Narsoplimab

mAbapprovedOrphan Drug FDA

Approved

Dec 23, 2025

Clinical trial activity

6 trials · 2 clinical orgs · 0 marketing orgs

Phase 1
0
Phase 2
5
Phase 3
2
Phase 4
0

Earliest trial started Aug 1, 2014 (NCT02222545)

Timeline

2010s

  1. Jan 1, 2014

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2017

    Earliest Phase 3 Sponsor(trial)

  3. Oct 22, 2018

    Orphan Drug Designation

2020s

  1. Dec 23, 2025

    Earliest FDA Approval

Indications

Mechanism of action

Approval history

  • approvedDec 23, 2025

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • oms721

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05855083Phase 2May 1, 2023Omeros Corporation
NCT03608033Phase 3Feb 16, 2018Omeros Corporation
NCT03205995Phase 3Feb 23, 2017Omeros Corporation
NCT02682407Phase 2Feb 1, 2016Omeros Corporation
NCT02355782N/AJan 28, 2015Medical University of Lodz
NCT02222545Phase 2Aug 1, 2014Omeros Corporation
Showing 6 of 6 trials
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Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Omeros CorporationFor profit5522014
Medical University of LodzAcademic/Hospital1112015
2 organizations
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