A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer

This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.

Start Date31 Mar 2026

Sponsor / Collaborator

Roche Holding AG

NCT06616155

/ RecruitingPhase 1/2IIT

Study of JAK Inhibition in Stem-Like Prostate Cancer (JASPER): A Phase 1b/2a Multicenter Study of Ruxolitinib and Enzalutamide in Castration Resistant Prostate Cancer

This phase I/II tests the safety, side effects and best dose of ruxolitinib in combination with enzalutamide and how well it works in treating patients with prostate cancer that remains despite blocking hormone production (castration-resistant) and that has spread from where it first started to other places in the body (metastatic). Ruxolitinib, a kinase inhibitor, slows down the growth of the tumor by blocking the proteins, JAK1 and JAK2, tumors use to grow. Enzalutamide, an androgen receptor inhibitor, works by blocking the effects of androgen (a male reproductive hormone). This may help stop the growth and spread of tumor cells that need testosterone to grow. Giving ruxolitinib in combination with enzalutamide may be safe, tolerable, and/or effective in treating metastatic castration-resistant prostate cancer.

Start Date30 Jan 2026

Sponsor / Collaborator

Rogel Cancer Center: University of Michigan

[+1]

NCT07230106

/ RecruitingPhase 2

A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of HS-20093 or SHR2554 Tablets in Combination With Novel Hormonal Agents in Participants With Metastatic Prostate Cancer

This is a phase II, multicentre clinical study investigating HS-20093 or SHR2554 in combination with a Novel Hormonal Agent (NHA) for advanced prostate cancer. The trial comprises two cohorts.

Start Date08 Dec 2025

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Enzalutamide

100 Translational Medicine associated with Enzalutamide

100 Patents (Medical) associated with Enzalutamide

4,109

Literatures (Medical) associated with Enzalutamide

01 Jun 2026·Health policy OPEN

Price transparency & out-of-pocket payments for medications: Implications of associated delivery fees in the United States

Article

Author: Kaye, Deborah R ; Scales, Charles D ; George, Daniel J ; Lee, Hui-Jie ; Bundorf, M Kate

Background:

Price transparency has been cited as a tool to reduce out-of-pocket (OOP) payments to patients. These tools for prescription drugs often focus on the price to patients for the drug alone. However, costs associated with drug delivery (i.e. infusion center fees, labs, etc) are often unknown and could impact the effectiveness of price transparency tools. Objective: To examine total OOP payments on day of drug receipt ("full day", i.e. drug + drug administration fees) out-of-pocket (OOP) payments associated with six first-line treatments for metastatic castrate resistant prostate cancer and compare these with payments for drug alone and by insurance type.

Methods:

Using the IBM Marketscan databases, we identify male patients who initiated treatment with one of six focus drugs (docetaxel, abiraterone, enzalutamide, sipuleucel-T, cabazitaxel, and radium-223) used to treat mCRPC from 07/01/2013-06/30/2019. We calculated total OOP payments on day of drug receipt (full day OOP payments) by drug type for six first line treatments. We then used a two-part model to assess the association of first-line therapy with OOP payments for the four most frequently prescribed during the study time period.

Results:

We find that there is variation in the proportion of payments for drug alone relative to full day payments across first-line treatments. However, regression-adjusted mean full day OOP payments are not statistically different across first-line treatments for mCRPC for the four most frequently prescribed drugs. There are differences in the likelihood that an individual will incur any OOP payment by first-line treatment type and by health plan type.

Conclusion:

These analyses suggest that when accounting for additional services required on the day of drug receipt, the amount a patient pays to receive a medication for mCRPC can be very different from the OOP payment for the drug alone; these payments also vary by drug and health plan type. Therefore, price transparency for drug alone may not lead to reduced OOP payments for patients.

