Floatz Rating
CCC48/100
Confidence
Indicative
Sponsor
Celcuity Inc
Modality
Small molecule
Development Phase
Phase 1/2
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
33Indicative
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT06190899CT.gov Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer | — | Recruiting | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
95High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Prostate Disorder
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Darolutamide (this asset) | Celcuity Inc | P1/2 | CCC · 48 |
| Dinitrogen Monoxide | Beth Israel Deaconess Medical Center | P4 | BB |
| Oxygen | Beth Israel Deaconess Medical Center | P4 | BB |
| Epoetin Alfa | Janssen-Ortho Inc., Canada | P3 | B |
| Nivolumab | Australian and New Zealand Urogenital and Prostate Cancer Trials Group | P2 | B |
| Bicalutamide | Memorial Sloan Kettering Cancer Center | P2 | B |
| STI571 | Novartis Pharmaceuticals | P2 | B |
| Gnrh | Memorial Sloan Kettering Cancer Center | P2 | B |
| Olaparib | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | P2 | B |
+18 more in the Prostate Disorder cohort
Other indications for Darolutamide
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Castration-Resistant Prostate Carcinoma | — | P4 | BBB · 78 |
| Breast Cancer | — | P2 | BBB · 73 |
| Prostate Adenocarcinoma | — | P3 | BB · 66 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Darolutamide in Prostate Disorder. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/darolutamide-prostate-disorder
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