FH1 Clinical Trials

Size	Price	Qty
10mg	USD 147
100mg	USD 577

Clinical Trials

A clinical trial sponsored by Sumitomo Pharma Co., Ltd. has completed recruitment to evaluate this small molecule candidate for the treatment of influenza. This first-in-human, single-center, randomized, double-blind, placebo-controlled Phase 1 study assessed the compound's clinical safety, overall tolerability, and immunogenicity profiles. These initial results establish a clinical foundation for assessing the candidate's therapeutic potential against influenza.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06460064	COMPLETED	Influenza	Sumitomo Pharma Co., Ltd.	2024-06-26	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-17)

Check the FH1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

FH1 functions as a selective small molecule regulator that modulates key intracellular signaling cascades essential for hepatic lineage commitment. By directing downstream gene expression and cell differentiation networks, FH1 promotes the functional differentiation of induced pluripotent stem cell-derived hepatocytes, providing valuable human cellular models for target validation and therapeutic evaluation in viral conditions such as influenza.

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>).