Firsocostat (ND-630, GS-0976) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 277

Clinical Trials

Multiple completed Phase 1 and Phase 2 clinical trials sponsored by Gilead Sciences have evaluated Firsocostat. Early-phase investigations assessed its pharmacokinetics and pharmacodynamic impact on hepatic fractional de novo lipogenesis in healthy subjects and individuals with hepatic impairment. Additionally, Phase 2 clinical trials evaluated the safety, tolerability, and therapeutic efficacy of Firsocostat as both monotherapy and combination therapy for patients with nonalcoholic steatohepatitis.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04971785	COMPLETED	Nonalcoholic Steatohepatitis	Gilead Sciences	2021-08-09	PHASE2
NCT03987074	COMPLETED	Nonalcoholic Steatohepatitis	Gilead Sciences	2019-07-29	PHASE2
NCT03449446	COMPLETED	Nonalcoholic Steatohepatitis	Gilead Sciences	2018-03-21	PHASE2
NCT02891408	COMPLETED	Nonalcoholic Steatohepatitis (NASH)	Gilead Sciences	2016-09-23	PHASE1
NCT02856555	COMPLETED	Nonalcoholic Steatohepatitis (NASH)	Gilead Sciences	2016-08-08	PHASE2
NCT02891408	Completed	Nonalcoholic Steatohepatitis (NASH)	Gilead Sciences	2016-09-23	Phase 1
NCT02876796	COMPLETED	PD Effects of GS-0976 (NDI-010976) on Fractional DNL	Gilead Sciences	2015-08	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-11-26)

Check the Firsocostat (ND-630, GS-0976) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Firsocostat reversibly binds to acetyl-CoA carboxylase isoforms 1 and 2 (ACC1 and ACC2), inhibiting the ATP-dependent carboxylation of acetyl-CoA to malonyl-CoA and suppressing downstream hepatic de novo lipogenesis. By reducing intracellular malonyl-CoA levels and decreasing lipid accumulation while promoting fatty acid oxidation, this mechanism directly addresses the metabolic dysregulation and hepatic steatosis characteristic of nonalcoholic steatohepatitis.

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>).