> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/abiraterone-ba408954-021b-43d1-95d4-f40199667ab6
> Record changed: 2026-11-04

# Abiraterone

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL254328)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL254328)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL254328)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL254328)

**Drug name**

Abiraterone

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL254328)

**Molecular weight**

349.52

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL254328)

**Structure (SMILES)**

C\[C@\]12CC\[C@H\](O)CC1=CC\[C@@H\]1\[C@@H\]2CC\[C@\]2(C)C(c3cccnc3)=CC\[C@@H\]12

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL254328)

### Brand names (2)

- zytiga
- Zytiga

### Other names (19)

- abiraterona
- Abiraterona
- abiraterone
- Abiraterone
- abiraterone \[INN\]
- ABIRATERONE \[MI\]
- ABIRATERONE \[USP IMPURITY\]
- ABIRATERONE \[VANDF\]
- Abiraterone \[WHO-DD\]
- abiraterone inn
- abiraterone mi
- abiraterone usp impurity
- abiraterone vandf
- abiraterone who dd
- cb 7598
- CB 7598
- CB-7598
- nsc 741232
- NSC-741232

## Identifiers

**ATC classification codes**

- L02BX03

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL254328)

**CAS registry numbers**

- 154229-19-3

**ChEMBL ID**

CHEMBL254328

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL254328)

**InChIKey**

GZOSMCIZMLWJML-VJLLXTKPSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL254328)

**PubChem compound IDs**

- 132971

**FDA ingredient codes (UNII)**

- G819A456D0

### RxNorm IDs (RxCUI) (2)

- 1100071
- 1100072

## Regulatory information

### United States

**Applicant**

JANSSEN BIOTECH

**Approval date**

28 Apr 2011

**Application number**

NDA202379

### European Union

**Status**

Authorised

**Status date**

5 Sept 2011

**Authorisation date**

5 Sept 2011

**Approved indications**

Zytiga is indicated with prednisone or prednisolone for: the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

**Product number**

EMEA/H/C/002321

**Authorisation holder**

Janssen-Cilag International

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

No

**Generic medicines**

1

**Biosimilar medicines**

0

**Advanced therapy**

No

**Conditional approval**

No

**Additional monitoring**

No

**Accelerated assessment**

Yes

**Exceptional circumstances**

No

#### Therapeutic areas

- Prostatic Neoplasms

European medicines record

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

### Other regulatory facts

**First in class**

Yes

**Orphan designation**

No

## Approval status

**United States (FDA)**

Approved

**European Union (EMA)**

Authorised

## Pharmacology

### Drug classification

**Pharmacology name**

abiraterone

**Type**

Synthetic organic

**Drug name stem**

\-terone

### Mechanisms of action (6)

- **Mechanism**  
Androgen Receptor antagonist

**Action type**  
Antagonist

**Target**  
Androgen receptor

**Protein identifier**  
P10275
- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
CYP17A1

**Gene symbol**  
CYP17A1

**Protein identifier**  
P05093

**Affinity units**  
pIC50

**Primary target**  
Yes
- **Mechanism**  
Cytochrome P450 17A1 inhibitor

**Action type**  
Inhibitor

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

**Protein identifier**  
P05093
- **Mechanism**  
Steroid 5-alpha-reductase inhibitor

**Action type**  
Inhibitor

**Target**  
Steroid 5-alpha-reductase

**Protein identifier**  
P18405
- **Mechanism**  
Steroid 5-alpha-reductase inhibitor

**Action type**  
Inhibitor

**Target**  
Steroid 5-alpha-reductase

**Protein identifier**  
P31213
- **Mechanism**  
Steroid 5-alpha-reductase inhibitor

**Action type**  
Inhibitor

**Target**  
Steroid 5-alpha-reductase

**Protein identifier**  
Q9H8P0

### Open Targets mechanisms (3)

- **Mechanism**  
Androgen Receptor antagonist

**Action type**  
Antagonist

**Target**  
Androgen receptor
- **Mechanism**  
Cytochrome P450 17A1 inhibitor

**Action type**  
Inhibitor

**Target**  
Steroid 17-alpha-hydroxylase/17,20 lyase
- **Mechanism**  
Steroid 5-alpha-reductase inhibitor

**Action type**  
Inhibitor

**Target**  
Steroid 5-alpha-reductase

### Investigated indications (7)

- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000196

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

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000673

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

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0001663

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

**Highest recorded phase**  
4

**Condition identifier**  
MONDO:0004992

**Subject identifier**  
D009369
- **Condition**  
Prostatic Neoplasms, Castration-Resistant

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0008315

**Subject identifier**  
D064129
- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0021259

**Subject identifier**  
D011471

### Open Targets indications (18)

- **Condition identifier**  
EFO\_0000196

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0000673

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0000521

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0002158

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0003330

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004956

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

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005062

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0005070

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005315
- **Condition identifier**  
MONDO\_0005494

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0008315
- **Condition identifier**  
MONDO\_0008315

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0015686

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0021259
- **Condition identifier**  
MONDO\_0021259

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0044881

**Highest recorded phase**  
1

### Reported adverse events (9)

- **Event**  
disease progression

**Reports**  
516

**Reporting signal score**

580.616
- **Event**  
drug hypersensitivity

**Reports**  
10

**Reporting signal score**

148.982
- **Event**  
hospitalisation

**Reports**  
331

**Reporting signal score**

202.112
- **Event**  
hot flush

**Reports**  
275

**Reporting signal score**

354.675
- **Event**  
hypokalaemia

**Reports**  
355

**Reporting signal score**

449.167
- **Event**  
injection site pain

**Reports**  
1

**Reporting signal score**

142.244
- **Event**  
prostate cancer

**Reports**  
190

**Reporting signal score**

353.162
- **Event**  
prostate cancer metastatic

**Reports**  
139

**Reporting signal score**

495.315
- **Event**  
prostatic specific antigen increased

**Reports**  
541

**Reporting signal score**  
1,854.21

### Trial references (69)

- NCT00268476  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00268476)
- NCT00924469  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00924469)
- NCT01485861  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01485861)
- NCT01574937  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01574937)
- NCT01741753  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01741753)
- NCT01756638  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01756638)
- NCT01795703  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01795703)
- NCT01828476  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01828476)
- NCT01972217  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01972217)
- NCT01995058  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01995058)
- NCT02254785  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02254785)
- NCT02429193  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02429193)
- NCT02758132  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02758132)
- NCT02772588  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02772588)
- NCT02789878  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02789878)
- NCT02867020  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02867020)
- NCT02883166  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02883166)
- NCT03141671  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03141671)
- NCT03348670  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03348670)
- NCT03414034  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03414034)
- NCT03418324  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03418324)
- NCT03480646  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03480646)
- NCT03511196  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03511196)
- NCT03556904  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03556904)
- NCT03860987  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03860987)

And 44 more, listed on the interactive page.

## Chemical properties

**Hydrogen bond acceptors**

2

**Hydrogen bond donors**

1

**Polar surface area**

33.12

**Calculated partition coefficient (ALogP)**

5.4

**Calculated partition coefficient (XLogP)**

4.6

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

1

**Rotatable bonds**

1

**Heavy atoms**

26

**Molecular formula**

C24H31NO

**Monoisotopic mass**

349.240564612

**Natural product**

Yes

## Evidence counts

**Recorded assays**

486

**Active assays**

64

### Active assay types (3)

- Confirmatory
- Other
- Screening

## 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)

## Biological measurements

These details could not be displayed.

## Related records

### Trials (125)

- 177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer
- 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer
- [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 Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant 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 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 1/2a 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 Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC
- A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
- A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan
- A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy
- A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors
- [A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)](https://trialight.com/data/trial/a-study-of-abemaciclib-ly2835219-with-abiraterone-in-men-a423427d-50cc-4e2f-9084-0fd606d51cf9.md)
- A Study of Abiraterone in Combination With SHR3162 in the Treatment of mCRPC
- A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
- A Study of BL-B01D1 Combination Therapy in Patients With Metastatic Castration-resistant Prostate Cancer

### Approved for (2)

- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md)
- [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md)

### In development for (12)

- [Fallopian tube cancer](https://trialight.com/data/condition/fallopian-tube-cancer-b95d05ee-41d5-565a-87e1-041170b88760.md) Phase 1
- [Hematopoietic and lymphoid cell neoplasm](https://trialight.com/data/condition/hematopoietic-and-lymphoid-cell-neoplasm-ed3616fa-22fe-5984-94b4-745416e01ef9.md) Phase 1
- [Lymphoma](https://trialight.com/data/condition/lymphoma-de4db685-7419-5e0e-b958-4591ffd69d43.md) Phase 1
- [Metastatic prostate carcinoma](https://trialight.com/data/condition/metastatic-prostate-carcinoma-d5fb1084-bad5-5db6-8240-897dc47ea451.md) Phase 3
- Primary peritoneal carcinoma Phase 1
- Prostate adenocarcinoma Phase 3
- [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) Phase 3
- [Prostate carcinoma](https://trialight.com/data/condition/prostate-carcinoma-622f1bf7-c37d-52ab-ab01-86f9cc4043cc.md) Phase 3
- Prostate neoplasm Phase 3
- Salivary gland carcinoma Phase 2
- [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) Phase 1
- Urinary tract obstruction Phase 2

### Other linked conditions (1)

- Bone fracture

### Targets (5)

- [AR](https://trialight.com/data/target/ar-a6af2dca-1d81-5967-9bce-dc5b29aacbbc.md) Androgen Receptor antagonist
- [CYP17A1](https://trialight.com/data/target/cyp17a1-593c155a-0d40-55ab-829f-9468945d0fdf.md) Cytochrome P450 17A1 inhibitor
- [SRD5A1](https://trialight.com/data/target/srd5a1-05c22107-0f3b-54ef-86d2-0212faac6d02.md) Steroid 5-alpha-reductase inhibitor
- [SRD5A2](https://trialight.com/data/target/srd5a2-6094932b-07bd-507e-80fe-6205004a84e6.md) Steroid 5-alpha-reductase inhibitor
- [SRD5A3](https://trialight.com/data/target/srd5a3-8798a5ea-9f31-5f8f-98d1-5852efcce00c.md) Steroid 5-alpha-reductase inhibitor

---

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