Drugs / Enzalutamide
Regulatory milestones approvals, filings & regulatory actions · 13 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (10) | US (FDA) | XTANDI | — | 2014-09-10 – 2026-07-24 | fda.gov ↗ |
| Approved | EU (EMA) | Xtandi | — | 2013-06-21 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Xtandi | — | 2013-04-26 | europa.eu ↗ |
| Approved | US (FDA) | XTANDI | — | 2012-08-31 | fda.gov ↗ |
Trials 226 · started per year
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US approved 2012
EU approved 2013
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Also used as a comparator or background therapy in 112 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07389174 Background | Feb 2026 → Jan 2027 expected | prostate adenocarcinoma | Shanghai Changzheng Hospital | Not yet recruiting | No outcome recorded |
| Phase 110 trials | ||||||
| Phase 1 | NCT07277270 Background | Dec 2025 → Jul 2026 overdue | neoplasm | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 1 | NCT05022849 Background | Sep 2021 → Mar 2026 | prostate neoplasm | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04033328 Background | Oct 2019 → Nov 2022 | prostate neoplasm | ORIC Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT03300505 Background | May 2019 → Jan 2023 | prostate cancer | University of Michigan Rogel Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT03110588 Background | May 2018 → Dec 2019 | metastatic prostate carcinoma | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
| Phase 1 | NCT03460977 Background | Apr 2018 → Apr 2028 expected | follicular lymphoma, prostate carcinoma, small cell lung carcinoma | Pfizer | Recruiting | No outcome recorded |
| Phase 1 | NCT03310541 Background | Oct 2017 → May 2023 | breast cancer, prostate cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02532114 Background | Dec 2015 → Nov 2017 | castration-resistant prostate carcinoma, metastatic prostate carcinoma, prostate adenocarcinoma | University of Washington | Completed | No outcome recorded |
| Phase 1 | NCT02380313 Background | Oct 2015 → May 2017 | cancer | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1 | NCT01362374 Background | Jul 2011 → Oct 2020 | neoplasm | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1/213 trials | ||||||
| Phase 1/2 | NCT07226986 Background | Dec 2025 → Jul 2028 expected | castration-resistant prostate carcinoma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07104110 Background | Oct 2025 → Oct 2027 expected | prostate cancer | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06702995 Background | Apr 2023 → May 2026 overdue | castration-resistant prostate carcinoma | Evopoint Biosciences Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05191017 Background | Sep 2022 → Jan 2025 | prostate carcinoma | Nuvation Bio Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05011188 Background | Jan 2022 → Jul 2027 expected | prostate carcinoma | Rahul Aggarwal | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05075577 Comparator | Dec 2021 → Oct 2024 | prostate cancer | ESSA Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1/2 | NCT04946370 Background | Aug 2021 → Oct 2027 expected | prostate cancer | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04179864 Background | Nov 2019 → Nov 2024 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Epizyme, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT04145375 Background | Nov 2019 → Dec 2027 expected | castration-resistant prostate carcinoma | Zenith Epigenetics | Enrolling by invitation | No outcome recorded |
| Phase 1/2 | NCT03568656 Background | Jul 2018 → Jul 2025 | breast cancer, castration-resistant prostate carcinoma, non-small cell lung carcinoma | CellCentric Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT03480646 Background | Nov 2017 → Feb 2021 | castration-resistant prostate carcinoma | Constellation Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT03177187 Background | Nov 2017 → Sep 2022 | castration-resistant prostate carcinoma | Institute of Cancer Research, United Kingdom | Terminated | No outcome recorded |
