Pivekimab sunirine
Also known as Decnupaz, Pivekimab sunirine-pvzy
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
BLA761460,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- AbbVie Inc. ABBV Source: Company record for AbbVie Inc. (opens in a new tab)
- Indication
- Acute Myeloid Leukemia Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- BLA 761460 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761460 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 CompletedFirst trial start 30 Jun 20261 linked trial
- Phase 3 CompletedFirst trial start 30 Jun 20261 linked trial
- Filed Completed
- Approved Current stageFirst approval 27 May 2026
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 Pivekimab sunirine. Editors add each one with its source.
Filed application
No filed application is on record for Pivekimab sunirine. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Pivekimab sunirine.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07581002ClinicalTrials.gov record for NCT07581002 (opens in a new tab)REVIVAL | A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) | Phase 2/3 | Recruiting | 660 (estimated) | Jun 2032 (estimated) | No |
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 |
|---|---|---|---|---|---|
| BLA761460Action letter for BLA761460 (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)
EMA's medicines data lists no human medicine with the same active substance as Pivekimab sunirine.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 761460 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07581002 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA BLA761460 (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.