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Yartemlea (NARSOPLIMAB)
Narsoplimab works by targeting and modulating the immune system to prevent damage to blood vessels.
At a glance
| Generic name | NARSOPLIMAB |
|---|---|
| Sponsor | Omeros Corp |
| Modality | Monoclonal antibody |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Narsoplimab-wuug inhibits MASP-2, the effector enzyme of the lectin pathway of the complement system, blocking lectin-dependent activation of complement component 3 (C3) and C4 without affecting the classical and alternative pathways of complement. In hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), MASP-2 inhibition is thought to prevent lectin pathway-mediated cellular injury, including endothelial cell injury in small blood vessels.
Approved indications
- hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA)
Common side effects
- Viral infections
- Sepsis
- Hemorrhage
- Diarrhea
- Vomiting
- Nausea
- Neutropenia
- Pyrexia
- Fatigue
- Hypokalemia
- Acute kidney injury
- Confusional state
Key clinical trials
- Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721 (PHASE2)
- I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients (PHASE2)
- Single Patient Expanded Access Treatment Plan For The Investigational Product Narsoplimab
- Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome (PHASE3)
- Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy (PHASE3)
- Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA (PHASE2)
- Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies (PHASE2)
- OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Yartemlea CI brief — competitive landscape report
- Yartemlea updates RSS · CI watch RSS
- Omeros Corp portfolio CI