Fabhalta
(Nipocalimab)Phase 3Monoclonal antibody
Johnson & JohnsonNipocalimab is used to treat a blood disorder called myasthenia gravis, where the immune system mistakenly attacks muscles and causes weakness and fatigue.[1] Fabhalta is currently being investigated across 19 indications[3], with its most advanced program in Phase 3.[1]
Fabhalta is one of 271 small molecule programs targeting Chronic Inflammatory Demyelinating Polyneuropathy. It is currently in Phase 3.
19
Indications
21
Total Trials
11
Active Trials
270
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[3][1]
Indication
Showing 10 of 19 indications
Competition
Competitive Landscape
791 competitors in Rheumatoid Arthritis
#DrugCompanyPhaseTrials
1Fabhalta
Johnson & JohnsonPhase 3
Rituxan
RochePreclinical
Simponi
Johnson & JohnsonPreclinical
Enbrel
IImmunex
Preclinical
Kineret
SSwedish Orphan Biovitrum
Preclinical
Cataflam
NovartisPreclinical
Rituxan
PfizerPreclinical
Vibramycin
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Preclinical
Certolizumab
Johnson & JohnsonPreclinical
Cimzia
UCBPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Myasthenia Gravis3 trials
Systemic Lupus Erythematosus2 trials
Rheumatoid Arthritis2 trials
Neonatal2 trials
11 more indications
Vaccine Response1 trial
Primary Sjogren's Syndrome1 trial
Idiopathic Inflammatory Myopathies1 trial
Warm Autoimmune Hemolytic Anemia1 trial
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating1 trial
Sjogren's Syndrome1 trial
Regulatory
FDA Approval Timeline[4]
Apr 29, 2025
IMAAVY
BLA BLA761430
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Nipocalimab. EMBL-EBI & Wellcome Sanger Institute.
- [4]
- [5]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Igg Receptor Fcrn Large Subunit P51 Antagonist[2]
- Modality
- Monoclonal antibody[2]
- Highest Phase
- Phase 3[1]
- Company