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 3 indications[3], with its most advanced program in Phase 3.[1]
Fabhalta is one of 28 small molecule programs targeting Myasthenia Gravis. It is currently in Phase 3.
3
Indications
21
Total Trials
10
Active Trials
27
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[3][1]
Indication
Competition
Competitive Landscape
26 competitors in Myasthenia Gravis
#DrugCompanyPhaseTrials
1Ultomiris
AstraZenecaApproved
Vyvgart
ArgenxApproved
Rysodeg
UCBApproved
Rituxan
RochePhase 3
Rayos
RRoxane Laboratories
Approved
Proair HFA
GGlaxo Dba Glaxosmithkline
Approved
Actemra
RochePhase 3
Blincyto
AmgenPhase 3
UPLIZNA
HHorizon Therapeutics Ireland DAC
Phase 3
Telitacicept
VVor Biopharma
Phase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Myasthenia Gravis3 trials
Rheumatoid Arthritis2 trials
Neonatal2 trials
Primary Sjogren's Syndrome1 trial
12 more indications
ART1 trial
Vaccine Response1 trial
Systemic Lupus Erythematosus1 trial
Myositis1 trial
Sjogren's Syndrome1 trial
Lupus Erythematosus, Systemic1 trial
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating1 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