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Placebo of Darolutamide
Placebo of Darolutamide is a nonsteroidal antiandrogen Small molecule drug developed by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie. It is currently in Phase 3 development for Nonmetastatic castration-resistant prostate cancer.
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 Nonmetastatic castration-resistant prostate cancer.
At a glance
| Generic name | Placebo of Darolutamide |
|---|---|
| Sponsor | Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie |
| 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
- Nonmetastatic castration-resistant prostate cancer
Common side effects
- Fatigue
- Musculoskeletal pain
- Hypertension
- Diarrhea
- Nausea
Key clinical trials
- Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study (PHASE3)
- Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (PHASE2, PHASE3)
- 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)
- Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (PHASE3)
- Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents (PHASE3)
- Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer (PHASE3)
- ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable) (PHASE3)
- ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents. (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo of Darolutamide CI brief — competitive landscape report
- Placebo of Darolutamide updates RSS · CI watch RSS
- Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie portfolio CI
Frequently asked questions about Placebo of Darolutamide
What is Placebo of Darolutamide?
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Related
- Drug class: All nonsteroidal antiandrogen drugs
- Target: All drugs targeting androgen receptor
- Manufacturer: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Nonmetastatic castration-resistant prostate cancer
- Compare: Placebo of Darolutamide vs similar drugs
- Pricing: Placebo of Darolutamide cost, discount & access