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ZK 245186
ZK 245186 is a Small molecule drug developed by Bayer. It is currently in Phase 2 development.
ZK 245186, also known as Mapracorat, is a small molecule glucocorticoid receptor agonist used to treat ocular inflammation and pain following cataract surgery. It is administered as an ophthalmic suspension, 3%, and has been studied in clinical trials for various ocular conditions, including cataract, inflammation, and conjunctivitis.
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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 | ZK 245186 |
|---|---|
| Sponsor | Bayer |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- HPA Axis Study in Adults (PHASE2)
- HPA Axis Study in Japanese Adults (PHASE2)
- Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis (PHASE2)
- Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery (PHASE2)
- Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis (PHASE2)
- Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery (PHASE3)
- Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery (PHASE3)
- Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation Following Cataract Surgery (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:
- ZK 245186 CI brief — competitive landscape report
- ZK 245186 updates RSS · CI watch RSS
- Bayer portfolio CI
Frequently asked questions about ZK 245186
What is ZK 245186?
Who makes ZK 245186?
What development phase is ZK 245186 in?
Related
- Manufacturer: Bayer — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing