Abiraterone acetate
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2011
- First approval year
- 2011
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Abiraterone acetate
- Molecular weight
- 391.56
- 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
- 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
- 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.
- ATC classification codes
- L02BX03
- CAS registry numbers
- 154229-18-2
- ChEMBL ID
- CHEMBL271227
- InChIKey
- UVIQSJCZCSLXRZ-UBUQANBQSA-N
- PubChem compound IDs
- 9821849
- RxNorm IDs (RxCUI)
- 1100071
- FDA ingredient codes (UNII)
- EM5OCB9YJ6
- Applicant
- JANSSEN BIOTECH
- Approval date
- 28 Apr 2011
- Application number
- NDA202379
- 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
- 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 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
- 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
- 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.
- 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
- NCT00473512
- NCT00485303
- NCT00638690
- NCT01023061
- NCT01186484
- NCT01314118
- NCT01503229
- NCT01786265
- NCT01848067
- NCT01913015
- NCT02034552
- NCT02123758
- NCT02217566
- NCT02257736
- NCT02268175
- NCT02703623
- NCT02849990
- NCT02924766
- NCT02949284
- NCT03007732
- NCT03279250
- NCT03360721
- NCT03431350
- NCT03565835
- NCT03587285
And 55 more, listed on the interactive page.
- Dose
- 1000 mg
- Route
- Oral
- How often
- Once daily
- 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
- 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
- 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.
- Recorded assays
- 344
- Active assays
- 17
- Confirmatory
- Other
- Screening
- Summary
- Antineoplastic Agents
- Steroid Synthesis Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
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)
- 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
- 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)
In development for (8)
- Breast cancer Phase 3
- Cancer Phase 1
- Classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency Phase 2
- Congenital adrenal hyperplasia Phase 2
- Kidney failure Phase 1
- Liver disorder Phase 1
- Non-small cell lung carcinoma Phase 1
- Tumor of salivary gland Phase 2
Other linked conditions (2)
- Neoplasm
- Prostate neoplasm
Targets (1)
- CYP17A1 Cytochrome P450 17A1 inhibitor