| Phase 1/2 | NCT02711956 Background | Dec 2016 → Nov 2019 | castration-resistant prostate carcinoma | Zenith Epigenetics | Completed | No outcome recorded |
| Phase 245 trials | ||||||
| Phase 2 | NCT06844383 Comparator | May 2026 → Mar 2029 expected | castration-resistant prostate carcinoma, prostate adenocarcinoma | Prostate Cancer Clinical Trials Consortium | Recruiting | No outcome recorded |
| Phase 2 | NCT07230106 Background | Dec 2025 → Dec 2028 expected | prostate cancer | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07268794 Background | Nov 2025 → Apr 2027 expected | metastatic prostate carcinoma, prostate adenocarcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06991556 Comparator | Jul 2025 → Mar 2032 expected | metastatic prostate carcinoma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT05873192 Background | Jun 2025 → Dec 2026 expected | prostate cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06734130 Background | Jan 2025 → Jan 2029 expected | metastatic prostate carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05726292 Background | Jan 2025 → Oct 2027 expected | prostate adenocarcinoma | University of Chicago | Recruiting | No outcome recorded |
| Phase 2 | NCT06992232 Background | Aug 2024 → Jul 2027 expected | metastatic prostate carcinoma | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | No outcome recorded |
| Phase 2 | NCT06582628 Comparator | Jul 2024 → Jan 2026 overdue | metastatic prostate carcinoma | Fundacion Oncosur | Recruiting | No outcome recorded |
| Phase 2 | NCT06378866 Comparator | Jun 2024 → Feb 2031 expected | castration-resistant prostate carcinoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT06312670 Background | May 2024 → Jan 2025 | metastatic prostate carcinoma, prostate adenocarcinoma | Pedro Barata, MD, MSc | Completed | No outcome recorded |
| Phase 2 | NCT05551117 Comparator | Jun 2023 → Jul 2024 | anal carcinoma, castration-resistant prostate carcinoma, hormone-resistant prostate carcinoma, laryngeal squamous cell carcinoma +4 | MacroGenics | Terminated | No outcome recorded |
| Phase 2 | NCT05526248 Comparator | Dec 2022 → Aug 2024 | prostate carcinoma | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT05588609 Background | Nov 2022 → Jul 2025 | castration-resistant prostate carcinoma | Partner Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT05422911 Comparator | Aug 2022 → Dec 2027 expected | metastatic malignant neoplasm, prostate carcinoma | Sun Pharmaceutical Industries, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT05212857 Background | Apr 2022 → Feb 2024 | prostate cancer | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT04655365 Background | Mar 2022 → Nov 2025 overdue | prostate cancer | CHU de Quebec-Universite Laval | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04335682 Comparator | Aug 2021 → Sep 2025 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Alliance Foundation Trials, LLC. | Completed | No outcome recorded |
| Phase 2 | NCT04869488 Comparator | Jul 2021 → Feb 2023 | metastatic prostate carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04557449 Background | Sep 2020 → Sep 2026 expected | breast neoplasm, liposarcoma, lung adenocarcinoma, prostate cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04332744 Background | Sep 2020 → May 2025 | metastatic prostate carcinoma | MedSIR | Completed | No outcome recorded |
| Phase 2 | NCT04207255 Background | Mar 2020 → Aug 2023 | prostate cancer | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 2 | NCT04262154 Background | Mar 2020 → Jul 2025 overdue | metastatic prostate carcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04116775 Background | Oct 2019 → Oct 2023 | metastatic prostate carcinoma | Julie Graff, MD | Unknown | No outcome recorded |
| Phase 2 | NCT03939689 Background | May 2019 → Sep 2023 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Progenics Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03763253 Background | Apr 2019 → Aug 2026 overdue | metastatic prostate carcinoma | Imperial College London | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03770455 Background | Jan 2019 → Dec 2020 | castration-resistant prostate carcinoma | Jodi Layton, MD | Terminated | No outcome recorded |
| Phase 2 | NCT03556904 Background | Dec 2018 → Jul 2023 | prostate cancer | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03418324 Background | Mar 2018 → Nov 2019 | prostate cancer | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03336983 Background | Dec 2017 → Jun 2022 | metastatic carcinoma in the bone, prostate cancer | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Completed | No outcome recorded |
| Phase 2 | NCT03314324 Comparator | Nov 2017 → Jan 2022 | castration-resistant prostate carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Completed | No outcome recorded |
| Phase 2 | NCT02799745 Comparator | Jun 2016 → Aug 2020 | prostate cancer | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02758132 Comparator | Mar → Sep 2016 | prostate cancer | University of Hawaii | Terminated | No outcome recorded |
| Phase 2 | NCT02685267 Comparator | Feb 2016 → Aug 2017 | prostate cancer | Prostate Cancer Clinical Trials Consortium | Terminated | No outcome recorded |
| Phase 2 | NCT02676986 Comparator | Aug 2015 → Dec 2016 | estrogen-receptor positive breast cancer | Queen Mary University of London | Completed | No outcome recorded |
| Phase 2 | NCT02379390 Comparator | Jun 2015 → May 2018 | metastatic prostate carcinoma | Sanofi | Terminated | No outcome recorded |
| Phase 2 | NCT02225704 Background | Jun 2015 → Jul 2017 | prostate cancer | Cancer Trials Ireland | Completed | No outcome recorded |
| Phase 2 | NCT02256111 Background | May 2015 → Feb 2018 | prostate carcinoma | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT02407054 Background | Apr 2015 → Sep 2018 | metastatic prostate carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT02525068 Background | Dec 2014 → Dec 2019 | prostate adenocarcinoma | Institute of Cancer Research, United Kingdom | Unknown | No outcome recorded |
| Phase 2 | NCT02312557 Background | Nov 2014 → Aug 2024 overdue | castration-resistant prostate carcinoma, hormone-resistant prostate carcinoma, post 5-alpha-reductase inhibitors treatment syndrome, prostate adenocarcinoma | OHSU Knight Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02254785 Comparator | Oct 2014 → May 2020 | castration-resistant prostate carcinoma | British Columbia Cancer Agency | Unknown | No outcome recorded |
| Phase 2 | NCT02268175 Background | Oct 2014 → Jan 2018 | prostate adenocarcinoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT01990196 Comparator | Sep 2014 → Sep 2024 overdue | prostate cancer | Jonsson Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01867333 Background | Aug 2013 → Sep 2022 | prostate cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT04787744 Background | Jul 2021 → Sep 2026 expected | metastatic prostate carcinoma | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03295565 Comparator | May 2017 → Dec 2020 | metastatic neoplasm, metastatic prostate carcinoma | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 2/3 | NCT02685397 Background | Oct 2016 → Apr 2027 expected | castration-resistant prostate carcinoma | Sir Mortimer B. Davis - Jewish General Hospital | Active not recruiting | No outcome recorded |
| Phase 337 trials | ||||||
| Phase 3 | NCT07711002 Background | Oct 2026 → Jun 2031 expected | metastatic prostate carcinoma | AstraZeneca | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07620574 Background | May 2026 → May 2030 expected | colorectal cancer, differentiated thyroid carcinoma, hepatocellular carcinoma, pancreatic neuroendocrine tumor +2 | Exelixis | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07611110 Comparator | May 2026 → Feb 2029 expected | prostate carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT07311694 Comparator | Feb 2026 → Dec 2027 expected | castration-resistant prostate carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07241416 Comparator | Dec 2025 → Mar 2027 expected | prostate carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07028853 Background | Sep 2025 → Sep 2028 expected | metastatic prostate carcinoma | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT06592924 Background | May 2025 → Mar 2031 expected | prostate adenocarcinoma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 3 | NCT06764485 Comparator | Mar 2025 → Sep 2027 expected | prostate carcinoma | Celgene Corporation | Recruiting | No outcome recorded |
| Phase 3 | NCT06691984 Comparator | Dec 2024 → Jan 2029 expected | castration-resistant prostate carcinoma | Amgen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06629779 Background | Oct 2024 → Dec 2026 expected | castration-resistant prostate carcinoma | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT06496581 Background | Sep 2024 → Feb 2033 expected | metastatic prostate carcinoma | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT06520345 Background | Jul 2024 → Dec 2027 expected | prostate carcinoma | Telix Pharmaceuticals (Innovations) Pty Limited | Recruiting | No outcome recorded |
| Phase 3 | NCT06320067 Background | Jun 2024 → Apr 2031 expected | metastatic prostate carcinoma | University College, London | Recruiting | No outcome recorded |
| Phase 3 | NCT06136624 Comparator | Dec 2023 → Aug 2028 expected | metastatic prostate carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06136650 Comparator | Dec 2023 → May 2028 expected | castration-resistant prostate carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06120491 Background | Nov 2023 → Sep 2027 expected | metastatic prostate carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04876651 Comparator | Aug 2023 → Jul 2025 | metastatic prostate carcinoma | Telix Pharmaceuticals (Innovations) Pty Limited | Terminated | No outcome recorded |
| Phase 3 | NCT05204927 Comparator | Feb 2022 → Aug 2024 overdue | metastatic prostate carcinoma | Curium US LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04455750 Background | Oct 2021 → Mar 2027 expected | castration-resistant prostate carcinoma, prostate adenocarcinoma | Alliance for Clinical Trials in Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04844749 Comparator | Jun 2021 → May 2023 | castration-resistant prostate carcinoma, hormone-resistant prostate carcinoma | Veru Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT04689828 Comparator | Jun 2021 → Oct 2022 overdue | prostate neoplasm | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04934722 Background | May 2021 → Oct 2022 | metastatic prostate carcinoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT04821622 Background | May 2021 → Feb 2026 overdue | prostate cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03850795 Comparator | Mar 2021 → Jun 2024 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Hinova Pharmaceuticals USA, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT04647526 Comparator | Feb 2021 → Nov 2023 overdue | castration-resistant prostate carcinoma | POINT Biopharma | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04446117 Comparator | Oct 2020 → Apr 2024 overdue | metastatic prostate carcinoma, prostate adenocarcinoma | Exelixis | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04115007 Comparator | Jun 2020 → Jun 2026 overdue | prostate carcinoma | UNICANCER | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04191096 Background | Feb 2020 → Oct 2022 | metastatic prostate carcinoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03834493 Background | Jul 2019 → Dec 2022 | prostate neoplasm | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03834519 Comparator | May 2019 → Mar 2022 | prostate neoplasm | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03395197 Background | Dec 2017 → Oct 2022 overdue | castration-resistant prostate carcinoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02975934 Comparator | Jun 2017 → Aug 2022 | castration-resistant prostate carcinoma | pharmaand GmbH | Completed | No outcome recorded |
| Phase 3 | NCT02987543 Comparator | Feb 2017 → Jun 2019 | prostate carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03016312 Background | Jan 2017 → Jun 2019 | castration-resistant prostate carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT06350825 Comparator | Jan 2016 → Dec 2027 expected | metastatic prostate carcinoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 3 | NCT02194842 Background | Oct 2015 → Feb 2024 overdue | prostate cancer | European Organisation for Research and Treatment of Cancer - EORTC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02438007 Comparator | Jun 2015 → Jul 2016 | prostate cancer | LTN PHARMACEUTICALS, INC. | Terminated | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT05700903 Comparator | Sep 2023 → Jul 2025 | dysautonomia, hypertensive disorder, kidney disorder, prostate cancer | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 4 | NCT05457257 Comparator | Jul 2022 → Oct 2024 overdue | castration-resistant prostate carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04597125 Comparator | Nov 2020 → Nov 2025 overdue | prostate carcinoma | Bayer | Active not recruiting | No outcome recorded |
Press releases naming this drug 29 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-22 | Pfizer | FDA Grants Priority Review for Pfizer’s TALZENNA Plus XTANDI for the Treatment of Metastatic Prostate Cancer pfizer.com ↗ |
| 2026-05-30 | Pfizer | TALZENNA Plus XTANDI Improves Radiographic Progression-Free Survival by More Than 50% in Metastatic Prostate Cancer pfizer.com ↗ |
| 2026-03-19 | Pfizer | TALZENNA Plus XTANDI Significantly Improves Radiographic Progression-Free Survival in Metastatic Prostate Cancer pfizer.com ↗ |
| 2025-10-19 | Pfizer | XTANDI® Plus Leuprolide Reduced Risk of Death by 40% vs Leuprolide Alone in Men with a Type of Advanced Prostate Cancer pfizer.com ↗ |
| 2025-07-10 | Pfizer | XTANDI® Plus Leuprolide Significantly Improves Survival Outcomes in Men with Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence pfizer.com ↗ |
| 2025-05-22 | Pfizer | Astellas and Pfizer’s XTANDI™ (enzalutamide) Shows Long-Term Overall Survival in Metastatic Hormone-Sensitive Prostate Cancer pfizer.com ↗ |
| 2025-02-13 | Pfizer | Pfizer’s TALZENNA® in Combination with XTANDI® Improves Survival Outcomes in Metastatic Castration Resistant Prostate Cancer pfizer.com ↗ |
| 2024-10-10 | Pfizer | Pfizer’s TALZENNA® in Combination with XTANDI® Prolongs Overall Survival in Phase 3 TALAPRO-2 Trial pfizer.com ↗ |
| 2024-01-08 | Pfizer | European Commission Approves Pfizer’s TALZENNA® in Combination with XTANDI® for Adult Patients with Metastatic Castration-Resistant Prostate Cancer pfizer.com ↗ |
| 2023-06-20 | Pfizer | Pfizer’s TALZENNA® in Combination with XTANDI® Receives U.S. FDA Approval pfizer.com ↗ |
| 2023-04-29 | Pfizer | XTANDI® (enzalutamide) plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide pfizer.com ↗ |
| 2023-03-16 | Pfizer | Phase 3 Study Shows XTANDI® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer pfizer.com ↗ |
| 2023-02-16 | Pfizer | Pfizer Announces Positive TALZENNA® and XTANDI® Combination Data from Phase 3 TALAPRO-2 Study pfizer.com ↗ |
| 2021-09-17 | Pfizer | Astellas’ and Pfizer’s XTANDI® (enzalutamide) Reduced Risk of Death by 34% in Men with Metastatic Hormone-Sensitive Prostate Cancer in Phase 3 ARCHES Study pfizer.com ↗ |
| 2021-06-23 | Pfizer | First Participant Dosed in Pfizer’s Pivotal Phase 3 TALAPRO-3 Combination Study of Talazoparib and Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (mCSPC) pfizer.com ↗ |
| 2020-05-29 | Pfizer | Final PROSPER Results Show XTANDI® (enzalutamide) Significantly Extends Overall Survival in Men with Non-Metastatic Castration-Resistant Prostate Cancer pfizer.com ↗ |
| 2020-02-11 | Pfizer | XTANDI® (enzalutamide) Demonstrates Significant Improvement in Overall Survival in Phase 3 PROSPER Trial of Patients with nmCRPC pfizer.com ↗ |
| 2019-12-16 | Pfizer | XTANDI® (enzalutamide) Approved by U.S. FDA for the Treatment of Metastatic Castration-Sensitive Prostate Cancer pfizer.com ↗ |
| 2019-08-21 | Pfizer | U.S. FDA Grants XTANDI® (enzalutamide) Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer pfizer.com ↗ |
| 2019-02-11 | Pfizer | Phase 3 ARCHES Trial Shows XTANDI® (enzalutamide) Significantly Improved Radiographic Progression-Free Survival in Men with Metastatic Hormone-Sensitive Prostate Cancer pfizer.com ↗ |
| 2018-12-20 | Pfizer | Astellas and Pfizer Announce Positive Top-Line Results from Phase 3 ARCHES Trial of XTANDI® (enzalutamide) in Men with Metastatic Hormone-Sensitive Prostate Cancer pfizer.com ↗ |
| 2018-08-22 | Pfizer | Pfizer and Astellas Amend Clinical Research Protocols for Two Phase 3 Trials of Enzalutamide in Patients with Hormone-Sensitive Prostate Cancer pfizer.com ↗ |
| 2018-07-13 | Pfizer | U.S. FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC) pfizer.com ↗ |
| 2018-03-19 | Pfizer | U.S. FDA Grants Priority Review for a Supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) in Non-Metastatic Castration-Resistant Prostate Cancer (CRPC) pfizer.com ↗ |
| 2018-02-05 | Pfizer | Phase 3 PROSPER Trial Shows XTANDI® (enzalutamide) Significantly Reduced the Risk of Metastasis or Death by 71 Percent in Men with Non-Metastatic Castration-Resistant Prostate Cancer pfizer.com ↗ |
| 2017-09-14 | Pfizer | Pfizer and Astellas Announce Positive Top-Line Results from Phase 3 PROSPER Trial of XTANDI (enzalutamide) in Patients with Non-Metastatic Castration-Resistant Prostate Cancer pfizer.com ↗ |
| 2017-06-09 | Pfizer | Astellas and Pfizer Announce Amendment to Clinical Research Protocol for Phase 3 PROSPER Trial of enzalutamide in Patients with Non-metastatic Castration-Resistant Prostate Cancer pfizer.com ↗ |
| 2016-12-14 | Pfizer | Pfizer and Astellas Announce Top-Line Results from Phase 4 PLATO Trial of XTANDI® (enzalutamide) Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer pfizer.com ↗ |
| 2016-10-21 | Pfizer | FDA Approves Supplemental New Drug Application for XTANDI® (enzalutamide) Capsules in Advanced Prostate Cancer pfizer.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 342 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Enzalutamide | “This regimen consists of Androgen Deprivation Therapy (ADT) (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix) combined with an oral Androgen Receptor (AR) inhibitor...” NCT07389174 ↗327“The drugs to be administered are: prednisone 5 mg orally twice daily, abiraterone 1000 mg orally once daily, enzalutamide 160 mg orally once daily, and cabazitaxel intravenous...” NCT03110588 ↗ “Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel,...” NCT03556904 ↗ “Bridging therapy including Anti-AR agents (example, abiraterone, enzalutamide) will be administered orally and radiotherapy, or chemotherapy (example, docetaxel) will be...” NCT05022849 ↗ “Darolutamide is the preferred ARPI for this study; however, patients may receive abiraterone, apalutamide, or enzalutamide at the discretion of their oncologist and based on...” NCT07645326 ↗ “Androgen deprivation with or without docetaxel chemotherapy, Abiraterone, Enzalutamide or any other proven agent) treatment as determined by treating physician (positive control).” NCT03763253 ↗ “Additional therapy following tumor board meeting : new generation hormonal therapy (abiraterone, enzalutamide, apalutamide or other approved) or chemotherapy (docetaxel).” NCT04115007 ↗ “Agents of interest included Abiraterone, Enzalutamide, Pembrolizumab, Ipilimumab, Carboplatin, Docetaxel, and Olaparib as well as combinations” NCT04399876 ↗ “ADT plus only 12 months of ARPI (apalutamide/enzalutamide) with the possibility to resume treatment with ARSI in case of a confirmed PSA rise.” NCT07260435 ↗ “Enzalutamide is a potent androgen receptor signalling inhibitor that blocks several steps in the androgen receptor signalling pathway.” NCT03869762 ↗ “The ARPI drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi).” NCT04597125 ↗ “ADT, abiraterone and each ARSI (Apalutamide, Darolutamide, Enzalutamide) will be administrated according to the standard of care” NCT06496581 ↗ “In addition to ADT, participants may be treated with second-generation anti-androgen drugs such as Abiraterone or Enzalutamide.” NCT06655259 ↗ “Patients received ADT plus second-generation ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years.” NCT06992232 ↗ “or a change of ARPI (to abiraterone or enzalutamide, administered orally on a continuous basis per product labelling)” PMID 39293462 ↗ Sep 2024 “Triplet or doublet therapy (ie. docetaxel/abiraterone, apalutamide，Rezvilutamide，darolutamide，enzalutamide)” NCT06350825 ↗ “Second generation ARPI (Abiraterone Acetate and Prednisolone, Enzalutamide, Apalutamide or Darolutamide).” NCT06320067 ↗ “arm C: MDT with 6 months ADT together with ARTA (enzalutamide 4 × 40 mg daily) for 6 months.” PMID 36503429 ↗ Dec 2022 “Enzalutamide, Darolutamide, Apalutamide as prescribed by the local investigator” NCT05849298 ↗ “In this trial, participants will be given either enzalutamide or abiraterone.” NCT06855277 ↗ “If Enzalutamide is used, 160 mg will be taken orally every 24 hours.” NCT05189457 ↗ “ARPI (abiraterone or enzalutamide or apalutamide or darolutamide)” NCT05974774 ↗ “Examples include enzalutamide, apalutamide, darolutamide.” NCT04946370 ↗ “enzalutamide 160 mg, orally” NCT02379390 ↗ “enzalutamide or abiraterone” NCT04876651 ↗ “Enzalutamide 160mg po qd” NCT06145308 ↗ “Enzalutamide” NCT06734130 ↗ “Enzalutamide” NCT05700903 ↗ |
| Known as | ASP9785 | “A Phase I Open-label Study to Evaluate the Effect of Multiple Doses of MDV3100 (ASP9785) on the Pharmacokinetics of Substrates for CYP2C8, CYP2C9, CYP2C19, and CYP3A4 in...” NCT01911728 ↗ |
| Known as | MDV3100 | “Enzalutamide, formerly known as MDV3100, is a rationally-designed second generation AR inhibitor which functions by blocking several steps in the AR signaling cascade.” NCT01942837 ↗12“Enzalutamide (formerly called MDV3100) targets multiple steps in the androgen-receptor-signaling pathway, the major driver of prostate-cancer growth.” PMID 22894553 ↗ Aug 2012 “Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer” NCT01547299 ↗ “Enzalutamide (MDV3100) 160 mg PO once daily for 6 months” NCT02203695 ↗ |
| Known as | NSC# 766085 | “A Phase II Study of Enzalutamide (NSC# 766085) for Patients With Androgen Receptor Positive Salivary Cancers” NCT02749903 ↗ |
| Known as | Xtandi | “Enzalutamide, sold under the brand name Xtandi, is a nonsteroidal antiandrogen medication which is used in the treatment of prostate cancer.” NCT05726292 ↗7“The ARPI drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi).” NCT04597125 ↗ “Brand name of darolutamide is Nubeqa; brand name of enzalutamide is Xtandi.” NCT04157088 ↗ “enzalutamide (Xtandi®, "Xtandi is a trademark of Astellas Pharma, Inc." )” NCT02380313 ↗ “Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi]” NCT05683964 ↗ “Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets” NCT05413421 ↗ |
| Action | Inhibit | “MDV3100 is an androgen-receptor antagonist that blocks androgens from binding to the androgen receptor and prevents nuclear translocation and co-activator recruitment of the...” PMID 20398925 ↗ Apr 2010 |
| Modality | Other / unclassified | “Anti-androgen medication for the treatment of metastatic castration-resistant prostate cancer.” NCT02685397 ↗ |
| Route | Oral | “enzalutamide 160 mg orally once a day” PMID 37142371 ↗ May 2023 |
| Target | AR | “enzalutamide suppresses AR signaling” PMID 24882673 ↗ May 2014 |