Xtandi
(Enzalutamide)ApprovedBiologic
AstellasEnzalutamide is used to treat prostate cancer by blocking male hormones that help cancer cells grow. It's used for advanced prostate cancer in men.[2] Xtandi is currently approved and in use across 42 indications[4].[1]
Xtandi is one of 633 biologic programs targeting Breast Cancer. It is currently in Approved.
42
Indications
305
Total Trials
53
Active Trials
632
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
7
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 42 indications
Competition
Competitive Landscape
744 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Xtandi
AstellasApproved
Lexiscan
AstellasPreclinical
Voltaren
NovartisPreclinical
Spravato
WWim Janssens
Preclinical
Sporanox
SSebela Pharmaceuticals Development LLC
Preclinical
Tricor
JJagotec
Preclinical
Cortef
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Preclinical
Vfend
PPrism Pharmaceuticals
Preclinical
Systemic Therapy
Bristol-Myers SquibbPreclinical
Tianeptine
PfizerPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Prostate Cancer124 trials
Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC)
Terminated·—·Phase 1·NCT02500901·2 enrolled
Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM)
Completed·—·Phase 2·NCT02057939·38 enrolled
Show 121 more trials
Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Active, not recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT02452008·60 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
Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
Recruiting·—·Phase 2·NCT03753243·32 enrolled
Management of Castration-Resistant Prostate Cancer with Oligometastases
Active, not recruiting·SSir Mortimer B. Davis - Jewish General Hospital·Phase 2/3·NCT02685397·102 enrolled
Crizotinib in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Completed·—·Phase 1·NCT02207504·24 enrolled
Enzalutamide in Patients With High-risk Prostate Cancer
Completed·—·Phase 2·NCT01927627·42 enrolled
Study of TRC105 With Abiraterone and With Enzalutamide in Prostate Cancer Patients Progressing on Therapy
Completed·—·Phase 2·NCT03418324·11 enrolled
Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer.
Unknown status·—·Phase 2·NCT04116775·32 enrolled
Detecting Metastases by PyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer.
Active, not recruiting·—·Phase 2·NCT04655365·50 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
Metastatic Prostate Cancer13 trials
Show 10 more trials
mCRPC6 trials
Patients With Advanced Solid Tumors4 trials
40 more indications
Breast Cancer3 trials
Advanced Solid Tumors2 trials
Triple-Negative Breast Cancer2 trials
Testosterone2 trials
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
Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance
Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT02286921·222 enrolled
Hepatocellular Carcinoma2 trials
Bladder Cancer2 trials
Overall Survival1 trial
First Line Therapy1 trial
PD-L1 Antibody1 trial
Cognitive Function1 trial
Phase II1 trial
Phase III Radium 223 mCRPC-PEACE III
Active, not recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT02194842·446 enrolled
Trial1 trial
The COSMYC Trial (COmbined Suppression of MYC)
Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT06922318·50 enrolled
Advanced/Metastatic Solid Tumors1 trial
Radiation Therapy1 trial
Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy
Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT02203695·86 enrolled
Pancreatic Cancer1 trial
Prostate1 trial
Enzalutamide + External Beam Rt For Prostate
Completed·—·Phase 2·NCT02028988·64 enrolled
Metabolism1 trial
Neoadjuvant1 trial
Metastatic1 trial
Tumor1 trial
Side Effects1 trial
Randomised Controlled Trial1 trial
HER2-Negative1 trial
Ovarian Tumor1 trial
Imaging1 trial
Survival1 trial
Efficacy1 trial
Cancers1 trial
Adenocarcinoma1 trial
Fallopian Tube Cancer1 trial
Randomized1 trial
Unspecified4 trials
Show 1 more trial
Regulatory
FDA Approval Timeline[5]
Aug 31, 2012
XTANDI
NDA NDA203415
Aug 4, 2020
XTANDI
NDA NDA213674
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Xtandi drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Enzalutamide. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Xtandi. U.S. Food & Drug Administration.
- [7]