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fedratinib

Generic: FEDRATINIB HYDROCHLORIDE·Brand: INREBIC, Inrebic

fedratinib: developed by 1 company · 2 clinical trials tracked · 1 FDA decision.

fedratinib evidence translation

What we can confirm

1 FDA record · 2 tracked trials

What it means

Source-backed records connect fedratinib to BMY; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could fedratinib → BMY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Myelofibrosis

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (2)
CompanyPhase
BRISTOL MYERS SQUIBB CO (BMY)Approved
BRISTOL MYERS SQUIBB CO (BMY)Approved
Clinical Trials (2)

Phase Ib/II Study Of Revumenib As Monotherapy Or In Combination With Jak Inhibitors In Patients With Myelofibrosis

NCT07734077·Phase 1/Phase 2
Not yet recruiting

Primary endpoint: Dose limiting toxicity (DLT)

Interventionalopen32 targetStarted 2026-12Completion 2028-121 site · United StatesJohn Mascarenhas

A Phase 1b/2 Study of BMS-986158 Monotherapy and in Combination With Either Ruxolitinib or Fedratinib in Participants With DIPSS-Intermediate or High Risk Myelofibrosis

NCT04817007·Phase 1/Phase 2·BMY
Active, not recruiting

Primary endpoint: Incidence of adverse events (AEs)

InterventionalRandomizedopen216 targetStarted 2021-03Completion 2028-0849 sites · Australia, France, Germany, Greece…Bristol-Myers Squibb
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE INREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). INREBIC is a kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) ( 1 ).(BMY)FDA ↗
NDA212327Type 1 - New Molecular EntityOrphan DrugPriorityOralCapsule

Frequently asked questions

Who is developing fedratinib?

fedratinib is being developed by BRISTOL MYERS SQUIBB CO.

How many clinical trials involve fedratinib?

BioSniper tracks 2 clinical trials involving fedratinib.

What is fedratinib's latest FDA decision?

The most recent tracked FDA decision for fedratinib is Approval for 1 INDICATIONS AND USAGE INREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). INREBIC is a kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) ( 1 )., dated August 16, 2019.