MedPath

Nipocalimab

Generic Name
Nipocalimab
Drug Type
Biotech
CAS Number
2211985-36-1
Unique Ingredient Identifier
87M90CV8NC

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

Published: Jun 24, 2025

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.

Continue reading the full research report

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

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Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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No PPB approvals found for this drug.

TGA Drug Approvals

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ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

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No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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Company
License Number
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Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
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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.

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