Cenerimod

Phase 3Small molecule

VViatris Innovation GmbH

Cenerimod is one of 8 small molecule programs targeting Nephritis, Lupus. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Nephritis, LupusRecruiting

Lupus Erythematosus, SystemicEnrolling by invitation

SLE - Systemic Lupus ErythematosusActive, not recruiting

Nephritis, LupusPhase 3

Recruiting

Lupus Erythematosus, SystemicPhase 3

Enrolling by invitation

SLE - Systemic Lupus ErythematosusPhase 2

Active, not recruiting

Competition

Competitive Landscape

7 competitors in Lupus Erythematosus, Systemic

#DrugCompanyPhaseTrials

Saphnelo

AstraZeneca

Phase 3

3 2

Fludara

Sanofi

Phase 2

2 3

Cytoxan

BBaxter Healthcare Corporation

Phase 2

2 4

Rapcabtagene Autoleucel

Novartis

Phase 2

1 5

Cenerimod

VViatris Innovation GmbH

Phase 3

3 6

Firsekibart

RRuijin Hospital

Phase 3

1 7

CC-97540

JJuno Therapeutics, Inc., a Bristol-Myers Squibb Company

Phase 2

1 8

AZD0120

AstraZeneca

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 3Active, not recruiting

Lupus Erythematosus, Systemic

NCT05672576

Q3 2027

Phase 3Active, not recruiting

Lupus Erythematosus, Systemic

NCT05648500

Q4 2027

Phase 2Active, not recruiting

SLE - Systemic Lupus Erythematosus

NCT07266090

Q1 2030

Phase 3Recruiting

Nephritis, Lupus

NCT07201129

Clinical

Trials by Indication[1]

Lupus Erythematosus, Systemic3 trials

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy

Active, not recruiting·VViatris Innovation GmbH·Phase 3·NCT05672576·451 enrolled

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy

Active, not recruiting·VViatris Innovation GmbH·Phase 3·NCT05648500·470 enrolled

A Phase 3, Multicenter, Open-label, Single-arm, Extension Study to Evaluate the Long-term Safety and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy

Enrolling by invitation·VViatris Innovation GmbH·Phase 3·NCT06475742·680 enrolled

Systemic Lupus Erythematosus2 trials

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE)

Completed·VViatris Innovation GmbH·Phase 2·NCT03742037·427 enrolled

A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus

Completed·VViatris Innovation GmbH·Preclinical·NCT02472795·105 enrolled

Women1 trial

To Study the Effect of Cenerimod on the Electrical Activity of the Heart, in Men and Women. To Study the Effect of Cenerimod on the Use of Oral Contraceptives in Women. To Study the Effect That Charcoal Has on the Elimination of Cenerimod From the Body, in Women and Men.

Completed·VViatris Innovation GmbH·Phase 1·NCT04255277·97 enrolled

Hepatic Impairment1 trial

A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of Cenerimod

Completed·VViatris Innovation GmbH·Phase 1·NCT04819464·24 enrolled

Impairment1 trial

The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics

Completed·VViatris Innovation GmbH·Phase 1·NCT05004311·16 enrolled

4 more indications

Oral1 trial

Single Oral Dose of 4 mg Cenerimod in Healthy Japanese and Caucasian Subjects

Completed·VViatris Innovation GmbH·Phase 1·NCT04052360·20 enrolled

Nephritis, Lupus1 trial

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

Recruiting·VViatris Innovation GmbH·Phase 3·NCT07201129·300 enrolled

SLE - Systemic Lupus Erythematosus1 trial

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

Active, not recruiting·VViatris Pharmaceuticals Co., Ltd.·Phase 2·NCT07266090·15 enrolled

Unspecified2 trials

A Study to Evaluate Cenerimod in Healthy Male Subjects

Completed·VViatris Innovation GmbH·Phase 1·NCT02914223·6 enrolled

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

Completed·VViatris Innovation GmbH·Phase 1·NCT07301723·6 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Cenerimod. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cenerimod compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cenerimod. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Viatris Innovation GmbH company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: VViatris Innovation GmbH

Cenerimod

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q4 2027

Q1 2030

Trials by Indication[1]

Lupus Erythematosus, Systemic3 trials

Systemic Lupus Erythematosus2 trials

Women1 trial

Hepatic Impairment1 trial

Impairment1 trial

Oral1 trial

Nephritis, Lupus1 trial

SLE - Systemic Lupus Erythematosus1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

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