Lanifibranor (IVA-337) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Lanifibranor (IVA-337) is being evaluated in multiple clinical trials spanning Phase 1 to Phase 3 for metabolic and fibrotic disorders, including nonalcoholic steatohepatitis (NASH), nonalcoholic fatty liver disease (NAFLD), type 2 diabetes mellitus, and diffuse cutaneous systemic sclerosis. Sponsored by entities such as Inventiva Pharma, Chia Tai Tianqing, and the University of Florida, these studies encompass both completed and active, non-recruiting statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04849728	ACTIVE_NOT_RECRUITING	NASH - Nonalcoholic Steatohepatitis	Inventiva Pharma	2021-08-19	PHASE3
NCT05232071	COMPLETED	NASH - Nonalcoholic Steatohepatitis; Diabetes Mellitus, Type 2	Inventiva Pharma	2022-06-29	PHASE2
NCT06126562	COMPLETED	Pharmacokinetic	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	2023-10-31	PHASE1
NCT03459079	COMPLETED	Nonalcoholic Fatty Liver Disease (NAFLD); Type 2 Diabetes (T2DM)	University of Florida	2018-08-14	PHASE2
NCT05232071	Active not recruiting	NASH - Nonalcoholic Steatohepatitis\|Diabetes Mellitus Type 2	Inventiva Pharma	2022-06-29	Phase 2
NCT03008070	COMPLETED	Non-Alcoholic Steatohepatitis (NASH)	Inventiva Pharma	2017-02-07	PHASE2
NCT03866369	COMPLETED	Healthy Subjects	Inventiva Pharma	2019-01-17	PHASE1
NCT03866369	Completed	Healthy Subjects	Inventiva Pharma\|Parexel	2019-01-17	Phase 1
NCT02503644	COMPLETED	Scleroderma, Diffuse; Diffuse Cutaneous Systemic Sclerosis	Inventiva Pharma	2015-10-29	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-02)

Check the Lanifibranor (IVA-337) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lanifibranor acts as a balanced pan-peroxisome proliferator-activated receptor (PPAR) agonist that binds and activates alpha, delta, and gamma PPAR isoforms, thereby modulating transcriptional programs that regulate lipid homeostasis, insulin sensitivity, and inflammation. This targeted gene regulation reduces hepatic steatosis and tissue fibrosis, directly supporting its clinical development for nonalcoholic steatohepatitis (NASH) and type 2 diabetes.

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>).