Clinical Trials

The clinical evaluation of Bexotegrast (PLN-74809) currently comprises a clinical trial sponsored by Pliant Therapeutics, Inc. to assess the compound's safety, tolerability, and efficacy across variable doses in patients with idiopathic pulmonary fibrosis. Designed as a randomized, double-blind, placebo-controlled Phase 2 investigation, its recruitment status is officially designated as terminated, with no additional clinical trials on record across any disease indication.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06097260 TERMINATED
Idiopathic Pulmonary Fibrosis
Pliant Therapeutics, Inc.
2023-11-16 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-05)

Check the Bexotegrast (PLN-74809) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bexotegrast (PLN-74809) functions as a potent dual selective inhibitor that binds αvβ6 and αvβ1 integrins with dissociation constants of 5.7 nM and 3.4 nM, respectively, thereby blocking integrin-mediated activation of transforming growth factor-beta (TGF-β) pathways. This molecular blockade inhibits downstream profibrotic signaling and suppresses fibrogenesis, providing direct therapeutic relevance for halting pathological tissue remodeling in idiopathic pulmonary fibrosis.

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>).

Note: Technical data last updated: Sep 1, 2026.