Inrebic

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

MyelofibrosisNivolumabEssential Thrombocythemia

49 competitors in Myelofibrosis

#DrugCompanyPhaseTrials

1

Jakafi

Incyte

Approved

552

Ojjaara

GGlaxo Dba Glaxosmithkline

Approved

83

Tepadina

Jazz Pharmaceuticals

Approved

—4

Rifadin

Sanofi

Approved

—5

Droxia

TTheravia

Approved

16

Sporanox

SSebela Pharmaceuticals Development LLC

Approved

—7

Vonjo

SSobi, Inc.

Phase 3

48

Xpovio

KKaryopharm Therapeutics Inc

Phase 3

39

Navitoclax

AbbVie

Phase 3

510

Fludara

Sanofi

Phase 2

4Show 35 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Essential Thrombocythemia3 trials

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·Phase 3·NCT03755518·38 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·Phase 3·NCT03952039·202 enrolled

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·Phase 1/2·NCT04446650·31 enrolled

Myelofibrosis3 trials

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

Recruiting·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·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

Myeloproliferative Neoplasms2 trials

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

Withdrawn·UUniversity of Chicago·Phase 1·NCT04955938

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

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

Adult Subject2 trials

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·Phase 1·NCT04702464·29 enrolled

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

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

Nivolumab1 trial

Fedratinib in Combination With Nivolumab

Active, not recruiting·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT05393674·30 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·Phase 1·NCT03983161·39 enrolled

Metformin1 trial

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

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

Fed1 trial

Individual Patient Compassionate Use of Fedratinib

Available·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·Phase 1·NCT05051553·58 enrolled

Effectiveness1 trial

Real World Evidence of Fedratinib Effectiveness in MF

Unknown status·GGruppo Italiano Malattie EMatologiche dell'Adulto··NCT05883904·93 enrolled

Acute Myeloid Leukemia1 trial

A Phase 2 Trial Investigating Decitabine in Combination With a JAK-Inhibitor as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant in Patients With Accelerated/Blast Phase Myeloproliferative Neoplasms

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

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Patent Landscape[5]

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