BMS-986205

Bristol-Myers Squibb · Phase 3 active Biologic

BMS-986205 is a NLRP3 inflammasome inhibitor Biologic drug developed by Bristol-Myers Squibb. It is currently in Phase 3 development for Acute coronary syndrome, Chronic kidney disease. Also known as: Linrodostat.

BMS-986205 is a selective inhibitor of the NLRP3 inflammasome that reduces excessive inflammatory responses by blocking a key protein complex involved in innate immunity.

BMS-986205 is a selective inhibitor of the NLRP3 inflammasome that reduces excessive inflammatory responses by blocking a key protein complex involved in innate immunity. Used for Acute coronary syndrome, Chronic kidney disease.

Likelihood of approval

62.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

• Baseline phase 3 → approval rate +58.3pp
  Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
• Immunology slight uplift +1.0pp
  Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
• Big-pharma sponsor +3.0pp
  Bristol-Myers Squibb is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	BMS-986205
Also known as	Linrodostat
Sponsor	Bristol-Myers Squibb
Drug class	NLRP3 inflammasome inhibitor
Target	NLRP3
Modality	Biologic
Therapeutic area	Immunology
Phase	Phase 3

Mechanism of action

The NLRP3 inflammasome is a multi-protein complex that activates caspase-1, leading to production of pro-inflammatory cytokines IL-1β and IL-18. By selectively inhibiting NLRP3, BMS-986205 dampens pathological inflammation without broadly suppressing immune function. This mechanism is relevant to inflammatory and autoinflammatory diseases where NLRP3 activation drives disease pathology.

Approved indications

• Acute coronary syndrome
• Chronic kidney disease

Common side effects

• Infection
• Elevated liver enzymes
• Gastrointestinal disorders

Key clinical trials

• A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer (PHASE3)
• Study of BMS-986205 and Nivolumab in Endometrial Cancer or Endometrial Carcinosarcoma That Has Not Responded to Treatment (PHASE2)
• Nivolumab, BMS-986205, and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (PHASE1)
• Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck (PHASE2)
• An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread (PHASE1, PHASE2)
• An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread (PHASE1, PHASE2)
• BMS-986205 and Nivolumab as First or Second Line Therapy in Treating Patients With Liver Cancer (PHASE1, PHASE2)
• A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• BMS-986205 CI brief — competitive landscape report
• BMS-986205 updates RSS · CI watch RSS
• Bristol-Myers Squibb portfolio CI

Frequently asked questions about BMS-986205

What is BMS-986205?

BMS-986205 is a NLRP3 inflammasome inhibitor drug developed by Bristol-Myers Squibb, indicated for Acute coronary syndrome, Chronic kidney disease.

How does BMS-986205 work?

BMS-986205 is a selective inhibitor of the NLRP3 inflammasome that reduces excessive inflammatory responses by blocking a key protein complex involved in innate immunity.

What is BMS-986205 used for?

BMS-986205 is indicated for Acute coronary syndrome, Chronic kidney disease.

Who makes BMS-986205?

BMS-986205 is developed by Bristol-Myers Squibb (see full Bristol-Myers Squibb pipeline at /company/bristol-myers-squibb).

Is BMS-986205 also known as anything else?

BMS-986205 is also known as Linrodostat.

What drug class is BMS-986205 in?

BMS-986205 belongs to the NLRP3 inflammasome inhibitor class. See all NLRP3 inflammasome inhibitor drugs at /class/nlrp3-inflammasome-inhibitor.

What development phase is BMS-986205 in?

BMS-986205 is in Phase 3.

What are the side effects of BMS-986205?

Common side effects of BMS-986205 include Infection, Elevated liver enzymes, Gastrointestinal disorders.

What does BMS-986205 target?

BMS-986205 targets NLRP3 and is a NLRP3 inflammasome inhibitor.

Related

• Drug class: All NLRP3 inflammasome inhibitor drugs
• Target: All drugs targeting NLRP3
• Manufacturer: Bristol-Myers Squibb — full pipeline
• Therapeutic area: All drugs in Immunology
• Indication: Drugs for Acute coronary syndrome
• Indication: Drugs for Chronic kidney disease
• Also known as: Linrodostat