01 Jun 2026·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Boolean network-based identification of optimal drug combinations for prostate cancer

Article

Author: Datta, Aniruddha ; Kumar, Addanki Pratap ; Bhattacharjee, Pranabesh

Prostate cancer is one of the most common cancers among men in the United States and is a leading cause of cancer-related deaths and the second most common cancer in men worldwide. In this study, we used a Boolean network model to analyze prostate cancer signaling pathways and to identify optimal drug combinations for precision therapy. By integrating publicly available biological signaling pathway data with recent research findings, we developed a comprehensive model that represents protein-protein interactions, gene mutations, and pathway dysregulation. Faults induced by mutations were modeled using the "stuck at 0" or "stuck at 1" fault paradigms, capturing the impact of genetic alterations on pathway behavior. The model was simulated across various drug combinations to determine which therapies could most effectively alleviate the aberrant signaling caused by specific mutations. To quantify therapeutic efficacy, we calculated a Size Difference (SD) score, a metric analogous to Hamming distance, measuring the deviation from normal, for each drug combination and fault scenario. The results revealed that drug combinations involving Berberine, Docetaxel, Olaparib, and Enzalutamide showed promising prediction efficacy (more than 90 %), indicating higher therapeutic potential. A distinguishing feature of this work is that, in addition to the standard prostate cancer drugs, we have included Berberine, a non-toxic natural compound with beneficial effects. These computational findings provide a framework for future experimental and clinical validation, which is necessary to confirm the therapeutic relevance of the predicted drug combinations.

01 May 2026·CELLULAR SIGNALLING

The YAP1 and EPHA3 receptor tyrosine kinase axis regulates cellular plasticity and treatment response

Article

Author: Dwead, Abdulrahman M ; Cinar, Bekir ; Khazaw, Kezhan ; Al-Mathkour, Marwah M

The transcriptional coregulator YAP1 and the receptor tyrosine kinase EPHA3 regulate key cellular processes, including cell interactions, motility, survival, tissue development, carcinogenesis, and metastasis. Although their individual roles have been extensively studied, their cooperative functions remain poorly understood. Here, we investigated the relationship between EPHA3 and YAP1 in human prostate tumor tissues and cell models. Integrated transcriptomic and immunological analyses reveal a strong positive correlation between YAP1 and EPHA3 expression, which is significantly associated with tumor progression. EPHA3 knockout reduces cell proliferation and increases sensitivity to the androgen receptor inhibitor enzalutamide and the YAP1-TEAD inhibitor CA3 in vitro. EPHA3 depletion also reduces GTP-bound active RHOA and phosphorylated ERK levels and differentially affects epithelial-mesenchymal transition and cancer stem cell programs. In addition, EPHA3 silencing attenuates cell migration and invasion, an effect dependent on YAP1 activation. Bioinformatics analysis further indicates that high YAP1 and EPHA3 correlate with developmental and EMT-related gene signatures. These results demonstrate that the YAP1-EPHA3 axis is a key mediator of cell survival, plasticity, and tumor progression, and may serve as a promising cancer drug target.

739

News (Medical) associated with Enzalutamide

24 Mar 2026

·www.prnewswire.com

International Harrington Prize Jointly Awarded to Drs. Arul Chinnaiyan and Charles Sawyers

