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Abiraterone Acetate (AA)
Abiraterone Acetate (AA) is a CYP17A1 inhibitor Small molecule drug developed by Janssen Research & Development, LLC. It is currently in Phase 3 development for Metastatic castration-resistant prostate cancer (mCRPC), High-risk castration-sensitive prostate cancer (in combination with androgen deprivation therapy).
Abiraterone acetate inhibits CYP17A1, a key enzyme in androgen synthesis, thereby reducing testosterone production in patients with castration-resistant prostate cancer.
Abiraterone Acetate (AA) is used to treat castration-resistant prostate cancer (CRPC) and oligometastatic CRPC. It is also being studied in combination with other treatments, such as patient-specific adaptive therapy and enzalutamide, in clinical trials for CRPC.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
Janssen Research & Development, LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 (AA) |
|---|---|
| Sponsor | Janssen Research & Development, LLC |
| Drug class | CYP17A1 inhibitor |
| Target | CYP17A1 (17α-hydroxylase/17,20-lyase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Abiraterone acetate is a prodrug that is converted to abiraterone in vivo. It selectively inhibits 17α-hydroxylase/17,20-lyase (CYP17A1), an enzyme critical for androgen biosynthesis in the testes, adrenal glands, and prostate cancer cells. By blocking this enzyme, it suppresses intratumoral and circulating androgens, slowing prostate cancer progression in patients who have become resistant to chemical castration.
Approved indications
- Metastatic castration-resistant prostate cancer (mCRPC)
- High-risk castration-sensitive prostate cancer (in combination with androgen deprivation therapy)
Common side effects
- Hypokalemia
- Hypertension
- Fluid retention/edema
- Fatigue
- Joint swelling/pain
- Diarrhea
Key clinical trials
- A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer (PHASE2)
- M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501) (PHASE1)
- A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (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)
- A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (PHASE1)
- A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer (PHASE1)
- REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial (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:
- Abiraterone Acetate (AA) CI brief — competitive landscape report
- Abiraterone Acetate (AA) updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI
Frequently asked questions about Abiraterone Acetate (AA)
What is Abiraterone Acetate (AA)?
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Who makes Abiraterone Acetate (AA)?
What drug class is Abiraterone Acetate (AA) in?
What development phase is Abiraterone Acetate (AA) in?
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Related
- Drug class: All CYP17A1 inhibitor drugs
- Target: All drugs targeting CYP17A1 (17α-hydroxylase/17,20-lyase)
- Manufacturer: Janssen Research & Development, LLC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic castration-resistant prostate cancer (mCRPC)
- Indication: Drugs for High-risk castration-sensitive prostate cancer (in combination with androgen deprivation therapy)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing