Drug Profile
Nipocalimab - Johnson & Johnson
Alternative Names: Anti-FcRn monoclonal antibody - Johnson & Johnson; JNJ 80202135; M 281Latest Information Update: 13 Feb 2024
Price :
$50
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At a glance
- Originator Momenta Pharmaceuticals
- Developer Janssen Research & Development; Johnson & Johnson
- Class Anti-inflammatories; Antianaemics; Antirheumatics; Monoclonal antibodies; Recombinant proteins
- Mechanism of Action Neonatal Fc receptor antagonists
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Phase III Autoimmune haemolytic anaemia; Haemolytic disease of newborn; Myasthenia gravis
- Phase II/III Chronic inflammatory demyelinating polyradiculoneuropathy
- Phase II Myositis; Rheumatoid arthritis; Sjogren's syndrome; Systemic lupus erythematosus
- Phase I Unspecified
Most Recent Events
- 09 Feb 2024 Nipocalimab receives Breakthrough Therapy status for Haemolytic disease of newborn in USA
- 20 Dec 2023 Phase-III clinical trials in Haemolytic disease of newborn (In adults) in United Kingdom, Israel, Brazil, Australia, USA (IV) (NCT05912517) (EudraCT2021-002359-12) (EudraCT2022-502629-16-00)
- 30 Nov 2023 Janssen Research & Development completes a phase-II trial in Sjogren's syndrome (Adjunctive treatment) in USA, Taiwan, Portugal, Spain, Poland, Netherlands, Italy, Japan, France, Germany (IV) (EudraCT2021-000665-32) (NCT04968912)