YARTEMLEA
YARTEMLEA (narsoplimab-wuug) is a MASP-2 inhibitor indicated for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The therapy is approved for use in adult and pediatric patients aged two years and older. It provides a targeted therapeutic option for managing the microvascular complications that can arise following a hematopoietic stem cell transplant.
How YARTEMLEA Works
Narsoplimab-wuug functions by inhibiting MASP-2, the effector enzyme of the lectin pathway in the complement system. This inhibition blocks the lectin-dependent activation of complement components C3 and C4 while leaving the classical and alternative pathways unaffected. In patients with TA-TMA, this process is intended to prevent lectin pathway-mediated damage to cells, specifically targeting the endothelial cells within small blood vessels.
Details
- Status
- Prescription
- First Approved
- 2025-12-23
- Routes
- N/A
- Dosage Forms
- INJECTION
YARTEMLEA Approval History
What YARTEMLEA Treats
1 indicationsYARTEMLEA is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Thrombotic Microangiopathy
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
YARTEMLEA FDA Label Details
ProIndications & Usage
FDA Label (PDF)YARTEMLEA is indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). YARTEMLEA is a MASP-2 inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.