Data updated: May 26, 2026
XTANDI (enzalutamide)
Androgen Receptor Antagonists
Trial Activity: Stable 86 active trials
Oncology
Approved 2012-08-31
Xtandi is a medication used for patients across several stages of prostate cancer. It helps those with castration-resistant forms of the disease as well as patients with metastatic castration-sensitive prostate cancer. It is also prescribed for individuals with non-metastatic castration-sensitive prostate cancer who are at a high risk for metastasis following biochemical recurrence.
How XTANDI Works
This drug works by blocking the androgen receptor signaling pathway at multiple stages. It prevents androgens from binding to their receptors, which stops the receptors from moving into the cell nucleus and interacting with DNA. By interfering with these signals, the medication decreases the growth of prostate cancer cells and triggers cell death.
Development Insights
Pfizer conducting 20 trials (8%)
280 indications explored (Broad Platform)
→ prostate cancer (64 trials)
→ metastatic castration-resistant prostate cancer (24 trials)
→ castration-resistant prostate carcinoma (17 trials)
11
Indications
--
Phase 3 Trials
6
Priority Reviews
13
Years on Market
Details
- Status
- Prescription
- First Approved
- 2012-08-31
- Patent Cliff
- 2037
- Revenue
- $590M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
XTANDI Approval History
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
36 FDA actions from 2012 to 2025 · 9 indication expansions
Jul 2016 SUPPL Priority
Mfg
Nov 2015 SUPPL Priority
Mfg
May 2014 SUPPL Priority
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What XTANDI Treats
3 indicationsXTANDI is approved for 3 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Castration-Resistant Prostate Cancer
- Metastatic Castration-Sensitive Prostate Cancer
- Non-Metastatic Castration-Sensitive Prostate Cancer
Source: FDA Label
XTANDI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
5
Same target(s) AND same indication — head-to-head.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 11 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in XTANDI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications XTANDI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to XTANDI
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
238 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02689427 results posted | 2015-0488 NCI-2016-00367, 2015-0488 | Ph 2 | completed | Enzalutamide and Paclitaxel Before Surgery in Treating Patients With Stage I-III Androgen Receptor-Positive Triple-Negative Breast Cancer |
| NCT06136650 | 5684-004 MK-5684-004, jRCT2031240030 | Ph 3 | recruiting | A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) |
| NCT07226986 | CAMO959A12103 2025-521859-23-00 | Ph 1, Ph 2 | recruiting | A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC |
| NCT06629779 | C2321003 2024-511652-40-00 | Ph 3 | recruiting | A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer. |
| NCT04262154 results posted | 19-461 | Ph 2 | active not recruiting | Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer |
| NCT06632977 PREDICT | A032102 NCI-2024-04960 | Ph 2 | recruiting | Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial |
| NCT04145375 | ZEN003694-500 | Ph 1, Ph 2 | enrolling by invitation | Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol |
| NCT04221542 | 20180146 2023-504361-23 | Ph 1 | recruiting | Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer |
| NCT04986423 | ZEN003694-201 | Ph 2 | recruiting | ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer |
| NCT05818683 | CR109321 78278343PCR1003, 2022-503132-14-00 | Ph 1 | recruiting | A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer |
| NCT06863272 | 2400-01A MK-2400-01A, 2024-516036-94-00 | Ph 1, Ph 2 | recruiting | 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) |
| NCT02319837 results posted | MDV3100-13 C3431004, 2024-513521-23-00 | Ph 3 | active not recruiting | Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) |
| NCT07570979 | CINR731A12101 2025-524080-20 | Ph 1 | recruiting | A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer |
| NCT02446444 ENZARAD | ANZUP1303 ACTRN12614000126617 | Ph 3 | active not recruiting | Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer |
| NCT06764485 rechARge | CA071-1000 2024-517422-25, U1111-1311-0532 | Ph 3 | recruiting | A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer |
| NCT03123978 | 914328 UCDCC#264, P30CA093373 | Ph 1 | completed | Enzalutamide and Niclosamide in Treating Patients With Recurrent or Metastatic Castration-Resistant Prostate Cancer |
| NCT07287150 InavoPC | CO45813 2025-521327-67-00 | Ph 2 | recruiting | A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer |
| NCT03460977 | C2321001 EZH2, 2023-509179-18-00 | Ph 1 | recruiting | A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma |
| NCT06136624 OMAHA-003 | 5684-003 2023-504899-25-00, MK-5684-003 | Ph 3 | recruiting | Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) |
| NCT07028853 | C2321008 MEVPRO-3, 2024-519369-24-00 | Ph 3 | recruiting | This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve. |
| NCT06520345 | 177Lu-TLX591-203 | Ph 3 | recruiting | The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global) |
