Last reviewed 2026-06-02 · How we verify

Abiraterone - Usual

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair · Phase 2 active Small molecule Under review

Abiraterone - Usual is a CYP17 inhibitor Small molecule drug developed by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair. It is currently in Phase 2 development for Metastatic castration-resistant prostate cancer. Also known as: ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet for Oral.

Abiraterone is an androgen biosynthesis inhibitor that blocks the production of testosterone in the body.

Abiraterone is a small molecule inhibitor that targets the cytochrome P450 17A1 enzyme, specifically inhibiting its steroid 17-alpha-hydroxylase/17,20 lyase activity. It is used to treat conditions such as prostate cancer and congenital adrenal hyperplasia, and is available in the form of abiraterone acetate.

Likelihood of approval

13.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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 - Usual
Also known as	ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet for Oral
Sponsor	Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Drug class	CYP17 inhibitor
Target	CYP17
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 2

Mechanism of action

Abiraterone works by inhibiting the enzyme CYP17, which is involved in the production of testosterone. By blocking this enzyme, abiraterone reduces the levels of testosterone in the body, which can slow the growth of prostate cancer cells.

Approved indications

Metastatic castration-resistant prostate cancer

Common side effects

Adrenal insufficiency
Hypertension
Fatigue
Diarrhea
Nausea
Vomiting
Headache
Dizziness
Muscle weakness
Joint pain

Key clinical trials

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 - Usual CI brief — competitive landscape report
Abiraterone - Usual updates RSS · CI watch RSS
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair portfolio CI

Frequently asked questions about Abiraterone - Usual

What is Abiraterone - Usual?

Abiraterone - Usual is a CYP17 inhibitor drug developed by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, indicated for Metastatic castration-resistant prostate cancer.

How does Abiraterone - Usual work?

Abiraterone is an androgen biosynthesis inhibitor that blocks the production of testosterone in the body.

What is Abiraterone - Usual used for?

Abiraterone - Usual is indicated for Metastatic castration-resistant prostate cancer.

Who makes Abiraterone - Usual?

Abiraterone - Usual is developed by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair (see full Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair pipeline at /company/han-xu-m-d-ph-d-fapcr-sponsor-investigator-irb-chair).

Is Abiraterone - Usual also known as anything else?

Abiraterone - Usual is also known as ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet for Oral.

What drug class is Abiraterone - Usual in?

Abiraterone - Usual belongs to the CYP17 inhibitor class. See all CYP17 inhibitor drugs at /class/cyp17-inhibitor.

What development phase is Abiraterone - Usual in?

Abiraterone - Usual is in Phase 2.

What are the side effects of Abiraterone - Usual?

Common side effects of Abiraterone - Usual include Adrenal insufficiency, Hypertension, Fatigue, Diarrhea, Nausea, Vomiting.

What does Abiraterone - Usual target?

Abiraterone - Usual targets CYP17 and is a CYP17 inhibitor.

Drug class: All CYP17 inhibitor drugs
Target: All drugs targeting CYP17
Manufacturer: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Metastatic castration-resistant prostate cancer
Also known as: ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet for Oral

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing