Last reviewed 2026-05-19 · How we verify

BMS-986371

Bristol-Myers Squibb · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

BMS-986371 is a Small molecule drug developed by Bristol-Myers Squibb. It is currently in Phase 1 development. Also known as: CC-99677.

BMS-986371 is a small molecule. It is being studied in a Phase 1 clinical trial to assess its effects on the drug levels of methotrexate in healthy male adult participants.

Likelihood of approval

12.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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-986371
Also known as	CC-99677
Sponsor	Bristol-Myers Squibb
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine (PHASE1)

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-986371 CI brief — competitive landscape report
BMS-986371 updates RSS · CI watch RSS
Bristol-Myers Squibb portfolio CI

Frequently asked questions about BMS-986371

What is BMS-986371?

BMS-986371 is a Small molecule drug developed by Bristol-Myers Squibb.

Who makes BMS-986371?

BMS-986371 is developed by Bristol-Myers Squibb (see full Bristol-Myers Squibb pipeline at /company/bristol-myers-squibb).

Is BMS-986371 also known as anything else?

BMS-986371 is also known as CC-99677.

What development phase is BMS-986371 in?

BMS-986371 is in Phase 1.

Manufacturer: Bristol-Myers Squibb — full pipeline
Also known as: CC-99677

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing