Clinical Trials

Numerous clinical trials, primarily sponsored by Bristol-Myers Squibb, evaluate the small-molecule agent BMS-986278 across Phase 1 through Phase 3. These studies investigate the drug for progressive fibrotic pulmonary conditions—specifically idiopathic pulmonary fibrosis and general pulmonary fibrosis—while also characterizing its pharmacokinetics, bioavailability, and safety in healthy volunteers and populations with renal or hepatic impairment. Overall recruitment status ranges from completed early-phase trials to active and not-yet-recruiting late-stage long-term extension studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07441408 NOT_YET_RECRUITING
Pulmonary Fibrosis
Bristol-Myers Squibb
 2026-12-16 PHASE3
NCT06025578 ACTIVE_NOT_RECRUITING
Progressive Pulmonary Fibrosis
Bristol-Myers Squibb
 2023-10-25 PHASE3
NCT06003426 ACTIVE_NOT_RECRUITING
Idiopathic Pulmonary Fibrosis
Bristol-Myers Squibb
 2023-09-14 PHASE3
NCT07422298 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2026-02-19 PHASE1
NCT06723535 COMPLETED
Kidney Failure, Chronic; Healthy Volunteers; Renal Impairment
Bristol-Myers Squibb
 2024-12-07 PHASE1
NCT06746402 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2025-02-10 PHASE1
NCT06715683 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2024-12-12 PHASE1
NCT06568458 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2024-09-19 PHASE1
NCT06425198 COMPLETED
Hepatic Impairment; Healthy Participants
Bristol-Myers Squibb
 2024-06-10 PHASE1
NCT05985590 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2023-08-18 PHASE1
NCT05932303 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2023-07-12 PHASE1
NCT05805904 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2023-03-29 PHASE1
NCT05684289 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2023-01-03 PHASE1
NCT04308681 COMPLETED
Pulmonary Fibrosis
Bristol-Myers Squibb
 2020-07-29 PHASE2
NCT04567667 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2020-10-15 PHASE1
NCT04468815 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2020-07-10 PHASE1
NCT03981094 COMPLETED
Idiopathic Pulmonary Fibrosis (IPF)
Bristol-Myers Squibb
 2019-05-10 PHASE1
NCT03429933 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2018-02-07 PHASE1
NCT03712540 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2018-09-06 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-14)

Check the BMS-986278 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BMS-986278 functions as a potent, orally active antagonist of lysophosphatidic acid receptor 1 (LPA1) with binding affinities (Kb) of 6.9 nM for human and 4.0 nM for mouse LPA1, thereby blocking downstream LPA1-mediated signaling pathways that drive cellular proliferation and profibrotic fibroblast activation. By suppressing pro-inflammatory and fibrotic cellular responses, this targeted inhibition disrupts aberrantly persistent extracellular matrix deposition, offering therapeutic efficacy in clinical investigations for idiopathic pulmonary fibrosis and progressive 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>).

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