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Enzalutamide capsule
Enzalutamide is an androgen receptor inhibitor that blocks the binding and nuclear translocation of androgens, preventing androgen-driven gene transcription in prostate cancer cells.
Enzalutamide is an androgen receptor inhibitor that blocks the binding and nuclear translocation of androgens, preventing androgen-driven gene transcription in prostate cancer cells. Used for Metastatic castration-resistant prostate cancer, Non-metastatic castration-resistant prostate cancer, Metastatic hormone-sensitive prostate cancer.
At a glance
| Generic name | Enzalutamide capsule |
|---|---|
| Also known as | Xantdi, Xtandi, ASP-9785, MDV3100 |
| Sponsor | CHU de Quebec-Universite Laval |
| Drug class | Androgen receptor antagonist |
| Target | Androgen receptor (AR) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Enzalutamide binds to the ligand-binding domain of the androgen receptor with high affinity, preventing androgen (testosterone and DHT) from activating the receptor. This blocks the translocation of the androgen receptor into the nucleus and its interaction with DNA, thereby inhibiting the expression of androgen-responsive genes essential for prostate cancer cell proliferation and survival. It is effective in both hormone-sensitive and castration-resistant prostate cancer.
Approved indications
- Metastatic castration-resistant prostate cancer
- Non-metastatic castration-resistant prostate cancer
- Metastatic hormone-sensitive prostate cancer
Common side effects
- Fatigue
- Hot flashes
- Diarrhea
- Musculoskeletal pain
- Headache
- Upper respiratory tract infection
- Seizures
Key clinical trials
- Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991) (PHASE3)
- A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer (PHASE1, PHASE2)
- A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer (PHASE2)
- A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer (PHASE2)
- Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC (PHASE3)
- An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC (PHASE2)
- Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365) (PHASE1, PHASE2)
- An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) (PHASE3)
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:
- Enzalutamide capsule CI brief — competitive landscape report
- Enzalutamide capsule updates RSS · CI watch RSS
- CHU de Quebec-Universite Laval portfolio CI