Zytiga
(Abiraterone)Phase 3Small molecule
Johnson & JohnsonAbiraterone is used to treat advanced prostate cancer in men by blocking the production of male hormones that fuel cancer growth.[1] Zytiga is currently being investigated across 21 indications[3], with its most advanced program in Phase 3.[1]
Zytiga is one of 355 small molecule programs targeting Prostate Adenocarcinoma. It is currently in Phase 3.
21
Indications
292
Total Trials
51
Active Trials
354
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
2
Patents
Pipeline
Status by Indication[3][1]
Indication
Showing 10 of 21 indications
Competition
Competitive Landscape
2828 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Zytiga
Johnson & JohnsonPhase 3
Tecentriq
RochePreclinical
Trodelvy
GileadPreclinical
Halaven
EisaiPreclinical
Tykerb
GSKPreclinical
Adriamycin
GGynecologic Oncology Group
Preclinical
Avastin
BBio-Thera Solutions
Preclinical
Nolvadex
SSan Diego Pacific Oncology & Hematology Associates
Preclinical
Prolia
AmgenPreclinical
Gemzar
GGynecologic Oncology Group
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Prostate Cancer125 trials
Show 122 more trials
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, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.
Not yet recruiting·JJames J. Peters Veterans Affairs Medical Center·Phase 2·NCT05422911·200 enrolled
Adaptive Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer
Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT02415621·19 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
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 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
Study of Abiraterone Acetate Without Exogenous Glucocorticoids in Men With Castration-resistant Prostate Cancer
Completed·—·Phase 2·NCT02025010·60 enrolled
Study of TRC105 With Abiraterone and With Enzalutamide in Prostate Cancer Patients Progressing on Therapy
Completed·—·Phase 2·NCT03418324·11 enrolled
Abiraterone Acetate17 trials
Show 14 more trials
BKM120+Abiraterone Acetate for Metastatic CRPC
Terminated·—·Phase 1·NCT01741753·4 enrolled
Metastatic Prostate Cancer12 trials
Show 9 more trials
mCRPC4 trials
34 more indications
Treatment2 trials
Oral1 trial
Advanced Solid Tumors1 trial
Hormone Therapy1 trial
Tics1 trial
HRR Gene Mutation1 trial
Impaired Renal Function1 trial
First-line Treatment1 trial
Salivary Gland Cancer1 trial
Advanced Solid Malignancies1 trial
Advanced Cancer1 trial
Neoadjuvant Therapy1 trial
Moderate Hepatic Impairment1 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
Adenocarcinoma1 trial
Cancer of the Prostate1 trial
Liquid Biopsy1 trial
Carboplatin1 trial
CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone
Active, not recruiting·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT03934840·22 enrolled
Chemotherapy1 trial
Advanced Malignancies1 trial
PSA Progression1 trial
Advanced/Metastatic Solid Tumors1 trial
Combination Therapy1 trial
Immune1 trial
A Novel Insight Into CRPC Progression and Immune: Evidence From Single-cell Spatial Transcriptome Multi-omics
Not yet recruiting·—··NCT07154914·396 enrolled
Cancers1 trial
Unspecified5 trials
XL-184+Abiraterone in Post-Chemo CRPC
Completed·—·Phase 1·NCT01574937·27 enrolled
Regulatory
FDA Approval Timeline[4]
Apr 28, 2011
ZYTIGA
NDA NDA202379
May 22, 2018
YONSA
NDA NDA210308
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Abiraterone. EMBL-EBI & Wellcome Sanger Institute.
- [4]
- [5]FDA Orange Book — Patent and exclusivity data for Zytiga. U.S. Food & Drug Administration.
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Androgen Receptor Antagonist; Cytochrome P450 17a1 Inhibitor; Steroid 5-Alpha-Reductase Inhibitor[2]
- Modality
- Small molecule[2]
- Highest Phase
- Phase 3[1]
- Company