Overview
Nipocalimab is under investigation in clinical trial NCT04119050 (Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
An Expert Report on Nipocalimab (Imaavy™): Mechanism, Clinical Development, and Strategic Positioning
Executive Summary
Nipocalimab, marketed under the brand name Imaavy™, represents a significant advancement in the treatment of immunoglobulin G (IgG)-mediated diseases. As a fully human, aglycosylated, effectorless monoclonal antibody, it operates by selectively blocking the neonatal Fc receptor (FcRn), a critical regulator of IgG homeostasis. Its molecular design, particularly its high-affinity, pH-independent binding to FcRn, distinguishes it within its therapeutic class and underpins a broad and ambitious clinical development program.
This report provides a comprehensive analysis of Nipocalimab, from its fundamental pharmacology to its clinical trial portfolio, recent regulatory approval, and strategic market positioning. The cornerstone of its clinical success to date is the landmark U.S. Food and Drug Administration (FDA) approval for generalized myasthenia gravis (gMG) in both adult and adolescent populations, granting it the broadest label in the FcRn inhibitor class at the time of its launch. This approval was based on the robust efficacy and safety data from the pivotal Phase 3 Vivacity-MG3 study, which demonstrated statistically significant and clinically meaningful improvements in disease activity and muscle strength, with evidence of long-term sustained disease control.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/19 | Phase 3 | Recruiting | |||
2024/08/01 | Phase 3 | Recruiting | |||
2024/06/10 | Phase 3 | Recruiting | |||
2023/09/08 | Phase 2 | Completed | |||
2023/06/22 | Phase 3 | Recruiting | |||
2023/04/25 | Phase 1 | Completed | |||
2022/05/18 | Phase 2 | Active, not recruiting | |||
2022/04/14 | Phase 2 | Recruiting | |||
2022/03/03 | Phase 2 | Recruiting | |||
2022/02/03 | N/A | TEMPORARILY_NOT_AVAILABLE |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.