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BMS-986165 Dose A
BMS-986165 Dose A is a PD-1 inhibitor Small molecule drug developed by Bristol-Myers Squibb. It is currently in Phase 2 development for Non-small cell lung cancer, PD-L1 positive, Melanoma.
BMS-986165 Dose A is an anti-PD-1 monoclonal antibody.
BMS-986165 Dose A is an anti-PD-1 monoclonal antibody. Used for Non-small cell lung cancer, PD-L1 positive, Melanoma.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies. -
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.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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-986165 Dose A |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
BMS-986165 Dose A works by binding to the PD-1 receptor on T cells, preventing its interaction with PD-L1 and thus enhancing the immune response against cancer cells.
Approved indications
- Non-small cell lung cancer, PD-L1 positive
- Melanoma
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Rash
- Pruritus
Key clinical trials
- A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis (PHASE3)
- Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus (PHASE2)
- A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (PHASE3)
- A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132 (PHASE4)
- A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis. (PHASE3)
- A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants (PHASE4)
- A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (PHASE3)
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-986165 Dose A CI brief — competitive landscape report
- BMS-986165 Dose A updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about BMS-986165 Dose A
What is BMS-986165 Dose A?
How does BMS-986165 Dose A work?
What is BMS-986165 Dose A used for?
Who makes BMS-986165 Dose A?
What drug class is BMS-986165 Dose A in?
What development phase is BMS-986165 Dose A in?
What are the side effects of BMS-986165 Dose A?
What does BMS-986165 Dose A target?
Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Bristol-Myers Squibb — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer, PD-L1 positive
- Indication: Drugs for Melanoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing