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BAY1002670
BAY1002670 is a Small molecule drug developed by Bayer. It is currently in Phase 2 development.
BAY1002670, also known as Vilaprisan, is a small molecule progesterone receptor modulator being developed by Bayer for the treatment of uterine fibroids, endometriosis, and heavy menstrual bleeding. It is a selective progesterone receptor modulator that has been studied in clinical trials for its pharmacodynamics, pharmacokinetics, and safety in healthy young women.
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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). -
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.
| 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 | BAY1002670 |
|---|---|
| Sponsor | Bayer |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (PHASE3)
- A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (PHASE3)
- Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3) (PHASE3)
- A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding (PHASE3)
- Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4) (PHASE3)
- Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis (PHASE2)
- Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned (PHASE1)
- Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (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:
- BAY1002670 CI brief — competitive landscape report
- BAY1002670 updates RSS · CI watch RSS
- Bayer portfolio CI
Frequently asked questions about BAY1002670
What is BAY1002670?
Who makes BAY1002670?
What development phase is BAY1002670 in?
Related
- Manufacturer: Bayer — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing