highly disabling mental health conditions, negatively impacting patients' quality of life and disrupting activities of daily living. A recent study reported the prevalence of probable GAD in Japan as 7.6% of the general population.1 "The approval of Effexor® in Japan for generalized anxiety disorder demonstrates the successful execution of our strategy to advance a differentiated and increasingly innovative portfolio in Japan, bringing forward value-added therapies that address a significant unmet need," said Philippe Martin, Viatris Chief R&D Officer. "This approval also reflects our ability to effectively implement an optimized lifecycle strategy for our established brands and to leverage our deep local expertise." "This approval marks the introduction of a new treatment option for adults in Japan living with GAD," said Corinne Le Goff, Viatris Chief Commercial Officer. "We look forward to leveraging our strong infrastructure and deep expertise in central nervous system therapies in Japan to bring access to this much needed treatment to patients." The approval of Effexor® for GAD is based on a Phase 3 placebo-controlled, randomized, double-blind, multicenter study of venlafaxine in patients with GAD conducted in Japan (Study B2411367), which achieved its primary objective of superiority of anxiolytic effects of venlafaxine compared to placebo at 8 weeks, based on the change in the Hamilton Anxiety Rating Scale (HAM-A) total score from baseline (two-sided p-value=0.012). All seven secondary efficacy endpoints as defined by the trial protocol were met. Effexor® was generally well tolerated with a profile consistent with its known safety profile in non-Japanese patients. In particular: Low discontinuation rates due to treatment emergent adverse events (TEAEs) were seen (7.3% vs 1.7% in placebo) with 3.9% vs 0.6% assessed as related to treatment. No serious TEAEs or TEAEs with severe intensity were observed (0% vs 1.1% and 0.6%, respectively, in placebo). These results and the results of a long-term extension study of venlafaxine in Japanese outpatients with GAD were included as part of the applications for approval. Effexor® is currently approved to treat GAD in more than 80 countries outside of Japan. About Generalized Anxiety Disorder (GAD) Generalized Anxiety Disorder (GAD) is a mental health disorder whose central symptom is chronic and uncontrollable "anxiety" or "worry" about everyday life events or activities. Other symptoms include difficulty to get enough sleep, muscle tension/stiffness, feeling restless, irritable, or finding it difficult to concentrate, which may cause impairment in social, occupational, or other areas of functioning. In Japan, the World Health Organization reports that 2.6% of the population will suffer from GAD in their lifetime. A recent study in Japan reported the prevalence of probable GAD is 7.6%1, suggesting that this condition may be significantly underdiagnosed. About Viatris' Innovative Portfolio in Japan Viatris' portfolio of innovative products in Japan includes approved products such as Spydia ® Nasal Spray (diazepam) for the treatment of status epilepticus. The company's pipeline in Japan includes investigational products such as pitolisant for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea syndrome and narcolepsy, and products in pivotal Phase 3 trials which are currently ongoing, such as selatogrel in acute myocardial infarction (AMI), Nefecon in IgA nephropathy, and cenerimod in systemic lupus erythematosus (SLE). About Viatris Viatris Inc. (Nasdaq: VTRS) is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a dynamic portfolio that spans generics, established brands and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai, China, and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X. References: Matsuyama S, Otsubo T, Nomoto K, Higa S, Takashio O. Prevalence of Generalized Anxiety Disorder in Japan: A General Population Survey. Neuropsychiatr Dis Treat. 2024;20:1355-1366. Forward-Looking Statements This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements that Viatris advances innovative portfolio with approval of Effexor® in Japan for adults with GAD; addresses a significant unmet need in Japan as first and only approved treatment option for GAD; the approval of Effexor® in Japan for generalized anxiety disorder demonstrates the successful execution of our strategy to advance a differentiated and increasingly innovative portfolio in Japan, bringing forward value-added therapies that address a significant unmet need; this approval also reflects our ability to effectively implement an optimized life cycle strategy for our established brands and leverage our deep local expertise; we look forward to leveraging our strong infrastructure and deep expertise in central nervous system therapies in Japan to bring access to this much needed treatment to patients; and the outcome of clinical trials. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the uncertainties inherent in research and development, including the outcomes of clinical trials; the ability to meet anticipated clinical endpoints; the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from clinical studies; failure to achieve the intended benefits of our strategic initiatives and priorities; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; failure to achieve expected or targeted future financial and operating performance and results; Viatris' or its partners' ability to develop, manufacture, and commercialize products; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; any significant breach of data security or data privacy or disruptions to our IT systems; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. SOURCE Viatris Inc. 21% more press release views with Request a Demo

Clinical ResultPhase 3Drug Approval

19 Mar 2026

·www.prnewswire.com

Viatris to Outline its Vision for Sustained Revenue and Earnings Growth Through 2030

Growing Base Business Evolving Into More Durable Portfolio of Higher-Margin Generics, Value-Added Medicines and Established Brands Expecting Impactful Near-Term Launches, Including Fast-Acting Meloxicam and Low-Dose Estrogen Weekly Patch in the U.S., and Pitolisant and Effexor® for GAD in Japan Unlocking Long-Term Value Through Potential Blockbusters Selatogrel and Cenerimod Strong Cash Flow Generation Enabling Capital Return and Disciplined Business Development Providing Long-Term Targets for Sustained Growth Through 2030 PITTSBURGH, March 19, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS) will host its Investor Event today, where members of the executive leadership team will outline the Company's strategic vision, key drivers and financial framework expected to deliver sustained revenue and earnings growth through 2030. Executive Commentary "Over the past several years, we have taken decisive actions to strengthen the foundation of Viatris by simplifying the portfolio, strengthening the balance sheet and stabilizing the base business," said Scott A. Smith , CEO, Viatris. "Today, we are entering the next phase of our evolution. With a growing base business, multiple anticipated near-term launches, a promising innovative pipeline and the financial flexibility to pursue disciplined accretive business development, we believe Viatris is well positioned to deliver sustained revenue and earnings growth through the end of the decade while continuing to create value for patients and shareholders." "Our diversified portfolio and strong cash flow generation provide significant financial flexibility to invest in growth while maintaining a disciplined capital allocation framework," said Doretta Mistras , CFO, Viatris. "We expect to have more than $11 billion in cash available for deployment through 2030, which would enable us to return capital to shareholders and pursue accretive business development to further strengthen our long-term growth profile." Key Elements to be Highlighted at the Investor Event During the event, the Company will highlight key elements supporting its long-term growth targets, including its: Strategic vision and priorities R&D capabilities and pipeline overview Commercial capabilities and building blocks of growth Portfolio strategy and business development Financial framework for accelerating shareholder value The Company believes these elements collectively support its framework for delivering sustained revenue and earnings growth through 2030. Long-Term Financial Targets and Capital Allocation At the event, the Company will also outline its long-term financial targets through 2030, including the capital allocation framework intended to support its future growth. For its Combined Long-Term Targets through 2030, the Company expects to deliver 5% to 6% Total Revenues CAGR, 7% to 8% Adjusted EBITDA CAGR, 9% to 10% Adjusted EPS CAGR and more than $3 billion in annual free cash flow in 2030. The Combined Long-Term Targets are comprised of the Company's Base Case Long-Term Targets and Potential Additional Drivers. For its Base Case Long-Term Targets through 2030, Viatris expects its base business, supported by anticipated upcoming launches of value-added medicines, to deliver 3% to 4% Total Revenues CAGR, 4% to 5% Adjusted EBITDA CAGR, including operating leverage from the cost savings resulting from its Enterprise-Wide Strategic Review, 6% to 7% Adjusted EPS CAGR, including the benefit from future expected share repurchases, and more than $2.7 billion in annual free cash flow in 2030. As part of its recently completed Enterprise-Wide Strategic Review, Viatris identified approximately $650 million in gross cost savings over a three-year period, with up to $250 million expected to be reinvested in the Company. Potential Additional Drivers include expected growth from accretive business development and the potential launches of selatogrel and cenerimod. The Company expects more than $11 billion in cash available for deployment through 2030 under its Base Case Long-Term Targets and has assumed that approximately 50% of the cash available for deployment through 2030 will be allocated to disciplined accretive business development. Investor Event Webcast A live webcast of the Investor Event will begin today at 10:00 a.m. ET and can be accessed on the Company's website at investor.viatris.com. Presentation materials and a replay of the webcast will also be available on the Company's website. Certain Key Terms and Presentation Matters Revenue and Earnings : Refers to Total Revenues, Adjusted EBITDA and Adjusted EPS. Key Exchange Rates Our 2026 financial guidance and long-term financial targets are based on the following budgeted exchange rates: Euro ($/EUR) 0.87, China Renminbi ($/CNY) 7.19, Japanese Yen ($/JPY) 144.35, and Indian Rupee ($/INR) 85.80. About Viatris Viatris Inc. (Nasdaq: VTRS) is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a dynamic portfolio that spans generics, established brands and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai, China, and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X. Forward-Looking Statements This press release contains "forward-looking statements". These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include, without limitation, statements about: long-term financial targets; vision for sustained revenue and earnings growth through 2030; growing base business evolving into more durable portfolio of higher-margin generics, value-added medicines and established brands; expecting impactful near-term launches, including fast-acting meloxicam and low-dose estrogen weekly patch in the U.S., and pitolisant and Effexor® for GAD in Japan; unlocking long-term value through potential blockbusters selatogrel and cenerimod; strong cash flow generation enabling capital return and disciplined business development; providing long-term targets for sustained growth through 2030; the Company's strategic vision, key drivers and financial framework expected to deliver sustained revenue and earnings growth through 2030; today, we are entering the next phase of our evolution; with a growing base business, multiple anticipated near-term launches, a promising innovative pipeline and the financial flexibility to pursue disciplined accretive business development, we believe Viatris is well positioned to deliver sustained revenue and earnings growth through the end of the decade while continuing to create value for patients and shareholders; our diversified portfolio and strong cash flow generation provide significant financial flexibility to invest in growth while maintaining a disciplined capital allocation framework; we expect to have more than $11 billion in cash available for deployment through 2030, which would enable us to return capital to shareholders and pursue accretive business development to further strengthen our long-term growth profile; key elements supporting long-term growth targets, including: strategic vision and priorities, R&D capabilities and pipeline overview, commercial capabilities and building blocks of growth, portfolio strategy and business development, financial framework for accelerating shareholder value; the Company believes these elements collectively support its framework for delivering sustained revenue and earnings growth through 2030; the capital allocation framework intended to support its future growth; Combined Long-Term Targets through 2030 of 5% to 6% Total Revenues CAGR, 7% to 8% Adjusted EBITDA CAGR, 9% to 10% Adjusted EPS CAGR and more than $3 billion in annual free cash flow in 2030; Combined Long-Term Targets are comprised of the Company's Base Case Long-Term Targets and Potential Additional Drivers; for Base Case Long-Term Targets through 2030, Viatris expects its base business, supported by anticipated upcoming launches of value-added medicines, to deliver 3% to 4% Total Revenues CAGR, 4% to 5% Adjusted EBITDA CAGR, including operating leverage from the cost savings resulting from its Enterprise-Wide Strategic Review, 6% to 7% Adjusted EPS CAGR, including the benefit from future expected share repurchases, and more than $2.7 billion in annual free cash flow in 2030; as part of its recently completed Enterprise-Wide Strategic Review, Viatris identified approximately $650 million in gross cost savings over a three-year period, with up to $250 million expected to be reinvested in the Company; Potential Additional Drivers include expected growth from accretive business development and the potential launches of selatogrel and cenerimod; the Company expects more than $11 billion in cash available for deployment through 2030 under its Base Case Long-Term Targets and has assumed that approximately 50% of the cash available for deployment through 2030 will be allocated to disciplined accretive business development; the goals or outlooks with respect to the Company's strategic initiatives and priorities, including but not limited to divestitures, acquisitions, strategic alliances, collaborations and partnerships, or other potential transactions; the anticipated benefits of such strategic initiatives or priorities, or restructuring activities; future opportunities for the Company and its products; regulatory submissions and decisions; the outcomes of clinical trials and research studies; R&D and new product development; launch plans; and any other statements regarding the Company's future operations, financial or operating results, capital allocation, dividend policy and payments, share repurchases, debt ratio and covenants, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, imperatives; competitions, commitments, confidence in future results, efforts to create, enhance or otherwise unlock value, and other expectations and targets for future periods. Forward-looking statements may often be identified by the use of words such as "will", "may", "could", "should", "would", "project", "believe", "anticipate", "expect", "plan", "estimate", "forecast", "potential", "pipeline", "intend", "continue", "target", "seek" and variations of these words or comparable words. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the possibility that the Company may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives and priorities; the possibility that the Company may be unable to achieve the intended or expected benefits of its enterprise-wide strategic review and related cost-saving and restructuring activities within the expected timeframe or at all; the possibility that the Company may be unable to achieve intended or expected benefits in connection with divestitures, acquisitions, strategic alliances, collaborations, or other transactions, or restructuring programs, within the expected timeframes or at all; goodwill or impairment charges or other losses; success of clinical trials and the Company's or its partners' ability to execute on new product opportunities and develop, manufacture and commercialize products; any changes in or difficulties with the Company's manufacturing facilities, including with respect to short- or long-term shutdowns, inspections, remediation and restructuring activities, supply chain continuity, inventory management, or the ability to meet anticipated demand; the Company's failure to achieve expected or targeted future financial and operating performance and results; the potential impact of natural or man-made disasters, public health outbreaks, fires, accidents, weather, unrest or other emergencies in regions where we or our partners or suppliers operate; actions and decisions of healthcare and pharmaceutical regulators; changes in relevant laws, regulations and policies and/or the application or implementation thereof, including but not limited to tax, healthcare and pharmaceutical laws, regulations and policies globally; the ability to attract, motivate and retain key personnel; the Company's liquidity, capital resources and ability to obtain financing; any regulatory, legal or other impediments to the Company's ability to bring new products to market; products in development that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; the scope, timing and outcome of any ongoing legal proceedings, including government inquiries or investigations, and the impact of any such proceedings on the Company; any significant breach of data security or data privacy or disruptions to our IT systems; risks associated with having significant operations globally; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in the Company's or its partners' customer and supplier relationships and customer purchasing patterns, including customer loss and business disruption being greater than expected following an adverse regulatory action, acquisition or divestiture; the impacts of competition, including decreases in sales or revenues as a result of the loss of market exclusivity for certain products; changes in the economic and financial conditions of the Company or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential for adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and