Buloxibutid Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

A Phase 2 clinical trial sponsored by Vicore Pharma AB is evaluating the therapeutic potential of buloxibutid in patients with idiopathic pulmonary fibrosis. This randomized, double-blind, placebo-controlled, multicenter study assesses the safety and efficacy of two dosages of buloxibutid over a 52-week treatment period. The trial's recruitment status is currently categorized as active, not recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06588686	ACTIVE_NOT_RECRUITING	Idiopathic Pulmonary Fibrosis (IPF)	Vicore Pharma AB	2024-12-09	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-17)

Check the Buloxibutid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Buloxibutid acts as a selective agonist of the angiotensin II type 2 receptor (AT2R) with a Ki value of 0.4 nM over AT1R (Ki > 10 µM), thereby activating downstream signaling pathways that suppress vascular remodeling and attenuate collagen deposition. This targeted inhibition of fibrotic extracellular matrix buildup improves local tissue hemodynamics and prevents structural remodeling, providing direct therapeutic relevance in the treatment of 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>).