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Darolutamide continuous
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 castration-resistant prostate cancer (mCRPC).
At a glance
| Generic name | Darolutamide continuous |
|---|---|
| Also known as | Darolutamide |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Drug class | Androgen receptor antagonist |
| Target | Androgen receptor (AR) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Darolutamide competitively binds to the androgen receptor with high affinity and selectivity, preventing activation by testosterone and dihydrotestosterone. This blocks the transcription of androgen-responsive genes essential for prostate cancer cell proliferation and survival. The continuous formulation maintains sustained androgen receptor antagonism to provide durable suppression of castration-resistant prostate cancer progression.
Approved indications
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
Common side effects
- Fatigue
- Hot flashes
- Hypertension
- Rash
- Diarrhea
Key clinical trials
- Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (PHASE2)
- Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment (PHASE1)
- A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC (PHASE2)
- A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation (PHASE2)
- CONVERT-HB1: Radical Prostatectomy After Systemic Therapy for High-volume Metastatic Hormone-sensitive Prostate Cancer (PHASE2)
- Working Out M0 Bipolar Androgen Therapy (PHASE2)
- Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer (PHASE3)
- Randomized Phase II Trial on Short Term Darolutamide Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer (PHASE2)
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 |
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