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Darolutamide Oral Tablet
Darolutamide is an androgen receptor antagonist that blocks the binding of androgens to the androgen receptor, inhibiting androgen-driven prostate cancer cell growth.
Darolutamide is an androgen receptor antagonist that blocks the binding of androgens to the androgen receptor, inhibiting androgen-driven prostate cancer cell growth. Used for Non-metastatic castration-resistant prostate cancer (nmCRPC), Metastatic hormone-sensitive prostate cancer (mHSPC).
At a glance
| Generic name | Darolutamide Oral Tablet |
|---|---|
| Sponsor | Santa Chiara Hospital |
| Drug class | Androgen receptor antagonist |
| Target | Androgen receptor (AR) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Darolutamide competitively binds to the ligand-binding domain of the androgen receptor with high affinity and selectivity, preventing activation by testosterone and dihydrotestosterone. This blocks downstream signaling that drives proliferation and survival of androgen-dependent prostate cancer cells. It is a non-steroidal antiandrogen with improved blood-brain barrier penetration compared to earlier-generation agents.
Approved indications
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic hormone-sensitive prostate cancer (mHSPC)
Common side effects
- Fatigue
- Hot flashes
- Hypertension
- Rash
- Diarrhea
- Nausea
Key clinical trials
- 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)
- A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies (PHASE3)
- A Study Called ARAMON to Learn to What Extent Does Study Treatment With Darolutamide Affects Testosterone Levels in Men With Prostate Cancer That Had Not Been Treated With Hormonal Therapy Compared to Treatment With Enzalutamide (PHASE2)
- Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED) (PHASE2)
- A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer. (PHASE2)
- Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (PHASE1)
- Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (PHASE3)
- A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer. (PHASE1)
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:
- Darolutamide Oral Tablet CI brief — competitive landscape report
- Darolutamide Oral Tablet updates RSS · CI watch RSS
- Santa Chiara Hospital portfolio CI