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CYT387

Sierra Oncology LLC - a GSK company · Phase 1 active Small molecule

CYT387 is a Small molecule drug developed by Sierra Oncology LLC - a GSK company. It is currently in Phase 1 development. Also known as: Momelotinib.

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
    Sierra Oncology LLC - a GSK company 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 nameCYT387
Also known asMomelotinib
SponsorSierra Oncology LLC - a GSK company
ModalitySmall molecule
PhasePhase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

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

Frequently asked questions about CYT387

What is CYT387?

CYT387 is a Small molecule drug developed by Sierra Oncology LLC - a GSK company.

Who makes CYT387?

CYT387 is developed by Sierra Oncology LLC - a GSK company (see full Sierra Oncology LLC - a GSK company pipeline at /company/sierra-oncology-llc-a-gsk-company).

Is CYT387 also known as anything else?

CYT387 is also known as Momelotinib.

What development phase is CYT387 in?

CYT387 is in Phase 1.

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