Floatz Rating
B62/100
Confidence
Indicative
Sponsor
Bayer
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
56High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07406282CT.gov A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics | — | Recruiting | — | — | — |
NCT06430411CT.gov Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study | — | Not Yet Recruiting | — | — | — |
NCT05999968CT.gov Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment | — | Completed | — | — | — |
NCT04736199CT.gov Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer | — | Completed | — | — | — |
NCT03237416CT.gov Drug-drug-interaction Study to Assess the Effect of Darolutamide on the Pharmacokinetics of Probe Substrates of CYP3A4 and P-gp in Healthy Male Volunteers | — | Completed | — | — | — |
NCT02363855CT.gov Phase 1 Dose Escalation Study of BAY 1841788 in Japanese Metastatic Castration-resistant Prostate Cancer (mCRPC) Subjects | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
73High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Prostate Neoplasm
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Darolutamide (this asset) | Bayer | P3 | B · 62 |
| Docetaxel | Merck Sharp & Dohme LLC | P4 | BBB |
| Degarelix | Novartis Pharmaceuticals | P4 | BBB |
| Prednisone | Merck Sharp & Dohme LLC | P3 | BBB |
| Abiraterone | Qilu Pharmaceutical Co., Ltd. | P3 | BB |
| Leuporelin | Dana-Farber Cancer Institute | P4 | BB |
| Radium Ra-223 | Bayer | P3 | BB |
| Prednisolone | Eli Lilly and Company | P3 | BB |
| Gozetotide | Telix Pharmaceuticals (Innovations) Pty Limited | P3 | BB |
+42 more in the Prostate Neoplasm 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 Neoplasm. 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-neoplasm
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