2026 Harrington Prize for Innovation in Medicine recognizes pioneering work in prostate cancer diagnosis and treatment CLEVELAND, March 24, 2026 /PRNewswire/ -- The thirteenth annual Harrington Prize for Innovation in Medicine has been jointly awarded to Arul Chinnaiyan, MD, PhD, Investigator, Howard Hughes Medical Institute and S.P. Hicks Endowed Professor of Pathology at the University of Michigan Medical School, and Charles L. Sawyers, MD, Investigator, Howard Hughes Medical Institute and Marie-Josée and Henry R. Kravis Chair in Human Oncology and Pathogenesis at the Memorial Sloan Kettering Cancer Center. The award recognizes their transformative discoveries that defined the molecular drivers of prostate cancer and pioneered precision therapies that have reshaped the diagnosis and treatment of prostate cancer worldwide. The Harrington Prize for Innovation in Medicine, established in 2014 by the Harrington Discovery Institute at University Hospitals and the American Society for Clinical Investigation (ASCI), honors physician-scientists who have moved science forward with achievements notable for innovation, creativity, and potential for clinical application. Drs. Chinnaiyan and Sawyers have together identified genetic changes that drive prostate cancer and pioneered breakthrough precision therapies. Dr. Chinnaiyan identified an abnormal gene fusion, TMPRSS2-ERG, that is the most common genetic driver of prostate cancer and is a foundational biomarker for prostate cancer diagnostics. Dr. Sawyers developed advanced androgen receptor inhibitors, enzalutamide and apalutamide, FDA-approved in 2012 and 2018, respectively. These drugs are a mainstay of prostate cancer treatment. (Earlier work by Dr. Sawyers brought to clinical practice the drug imatinib, a tyrosine kinase inhibitor that revolutionized treatment of chronic myeloid leukemia.) Drs. Chinnaiyan and Sawyers also co-led a team that discovered high rates of mutations in advanced prostate cancers that make them susceptible to a class of drugs called PARP inhibitors, such as olaparib. Today these drugs are a standard treatment for prostate cancer. Together, Drs. Chinnaiyan and Sawyers have developed the contemporary framework for diagnosis and treatment of advanced prostate cancer and a basis for next generation therapies. The Harrington Prize for Innovation in Medicine recognizes their impact in improving outcomes in this deadly disease. "The Harrington Prize recognizes scientific breakthroughs that change the course of medicine, and the work of Drs. Chinnaiyan and Sawyers exemplifies this mission. Their ground-breaking discoveries in cancer genomics and precision oncology demonstrate the extraordinary impact of scientific curiosity paired with clinical purpose," said Priscilla Hsue, MD, Chizuko and Nobuyuki Kawata Chair, Chief of Cardiology, UCLA, Professor of Medicine, David Geffen School of Medicine UCLA, and 2025-2026 ASCI President. "Drs. Chinnaiyan and Sawyers embody the very best of physician‑scientist innovation. Their contributions underscore the power of advancing bold scientific ideas all the way to patient care, and they inspire a generation of innovators committed to turning discovery into cures," said Jonathan S. Stamler, MD, President and Co-Founder, Harrington Discovery Institute, Distinguished University Professor, Robert S. and Sylvia K. Reitman Family Foundation Chair of Cardiovascular Innovation, and Professor of Medicine and of Biochemistry at University Hospitals and Case Western Reserve University. A committee composed of members of the ASCI Council and the Harrington Discovery Institute Scientific Advisory Board reviewed nominations from leading academic medical centers from seven countries before selecting the 2026 Harrington Prize recipient. In addition to receiving the Prize's $20,000 honorarium, co-recipients Dr. Chinnaiyan and Dr. Sawyers will deliver the Harrington Prize Lecture at the 2026 AAP/ASCI/APSA Joint Meeting on April 17, and they will be featured speakers at the 2026 Harrington Scientific Symposium on May 20. They are invited to publish an essay in the Journal of Clinical Investigation. The Harrington Prize has recognized outstanding and diverse innovations in medicine since 2014: 2014: Harry Dietz, MD, Johns Hopkins University, for his contributions to the understanding of the biology and treatment of Marfan syndrome, a disorder leading to deadly aneurysms in children and adults. 2015: Douglas R. Lowy, MD, The National Cancer Institute, in recognition of his discoveries that led to the development of the Human Papillomavirus vaccine to prevent cervical cancer. 2016: Jeffrey M. Friedman, MD, PhD, The Rockefeller University, for his discovery of leptin, which controls feeding behavior and is used to treat related clinical disorders. 2017: Jointly awarded to Daniel J. Drucker, MD, Mount Sinai Hospital, Canada, Joel F. Habener, MD, Massachusetts General Hospital, and Jens J. Holst, MD, DMSc, University of Copenhagen, Denmark, for their discovery of incretin hormones and for the translation of these findings into transformative therapies for major metabolic diseases such as diabetes. 2018: Helen H. Hobbs, MD, UT Southwestern Medical Center, for the discovery of the link between a gene mutation (PCSK9) and lower levels of LDL, which has improved the treatment of high cholesterol. 2019: Carl H. June, MD, University of Pennsylvania, for advancing the clinical application of CAR T therapy for cancer treatment, and for his sustained contributions to the field of cellular immunology. 2020: Stuart H. Orkin, MD, Harvard University, for breakthrough discoveries on red blood cells that offer new treatments for patients with sickle cell disease and beta-thalassemia, which are among the most common genetic disorders. 2021: Warren J. Leonard, MD, and John J. O'Shea, MD, NIH, for their respective contributions to the field of immunology, from fundamental discovery to therapeutic impact. 2022: James E. Crowe Jr., MD, Vanderbilt University, and Michel C. Nussenzweig, MD, PhD, The Rockefeller University, for their groundbreaking work, which has elucidated fundamental principles of the human immune response and enabled the use of human antibodies to treat COVID-19. 2023: Jean Bennett, MD, PhD, University of Pennsylvania, and Albert M. Maguire, MD, University of Pennsylvania, for their groundbreaking translational research to restore sight in inherited genetic diseases. 2024: Arlene H. Sharpe, MD, PhD, Harvard Medical School, for her breakthrough discoveries in immune regulation, which have led to new cancer therapies that act by boosting the immune response to cancer. 2025: Owen N. Witte, MD, University of California, Los Angeles, for his foundational discoveries of targeted therapies that have transformed modern cancer treatment. SOURCE Harrington Discovery Institute 21% more press release views with Request a Demo

Drug Approval

23 Mar 2026

·www.biospace.com

Damora Therapeutics Appoints Biotechnology Leader Jennifer Jarrett as President and Chief Executive Officer; Adds Two Industry Veterans to Board of Directors

-- Ms. Jarrett brings nearly three decades of executive leadership in biotech, tech and finance -- -- Biotech leaders Dr. Cameron Turtle and Mike Landsittel appointed to Board of Directors -- -- Peter Harwin named Chairman of the Board of Directors -- BOSTON, March 23, 2026 (GLOBE NEWSWIRE) -- Damora Therapeutics, Inc. (NASDAQ: DMRA), a biotechnology company working to fundamentally redefine care for patients with blood disorders, today announced that its Board of Directors has appointed Jennifer Jarrett as President and Chief Executive Officer, effective March 30, 2026. Ms. Jarrett will also serve on the company’s Board of Directors. “We are excited to welcome Jen to Damora as we accelerate our efforts to bring innovative medicines to patients with mutant calreticulin (mutCALR)-driven myeloproliferative neoplasm (MPNs),” said Peter Harwin, Chairman of the Board of Directors of Damora Therapeutics. “With a track record of success in oncology drug development and building and leading high-growth companies, Jen brings a unique set of strategic and operational experience that will be invaluable as we unlock Damora’s potential.” “I am thrilled to join Damora, and I look forward to working alongside the company’s talented and purpose-driven employees to realize our mission of redefining care for people with blood disorders,” said Jennifer Jarrett, President and Chief Executive Officer of Damora Therapeutics. “With a portfolio of potential best-in-class therapies, a strong balance sheet, and experienced board and executive leadership, Damora is exceptionally well positioned to rapidly develop our lead program, DMR-001, while also strategically advancing additional pipeline assets to treat the full spectrum of patients with mutCALR-driven MPNs.” Ms. Jarrett is a seasoned executive with nearly three decades of experience in corporate strategy, finance and investor relations, drug development, and organizational leadership. Most recently, she served as Chief Operating Officer of Arcus Biosciences, a development-stage oncology company. During her tenure, she also served as Chief Financial Officer and a member of the company’s Board of Directors. Prior to Arcus, Ms. Jarrett served as Vice President of Corporate Development and Capital Markets at Uber Technologies, Inc. Previously, she was Chief Financial Officer of Medivation, a commercial oncology company that developed the blockbuster medicine XTANDI ® (enzalutamide) for prostate cancer, through the company’s acquisition by Pfizer. Ms. Jarrett spent 20 years in investment banking, including at Citigroup, where she ran the firm’s west coast life sciences investment banking practice, and prior to that at Credit Suisse and Donaldson, Lufkin & Jenrette. Ms. Jarrett received a B.A. in Economics from Dartmouth College and an M.B.A. from Stanford University Graduate School of Business. She serves on the boards of Sagimet Biosciences, Syndax Pharmaceuticals and Zura Bio. Two Biotech Leaders Appointed to Board of Directors Damora Therapeutics also announced today the appointment of Cameron Turtle, D.Phil., Chief Executive Officer of Spyre Therapeutics, and Mike Landsittel, former Chief Financial Officer of Blueprint Medicines, to the company’s Board of Directors. In addition, Peter Harwin, Founding Partner at Fairmount Funds Management, LLC, and a current member of Damora’s Board of Directors, has been named Chairman. “Cameron and Mike bring to Damora incredible experience building and leading successful companies from development to commercialization across global markets, with a deep understanding of the biotech landscape and capital markets. We welcome their complementary expertise and perspective to our board,” said Mr. Harwin. Mr. Harwin added, “The Board of Directors also extends our gratitude to departing directors Dr. Carl Goldfischer, Dr. Jayson Dallas and Amit Munshi for their vision and leadership, which enabled the recent Damora-Galecto transaction and our strategy to deliver value to patients and shareholders.” Dr. Turtle is an experienced leader in building, financing, and shaping biopharma organizations from preclinical development to late-stage clinical trials and commercialization. Dr. Turtle currently serves as the Chief Executive Officer of Spyre Therapeutics. Previously, he served as Venture Partner at Foresite Labs, Chief Strategy Officer of BridgeBio Pharma and Chief Business Officer of Eidos Therapeutics. Prior to joining Eidos, he was a consultant at McKinsey & Company. Dr. Turtle received a B.S. with honors in bioengineering from the University of Washington and a D.Phil. in cardiovascular medicine from the University of Oxford, St. John’s College, where he was a Rhodes Scholar. Mr. Landsittel has broad biotech experience spanning strategic finance, corporate and business development, investor relations and organizational leadership. For more than a decade, Mr. Landsittel led strategic finance and operations functions at Blueprint Medicines, most recently as Chief Financial Officer, through the company’s acquisition by Sanofi. While at Blueprint, he led efforts to raise approximately $4 billion in capital through a variety of transactions and helped lead the company’s transition to a commercial immunology company with the launch of AYVAKIT ® (avapritinib). Prior to joining Blueprint, he served as Senior Director of Finance at Algeta ASA, through the company’s acquisition by Bayer, and held financial planning, business development and corporate strategy roles at Infinity Pharmaceuticals and Genzyme Corporation. Mr. Landsittel received a B.B.A. from the University of Michigan and an M.B.A. from the Tuck School of Business at Dartmouth College. About Damora Therapeutics Damora Therapeutics is an innovative biotechnology company that aims to fundamentally redefine care for people with hematologic disorders. We are advancing a new generation of biologics to treat mutant calreticulin-driven myeloproliferative neoplasms, including essential thrombocythemia and myelofibrosis, where there is significant medical need for disease-modifying treatments. With multiple programs with best-in-class potential on track to enter clinical development in 2026, our goal is to rapidly bring forward optimized therapies with broad mutation coverage and exceptional convenience to dramatically improve patient outcomes. For more information, visit or follow us on LinkedIn. Forward-Looking Statements Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to the Company’s expectations, hopes, beliefs, intentions or strategies regarding the future of its assets, pipeline and business. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting the Company will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the Company’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the headings “Risk Factors,” “Cautionary Information Regarding Forward-Looking Statements” or “Cautionary Statement Regarding Forward-Looking Statements” in the Company’s most recent filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. The Company does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. Media Contact: Lia Dangelico Deerfield Group lia.dangelico@deerfieldgroup.com Investor Contact: Brian Ritchie LifeSci Advisors britchie@lifesciadvisors.com

Executive Change

19 Mar 2026

·www.fiercepharma.com

Pfizer eyes earlier Talzenna use after phase 3 prostate cancer win

The interim analysis of the Talapro-3 trial revealed what Pfizer called a “strong trend” toward improved overall survival. Pfizer is eyeing an earlier use of its PARP inhibitor Talzenna after a positive phase 3 trial in metastatic hormone-sensitive prostate cancer (mHSPC).The phase 3 Talapro-3 trial met its primary endpoint by showing the combo of Talzenna and Pfizer and Astellas’ prostate cancer drug Xtandi significantly reduced the risk of tumor progression or death compared with Xtandi and placebo. This was in patients with homologous recombination repair (HRR) gene-mutated mHSPC, Pfizer announced in a Thursday, March 19 release.The radiographic progression-free survival result “markedly exceeded” the prespecified target of a 37% improvement, according to the company. Pfizer described the efficacy as “consistent” between BRCA-mutated and non-BRCA-mutated subgroups. The interim analysis also revealed what Pfizer called a “strong trend” toward improved overall survival, a key secondary endpoint. The New York pharma also cited benefits in other secondary endpoints such as overall response rate, duration of response and time to PSA progression.With the positive readout, Pfizer said it plans to discuss these results with global regulators for potential submissions for approvals. HRR mutations are found in about 25% of metastatic prostate cancers and are associated with a worse prognosis, Pfizer’s chief oncology officer, Jeff Legos, Ph.D., noted in a statement. Despite existing treatment, 50% to 65% of patients with metastatic castration-sensitive prostate cancer progress to metastatic castration-resistant prostate cancer (mCRPC) within two years, according to Pfizer.As the Talzenna-Xtandi combo is already approved in HRR-mutated mCRPC, the “unprecedented results” from Talapro-3 show its potential to benefit patients earlier in the disease course, Legos added.The Talapro-3 readout gives Pfizer another opportunity to expand the reach of Talzenna after a recent FDA snub in a broader mCRPC population. In May 2025, an FDA advisory committee voted unanimously against the approval of Talzenna and Xtandi for mCRPC patients without HRR gene mutations, based on data from the phase 3 Talapro-2 trial. The FDA, after questioning the validity of Talapro-2’s findings in the non-mutant subgroup, followed the panel’s recommendation in June with a label update for Talzenna to only add new overall survival data in its existing HRR-mutated mCRPC indication. Before the latest Talzenna readout, the FDA had approved Johnson & Johnson’s two-drug PARP combo Akeega in BRCA2-mutated mHSPC. Talzenna could be the first PARP inhibitor to enter a broader HRR-mutant mHSPC setting. Compared with Xtandi, the leading androgen receptor inhibitor, Talzenna is a relatively small product within Pfizer’s oncology portfolio and the PARP inhibitor class. In 2025, Talzenna generated $182 million in sales, up 55.6% year on year. Xtandi received its mHSPC nod from the FDA in 2019 and then became the first androgen receptor inhibitor approved in nonmetastatic castration-sensitive prostate cancer in 2023.Besides Talzenna, Pfizer is also pairing Xtandi with its experimental EZH2 inhibitor mevrometostat in mHSPC in the phase 3 Mevpro-3 trial. The phase 3 Mevpro-1 trial for the drug and Xtandi in mCRPC following treatment with J&J’s Zytiga is expected to read out this year.Editor's Note: The story has been corrected to reflect that J&J's Akeega is already FDA-approved in an mHSPC subset.

Phase 3Clinical ResultDrug Approval

100 Deals associated with Enzalutamide

External Link

KEGG	Wiki	ATC	Drug Bank
D10218	Enzalutamide	L02BB04	DB08899

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Prostatic Cancer	South Korea	Astellas Pharma Korea, Inc.	03 Dec 2024
Castration-sensitive prostate cancer	United States	Astellas Pharma US, Inc.	16 Nov 2023
HRR Gene-mutated Castration-Resistant Prostate Cancer	United States	Pfizer Inc.	20 Jun 2023
Metastatic Prostate Carcinoma	Japan	Astellas Pharma, Inc.	29 May 2020
Castration-Resistant Prostatic Cancer	European Union	Astellas Pharma Europe Ltd.	21 Jun 2013
Castration-Resistant Prostatic Cancer	Iceland	Astellas Pharma Europe Ltd.	21 Jun 2013
Castration-Resistant Prostatic Cancer	Liechtenstein	Astellas Pharma Europe Ltd.	21 Jun 2013
Castration-Resistant Prostatic Cancer	Norway	Astellas Pharma Europe Ltd.	21 Jun 2013
Hormone-dependent prostate cancer	European Union	Astellas Pharma Europe Ltd.	21 Jun 2013
Hormone-dependent prostate cancer	Iceland	Astellas Pharma Europe Ltd.	21 Jun 2013
Hormone-dependent prostate cancer	Liechtenstein	Astellas Pharma Europe Ltd.	21 Jun 2013
Hormone-dependent prostate cancer	Norway	Astellas Pharma Europe Ltd.	21 Jun 2013
Metastatic castration-resistant prostate cancer	United States	Astellas Pharma US, Inc.	31 Aug 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	China	Pfizer Inc.	27 Sep 2021
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Japan	Pfizer Inc.	27 Sep 2021
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Argentina	Pfizer Inc.	27 Sep 2021
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Australia	Pfizer Inc.	27 Sep 2021
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Belgium	Pfizer Inc.	27 Sep 2021
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Bulgaria	Pfizer Inc.	27 Sep 2021
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Canada	Pfizer Inc.	27 Sep 2021
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Czechia	Pfizer Inc.	27 Sep 2021
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Finland	Pfizer Inc.	27 Sep 2021
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	France	Pfizer Inc.	27 Sep 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02194842 (PEACE-3 \| EORTC1333, ASCO_GU2026 \| BusinessWire) Manual	Phase 3	Metastatic castration-resistant prostate cancer	446	Enzalutamide + Radium-223	cxprljvzkg(cwocrevpoy) = gawrttcsio lpgkkqffko (edmiqxxwwe ) View more	Positive	26 Feb 2026
				Enzalutamide	cxprljvzkg(cwocrevpoy) = yzxdakljmd lpgkkqffko (edmiqxxwwe ) View more
NCT02286921 (TRANSFORMER, ASCO_GU2026)	Phase 3	Metastatic castration-resistant prostate cancer	157	Enzalutamide	mizsseoqbp(whkyouuxeg) = ehinwmzaur jxlsunepml (lubymlkpps ) View more	Negative	26 Feb 2026
				Bipolar Androgen Therapy (BAT)	mizsseoqbp(whkyouuxeg) = dgjwoeqolr jxlsunepml (lubymlkpps ) View more
NCT06096870 (ASCO_GU2026)	Phase 2	Non-metastatic prostate cancer	50	Enzalutamide	weywhmsrro(ulbhhwjlhf) = myzstfbpva nudbgnymly (apbnljgabn, -81 to -100) View more	Positive	26 Feb 2026
ASCO_GU2026	Not Applicable	Metastatic Castration-Sensitive Prostate Carcinoma FOXA1 \| DUOXA1 \| BIRC5	76	ADT plus enzalutamide	jpsvfeqjti(vaktinagag) = cfohlrlfyj ytsshwukra (heohcdmckq )	Positive	26 Feb 2026
NCT03809000 (RTOG 3506 (STEEL), ASCO_GU2026)	Phase 2	Prostatic Cancer	188	LHRH analog + Enzalutamide 160 mg	tlcivprncj(qwqxyybkul): HR = 0.62 (80.0% CI, 0.42 - 0.91), P-Value = 0.052	Positive	26 Feb 2026
				LHRH analog
NCT02319837 (EMBARK, ASCO_GU2026)	Phase 3	-	1,061	Enzalutamide + Leuprolide	sppwjyfarv(uyylsfqgaw) = bclmyllhem pryokpmgxw (suqmwwirup ) View more	Positive	26 Feb 2026
				Leuprolide	sppwjyfarv(uyylsfqgaw) = ptdpeuzhks pryokpmgxw (suqmwwirup ) View more
ASCO_GU2026	Not Applicable	Prostatic Cancer	195	Abiraterone acetate	hymsbtckhr(htvjyfgqcr) = ktbxalnuyk msgadmhzcq (jnluneklcc ) View more	Negative	26 Feb 2026
				Apalutamide	hymsbtckhr(htvjyfgqcr) = rimwhbpsjx msgadmhzcq (jnluneklcc ) View more
ASCO_GU2026	Not Applicable	Metastatic Castration-Sensitive Prostate Carcinoma First line	1,274	Enzalutamide	pbnbznjmsq(ujtriescfn) = wyoilxolii kmidmmcmuy (rzrtkvgmws, NE - NE) View more	Positive	26 Feb 2026
				Apalutamide	pbnbznjmsq(ujtriescfn) = rgloeqlrom kmidmmcmuy (rzrtkvgmws, NE - NE) View more
NCT05726292 (ASCO_GU2026)	Phase 2	Localized Prostate Carcinoma Neoadjuvant	90	LHRH agonist/antagonist + Enzalutamide + Relacorilant	ajausrexpg(gannlugdca): P-Value = 0.15 View more	Positive	26 Feb 2026
				LHRH agonist/antagonist + Enzalutamide + Placebo
ASCO_GU2026	Not Applicable	Metastatic Prostate Carcinoma	344	Enzalutamide (Charlson Comorbidity Index ≥3)	qgxfwjbyfv(lkqxdbvpld) = roofodluyd ibjnfmmjjo (sdqnplfucz, 25.9 - 55.1) View more	Positive	26 Feb 2026
				Abiraterone (Charlson Comorbidity Index ≥3)	qgxfwjbyfv(vwxcwrrkhb) = pyjlwgtcbf lqmunwbdtz (ljiaisvwfp )

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Approval

Accelerate your research with the latest regulatory approval information.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis