Halofuginone Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 477

Clinical Trials

Multiple clinical trials evaluate the therapeutic profile of this compound across Phase 1 and Phase 2 studies in oncology and chronic disease indications, including Kaposi sarcoma, progressive solid tumors, liver cirrhosis, primary myelofibrosis, breast cancer, and healthy volunteer cohorts. Sponsored by the National Cancer Institute, the European Organisation for Research and Treatment of Cancer, academic medical centers, research institutes, and biopharmaceutical companies, these investigations encompass recruitment statuses ranging from completed to recruiting and not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04172779	Not yet recruiting	Cirrhosis Liver	University of Texas Southwestern Medical Center\|National Cancer Institute (NCI)	2024-07	Phase 2
NCT05279001	Recruiting	Myelofibrosis	Suzhou Zelgen Biopharmaceuticals Co.Ltd	2024-07-01	Phase 1
NCT06316336	Not yet recruiting	Healthy Vollunteer	Pharma Nueva	2024-06-10	Phase 1
NCT06156761	Not yet recruiting	Breast Cancer	Cancer Institute and Hospital Chinese Academy of Medical Sciences\|CSPC Ouyi Pharmaceutical Co. Ltd.	2023-11-28	Not Applicable
NCT00064142	COMPLETED	AIDS-related Kaposi Sarcoma; Recurrent Kaposi Sarcoma	National Cancer Institute (NCI)	2003-05	PHASE2
NCT00027677	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	European Organisation for Research and Treatment of Cancer - EORTC	2001-08	PHASE1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Halofuginone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Halofuginone competitively inhibits prolyl-tRNA synthetase with a Ki of 18.3 nM, which down-regulates Smad3 expression and selectively suppresses downstream TGF-β signaling cascades. This pathway blockade inhibits extracellular matrix deposition and cellular proliferation, demonstrating targeted activity relevant to clinical investigations in progressive solid tumors and Kaposi sarcoma.

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>).