Inrebic

(Fedratinib)

Phase 3Small molecule

Bristol-Myers Squibb

Inrebic is one of 52 small molecule programs targeting Myelofibrosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

MyelofibrosisActive, not recruiting

NivolumabActive, not recruiting

Essential ThrombocythemiaTerminated

MyelofibrosisPhase 2

Active, not recruiting

NivolumabPhase 2

Active, not recruiting

Essential ThrombocythemiaPhase 3

Terminated

Competition

Competitive Landscape

48 competitors in Myelofibrosis

#DrugCompanyPhaseTrials

Jakafi

Incyte

Approved

55 2

Ojjaara

GGlaxo Dba Glaxosmithkline

Approved

7 3

Rifadin

Tepadina

Droxia

1 6

Sporanox

SSebela Pharmaceuticals Development LLC

Vonjo

5 8

Xpovio

KKaryopharm Therapeutics Inc

Phase 3

3 9

Navitoclax

AbbVie

Phase 3

5 10

Rytelo

GGeron Corporation

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Active, not recruiting

Essential Thrombocythemia

NCT04446650

Q4 2027

Phase 2Recruiting

Acute Myeloid Leukemia

NCT04282187

Recruiting

Myelofibrosis

NCT06073847

Q4 2028

PreclinicalNot yet recruiting

Myelofibrosis

NCT07734077

Clinical

Trials by Indication[1]

Myelofibrosis3 trials

A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT06073847·137 enrolled

A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT04817007·216 enrolled

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

Not yet recruiting·JJohn Mascarenhas·Preclinical·NCT07734077·32 enrolled

Essential Thrombocythemia3 trials

A Study of Fedratinib in Japanese Subjects With DIPSS (Dynamic International Prognostic Scoring System)- Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT04446650·31 enrolled

An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT03952039·202 enrolled

A Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT03755518·38 enrolled

Adult Subject2 trials

Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03983239·32 enrolled

A Study to Evaluate the Effect of a Dual CYP2C19 and CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04702464·29 enrolled

Myeloproliferative Neoplasms2 trials

Combination of Fedratinib and Decitabine for Myeloproliferative Neoplasms (MPN)- Accelerated Phase (AP)/Blast Phase (BP)

Terminated·JJoseph Jurcic·Phase 1·NCT05524857·2 enrolled

A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms

Withdrawn·UUniversity of Chicago·Phase 1·NCT04955938

Metformin1 trial

Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04231435·24 enrolled

6 more indications

Hepatic Impairment1 trial

A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03983161·39 enrolled

Fed1 trial

Individual Patient Compassionate Use of Fedratinib

Available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT03723148

Adult1 trial

A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05051553·58 enrolled

Recruiting·UUniversity of Washington·Phase 2·NCT04282187·25 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 16, 2019

INREBIC

NDA NDA212327

Aug 16, 2019

INREBIC

NDA NDA212327

Nov 23, 2021

INREBIC

NDA NDA212327

Dec 3, 2021

INREBIC

NDA NDA212327

May 15, 2023

INREBIC

NDA NDA212327

Jul 30, 2024

INREBIC

NDA NDA212327

May 12, 2025

INREBIC

NDA NDA212327

Mar 18, 2026

INREBIC

NDA NDA212327

Jul 20, 2026

INREBIC

NDA NDA212327

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Fedratinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fedratinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fedratinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA212327). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Inrebic. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Bristol-Myers Squibb

Patent Landscape[5]

Patent Cliff

Dec 16, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7825246Dec 16, 2026

8138199Jun 30, 2028

7528143Nov 16, 2031

10391094Jun 4, 2032

11400092Sep 24, 2039

Inrebic

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q4 2028

Trials by Indication[1]

Myelofibrosis3 trials

Essential Thrombocythemia3 trials

Adult Subject2 trials

Myeloproliferative Neoplasms2 trials

Metformin1 trial

Hepatic Impairment1 trial

Fed1 trial

Adult1 trial

Effectiveness1 trial

Nivolumab1 trial

Acute Myeloid Leukemia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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