FN-1501 Clinical Trials

Size	Price	Qty
5mg	USD 257

Clinical Trials

Multiple Phase 1 clinical trials sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. evaluated FN-1501 to assess its safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. These early-phase studies targeted advanced solid tumors and relapsed or refractory acute myeloid leukemia, though trial records indicate that the investigations have since been terminated. Overall, these efforts reflect the initial therapeutic exploration of FN-1501 against both hematologic malignancies and advanced cancers.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03690154	TERMINATED	Advanced Cancer; Solid Tumors; Acute Myeloid Leukemia Refractory; Acute Myeloid Leukemia, in Relapse	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	2018-07-23	PHASE1
NCT03690154	Terminated	Advanced Cancer\|Solid Tumors\|Acute Myeloid Leukemia Refractory\|Acute Myeloid Leukemia in Relapse	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	2018-07-23	Phase 1

(data from https://clinicaltrials.gov, updated on 2023-10-13)

Check the FN-1501 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

FN-1501 potently binds to Fms-like receptor tyrosine kinase 3 (FLT3) and cyclin-dependent kinases (CDK2, CDK4, and CDK6), suppressing downstream phosphorylation cascades and disrupting cell cycle progression alongside oncogenic survival signaling. By inducing cell cycle arrest and apoptosis in driven malignant cells, FN-1501 exhibits targeted antiproliferative efficacy directly relevant to the treatment of solid tumors and refractory or relapsed acute myeloid leukemia.

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>).