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Zytiga
Zytiga, marketed by Bukwang Pharmaceutical, is a treatment for malignant tumors of the prostate with a well-established presence in the market. The drug's key composition patent is set to expire in 2028, providing a period of exclusivity that supports its competitive position. The primary risk to Zytiga is the potential increase in competition following the patent expiry in 2028.
At a glance
| Generic name | Zytiga |
|---|---|
| Also known as | Zytiga 500mg, Abiraterone Acetate |
| Sponsor | Bukwang Pharmaceutical |
| Target | Cytochrome P450 11B2, mitochondrial, Androgen receptor, Cytochrome P450 11B1, mitochondrial |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Malignant tumor of prostate
- Metastatic castration-resistant prostate cancer
Common side effects
- Fatigue
- Arthralgia
- Hypertension
- Nausea
- Edema
- Hypokalemia
- Hot flush
- Diarrhea
- Vomiting
- Upper respiratory infection
- Cough
- Headache
Serious adverse events
- Hepatotoxicity
- Cardiac disorders
- Pneumonia
- Cardio-respiratory arrest
- General physical health deterioration
- Disease progression
- Treatment-emergent adverse events resulting in death
Key clinical trials
- Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response (PHASE3)
- A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss (PHASE2)
- A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer (PHASE1, PHASE2)
- Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma (PHASE2)
- Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP Patients (PHASE2)
- A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02) (PHASE1, PHASE2)
- A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer (PHASE2)
- A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) (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:
- Zytiga CI brief — competitive landscape report
- Zytiga updates RSS · CI watch RSS
- Bukwang Pharmaceutical portfolio CI