Related Experiment Video
Updated: May 19, 2026
11:08
Advances in Human Induced Pluripotent Stem Cell-Derived Chimeric Antigen Receptor-Expressing Natural Killer Cells
Published on: February 14, 2025
Narsoplimab: First Approval
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
Drugs
|May 17, 2026
Summary
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.
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.
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