Resatorvid (TAK-242) Clinical Trials

Size	Price	Qty
5mg	USD 157
25mg	USD 547

Clinical Trials

Multiple clinical trials spanning Early Phase 1 through Phase 3 have evaluated Resatorvid (TAK-242) across inflammatory and hepatic conditions, including sepsis, acute-on-chronic liver failure, alcoholic hepatitis, alcoholic liver cirrhosis, and pain hypersensitivity. Sponsored by pharmaceutical companies and academic investigators—such as Takeda and Yaqrit Ltd—these studies display recruitment statuses ranging from completed and terminated to not yet recruiting and unknown. Notably, these investigations include a completed Phase 3 trial in sepsis and a Phase 2 trial focused on liver disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06890039	NOT_YET_RECRUITING	Acute-On-Chronic Liver Failure; Alcoholic Hepatitis; Liver Cirrhosis, Alcoholic	Yaqrit Ltd	2025-09-01	PHASE2
NCT07092215	COMPLETED	Pain	Stefan Heber	2025-06-17	EARLY_PHASE1
NCT04620148	UNKNOWN	Acute-On-Chronic Liver Failure	Akaza Bioscience Ltd	2021-12	PHASE2
NCT04620148	Unknown status	Acute-On-Chronic Liver Failure	Akaza Bioscience Ltd\|Iqvia Pty Ltd	2021-12	Phase 2
NCT00633477	TERMINATED	Sepsis	Takeda	2008-02	PHASE3
NCT00143611	COMPLETED	Sepsis	Takeda	2005-09	PHASE3

(data from https://clinicaltrials.gov, updated on 2025-07-29)

Check the Resatorvid (TAK-242) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Resatorvid (TAK-242) selectively binds to Toll-like receptor 4 (TLR4), inhibiting downstream recruitment of adapter molecules MyD88 and TRIF and suppressing lipopolysaccharide-induced production of pro-inflammatory mediators such as nitric oxide, TNF-α, and IL-6 in macrophages. By disrupting hyperactive TLR4-mediated signaling cascades and associated cellular autophagy, Resatorvid reduces systemic inflammatory damage, providing a therapeutic rationale for its clinical investigation in sepsis, acute-on-chronic liver failure, and alcoholic hepatitis.

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>).