> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/abiraterone-acetate-2c6662c6-31e9-49ed-a022-f76f326fbd3e
> Record changed: 2026-10-13

# Abiraterone acetate

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL271227)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL271227)

First approval year

2011

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL271227)

## Development status

**First approval year**

2011

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL271227)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL271227)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL271227)

**Drug name**

Abiraterone acetate

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL271227)

**Molecular weight**

391.56

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL271227)

**Structure (SMILES)**

CC(=O)O\[C@H\]1CC\[C@@\]2(C)C(=CC\[C@@H\]3\[C@@H\]2CC\[C@\]2(C)C(c4cccnc4)=CC\[C@@H\]32)C1

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL271227)

### Brand names (12)

- abiraterone accord
- Abiraterone accord
- abiraterone acetate component of akeega
- Abiraterone acetate component of akeega
- abiraterone krka
- Abiraterone krka
- abiraterone mylan
- Abiraterone mylan
- yonsa
- Yonsa
- zytiga
- Zytiga

### Other names (36)

- ABIRATERONE (AS ACETATE)
- abiraterone acetate
- Abiraterone acetate
- ABIRATERONE ACETATE \[JAN\]
- ABIRATERONE ACETATE \[MART.\]
- ABIRATERONE ACETATE \[MI\]
- ABIRATERONE ACETATE \[ORANGE BOOK\]
- ABIRATERONE ACETATE \[USAN\]
- ABIRATERONE ACETATE \[USP MONOGRAPH\]
- ABIRATERONE ACETATE \[USP-RS\]
- ABIRATERONE ACETATE \[VANDF\]
- Abiraterone acetate \[WHO-DD\]
- abiraterone acetate jan
- abiraterone acetate mart
- abiraterone acetate mi
- abiraterone acetate orange book
- abiraterone acetate usan
- abiraterone acetate usp monograph
- abiraterone acetate usp rs
- abiraterone acetate vandf
- abiraterone acetate who dd
- abiraterone as acetate
- akeega component abiraterone acetate
- AKEEGA COMPONENT ABIRATERONE ACETATE
- androsta 5 16 dien 3 ol 17 3 pyridinyl acetate ester 3 beta

And 11 more, listed on the interactive page.

## Identifiers

**ATC classification codes**

- L02BX03

**CAS registry numbers**

- 154229-18-2

**ChEMBL ID**

CHEMBL271227

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL271227)

**InChIKey**

UVIQSJCZCSLXRZ-UBUQANBQSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL271227)

**PubChem compound IDs**

- 9821849

**RxNorm IDs (RxCUI)**

- 1100071

**FDA ingredient codes (UNII)**

- EM5OCB9YJ6

## Regulatory information

### United States

**Applicant**

JANSSEN BIOTECH

**Approval date**

28 Apr 2011

**Application number**

NDA202379

### European Union

**Status**

Authorised

**Status date**

24 Jun 2021

**Authorisation date**

24 Jun 2021

**Approved indications**

Abiraterone Krka is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1) the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1) the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

**Product number**

EMEA/H/C/005649

**Authorisation holder**

Krka, d.d., Novo mesto

**Priority medicines scheme**

No

**Generic**

Yes

**Biosimilar**

No

**Generic medicines**

2

**Biosimilar medicines**

0

**Advanced therapy**

No

**Conditional approval**

No

**Additional monitoring**

No

**Accelerated assessment**

No

**Exceptional circumstances**

No

#### Therapeutic areas

- Prostatic Neoplasms

European medicines record

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/abiraterone-krka)

### Other regulatory facts

**Patents**

2

**Designations**

1

**Earliest recorded loss of exclusivity**

20 May 2034

**First in class**

Yes

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

Yes

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

abiraterone acetate

**Type**

Synthetic organic

**Drug name stem**

\-terone

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Oral

### Mechanisms of action

- **Mechanism**  
Cytochrome P450 17A1 inhibitor

**Action type**  
Inhibitor

**Target**  
Steroid 17-alpha-hydroxylase/17,20 lyase

**Protein identifier**  
P05093

### Open Targets mechanisms

- **Mechanism**  
Cytochrome P450 17A1 inhibitor

**Action type**  
Inhibitor

**Target**  
Steroid 17-alpha-hydroxylase/17,20 lyase

### DrugCentral mechanisms

- **Action type**  
Inhibitor

**Gene symbol**  
CYP17A1

**Protein identifier**  
P05093

**Organism**  
Homo sapiens

**Target development level**  
Clinical

### Investigated indications (12)

- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000196

**Subject identifier**  
D011471
- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000673

**Subject identifier**  
D011471
- **Condition**  
Liver Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0001421

**Subject identifier**  
D008107
- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0001663

**Subject identifier**  
D011471
- **Condition**  
Carcinoma, Non-Small-Cell Lung

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0003060

**Subject identifier**  
D002289
- **Condition**  
Salivary Gland Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003826

**Subject identifier**  
D012468
- **Condition**  
Renal Insufficiency

**Highest recorded phase**  
1

**Condition identifier**  
HP:0000083

**Subject identifier**  
D051437
- **Condition**  
Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0004992

**Subject identifier**  
D009369
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0007254

**Subject identifier**  
D001943
- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
MONDO:0008315

**Subject identifier**  
D011471
- **Condition**  
Adrenal Hyperplasia, Congenital

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0008728

**Subject identifier**  
D000312
- **Condition**  
Adrenal Hyperplasia, Congenital

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0018479

**Subject identifier**  
D000312

### Open Targets indications (31)

- **Condition identifier**  
EFO\_0000196

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0000673

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0001421

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0001663
- **Condition identifier**  
EFO\_0003826

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0003863
- **Condition identifier**  
EFO\_0009006

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0009870

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0000083

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0004669

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004989

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0004992

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004992

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005082

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005154

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0005159

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005233

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005494

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0006639

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0007254

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0007254

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0008315
- **Condition identifier**  
MONDO\_0008315

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0008728

**Highest recorded phase**  
1

And 6 more, listed on the interactive page.

### Reported adverse events (9)

- **Event**  
disease progression

**Reports**  
516

**Reporting signal score**

576.149
- **Event**  
drug hypersensitivity

**Reports**  
10

**Reporting signal score**

150.5
- **Event**  
hospitalisation

**Reports**  
331

**Reporting signal score**

198.806
- **Event**  
hot flush

**Reports**  
275

**Reporting signal score**

351.545
- **Event**  
hypokalaemia

**Reports**  
355

**Reporting signal score**

445.478
- **Event**  
injection site pain

**Reports**  
1

**Reporting signal score**

143.496
- **Event**  
prostate cancer

**Reports**  
192

**Reporting signal score**

357.003
- **Event**  
prostate cancer metastatic

**Reports**  
139

**Reporting signal score**

494.141
- **Event**  
prostatic specific antigen increased

**Reports**  
541

**Reporting signal score**  
1,852.38

### Trial references (80)

- NCT00473512  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00473512)
- NCT00485303  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00485303)
- NCT00638690  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00638690)
- NCT01023061  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01023061)
- NCT01186484  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01186484)
- NCT01314118  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01314118)
- NCT01503229  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01503229)
- NCT01786265  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01786265)
- NCT01848067  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01848067)
- NCT01913015  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01913015)
- NCT02034552  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02034552)
- NCT02123758  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02123758)
- NCT02217566  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02217566)
- NCT02257736  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02257736)
- NCT02268175  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02268175)
- NCT02703623  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02703623)
- NCT02849990  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02849990)
- NCT02924766  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02924766)
- NCT02949284  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02949284)
- NCT03007732  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03007732)
- NCT03279250  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03279250)
- NCT03360721  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03360721)
- NCT03431350  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03431350)
- NCT03565835  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03565835)
- NCT03587285  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03587285)

And 55 more, listed on the interactive page.

