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BAY85-3934
BAY85-3934 is a Small molecule drug developed by Bayer. It is currently in Phase 2 development.
BAY85-3934 is a small molecule used in clinical trials to study its effects on conditions such as anemia and chronic renal insufficiency. It has been studied in a randomized, placebo-controlled trial as a potential treatment for these conditions.
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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 | BAY85-3934 |
|---|---|
| Sponsor | Bayer |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study to Learn More About the Long-term Safety and Effectiveness of Molidustat as a Treatment for Japanese Men and Women With Renal Anemia
- Maintenance Treatment of Renal Anemia in Dialysis Subjects (PHASE3)
- A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects (PHASE3)
- A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects (PHASE3)
- A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects (PHASE3)
- A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects (PHASE3)
- Single Dose Group Stratified Study in Renal Impaired and Healthy Aged and Gender Matched Subjects (PHASE1)
- To Investigate Pharmacokinetics (Absorption, Distribution, Elimination), Safety and Tolerability of a Single Oral Dose of 75 mg Molidustat Tablet in Male and Female Subjects Requiring Hemo- or Peritoneal Dialysis Compared to Healthy Subjects (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:
- BAY85-3934 CI brief — competitive landscape report
- BAY85-3934 updates RSS · CI watch RSS
- Bayer portfolio CI
Frequently asked questions about BAY85-3934
What is BAY85-3934?
Who makes BAY85-3934?
What development phase is BAY85-3934 in?
Related
- Manufacturer: Bayer — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing