Narsoplimab
Also known as Yartemlea, Narsoplimab-wuug
OMEROS CORP OMER · Atypical Hemolytic Uremic Syndrome; Thrombotic Microangiopathies
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
Approved
BLA761152,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- OMEROS CORP OMER Source: Company record for OMEROS CORP (opens in a new tab)
- Indications
- Atypical Hemolytic Uremic Syndrome; Thrombotic Microangiopathies Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- BLA 761152 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761152 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 2 May 20181 linked trial
- Filed Completed
- Approved Current stageFirst approval 23 Dec 2025
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Narsoplimab. Editors add each one with its source.
Filed application
No filed application is on record for Narsoplimab. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Narsoplimab.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT03205995ClinicalTrials.gov record for NCT03205995 (opens in a new tab)aHUS | Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome | Phase 3 | Terminated | 6 (actual) | 2 Feb 2021 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03205995 (opens in a new tab) |
Posted results on ClinicalTrials.gov for aHUS Serious adverse events (From Day 1 to Final Study Visit (up to Day 771)): OMS721 (Narsoplimab) 5 of 6 Source: ClinicalTrials.gov results for NCT03205995 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing aHUS (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| BLA761152Action letter for BLA761152 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Opinion
Yartemlea (EMEA/H/C/005247)
- Authorised
- Not given
- Therapeutic area
- Thrombotic Microangiopathies;Hematopoietic Stem Cell Transplantation
- Marketing authorisation holder
- Omeros Ireland Limited
- Active substance (INN)
- Narsoplimab
- ATC code
- L01FX
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Yartemlea (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 761152 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT03205995 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA BLA761152 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.