Last reviewed · How we verify
M281
At a glance
| Generic name | M281 |
|---|---|
| Also known as | Nipocalimab, JNJ-80202135 |
| Sponsor | Janssen Research & Development, LLC |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN) (PHASE2)
- Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia (PHASE2, PHASE3)
- Nipocalimab in Moderate to Severe Sjogren's Disease (PHASE3)
- A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) (PHASE3)
- Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (PHASE2, PHASE3)
- A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis (PHASE2, PHASE3)
- A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis (PHASE3)
- A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- M281 CI brief — competitive landscape report
- M281 updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI