Fedratinib
- Generic Name
- Fedratinib
- Brand Names
- Inrebic
- Drug Type
- Small Molecule
- Chemical Formula
- C27H36N6O3S
- CAS Number
- 936091-26-8
- Unique Ingredient Identifier
- 6L1XP550I6
- Background
Fedratinib, also known as SAR302503 and TG101348, is a tyrosine kinase inhibitor used to treat intermediate-2 and high risk primary and secondary myelofibrosis. It is an anilinopyrimidine derivative.
Fedratinib was granted FDA approval on August 16, 2019.
- Indication
Fedratinib 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.
- Associated Conditions
- Secondary Myelofibrosis, Primary Myelofibrosis (PMF)
- Associated Therapies
- -
A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
- Conditions
- Interventions
- First Posted Date
- 2023-10-10
- Last Posted Date
- 2024-11-06
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 137
- Registration Number
- NCT06073847
- Locations
- 🇰🇷
Local Institution - 0001, Seoul, Korea, Republic of
🇰🇷Novotech Laboratory Korea Co., Ltd., Seoul, Korea, Republic of
🇰🇷Bristol-Myers Squibb YH, Seoul, Korea, Republic of
Real World Evidence of Fedratinib Effectiveness in MF
- First Posted Date
- 2023-06-01
- Last Posted Date
- 2024-02-08
- Target Recruit Count
- 93
- Registration Number
- NCT05883904
- Locations
- 🇮🇹
Ematologia FONDAZIONE IRCCS CA' GRANDA, OSPEDALE MAGGIORE POLICLINICO, Milano, Italy
A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants
- First Posted Date
- 2021-09-21
- Last Posted Date
- 2022-06-27
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 58
- Registration Number
- NCT05051553
- Locations
- 🇺🇸
Syneos Health Clinical Research Services, Llc, Miami, Florida, United States
A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms
- Conditions
- Interventions
- First Posted Date
- 2021-07-09
- Last Posted Date
- 2024-07-31
- Lead Sponsor
- University of Chicago
- Registration Number
- NCT04955938
- Locations
- 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States
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)
- Conditions
- Interventions
- First Posted Date
- 2021-03-25
- Last Posted Date
- 2024-05-10
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 216
- Registration Number
- NCT04817007
- Locations
- 🇷🇴
Local Institution - 0052, Bucuresti, Cluj, Romania
🇷🇴Local Institution - 0083, Bucuresti, Romania
🇷🇴Local Institution - 0051, Cluj, Romania
A Study to Evaluate the Effect of a Dual CYP2C19 and CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects
- First Posted Date
- 2021-01-11
- Last Posted Date
- 2021-11-29
- Lead Sponsor
- Celgene
- Target Recruit Count
- 29
- Registration Number
- NCT04702464
- Locations
- 🇺🇸
PPD Phase 1 Clinic, Austin, Texas, United States
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)
- First Posted Date
- 2020-06-25
- Last Posted Date
- 2024-09-30
- Lead Sponsor
- Celgene
- Target Recruit Count
- 31
- Registration Number
- NCT04446650
- Locations
- 🇯🇵
Local Institution - 016, Osaka, Japan
🇯🇵Local Institution - 014, Sapporo, Japan
🇯🇵Local Institution - 021, Suwa, Nagano, Japan
Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms
- Conditions
- Interventions
- First Posted Date
- 2020-02-24
- Last Posted Date
- 2024-03-20
- Lead Sponsor
- University of Washington
- Target Recruit Count
- 25
- Registration Number
- NCT04282187
- Locations
- 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin
- Conditions
- Interventions
- First Posted Date
- 2020-01-18
- Last Posted Date
- 2020-05-21
- Lead Sponsor
- Celgene
- Target Recruit Count
- 24
- Registration Number
- NCT04231435
- Locations
- 🇺🇸
PPD Phase 1 Clinic, Austin, Texas, United States
A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment
- First Posted Date
- 2019-06-12
- Last Posted Date
- 2023-03-17
- Lead Sponsor
- Celgene
- Target Recruit Count
- 39
- Registration Number
- NCT03983161
- Locations
- 🇺🇸
University Of Miami Miller School Of Medicine, Miami, Florida, United States
🇺🇸Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville, Knoxville, Tennessee, United States
🇺🇸Orlando Clinical Research Center OCRC, Orlando, Florida, United States
Drug Development Updates
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