cenerimod (ACT-334441) / Idorsia, Viatris, Nxera Pharma - LARVOL DELTA

Cenerimod, a selective S1PR1 modulator, induces changes in BCR and TCR repertoire in systemic lupus erythematosus: Post-hoc analysis from the placebo-controlled Phase 2b CARE trial (ACR Convergence 2026) - No abstract available

Clinical • P2b data • Retrospective data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • S1PR1

Transcriptional changes associated with cenerimod therapy, a selective S1PR1 modulator, in systemic lupus erythematosus: analysis from the placebo-controlled Phase 2b CARE trial (ACR Convergence 2026) - No abstract available

Clinical • P2b data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • S1PR1

OPUS-1: A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=470 | Active, not recruiting | Sponsor: Viatris Innovation GmbH | Trial completion date: May 2027 ➔ Sep 2027 | Trial primary completion date: Oct 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

OPUS OLE: Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=680 | Enrolling by invitation | Sponsor: Viatris Innovation GmbH | Trial completion date: May 2028 ➔ Sep 2032 | Trial primary completion date: May 2028 ➔ Sep 2032

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Cenerimod, a selective S1PR1 modulator, induces changes in BCR and TCR repertoire in systemic lupus erythematosus: post-hoc analysis from the placebo-controlled Phase 2b CARE trial (EULAR 2026) - P2, P3 | "Conclusions Cenerimod reshapes BCR and TCR repertoires in SLE after 6 months of treatment by reducing clone persistence and dominance while maintaining structural integrity. These changes suggest adaptive immune rebalancing and further support the therapeutic potential of cenerimod, currently under evaluation in three phase 3 trials in both SLE, OPUS 1 (NCT05672576) and OPUS 2 (NCT05648500), and lupus nephritis (NCT07201129)."

Clinical • IO biomarker • P2b data • Retrospective data • Glomerulonephritis • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Influenza • Leukopenia • Lupus • Lupus Nephritis • Nephrology • Respiratory Diseases • Systemic Lupus Erythematosus • S1PR1

Comparative effectiveness and safety of biologics and targeted small-molecule therapies plus stable background therapy in systemic lupus erythematosus: a systematic review and network meta-analysis. (PubMed, Front Immunol) - "For SRI-4 response, Telitacicept was superior to Belimumab and Ustekinumab outperformed Epratuzumab...Deucravacitinib and Anifrolumab were more effective for CLASI-50 achievement than Baricitinib. Anifrolumab, Iberdomide, and Telitacicept were associated with a higher incidence of AEs (e.g., upper respiratory tract infections, urinary tract infection, and herpes zoster) compared with other interventions, which may be related to their immunomodulatory mechanisms of action. Cenerimod was associated with the lowest risk of SAEs, and IL-2 showed the lowest risk of infection-related AEs. Telitacicept and Ustekinumab demonstrated superior efficacy for SRI-4 response; Upadacitinib superior for BICLA response and LLDAS achievement; Deucravacitinib and Anifrolumab showed advantages in CLASI-50 improvement, suggesting therapeutic potential for SLE with cutaneous manifestations. Although current findings indicate that these interventions have favorable efficacy and safety profiles,..."

Clinical • HEOR • Journal • Retrospective data • Review • Cutaneous Lupus Erythematosus • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Nephrology • Respiratory Diseases • Systemic Lupus Erythematosus • Varicella Zoster • IL2

A Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of Cenerimod in Adult Chinese Participants With Moderate-to-severe Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2 | N=15 | Active, not recruiting | Sponsor: Viatris Pharmaceuticals Co., Ltd. | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

ID-064-108: A trial to evaluate the absolute bioavailability of cenerimod in healthy male participants (clinicaltrialsregister.eu) - P1 | N=6 | Completed | Sponsor: Viatris Innovation GmbH | Recruiting ➔ Completed

Trial completion

Cenerimod: Data readout from P3 OPUS-1 trial (NCT05648500) for SLE by the end of 2026 (Idorsia) - Q1 2026 Results

P3 data • Lupus • Systemic Lupus Erythematosus

OPUS-1: A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=470 | Active, not recruiting | Sponsor: Viatris Innovation GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Trial to Evaluate the Absolute Bioavailability of Cenerimod in Healthy Male Participants (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Viatris Innovation GmbH | Active, not recruiting ➔ Completed

Trial completion

EFFECT OF CENERIMOD ON QUALITY OF LIFE IN SYSTEMIC LUPUS ERYTHEMATOSUS PATIENTS: RESULTS FROM THE PHASE 2 CARE STUDY (LUPUS 2026) - "Conclusions Patients with cenerimod 4 mg groups showed meaning full improvements in the mental and physical components of the SF-36v2 scores compared to placebo at month 6. Further evaluation of the SF-36v2 scores will be performed in the phase III program."

Clinical • HEOR • P2 data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • S1PR1

Transcriptional changes associated with cenerimod therapy, a selective S1PR1 modulator, in systemic lupus erythematosus: results from the placebo controlled Phase 2b CARE trial (LUPUS 2026) - P2 | "Cenerimod 2 mg showed less pronounced effects; placebo showed minimal changes.Abstract PO:11:303 Figure 1 Conclusions Transcriptional and cell subset analyses show that cenerimod modulates key pathogenic mechanisms such as interferon and T-cell signaling, while preserving host defense. These findings further support its therapeutic potential, currently evaluated in phase 3 trials (OPUS 1 and OPUS 2)."

Clinical • P2b data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD4 • CD8 • S1PR1

EFFECT OF CENERIMOD, AN S1P1 MODULATOR, ON FATIGUE IN SLE: RESULTS FROM THE PHASE 2 CARE STUDY (LUPUS 2026) - P2 | "The 4 mg group exhibited a greater median (IQR) change of 15.63 (3.13, 25.0) compared to placebo 0.00 (-9.38, 12.50) in the high IFN-1 gene expression subgroup (table 1). Conclusions Improvements in mSLEDAI-2K scores in SLE patients treated with cenerimod 4 mg for 6 months were paralleled by relevant improvements in fatigue scores compared to placebo in the subgroup of patients with high IFN-1 gene expression."

P2 data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • S1PR1

ID-064-108: A trial to evaluate the absolute bioavailability of cenerimod in healthy male participants (clinicaltrialsregister.eu) - P1 | N=6 | Recruiting | Sponsor: Viatris Innovation GmbH

New P1 trial

A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Viatris Innovation GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

OPUS-2: A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=451 | Active, not recruiting | Sponsor: Viatris Innovation GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Trial to Evaluate the Absolute Bioavailability of Cenerimod in Healthy Male Participants (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Viatris Innovation GmbH | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of Cenerimod in Adult Chinese Participants With Moderate-to-severe Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2 | N=15 | Enrolling by invitation | Sponsor: Viatris Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Trial to Evaluate the Absolute Bioavailability of Cenerimod in Healthy Male Participants (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Viatris Innovation GmbH

New P1 trial

A Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of Cenerimod in Adult Chinese Participants With Moderate-to-severe Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2 | N=15 | Not yet recruiting | Sponsor: Viatris Pharmaceuticals Co., Ltd.

New P2 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Post-hoc Analysis of Sustained Response Over Time in Systemic Lupus Erythematosus Patients Treated with Cenerimod in CARE (Phase 2 B) Study (ACR Convergence 2025) - P2, P3 | "This analysis showed that over a period of 12 months, patients in the cenerimod Ex-4 mg group were 1.43 times more likely to achieve a 4-month sustained response than those receiving placebo.The ongoing confirmatory Phase 3 program OPUS (NCT05648500 and NCT05672576) will further evaluate the safety and efficacy of 4 mg cenerimod in adults with SLE."

Clinical • P2b data • Retrospective data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Effect of Cenerimod on Four Main Clinical Items of SLEDAI-2K Score in SLE Patients in a Phase 2b Study (ACR Convergence 2025) - P2, P3 | "This post-hoc analysis provided insights to the trends in improvements of four individual SLEDAI-2K clinical components when patients were treated with cenerimod 4 mg dose for 6 months. There was no obvious difference in arthritis or rash scores vs placebo. However, as compared to placebo, better early improvement was seen in alopecia (from month 4) and mucosal ulcers (from month 4) until month 6."

Clinical • P2b data • Alopecia • Immunology • Inflammatory Arthritis • Lupus • Rheumatology • Systemic Lupus Erythematosus

CARE: Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P2 | N=427 | Completed | Sponsor: Viatris Innovation GmbH | Phase classification: P2b ➔ P2

Phase classification • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Viatris Innovation GmbH

New P3 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus