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 40 indications[4].[1]
Xtandi is one of 786 biologic programs targeting Bone Metastasis. It is currently in Approved.
40
Indications
296
Total Trials
59
Active Trials
785
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
7
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 40 indications
Competition
Competitive Landscape
2828 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Xtandi
AstellasApproved
Avastin
BBio-Thera Solutions
Preclinical
Voltaren
NovartisPreclinical
Methylthioninium Chloride
PProvepharm SAS
Preclinical
Zinecard
CChildren's Oncology Group
Preclinical
Recentin
NNational Cancer Institute (NCI)
Preclinical
Tricor
JJagotec
Preclinical
Acupan
YYonsei University
Preclinical
Aquasol E
NNational Eye Institute (NEI)
Preclinical
Paracetamol
GSKPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Prostate Cancer120 trials
Show 117 more trials
Detecting Metastases by PyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer.
Active, not recruiting·—·Phase 2·NCT04655365·50 enrolled
Crizotinib in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Completed·—·Phase 1·NCT02207504·24 enrolled
Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
Recruiting·—·Phase 2·NCT03753243·32 enrolled
Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC)
Terminated·—·Phase 1·NCT02500901·2 enrolled
Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer.
Unknown status·—·Phase 2·NCT04116775·32 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
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
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 Enzalutamide in Patients With Castration-resistant Prostate Cancer
Completed·—·Phase 2·NCT01942837·67 enrolled
Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM)
Completed·—·Phase 2·NCT02057939·38 enrolled
Metastatic Prostate Cancer11 trials
Show 8 more trials
mCRPC9 trials
Show 6 more trials
Breast Cancer8 trials
Show 5 more trials
39 more indications
Testosterone2 trials
Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression
Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT04363164·150 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
Patients With Advanced Solid Tumors2 trials
Hepatocellular Carcinoma2 trials
Bladder Cancer2 trials
Prostate2 trials
Enzalutamide + External Beam Rt For Prostate
Completed·—·Phase 2·NCT02028988·64 enrolled
Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate
Completed·—·Phase 2·NCT02268175·75 enrolled
Triple-Negative Breast Cancer2 trials
Survival1 trial
Efficacy1 trial
Cancers1 trial
Metabolism1 trial
Neoadjuvant1 trial
First Line Therapy1 trial
Overall Survival1 trial
Metastatic1 trial
Imaging1 trial
HER2-Negative1 trial
Pancreatic Cancer1 trial
Ovarian Tumor1 trial
Tics1 trial
Bone Metastasis1 trial
Advanced Solid Tumors1 trial
Endometrial Cancer1 trial
Advanced Solid Malignancies1 trial
Adenocarcinoma1 trial
Randomized1 trial
Fallopian Tube Cancer1 trial
Side Effects1 trial
Metastasis1 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
Randomised Controlled Trial1 trial
PD-L1 Antibody1 trial
Cognitive Function1 trial
Pembrolizumab1 trial
Unspecified5 trials
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]