Ireland
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Priya Life Science Compound trial record
Compound · clinical trials

Pivekimab Sunirine clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 2 trials in our USA, France, South Korea, Taiwan, UK, Italy, Australia, China, Spain, Austria and Israel registers that name Pivekimab Sunirine as an intervention. Synced 9 Nov 2026
2Current trials
2Recruiting now
1Lead sponsor
11Country registers
At a glance

Pivekimab Sunirine is named as an intervention in 2 current clinical trials in our USA, France, South Korea, Taiwan, UK, Italy, Australia, China, Spain, Austria and Israel registers. 2 are recruiting patients now. The most common phase is Phase 1. The lead sponsor is AbbVie. The most-studied condition is Acute Myeloid Leukemia. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.

Where Pivekimab Sunirine is approved

All regulators →

Of the three regulators tracked here, the first to approve Pivekimab Sunirine was the US, on 27 May 2026.

USUnited States (FDA)
27 May 2026
Decnupaz
BLA761460 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC
  • 1 EU orphan designation, most recently for treatment of blastic plasmacytoid dendritic cell neoplasm (26 Jun 2020, positive)

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

How Pivekimab Sunirine works

All drug targets →
  • Interleukin-3 receptor subunit alpha binding agent Binding agent
    Target: Interleukin-3 receptor subunit alpha
    ✓ In ChEMBL and the Guide to Pharmacology
Diseases it has been tested for in clinical trials, by furthest phase
  • Acute myeloid leukemiaPhase 2/3
  • B-cell acute lymphoblastic leukemiaPhase 1/2
  • CD4+/CD56+ hematodermic neoplasmPhase 1/2
  • T-cell acute lymphoblastic leukemiaPhase 1/2
  • Mixed phenotype acute leukemiaPhase 1/2

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297991, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 14543, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Pivekimab Sunirine

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting2100%

Trials by phase

  • Phase 1150%
  • Phase 2/3150%
01

Clinical trials of Pivekimab Sunirine

2 trials
StudyPhaseStatusLead sponsorRegisters
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)
NCT07581002 · Acute Myeloid Leukemia
Phase 2/3 Recruiting AbbVie USA, China, France, Spain, Austria, South Korea, Taiwan, Israel
A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
NCT07306832 · Acute Myeloid Leukemia
Phase 1 Recruiting AbbVie UK, USA, France, Italy, South Korea, Taiwan, Australia

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Pivekimab Sunirine in the EU trials register (CTIS)

1 trial

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Pivekimab Sunirine. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

StudyPhaseStatusSponsorCountries
A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML).
2024-520125-36-00 · CTIS ↗ · Neoplasms
Phase 1 Ongoing AbbVie Deutschland GmbH & Co. KG Spain, Hungary, Czechia + 3 more
03

Conditions studied with Pivekimab Sunirine

1 condition
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
AbbVie2
05

By country register

RegisterTrialsRecruiting
Clinical trials in USA22
Clinical trials in France22
Clinical trials in South Korea22
Clinical trials in Taiwan22
Clinical trials in UK11
Clinical trials in Italy11
Clinical trials in Australia11
Clinical trials in China11
Clinical trials in Spain11
Clinical trials in Austria11
Clinical trials in Israel11
EU register (CTIS)1—

A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.

06

Related compounds

07

Questions about Pivekimab Sunirine trials

How many clinical trials are testing Pivekimab Sunirine?

2 current trials in our USA, France, South Korea, Taiwan, UK, Italy, Australia, China, Spain, Austria and Israel registers name Pivekimab Sunirine as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Pivekimab Sunirine trials recruiting patients?

Yes. 2 of the 2 trials are recruiting: 2 with sites in USA, 2 with sites in France, 2 with sites in South Korea, 2 with sites in Taiwan, 1 with sites in UK, 1 with sites in Italy, 1 with sites in Australia, 1 with sites in China, 1 with sites in Spain, 1 with sites in Austria and 1 with sites in Israel. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Pivekimab Sunirine clinical trials?

The lead sponsor is AbbVie. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Pivekimab Sunirine works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Pivekimab Sunirine works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Pivekimab Sunirine (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.