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Abiraterone acetate tablets
Abiraterone acetate tablets is a CYP17 inhibitor Small molecule drug developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. It is currently in Phase 2 development for Prostate cancer. Also known as: ZYTIGA®.
CYP17 inhibitor
Abiraterone acetate tablets are a small molecule inhibitor that targets the cytochrome P450 17A1 enzyme, specifically inhibiting its steroid 17-alpha-hydroxylase/17,20 lyase activity. They are used to treat conditions such as high-risk localized prostate carcinoma and prostate cancer, as well as other conditions including healthy volunteers, according to ClinicalTrials.gov.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Abiraterone acetate tablets |
|---|---|
| Also known as | ZYTIGA® |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Drug class | CYP17 inhibitor |
| Target | CYP17 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Abiraterone acetate is a CYP17 inhibitor that blocks the production of androgens, leading to a decrease in testosterone levels in the body.
Approved indications
- Prostate cancer
Common side effects
- Fatigue
- Hypertension
- Diarrhea
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)
- 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)
- Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (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 Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer (PHASE3)
- ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer (PHASE1)
- Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (China Cohort) (PHASE3)
- A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer (PHASE1, 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:
- Abiraterone acetate tablets CI brief — competitive landscape report
- Abiraterone acetate tablets updates RSS · CI watch RSS
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. portfolio CI
Frequently asked questions about Abiraterone acetate tablets
What is Abiraterone acetate tablets?
How does Abiraterone acetate tablets work?
What is Abiraterone acetate tablets used for?
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Is Abiraterone acetate tablets also known as anything else?
What drug class is Abiraterone acetate tablets in?
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Related
- Drug class: All CYP17 inhibitor drugs
- Target: All drugs targeting CYP17
- Manufacturer: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Prostate cancer
- Also known as: ZYTIGA®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing