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.
Mechanism and Biochemical Profile
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>).
- Bexotegrast (PLN-74809) Solubility in DMSO
- Bexotegrast (PLN-74809) Stock Solution
- Bexotegrast (PLN-74809) Storage
- Bexotegrast (PLN-74809) Stability
- Bexotegrast (PLN-74809) Molecular Weight
- Bexotegrast (PLN-74809) CAS Number
- Bexotegrast (PLN-74809) Chemical Structure (2D and 3D)
- Bexotegrast (PLN-74809) SDS|MSDS
Note: Technical data last updated: Sep 1, 2026.