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BAY85-8501
BAY85-8501 is a SGLT2 inhibitor Small molecule drug developed by Bayer. It is currently in Phase 2 development for Type 2 diabetes.
BAY85-8501 is a small molecule that targets the SGLT2 receptor.
BAY85-8501 is a small molecule that targets the SGLT2 receptor. Used for Type 2 diabetes.
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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 | BAY85-8501 |
|---|---|
| Sponsor | Bayer |
| Drug class | SGLT2 inhibitor |
| Target | SGLT2 |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 2 |
Mechanism of action
By inhibiting SGLT2, BAY85-8501 reduces glucose reabsorption in the kidneys, thereby lowering blood glucose levels. This mechanism is particularly useful for the treatment of type 2 diabetes.
Approved indications
- Type 2 diabetes
Common side effects
- Increased risk of genital yeast infections
- Increased risk of urinary tract infections
- Dehydration
Key clinical trials
- Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis (PHASE2)
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:
- BAY85-8501 CI brief — competitive landscape report
- BAY85-8501 updates RSS · CI watch RSS
- Bayer portfolio CI
Frequently asked questions about BAY85-8501
What is BAY85-8501?
How does BAY85-8501 work?
What is BAY85-8501 used for?
Who makes BAY85-8501?
What drug class is BAY85-8501 in?
What development phase is BAY85-8501 in?
What are the side effects of BAY85-8501?
What does BAY85-8501 target?
Related
- Drug class: All SGLT2 inhibitor drugs
- Target: All drugs targeting SGLT2
- Manufacturer: Bayer — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing