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Narsoplimab: First Approval.

Matt Shirley1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|May 17, 2026
PubMed
Summary
This summary is machine-generated.

Narsoplimab, a MASP-2 inhibitor, is now approved in the USA for treating hematopoietic stem cell transplantation-associated thrombotic microangiopathy (TA-TMA). This milestone follows its development for reducing complement pathway-mediated injury in TA-TMA patients.

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Area of Science:

  • Immunology
  • Hematology
  • Pharmacology

Background:

  • Narsoplimab is a monoclonal antibody targeting mannan-binding lectin-associated serine protease 2 (MASP-2).
  • It is developed for treating hematopoietic stem cell transplantation (HCT)-associated thrombotic microangiopathy (TA-TMA).
  • MASP-2 inhibition aims to reduce lectin complement pathway-mediated cellular injury.

Purpose of the Study:

  • To summarize the development milestones of narsoplimab.
  • To highlight the first regulatory approval of narsoplimab for TA-TMA.

Main Methods:

  • Review of narsoplimab's development pathway.
  • Analysis of regulatory submissions and approvals.

Main Results:

  • Narsoplimab received its first US approval in December 2025 for adult and pediatric patients (≥2 years) with TA-TMA.
  • A Marketing Authorisation Application is under review in the EU.

Conclusions:

  • Narsoplimab represents a significant advancement in TA-TMA treatment.
  • The drug's approval marks a key milestone in managing HCT-associated complications.