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Erleada (apalutamide)
Erleada blocks the androgen receptor, a protein that helps cancer cells grow.
Erleada (apalutamide) is a small molecule drug developed by Janssen Biotech that targets the androgen receptor. It is used to treat castration-resistant prostate cancer, including metastasis from malignant tumors of the prostate. Erleada was FDA-approved in 2018 and is currently patented. As a small molecule, it works by blocking the androgen receptor, which is a protein that helps cancer cells grow. Key safety considerations include potential side effects such as fatigue, diarrhea, and high blood pressure.
At a glance
| Generic name | apalutamide |
|---|---|
| Sponsor | Johnson & Johnson |
| Target | Androgen receptor |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2018 |
| Annual revenue | 2600 |
Mechanism of action
Apalutamide is an Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. Apalutamide inhibits AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription. major metabolite, N-desmethyl apalutamide, is less potent inhibitor of AR, and exhibited one-third the activity of apalutamide in an in vitro transcriptional reporter assay. Apalutamide administration caused decreased tumor cell proliferation and increased apoptosis leading to decreased tumor volume in mouse xenograft models of prostate cancer.
Approved indications
- Castration-resistant prostate cancer
- Malignant tumor of prostate
- Metastasis from malignant tumor of prostate
Common side effects
- Fatigue
- Rash
- Hypertension
- Hot flush
- Arthralgia
- Diarrhea
- Decreased appetite
- Fall
- Weight decreased
- Fracture
- Pruritus
- Vomiting
Key clinical trials
- Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response (PHASE3)
- Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma (PHASE2)
- Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland (PHASE2)
- A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma (PHASE2)
- Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP Patients (PHASE2)
- A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (PHASE3)
- Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer (PHASE2)
- A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Erleada CI brief — competitive landscape report
- Erleada updates RSS · CI watch RSS
- Johnson & Johnson portfolio CI