Zytiga
(Abiraterone)ApprovedSmall molecule
Johnson & JohnsonAbiraterone is used to treat advanced prostate cancer in men by blocking the production of male hormones that fuel cancer growth.[2] Zytiga is currently approved and in use across 30 indications[4].[1]
Zytiga is one of 320 small molecule programs targeting Prostate Adenocarcinoma. It is currently in Approved.
30
Indications
303
Total Trials
40
Active Trials
319
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
2
Patents
Pipeline
Status by Indication[4][1]
Indication
Recruiting
Showing 10 of 30 indications
Competition
Competitive Landscape
348 competitors in Prostate Cancer
#DrugCompanyPhaseTrials
1Zytiga
Johnson & JohnsonApproved
Cabometyx
Bristol-Myers SquibbPhase 3
Androgen Deprivation Therapy
Johnson & JohnsonPhase 3
Paraplatin
AAvyxa
Phase 3
Rubraca
Bristol-Myers SquibbPhase 3
Glucophage
EMD SeronoPhase 3
PSMA-1007
AABX advanced biochemical compounds GmbH
Phase 3
SHR3680
JJiangsu HengRui Medicine Co., Ltd.
Phase 3
Trexall
Jazz PharmaceuticalsPreclinical
Duragesic
CCephalon
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Prostate Cancer114 trials
Show 111 more trials
Study of TRC105 With Abiraterone and With Enzalutamide in Prostate Cancer Patients Progressing on Therapy
Completed·—·Phase 2·NCT03418324·11 enrolled
Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer
Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT03511196·17 enrolled
Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.
Not yet recruiting·JJames J. Peters Veterans Affairs Medical Center·Phase 2·NCT05422911·200 enrolled
A Phase II Study of Increased-Dose Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer
Completed·—·Phase 2·NCT01637402·41 enrolled
A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy
Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT03043807·26 enrolled
Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
Recruiting·—·Phase 2·NCT04734730·70 enrolled
Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy
Completed·—·Phase 2·NCT02903368·118 enrolled
Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer
Completed·—·Phase 2·NCT01717053·37 enrolled
Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer
Completed·—·Phase 2·NCT01393730·40 enrolled
Neoadjuvant Therapy of Abiraterone Plus ADT for High Risk Prostate Cancer
Unknown status·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT04356430·75 enrolled
Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer
Completed·—·Phase 2·NCT03098836·93 enrolled
Abiraterone Race in Metastatic Castrate-resistant Prostate Cancer
Completed·—·Phase 2·NCT01940276·100 enrolled
Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer
Recruiting·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT05406999·900 enrolled
A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer
Active, not recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 1/2·NCT04194554·102 enrolled
Abiraterone Acetate17 trials
Show 14 more trials
BKM120+Abiraterone Acetate for Metastatic CRPC
Terminated·—·Phase 1·NCT01741753·4 enrolled
A Study Examining Doses of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency
Completed·Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01495910·6 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01495910·6 enrolledMetastatic Prostate Cancer16 trials
Show 13 more trials
Breast Cancer3 trials
41 more indications
Congenital Adrenal Hyperplasia2 trials
Randomized2 trials
Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone and Apalutamide for Rising PSA After RP (FORMULA-509)
Active, not recruiting·—·Phase 2·NCT03141671·345 enrolled
Androgen Deprivation Therapy2 trials
Neoadjuvant Therapy1 trial
Moderate Hepatic Impairment1 trial
Advanced/Metastatic Solid Tumors1 trial
PSA Progression1 trial
Chemotherapy1 trial
Carboplatin1 trial
CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone
Active, not recruiting·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT03934840·22 enrolled
Trial1 trial
Advanced Cancer1 trial
Cancers1 trial
Prostate1 trial
Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate
Completed·—·Phase 2·NCT02268175·75 enrolled
Cancer of the Prostate1 trial
Hormone Therapy1 trial
Advanced Malignancies1 trial
Randomised Controlled Trial1 trial
Adrenocortical Carcinoma1 trial
Activity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical Carcinoma
Unknown status·AAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia·Phase 2·NCT03145285·10 enrolled
Testosterone1 trial
RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)
Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT02090114·112 enrolled
Complete Response1 trial
Liquid Biopsy1 trial
Oral1 trial
Combination Therapy1 trial
Advanced Solid Tumors1 trial
Tics1 trial
HRR Gene Mutation1 trial
Impaired Renal Function1 trial
First-line Treatment1 trial
Salivary Gland Cancer1 trial
Advanced Solid Malignancies1 trial
CLE1 trial
Pharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms
Active, not recruiting·HHan Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair·Phase 2/3·NCT03348670·600 enrolled
Ablation1 trial
Unspecified4 trials
XL-184+Abiraterone in Post-Chemo CRPC
Completed·—·Phase 1·NCT01574937·27 enrolled
Regulatory
FDA Approval Timeline[5]
Apr 28, 2011
ZYTIGA
NDA NDA202379
May 22, 2018
YONSA
NDA NDA210308
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Zytiga drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Abiraterone. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Zytiga. U.S. Food & Drug Administration.
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Androgen Receptor Antagonist; Cytochrome P450 17a1 Inhibitor; Steroid 5-Alpha-Reductase Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company