Fedratinib (TG101348) Clinical Trials

Size	Price	Qty
5mg	USD 147
1g	USD 1,970

Clinical Trials

Numerous Phase 1 through Phase 3 clinical trials, sponsored by pharmaceutical companies and academic institutions, have evaluated the safety, pharmacokinetics, and efficacy of fedratinib. These studies encompass recruitment statuses ranging from active and recruiting to completed and terminated, focusing primarily on myeloproliferative neoplasms—including primary, post-polycythemia vera, and post-essential thrombocythemia myelofibrosis—as well as IDH-mutated blood cancers, hepatic impairment, and healthy volunteers.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07734077	NOT_YET_RECRUITING	Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis	John Mascarenhas	2026-12-01	PHASE1; PHASE2
NCT04817007	ACTIVE_NOT_RECRUITING	Myelofibrosis	Bristol-Myers Squibb	2021-03-22	PHASE1; PHASE2
NCT04282187	RECRUITING	Acute Myeloid Leukemia; Essential Thrombocythemia; Myelodysplastic Syndrome; Myelodysplastic/Myeloproliferative Neoplasm; Myeloproliferative Neoplasm; Myeloproliferative Neoplasm, Not Otherwise Specified; Polycythemia Vera; Primary Myelofibrosis; Secondary Myelofibrosis	University of Washington	2020-03-24	PHASE2
NCT05393674	COMPLETED	Primary Myelofibrosis; Secondary Myelofibrosis	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	2022-06-14	PHASE2
NCT05177211	COMPLETED	Myeloproliferative Neoplasm; Chronic Neutrophilic Leukemia; MDS	H. Lee Moffitt Cancer Center and Research Institute	2022-03-01	PHASE2
NCT05127174	TERMINATED	Myeloproliferative Neoplasm	H. Lee Moffitt Cancer Center and Research Institute	2022-03-14	PHASE1
NCT05524857	TERMINATED	Myeloproliferative Neoplasm	Joseph Jurcic	2022-01-28	PHASE1
NCT04446650	ACTIVE_NOT_RECRUITING	Primary Myelofibrosis	Bristol-Myers Squibb	2020-10-12	PHASE1; PHASE2
NCT04629508	COMPLETED	Myelofibrosis; Polycythemia Vera; Thrombocythemia	Incyte Corporation	2021-07-12	PHASE2
NCT04955938	WITHDRAWN	IDH Mutation; IDH1 Mutation; IDH2 Gene Mutation; Blood Cancer; Myeloproliferative Neoplasm	University of Chicago	2021-10-29	PHASE1
NCT03983161	COMPLETED	Healthy Volunteers; Hepatic Impairment	Celgene	2019-09-04	PHASE1
NCT03952039	COMPLETED	Primary Myelofibrosis; Post-Polycythemia Vera; Myelofibrosis	Celgene	2019-09-09	PHASE3
NCT05051553	COMPLETED	Healthy Volunteers	Bristol-Myers Squibb	2021-09-21	PHASE1
NCT03755518	TERMINATED	Primary Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis	Celgene	2019-03-27	PHASE3
NCT04955938	Recruiting	IDH Mutation\|IDH1 Mutation\|IDH2 Gene Mutation\|Blood Cancer\|Myeloproliferative Neoplasm	University of Chicago	2021-10-29	Phase 1
NCT05051553	Completed	Healthy Volunteers	Bristol-Myers Squibb	2021-09-21	Phase 1
NCT04702464	COMPLETED	Healthy Volunteers	Celgene	2021-01-12	PHASE1
NCT04702464	Completed	Healthy Volunteers	Celgene\|Impact Biomedicines Inc. a wholly owned subsidiary of Celgene Corporation	2021-01-12	Phase 1
NCT04231435	COMPLETED	Healthy Volunteers	Celgene	2019-12-18	PHASE1
NCT03983239	COMPLETED	Healthy Volunteers	Celgene	2019-06-21	PHASE1
NCT03983161	Completed	Healthy Volunteers\|Hepatic Impairment	Celgene\|Impact Biomedicines Inc. a wholly owned subsidiary of Celgene Corporation	2019-09-04	Phase 1
NCT03983239	Completed	Healthy Volunteers	Celgene\|Impact Biomedicines Inc. a wholly owned subsidiary of Celgene Corporation	2019-06-21	Phase 1
NCT00724334	COMPLETED	Myelofibrosis	Bristol-Myers Squibb	2008-07	PHASE1; PHASE2
NCT01836705	COMPLETED	Neoplasm Malignant	Bristol-Myers Squibb	2013-05	PHASE1
NCT00631462	COMPLETED	Myelofibrosis	TargeGen	2008-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-29)

Check the Fedratinib (TG101348) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fedratinib acts as a selective, ATP-competitive inhibitor of Janus kinase 2 (JAK2), blocking downstream STAT5 phosphorylation and suppressing hyperactive intracellular signaling pathways. By inducing apoptosis and blocking abnormal proliferation in JAK2-mutated cells, this molecular mechanism halts disease progression and reduces burden in myeloproliferative neoplasms, including primary myelofibrosis.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).