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Zytiga (abiraterone-acetate)
Zytiga (generic name: abiraterone-acetate) is a Cytochrome P450 17A1 Inhibitor drug developed by Johnson & Johnson. It is currently FDA-approved (first approved 2011) for Malignant tumor of prostate, Metastatic castration-resistant prostate cancer.
Zytiga blocks the production of male hormones that fuel prostate cancer growth.
Zytiga (abiraterone-acetate) is a small molecule cytochrome P450 17A1 inhibitor developed by Janssen Biotech, targeting the steroid 17-alpha-hydroxylase/17,20 lyase enzyme. It is used to treat metastatic castration-resistant prostate cancer and is FDA-approved since 2011. Zytiga works by inhibiting the production of androgens, which are hormones that fuel the growth of prostate cancer cells. The commercial status of Zytiga is patented, and it is not yet available as a generic medication. Key safety considerations include hypertension, hypokalemia, and cardiac disorders.
At a glance
| Generic name | abiraterone-acetate |
|---|---|
| Sponsor | Johnson & Johnson |
| Drug class | Cytochrome P450 17A1 Inhibitor |
| Target | Steroid 17-alpha-hydroxylase/17,20 lyase |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2011 |
| Annual revenue | 1500 |
Mechanism of action
Abiraterone acetate is converted in vivo to abiraterone, an androgen biosynthesis inhibitor, that inhibits 17 -hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in testicular, adrenal, and prostatic tumor tissues and is required for androgen biosynthesis.CYP17 catalyzes two sequential reactions: 1) the conversion of pregnenolone and progesterone to their 17-hydroxy derivatives by 17-hydroxylase activity and 2) the subsequent formation of dehydroepiandrosterone (DHEA) and androstenedione, respectively, by C17, 20-lyase activity. DHEA and androstenedione are androgens and are precursors of testosterone. Inhibition of CYP17 by abiraterone can also result in increased mineralocorticoid production by the adrenals [see Warnings and Precautions (5.1)].Androgen sensitive prostatic carcinoma responds to treatment that decreases androgen levels. Androgen deprivation therapies, such as treatment with GnRH agonists or orchiectomy, decrease androgen production in t
Approved indications
- Malignant tumor of prostate
- Metastatic castration-resistant prostate cancer
Common side effects
- Anemia
- Elevated alkaline phosphatase
- Hypertriglyceridemia
- Lymphopenia
- Hypercholesterolemia
- Hyperglycemia
- Hypokalemia
- Fatigue
- Arthralgia
- Hypertension
- Nausea
- Edema
Drug interactions
- CYP2C8 Substrates
- P-glycoprotein Substrates
- SLCO1B1 Substrates
Key clinical trials
- 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)
- Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma (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)
- M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501) (PHASE1)
- A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer (PHASE1,PHASE2)
- Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (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:
- Zytiga CI brief — competitive landscape report
- Zytiga updates RSS · CI watch RSS
- Johnson & Johnson portfolio CI
Frequently asked questions about Zytiga
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Related
- Drug class: All Cytochrome P450 17A1 Inhibitor drugs
- Target: All drugs targeting Steroid 17-alpha-hydroxylase/17,20 lyase
- Manufacturer: Johnson & Johnson — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Malignant tumor of prostate
- Indication: Drugs for Metastatic castration-resistant prostate cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing