Last reviewed · How we verify
Apalutamide Oral Tablet
Apalutamide is an androgen receptor inhibitor that blocks the binding and nuclear translocation of androgens, preventing androgen-driven prostate cancer cell growth.
Apalutamide is an androgen receptor inhibitor that blocks the binding and nuclear translocation of androgens, preventing androgen-driven prostate cancer cell growth. Used for Metastatic castration-resistant prostate cancer (mCRPC), Non-metastatic castration-resistant prostate cancer (nmCRPC).
At a glance
| Generic name | Apalutamide Oral Tablet |
|---|---|
| Sponsor | Santa Chiara Hospital |
| Drug class | Androgen receptor antagonist |
| Target | Androgen receptor (AR) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Apalutamide binds to the ligand-binding domain of the androgen receptor with high affinity and specificity, preventing androgen (testosterone and DHT) from activating the receptor. This blocks downstream signaling that drives prostate cancer cell proliferation and survival. It also inhibits nuclear translocation of the androgen receptor, providing dual mechanisms of androgen receptor antagonism.
Approved indications
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
Common side effects
- Fatigue
- Hot flashes
- Rash
- Diarrhea
- Nausea
- Falls
- Seizures
Key clinical trials
- A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma (PHASE2)
- A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (PHASE3)
- A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC (PHASE3)
- A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy (PHASE3)
- An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) (PHASE3)
- A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC) (PHASE4)
- ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer (PHASE1)
- An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC (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:
- Apalutamide Oral Tablet CI brief — competitive landscape report
- Apalutamide Oral Tablet updates RSS · CI watch RSS
- Santa Chiara Hospital portfolio CI