inherent uncertainties involved in the estimates and judgments used in the preparation of financial statements, and the providing of estimates of financial measures, in accordance with U.S. GAAP and related standards or on an adjusted basis. For more detailed information on the risks and uncertainties associated with Viatris Inc. ("Viatris" or the "Company"), see the risks described in Part I, Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2025, and our other filings with the SEC. You can access Viatris' filings with the SEC through the SEC website at or through our website and Viatris strongly encourages you to do so. Viatris routinely posts information that may be important to investors on our website at investor.viatris.com, and we use this website address as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). The contents of our website are not incorporated into this press release or our filings with the SEC. Viatris undertakes no obligation to update any statements herein for revisions or changes after the date of this press release other than as required by law. In particular, certain statements in this release relate to our "long-term financial targets", including but not limited to providing long-term targets for 2026-2030, including base case long-term target CAGR of 3-4% for Total Revenues, 4-5% for Adjusted EBITDA, 6-7% for Adjusted EPS; >$2.7B base case long-term target for free cash flow by 2030; potential additional drivers for selatogrel and cenerimod of +1% for total revenues and 0% for Adjusted EBITDA and Adjusted EPS; potential additional drivers for accretive business development of 1% for Total Revenues and 3% for Adjusted EBITDA and Adjusted EPS; combined long-term target CAGR of 5-6% for Total Revenues, 7-8% for Adjusted EBITDA and 9-10% for Adjusted EPS; >$3B combined long-term target free cash flow by 2030; and >$11 billion in cash available for deployment by 2030. Viatris believes that the assumptions used as a basis for the long-term financial targets are reasonable based on the information available to management at this time. However, this information is not fact, and you are cautioned not to place undue reliance on any such information. While certain of these statements might use language that imply a level of certainty about the likelihood that Viatris will attain its long-term financial targets, it is possible that Viatris will not attain them in the timeframe noted or at all. The long-term financial targets reflect assumptions as to key exchange rates as well as regarding certain business decisions that are subject to change. Important factors that may affect actual results and cause the long-term financial targets not to be achieved, or that may change the underlying variables and assumptions on which the long-term financial targets were based and cause the long-term financial targets to differ materially, include, but are not limited to, risks and uncertainties relating to our strategic priorities and initiatives, restructuring activities, inability to manage base business erosion, failure to bring new products to market on the expected timeframes or at all, failure to execute stock repurchases consistent with current expectations, stock price volatility, higher than anticipated SG&A, gross margins and R&D spend, industry performance, interest rate volatility, foreign exchange rates, tax rates, the regulatory environment and general business and economic conditions, as well as those set forth in the first paragraph of this "Forward Looking Statements" slide. In addition, although certain of the long-term financial targets are presented with numerical specificity, they are still forward-looking statements that involve inherent risks and uncertainties. Further, the long-term financial targets cover multiple years and such information by its nature becomes less reliable with each successive year. Accordingly, there can be no assurance that any aspect of long-term financial targets will be realized or that actual results will not differ materially. Therefore, you should construe these statements regarding the long-term financial targets only as goals, targets and objectives rather than promises of future performance or absolute statements. Non-GAAP Financial Measures This press release includes the presentation and discussion of certain financial information that differs from what is reported under accounting principles generally accepted in the United States ("U.S. GAAP"). These non-GAAP financial measures, including, but not limited to, adjusted EBITDA, free cash flow, and adjusted EPS are presented in order to supplement investors' and other readers' understanding and assessment of the financial performance of Viatris. Free cash flow refers to