Floatz Rating
BB67/100
Confidence
Indicative
Sponsor
Bayer
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
63High 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 | — | — | — |
NCT07086651CT.gov A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC) | — | Completed | — | — | — |
NCT06430411CT.gov Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study | — | Not Yet Recruiting | — | — | — |
NCT06095089CT.gov A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer | — | Recruiting | — | — | — |
NCT05295927CT.gov A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) | — | Terminated | — | — | — |
NCT04295447CT.gov Adjuvant Apalutamide in Subjects With High-risk Localized or Locally Advanced Prostate Cancer After Radical Prostatectomy | — | Active Not Recruiting | — | — | — |
NCT04557059CT.gov A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT04523207CT.gov A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases | — | Completed | — | — | — |
NCT04108208CT.gov A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC) | — | Active Not Recruiting | — | — | — |
NCT04034095CT.gov A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan | — | Completed | — | — | — |
Show 8 more trialsShow fewer
NCT03767244CT.gov A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy | — | Active Not Recruiting | — | — | — |
NCT03523442CT.gov A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT02924766CT.gov A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE) | — | Completed | — | — | — |
NCT02531516CT.gov An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS | — | Active Not Recruiting | — | — | — |
NCT02257736CT.gov An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) | — | Active Not Recruiting | — | — | — |
NCT02123758CT.gov A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT01946204CT.gov A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT03523338CT.gov An Expanded Access Protocol for Apalutamide Treatment of Participants With Non-Metastatic Castration-Resistant Prostate Cancer | — | No Longer Available | — | — | — |
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 |
|---|---|---|---|
| Apalutamide (this asset) | Bayer | Approved | BB · 67 |
| Docetaxel | Merck Sharp & Dohme LLC | P4 | BBB |
| Prednisone | Merck Sharp & Dohme LLC | P3 | BBB |
| Degarelix | Novartis Pharmaceuticals | P4 | 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 Apalutamide
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Metastatic Prostate Carcinoma | — | P4 | BB · 67 |
| Prostate Carcinoma | — | P3 | BB · 64 |
| Castration-Resistant Prostate Carcinoma | — | P3 | B · 62 |
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. Apalutamide 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/apalutamide-prostate-neoplasm
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