Clinical Trials

Linrodostat (BMS-986205) has been evaluated in numerous clinical trials spanning Phase 1, Phase 2, and Phase 3 studies to assess safety, pharmacokinetics, and therapeutic efficacy. These trials involve healthy volunteers as well as patients with advanced cancer, glioblastoma, melanoma, non-small cell lung cancer, urinary bladder neoplasms, and oral cavity squamous cell carcinomas. Sponsored by Bristol-Myers Squibb alongside academic institutions such as Northwestern University and Dana-Farber Cancer Institute, trial recruitment statuses range from completed to active not recruiting, terminated, or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04047706 ACTIVE_NOT_RECRUITING
Glioblastoma
Northwestern University
 2019-08-13 PHASE1
NCT04106414 ACTIVE_NOT_RECRUITING
Endometrial Adenocarcinoma; Endometrial Carcinosarcoma
Memorial Sloan Kettering Cancer Center
 2019-09-24 PHASE2
NCT03661320 ACTIVE_NOT_RECRUITING
Urinary Bladder Neoplasms; Muscle-Invasive Bladder Cancer
Bristol-Myers Squibb
 2018-11-06 PHASE3
NCT03854032 ACTIVE_NOT_RECRUITING
Lip; Oral Cavity Squamous Cell Carcinoma; Pharynx; Larynx; Squamous Cell Carcinoma
Thomas Jefferson University
 2019-04-09 PHASE2
NCT03459222 COMPLETED
Advanced Cancer
Bristol-Myers Squibb
 2018-05-30 PHASE1; PHASE2
NCT03519256 TERMINATED
Urinary Bladder Neoplasms
Bristol-Myers Squibb
 2018-08-02 PHASE2
NCT02935634 COMPLETED
Advanced Gastric Cancer
Bristol-Myers Squibb
 2016-11-29 PHASE2
NCT02996110 COMPLETED
Advanced Cancer
Bristol-Myers Squibb
 2017-02-02 PHASE2
NCT02658890 COMPLETED
Advanced Cancer; Melanoma; Non-Small Cell Lung Cancer
Bristol-Myers Squibb
 2016-04-14 PHASE1; PHASE2
NCT03417037 WITHDRAWN
Lung Cancer; Non-Small Cell Lung Cancer
Bristol-Myers Squibb
 2018-05-24 PHASE3
NCT03792750 COMPLETED
Advanced Cancer
Bristol-Myers Squibb
 2018-12-31 PHASE1; PHASE2
NCT03695250 TERMINATED
Metastatic Hepatocellular Carcinoma; Stage III Hepatocellular Carcinoma AJCC v8; Stage IIIA Hepatocellular Carcinoma AJCC v8; Stage IIIB Hepatocellular Carcinoma AJCC v8; Stage IV Hepatocellular Carcinoma AJCC v8; Stage IVA Hepatocellular Carcinoma AJCC v8; Stage IVB Hepatocellular Carcinoma AJCC v8; Unresectable Hepatocellular Carcinoma
Edward Kim
 2018-10-16 PHASE1; PHASE2
NCT03329846 COMPLETED
Melanoma; Skin Cancer
Bristol-Myers Squibb
 2017-11-30 PHASE3
NCT02750514 TERMINATED
Advanced Cancer
Bristol-Myers Squibb
 2016-05-09 PHASE2
NCT04007588 WITHDRAWN
Melanoma Stage III; Melanoma Stage IV
Dana-Farber Cancer Institute
 2019-09-06 PHASE2
NCT03936374 COMPLETED
Healthy
Bristol-Myers Squibb
 2019-05-08 PHASE1
NCT03936374 Completed
Healthy
Bristol-Myers Squibb
 2019-05-08 Phase 1
NCT03192943 COMPLETED
Advanced Cancer
Bristol-Myers Squibb
 2017-06-23 PHASE1
NCT03386838 WITHDRAWN
Head and Neck Cancer
Bristol-Myers Squibb
 2018-03-28 PHASE3
NCT03374228 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2018-01-04 PHASE1
NCT03378310 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2017-12-21 PHASE1
NCT03362411 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2017-11-09 PHASE1
NCT03346837 COMPLETED
Malignancies Multiple
Bristol-Myers Squibb
 2017-11-22 PHASE1
NCT03312426 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2017-10-09 PHASE1
NCT03362411 Completed
Healthy Volunteers
Bristol-Myers Squibb
 2017-11-09 Phase 1
NCT03247283 COMPLETED
Cancer
Bristol-Myers Squibb
 2017-07-19 PHASE1
NCT03312426 Completed
Healthy Volunteers
Bristol-Myers Squibb
 2017-10-09 Phase 1

(data from https://clinicaltrials.gov, updated on 2025-06-29)

Check the Linrodostat (BMS-986205) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Linrodostat (BMS-986205) acts as a potent, irreversible inhibitor of indoleamine 2,3-dioxygenase 1 (IDO1) that blocks the enzymatic conversion of tryptophan to kynurenine, thereby mitigating kynurenine-mediated immunosuppressive signaling and restoring cytotoxic T-cell function. By re-establishing anti-tumor immune activity within the tumor microenvironment, this mechanism provides the rationale for its clinical investigation in advanced malignancies, including non-small cell lung cancer, melanoma, and glioblastoma.

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.