U.S. GAAP net cash provided by operating activities less capital expenditures. Adjusted EBITDA refers to as U.S. GAAP net earnings (loss) adjusted for income tax provision (benefit), interest expense and depreciation and amortization (to calculate EBITDA) and further adjusted for share-based compensation expense, litigation settlements and other contingencies, net, loss on divestitures of businesses, impairment of goodwill and restructuring, acquisition and divestiture related and other special items. Adjusted EPS refers to adjusted net earnings divided by the weighted average number of diluted shares of common stock outstanding. Investors and other readers should consider non-GAAP measures only as supplements to, not as substitutes for or as superior measures to, the measures of financial performance prepared in accordance with U.S. GAAP. Long-Term Financial Targets The Company is not providing forward-looking information for U.S. GAAP net (loss) earnings, EPS or U.S. GAAP net cash provided by operating activities or a quantitative reconciliation of its long-term targets for adjusted EBITDA CAGR, adjusted EPS CAGR and free cash flow to their most directly comparable U.S. GAAP measures, U.S. GAAP net earnings (loss) CAGR, EPS CAGR and U.S. GAAP net cash provided by operating activities, respectively, because it is unable to predict with reasonable certainty the ultimate outcome of certain significant items, including integration, acquisition and divestiture-related expenses, restructuring expenses, asset impairments, litigation settlements, future share repurchases, and other contingencies, such as changes to contingent consideration, acquired IPR&D and certain other gains or losses, including for the fair value accounting impact for equity investments, as well as related income tax accounting because certain of these items have not occurred, are out of the Company's control and/or cannot be reasonably predicted without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on U.S. GAAP reported results for the relevant periods. SOURCE Viatris Inc. 21% more press release views with Request a Demo

Financial Statement

100 Deals associated with Cenerimod

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KEGG	Wiki	ATC	Drug Bank
D11283	-	-	DB12705

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lupus Nephritis	Phase 3	China	Corden Pharma GmbH	16 Jan 2026
Lupus Nephritis	Phase 3	China	Viatris, Inc.	16 Jan 2026
Lupus Nephritis	Phase 3	China	Idorsia (Beijing) Pharmaceuticals Co., Ltd.	16 Jan 2026
Systemic Lupus Erythematosus	Phase 3	Japan	Viatris, Inc.	13 Dec 2022
Systemic Lupus Erythematosus	Phase 3	Argentina	Viatris, Inc.	13 Dec 2022
Systemic Lupus Erythematosus	Phase 3	Brazil	Viatris, Inc.	13 Dec 2022
Systemic Lupus Erythematosus	Phase 3	Bulgaria	Viatris, Inc.	13 Dec 2022
Systemic Lupus Erythematosus	Phase 3	Colombia	Viatris, Inc.	13 Dec 2022
Systemic Lupus Erythematosus	Phase 3	France	Viatris, Inc.	13 Dec 2022
Systemic Lupus Erythematosus	Phase 3	Greece	Viatris, Inc.	13 Dec 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03742037 (CARE, ACR2025)	Phase 2	Systemic Lupus Erythematosus	427	Cenerimod 4 mg	evjfnarbjd(avgbgkoubd) = eqobkjxygo kmhrbhkbad (zhaeuzhbqx ) View more	Positive	24 Oct 2025
				Placebo	evjfnarbjd(avgbgkoubd) = ljeotuuuwv kmhrbhkbad (zhaeuzhbqx ) View more
NCT03742037 (CARE, EULAR2025)	Phase 2	Systemic Lupus Erythematosus	427	Cenerimod 0.5 mg	ccmynmqjqn(koxnofydyc) = nirkgsdnfl lfxhgzasof (vrpxqxvqer )	Positive	11 Jun 2025
				Placebo	ccmynmqjqn(koxnofydyc) = ybpfulhjww lfxhgzasof (vrpxqxvqer )
NCT03742037 (CARE, EULAR2023)	Phase 2	IFN-1 gene expression signature \| anti-dsDNA antibody levels	427	Cenerimod 4 mg	bfcwvshjnp(yaxxpusefw) = cgdmejosfw vgfppzsuga (eapqdrfgap ) View more	Positive	31 May 2023
				Placebo	bfcwvshjnp(yaxxpusefw) = bxdjuowpcp vgfppzsuga (eapqdrfgap ) View more
NCT03742037 (ACR2022) Manual	Phase 2	Systemic Lupus Erythematosus	427	Cenerimod	ilcalmrxla(xmvoqaafwu) = AEs were similar across treatment groups. The % of reported hypertension AEs was higher in the cenerimod 1 and 4 mg groups vs PBO ejhyrixsxw (xjdmoytmlf )	-	12 Sep 2022
NCT02472795 (CTgov)	Phase 1/2	Systemic Lupus Erythematosus	105	Cenerimod (Cenerimod 0.5 mg (Part A))	bqgzzoutqh(hnklkvdtec) = xgqznuzcsh fzyhsdcoyu (mvnsqwnwhg, 0.48) View more	-	26 Feb 2020
				Cenerimod (Cenerimod 1 mg (Part A))	bqgzzoutqh(hnklkvdtec) = oeetymncxl fzyhsdcoyu (mvnsqwnwhg, 0.68) View more
NCT02472795 (Pubmed \| Lupus Sci Med)	Phase 1/2	Systemic Lupus Erythematosus	105	Cenerimod 0.5 mg	rzcqhofeav(wfylozyepg) = deorxxzcer mznpcefmww (ipoanamynl )	Positive	01 Jan 2019
				Cenerimod 1 mg	rzcqhofeav(wfylozyepg) = bellpzmnye mznpcefmww (ipoanamynl )

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