| NCT05873192 | 2022-0339 NCI-2023-03938 | Ph 2 | recruiting | Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer |
| NCT06616155 | UMCC 2023.109 NCI-2024-06533, HUM00249478 | Ph 1, Ph 2 | recruiting | Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer |
| NCT06551324 MEVPRO-1 | C2321014 2024-511650-50-00 | Ph 3 | active not recruiting | A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1). |
| NCT06991556 | CJSB462C12201 2024-520156-22-00 | Ph 2 | recruiting | An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) |
| NCT03860987 | 190062 19-C-0062 | Ph 2 | active not recruiting | Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer |
| NCT04191096 results posted | 3475-991 MK-3475-991, KEYNOTE-991 | Ph 3 | completed | Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991) |
| NCT03768063 IMbrella B | BO40729 2023-506184-34-00 | Ph 3 | active not recruiting | A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study |
| NCT02555189 results posted | 15G.322 CLEE011XUS12T, c15-153 | Ph 1, Ph 2 | terminated | Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression |
| NCT05457257 results posted | D081LC00002 | Ph 4 | active not recruiting | Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations |
| NCT06378866 DIVINE | MC230502 R01CA286127, 23-012176 | Ph 2 | recruiting | Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial |
| NCT04076059 China ARCHES results posted | 9785-CL-0336 CTR20190132 | Ph 3 | active not recruiting | An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) |
| NCT06576037 | 2024-0474 NCI-2024-07312 | Ph 1 | recruiting | Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin |
| NCT06592924 TRIPLE-SWITCH | CCTG-PR26 CCTG-PR26, NCI-2024-07535 | Ph 3 | recruiting | Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response |
| NCT03869762 DICE | CTRIAL-IE 17-17 | Ph 2 | terminated | Denosumab in Combination With Enzalutamide in Progressive Metastatic Castrate-resistant Prostate Cancer and Bone Metastases. |
| NCT02960022 | 9785-CL-0123 2016-001694-32, 2023-510298-33-00 | Ph 2 | recruiting | A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study |
| NCT05112965 | YO42713 | Ph 3 | active not recruiting | An Extension Study in Participants Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella C) |
| NCT04363164 | J2060sIRB IRB00312725 | Ph 2 | recruiting | Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression |
| NCT06120491 EvoPAR-PR01 | D9723C00001 2023-504214-30-00 | Ph 3 | recruiting | Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents |
| NCT03899155 | CA209-8TT 2018-004362-34 | Ph 2 | recruiting | Pan Tumor Rollover Study |
| NCT03674814 | IRB18-0152 P50CA180995 | Ph 1 | completed | Study of Drug 1 (Enzalutamide) Plus Drug 2 (Relacorilant) for Patients With Prostate Cancer |
| NCT06096870 | 10001556 001556-C | Ph 2 | recruiting | Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy |
| NCT06457919 | 24-103 | Ph 1, Ph 2 | recruiting | A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer |
| NCT05751941 | MCC-22003 | Ph 2 | recruiting | Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer |
| NCT05526248 ARAMON results posted | 21953 | Ph 2 | completed | A Study Called ARAMON to Learn to What Extent Does Study Treatment With Darolutamide Affects Testosterone Levels in Men With Prostate Cancer That Had Not Been Treated With Hormonal Therapy Compared to Treatment With Enzalutamide |
| NCT04179864 CELLO-1 results posted | EZH-1101 2019-003649-14 | Ph 1, Ph 2 | terminated | A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer |
| NCT06691984 | 20230005 2024-513968-25 | Ph 3 | active not recruiting | Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute) |
| NCT05726292 | IRB22-1318 | Ph 2 | recruiting | A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer |
| NCT03344211 | 4P-16-2 NCI-2017-01418, 4P-16-2 | Ph 2 | active not recruiting | Enzalutamide With or Without Radium Ra 223 Dichloride in Patients With Metastatic, Castration-Resistant Prostate Cancer |
| NCT06257693 | EP-001 ZIABC011081 | Ph 1 | recruiting | Enzalutamide Implants (Enolen) in Patients With Prostate Cancer |
Showing 50 of 238 trials
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Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XTANDI FDA Label Details
Indications & Usage
FDA Label (PDF)XTANDI is indicated for the treatment of Castration-Resistant Prostate Cancer; Metastatic Castration-Sensitive Prostate Cancer; Non-Metastatic Castration-Sensitive Prostate Cancer.
View full patent landscape →
7 OB patents · 3 families ·
98 international docs across 30 countries
XTANDI Patents & Exclusivity
Latest Patent: Feb 2037
Exclusivity: Nov 2026
Patents (7 active)
US12161628
Expires Feb 23, 2037
US12502357
Expires Sep 11, 2033
US12447128
Expires Sep 11, 2033
US11839689
Expires Sep 11, 2033
US7709517
Expires Aug 13, 2027
US8183274
Expires Aug 24, 2026
US9126941
Expires May 15, 2026
Exclusivity
I-926
Until Nov 2026
I-926
Until Nov 2026
I-926
Until Nov 2026
I-926
Until Nov 2026
I-926
Until Nov 2026
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for XTANDI
Revenue Insights
- • Q4-2025: $590M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 80 active patents
Trial Analysis
- • 238 total trials
- • Stage: Stable
Competitive Landscape
- • 6 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment