Abiraterone
Highest phase reached
Approved
Drug type
Small molecule
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Abiraterone
- Molecular weight
- 349.52
- 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
- zytiga
- Zytiga
- 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
- ATC classification codes
- L02BX03
Sources for recorded values
- CAS registry numbers
- 154229-19-3
- ChEMBL ID
- CHEMBL254328
- InChIKey
- GZOSMCIZMLWJML-VJLLXTKPSA-N
- PubChem compound IDs
- 132971
- FDA ingredient codes (UNII)
- G819A456D0
- 1100071
- 1100072
- Applicant
- JANSSEN BIOTECH
- Approval date
- 28 Apr 2011
- Application number
- NDA202379
- 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
- First in class
- Yes
- Orphan designation
- No
- United States (FDA)
- Approved
- European Union (EMA)
- Authorised
- Pharmacology name
- abiraterone
- Type
- Synthetic organic
- Drug name stem
- -terone
- 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
- 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
- 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
- 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
- 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
- NCT00268476
- NCT00924469
- NCT01485861
- NCT01574937
- NCT01741753
- NCT01756638
- NCT01795703
- NCT01828476
- NCT01972217
- NCT01995058
- NCT02254785
- NCT02429193
- NCT02758132
- NCT02772588
- NCT02789878
- NCT02867020
- NCT02883166
- NCT03141671
- NCT03348670
- NCT03414034
- NCT03418324
- NCT03480646
- NCT03511196
- NCT03556904
- NCT03860987
And 44 more, listed on the interactive page.
- 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
- Recorded assays
- 486
- Active assays
- 64
- Confirmatory
- Other
- Screening
- Antineoplastic Agents
- Steroid Synthesis Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
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)
- 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
- 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)
- 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)
In development for (12)
- Fallopian tube cancer Phase 1
- Hematopoietic and lymphoid cell neoplasm Phase 1
- Lymphoma Phase 1
- Metastatic prostate carcinoma Phase 3
- Primary peritoneal carcinoma Phase 1
- Prostate adenocarcinoma Phase 3
- Prostate cancer Phase 3
- Prostate carcinoma Phase 3
- Prostate neoplasm Phase 3
- Salivary gland carcinoma Phase 2
- Triple-negative breast carcinoma Phase 1
- Urinary tract obstruction Phase 2
Other linked conditions (1)
- Bone fracture