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Standard Darolutamide
Darolutamide is a nonsteroidal antiandrogen that competitively inhibits the action of androgens, such as testosterone and dihydrotestosterone, at their receptor sites in various tissues.
Darolutamide is a nonsteroidal antiandrogen that competitively inhibits the action of androgens, such as testosterone and dihydrotestosterone, at their receptor sites in various tissues. Used for Metastatic castration-resistant prostate cancer.
At a glance
| Generic name | Standard Darolutamide |
|---|---|
| Sponsor | Jena University Hospital |
| Drug class | Nonsteroidal antiandrogen |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This results in a decrease in the growth and spread of prostate cancer cells. By blocking the effects of androgens, darolutamide can help slow the progression of the disease.
Approved indications
- Metastatic castration-resistant prostate cancer
Common side effects
- Fatigue
- Musculoskeletal pain
- Hypertension
- Diarrhea
- Nausea
Key clinical trials
- Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response (PHASE3)
- A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer
- A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) (PHASE4)
- PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC.
- Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (PHASE2)
- Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (PHASE1)
- Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (PHASE3)
- Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.
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 |