## Dosing

**Dose**

1000 mg

**Route**

Oral

**How often**

Once daily

### Conditions of use (4)

- Do not crush or chew tablets
- Do not eat food 2 hours before and 1 hour after taking the dose
- Swallow whole with water
- Take on an empty stomach

## Chemical properties

**Hydrogen bond acceptors**

3

**Hydrogen bond donors**

0

**Polar surface area**

39.19

**Calculated partition coefficient (ALogP)**

5.97

**Calculated partition coefficient (XLogP)**

5.2

**Prodrug**

Yes

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

1

**Rotatable bonds**

2

**Heavy atoms**

29

**Molecular formula**

C26H33NO2

**Monoisotopic mass**

391.251129295

**Natural product**

Yes

## National Drug Codes

- 0143-9597
- 0378-6920
- 0378-6921
- 0904-6948
- 16714-963
- 42291-024
- 42291-073
- 43598-358
- 43598-468
- 47335-401
- 50268-032
- 51407-503
- 51407-989
- 57894-050
- 57894-100
- 57894-150
- 57894-195
- 60687-790
- 64980-418
- 68001-489
- 68001-673
- 68462-135
- 68462-882
- 71921-177
- 71921-178

And 20 more, listed on the interactive page.

## Evidence counts

**Recorded assays**

344

**Active assays**

17

### Active assay types (4)

- Confirmatory
- Other
- Screening
- Summary

## Pharmacologic actions

- Antineoplastic Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000970.html)
- Steroid Synthesis Inhibitors  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D065088.html)
- Cytochrome P-450 Enzyme Inhibitors  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D065607.html)

## Related records

### Trials (333)

- 177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer
- 3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy
- [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)](https://trialight.com/data/trial/a-clinical-study-of-ifinatamab-deruxtecan-based-treatment-99be48a0-44f7-46eb-bdf5-d3d2adc6018e.md)
- A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
- A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer
- A Comparative Study of Bioavailability of 3 New Abiraterone Acetate Tablets With Current Commercial Tablet
- A Drug-Drug Interaction Study of Abiraterone Acetate Plus Prednisone With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer
- A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer
- A Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Prostate Cancer
- A Multicenter Phase I/II Trial of Abiraterone Acetate + BEZ235 in Metastatic, Castration-Resistant Prostate Cancer
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer
- A Novel Insight Into CRPC Progression and Immune: Evidence From Single-cell Spatial Transcriptome Multi-omics
- A Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Impaired Renal Function Compared to Individuals With Normal Renal Function
- A Pharmacokinetics Study to Assess Abiraterone Acetate Capsule and Tablet Formulations in Patients With Prostate Cancer
- A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies
- [A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors](https://trialight.com/data/trial/a-phase-1-2a-study-of-db-1311-bnt324-in-advanced-metastatic-b09e4d50-e189-4c38-848b-2e45efa5d49d.md)
- A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer
- A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone in Participants With Prostate Cancer
- A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone in Participants With Prostate Cancer Who Have Received Docetaxel
- A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer

### Approved for (4)

- [Metastatic prostate carcinoma](https://trialight.com/data/condition/metastatic-prostate-carcinoma-d5fb1084-bad5-5db6-8240-897dc47ea451.md)
- [Prostate adenocarcinoma](https://trialight.com/data/condition/prostate-adenocarcinoma-84e3e3af-1ae1-5760-8157-8d9fc0cff608.md)
- [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md)
- [Prostate carcinoma](https://trialight.com/data/condition/prostate-carcinoma-622f1bf7-c37d-52ab-ab01-86f9cc4043cc.md)

### In development for (8)

- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 3
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 1
- Classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency Phase 2
- Congenital adrenal hyperplasia Phase 2
- [Kidney failure](https://trialight.com/data/condition/kidney-failure-f26737b4-3a55-50be-b6c3-b76514cb5067.md) Phase 1
- [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) Phase 1
- [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Phase 1
- Tumor of salivary gland Phase 2

### Other linked conditions (2)

- Neoplasm
- [Prostate neoplasm](https://trialight.com/data/condition/prostate-neoplasm-28a8a0a9-1d2f-5539-80c9-7eb822c444fc.md)

### Targets (1)

- [CYP17A1](https://trialight.com/data/target/cyp17a1-593c155a-0d40-55ab-829f-9468945d0fdf.md) Cytochrome P450 17A1 inhibitor

---

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