Last reviewed · How we verify

BAY3018250 Dose 2 infusion

Bayer · Phase 1 active Small molecule ✓ Verified Jun 2026

BAY3018250 Dose 2 infusion is a Small molecule drug developed by Bayer. It is currently in Phase 1 development.

BAY3018250 Dose 2 infusion is being studied in a clinical trial to assess its safety and effects in healthy Japanese men and adult participants aged 18 to 55 years. The trial is investigating BAY3018250's safety, tolerability, pharmacokinetics, and pharmacodynamics in relation to acute venous and arterial thrombotic and thromboembolic events.

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
    Bayer 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 nameBAY3018250 Dose 2 infusion
SponsorBayer
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 BAY3018250 Dose 2 infusion

What is BAY3018250 Dose 2 infusion?

BAY3018250 Dose 2 infusion is a Small molecule drug developed by Bayer.

Who makes BAY3018250 Dose 2 infusion?

BAY3018250 Dose 2 infusion is developed by Bayer (see full Bayer pipeline at /company/bayer).

What development phase is BAY3018250 Dose 2 infusion in?

BAY3018250 Dose 2 infusion is in Phase 1.

Related

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