A Randomized, Double-Blind, Placebo-Controlled, 2-Cohort, Phase III Study of Saruparib Combined With Physician's Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone-Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA-directed 177Lutetium-Containing Therapy Without Disease Progression, and With Prostate-Specific Antigen ≥ 0.2 ng/mL: EvoPAR-Prostate05

The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received docetaxel chemotherapy or a prostate-specific membrane antigen (PSMA)-directed lutetium-177 radioligand therapy with no evidence of disease progression and PSA ≥ 0.2 ng/mL.

Start Date01 Oct 2026

Sponsor / Collaborator

AstraZeneca PLC

NCT07592910

/ Not yet recruitingPhase 2

A Phase 2, Open-label, Single-Arm Study of Mevrometostat Plus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer Following Prior Androgen Receptor Pathway Inhibitor Therapy (MOMENT)

The purpose of this study is to find out whether mevrometostat in combination with enzalutamide delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have previously received enzalutamide, darolutamide, or apalutamide in the metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic castration-resistant prostate cancer (nmCRPC) setting but have not previously progressed on abiraterone.

Start Date01 Aug 2026

Sponsor / Collaborator

The Prostate Cancer Clinical Trials Consortium LLC

[+3]

NCT07683013

/ Not yet recruitingPhase 1

An Open-Label, Dose-Escalation, Multicenter Phase 1 Study to Evaluate the Safety, Tolerability, and Efficacy of CP-PCA07 in Combination With Enzalutamide in Patients With Castration-Resistant Prostate Cancer

The purpose of this clinical study is to evaluate the safety, tolerability, and efficacy of CP-PCA07 in combination with enzalutamide in patients with castration-resistant prostate cancer (CRPC).
This is an open-label, dose-escalation, multicenter Phase 1 study. The primary objective is to assess the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) to determine the recommended Phase 2 dose (RP2D) of the combination therapy.
The secondary objective is to assess changes in Prostate-Specific Antigen (PSA) levels and pharmacokinetic characteristics.
Exploratory objectives include assessment of tumor response, disease control, progression-free survival, and biomarker analyses, including AR-V7 status, according to RECIST version 1.1 and other applicable criteria.

Start Date01 Jul 2026

Sponsor / Collaborator

HYUNDAI BIOSCIENCE Co., Ltd.

100 Clinical Results associated with Enzalutamide

100 Translational Medicine associated with Enzalutamide

100 Patents (Medical) associated with Enzalutamide

4,292

Literatures (Medical) associated with Enzalutamide

01 Oct 2026·CELLULAR SIGNALLING

NUSAP1 mediates enzalutamide resistance in prostate cancer via Wnt/β-catenin signalling–dependent regulation of AR and AR-V7

Article

Author: Li, Jiaxin ; Zhao, Ruining ; Wang, Ning ; Jia, Yaodong ; Yang, Xiaobao ; Jiang, Congrong ; Li, Yajie ; Nie, Lihong ; Wang, Libin

BACKGROUND:

Castration-resistant prostate cancer (CRPC) demonstrates significant resistance to androgen deprivation therapy (ADT), presenting a substantial therapeutic challenge. Although the reactivation of androgen receptor (AR) signalling is a key driver of this resistance, the specific regulatory mechanisms involved remain unclear. Nucleolar and spindle-associated protein 1 (NUSAP1) is overexpressed in various malignancies; however, its function in mediating resistance to enzalutamide (ENZ) has yet to be elucidated. This study aims to clarify the influence of NUSAP1 on ENZ resistance in prostate cancer.

METHODS:

Bioinformatics analyses were conducted on three GEO datasets (GSE3325, GSE27616, and GSE35988) to identify potential genes linked to metastatic CRPC. Subsequent functional experiments, such as CCK-8, colony formation, Wound-healing, and Transwell assays, were carried out to assess the impact of knockdown NUSAP1 on proliferation, migration, and invasion in ENZ-resistant prostate cancer cells (MDVR and 22Rv1). Western blot and RT-qPCR analyses were employed to explore underlying molecular mechanisms. Pharmacological interventions and rescue experiments utilizing R1881, Laduviglusib, and DK419 were executed to investigate pathway interactions. Additionally, a xenograft mouse model was established to validate the observed in vivo effects.

RESULTS:

Bioinformatics analysis revealed NUSAP1 as a pivotal prognostic gene significantly linked to overall survival (OS, P = 0.02) and disease-free survival (DFS, P = 0.0018) in prostate cancer. Elevated NUSAP1 expression was observed in ENZ-resistant prostate cancer cells. Knockdown of NUSAP1 markedly impeded cell proliferation, migration, and invasion, while increasing the cells' sensitivity to ENZ both in vitro and in vivo. Subsequent investigations illustrated that NUSAP1 promotes β-Catenin translocation to the nucleus and increased Wnt/β-Catenin signalling activity, and then amplifies downstream AR signalling.

CONCLUSIONS:

The results indicate that NUSAP1 enhanced prostate cancer ENZ resistance through activation of the Wnt/β-Catenin-AR/AR-V7 signalling pathway. Targeting NUSAP1 could offer a potential therapeutic approach to address ENZ resistance in CRPC.

01 Aug 2026·JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Exposure-safety analyses of talazoparib in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) in the TALAPRO-2 trial

Article

Author: Lincha, Victor Ruberio ; Hoffman, Justin ; Matsubara, Nobuaki ; DeAnnuntis, Liza ; Azad, Arun A ; Wang, Diane D ; Zohren, Fabian ; Hadigol, Mark ; Agarwal, Neeraj ; Wang, Yibo

The TALAPRO-2 trial (NCT03395197) showed that the addition of talazoparib, a potent PARP inhibitor, to enzalutamide significantly improved radiographic progression-free survival in patients with mCRPC. Due to adverse events (AEs), approximately 62% of patients experienced dose interruption and 53% of patients experienced dose reduction of talazoparib in TALAPRO-2 trial. Hematologic AEs such as anemia, thrombocytopenia, and neutropenia were the most common AEs leading to dose interruptions or reductions. We investigated the relationship between talazoparib exposure as well as baseline patients/disease characteristics and Grade ≥ 3 anemia, thrombocytopenia, and neutropenia using graphical examination and Cox proportional hazard models. The results indicated that higher talazoparib exposure, C_{avg, t}, was associated with a higher risk of Grade ≥ 3 anemia, thrombocytopenia, and neutropenia. Additionally, among the other baseline factors, we observed that higher risk of all tested safety endpoints was associated with lower baseline hemoglobin. In addition, higher risk of anemia was associated with lower baseline body weight and higher baseline lactate dehydrogenase. Higher risk of neutropenia was associated with lower baseline absolute neutrophil count and lower baseline body weight. These findings support the proposed dose modification algorithm as an effective approach for management of AEs.

01 Aug 2026·JOURNAL OF CHROMATOGRAPHY A

Efficient extraction of fluorinated non-steroidal androgen receptor antagonists on a novel trifluoromethyl functionalized magnetic microporous organic network

Article

Author: Kang, Jia-Mei ; Liu, Can ; Cui, Yuan-Yuan ; Yang, Cheng-Xiong

Given the widespread clinical use, environmental persistence, and potential ecological and health risks of non-steroidal androgen receptor antagonists (NSAAs), developing a highly selective and sensitive method to detect their residues in aquatic environments is of significant importance and poses considerable challenges. Based on the hydrophobicity and fluorine-containing characteristics of NSAAs, this study designed and prepared a novel trifluoromethyl functionalized magnetic microporous organic network (MMON-CF₃) for the efficient and selective magnetic solid-phase extraction (MSPE) of three typical NSAAs, namely flutamide, bicalutamide, and enzalutamide, from environmental water samples before HPLC-UV quantification. The as-prepared MMON-CF₃ features a uniform core-shell structure, high specific surface area, good hydrophobicity, and superparamagnetism. These characteristics endow the material with outstanding extraction capability and selectivity toward the target NSAAs, driven by distinctive F-F contacts, hydrogen-bonding interactions, hydrophobic adsorption, and π-π conjugation. Under optimum extraction parameters, the developed MMON-CF₃-MSPE-HPLC-UV method demonstrated satisfactory analytical performance for the three analytes, including low limits of detection (0.1-0.2 μg L^-1), a broad linear range (0.5-1000 μg L^-1), high enrichment factors (91.2-95.6), minimal adsorbent dosage (3 mg), and fast extraction equilibrium (6 min). The present work underscores the promising application potential of fluorinated MON-based materials in the sample pretreatment of fluorinated pharmaceutical contaminants from complicated environmental matrices.

800

News (Medical) associated with Enzalutamide

28 Jul 2026

·www.businesswire.com

Shionogi Announces U.S. Availability of XOCOVA ® (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure*

FLORHAM PARK, N.J.--(BUSINESS WIRE)--Shionogi Inc., a New Jersey-based subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced U.S. availability of XOCOVA® (ensitrelvir), an oral antiviral, approved for post-exposure prophylaxis (PEP) of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19.2 XOCOVA offers a new approach to help prevent COVID-19 by blocking viral replication during the critical window between exposure and COVID-19 symptom onset.4,5 XOCOVA is taken once daily, with three 125 mg tablets (375 mg) taken at the same time on the first day, followed by one 125 mg tablet on days two through five. XOCOVA should be taken as soon as possible and within 72 hours following contact with an individual who has COVID‑19.1 “With XOCOVA, we have a novel oral option to help prevent COVID-19 after exposure, and it is available just in time for the annual late summer spike,” said Charles Vega, MD, FAAFP, Health Sciences Clinical Professor, University of California, Irvine, School of Medicine. “Taking XOCOVA to help prevent COVID-19 in the critical window between exposure and symptom onset makes sense for anyone who wants to try to avoid illness, and it could be especially beneficial for older adults and individuals with health conditions that may put them at higher risk for severe illness. Now, in addition to recommending my patients stay updated with vaccinations, I’ll be talking to them about XOCOVA, so they are ready to act quickly in the event of an exposure.” The U.S. has experienced a COVID-19 summer spike every year since 2020.3 Biobot Analytics, a wastewater intelligence company with continuous and longitudinal data on pathogens from wastewater, reports that SARS-CoV-2 levels are beginning to rise, providing an early, population-level signal that another COVID-19 summer wave may be taking shape.6 Scenario modeling from The U.S. Centers for Disease Control and Prevention indicates there may be increased COVID-19 activity in regions (South and West) which did not experience a substantial level of COVID-19 activity during the most recent fall and winter months.3 “Post-exposure prophylaxis, or PEP for short, has been used successfully with influenza as well as HIV and other sexually transmitted infections, and it has the potential to help reduce the burden of COVID-19,” said David Wohl, MD, Professor of Medicine, The University of North Carolina at Chapel Hill, School of Medicine. “The availability of XOCOVA means that now, for the first time, there’s an oral option that can help prevent COVID-19 after exposure. Since XOCOVA must be taken within 72 hours of exposure, having it on hand can help ensure it is taken within the critical window between exposure and COVID-19 symptom onset.” Having XOCOVA on hand can help appropriate patients be prepared in the event of a COVID-19 exposure. Before taking XOCOVA, individuals should review the dosing and administration instructions and check the expiration date on the blister pack. They should also speak with a healthcare professional if there are any changes to their medications (including prescription and over-the-counter medicines), vitamins or supplements and verify they are not pregnant or breastfeeding. Shionogi is supporting the availability of XOCOVA through professional and consumer education and partnerships with national and regional pharmacies to ensure product availability. Select retail pharmacies across the U.S. will have XOCOVA in stock, and all retail pharmacies can order it from Shionogi’s wholesale distribution partners. Shionogi has a commercial co-pay offer for XOCOVA that helps eligible, commercially insured patients with out-of-pocket costs. Eligible patients may pay as little as $0 per prescription fill. Details about eligibility are available at https://www.xocova.com/. All components of XOCOVA are produced in the U.S. including active pharmaceutical ingredient production, drug product formulation, packaging, quality control, release testing, and supply chain and distribution. The Ongoing Impact of COVID-19 COVID-19 remains highly transmissible, driven by Omicron and its subvariants, and up to 47% of people living with an infected individual may develop COVID-19.7 The U.S. Centers for Disease Control and Prevention estimates that between October 1, 2025, and July 11, 2026, there were 4.2-12.7 million new cases in the U.S., resulting in 840,000 – 2.3 million outpatient visits, 130,000 – 250,000 hospitalizations and 14,000 - 42,000 deaths.8 Beyond acute infection, COVID-19 can have lasting impacts. People diagnosed with COVID-19 had increased rates of both new and worsening neurologic, cardiovascular, respiratory, and chronic kidney conditions during the year following infection.9-,10,11,12,13,14,15,16,17,18 COVID-19 also disproportionately affects older adults with greater risk for severe illness and death in close-community settings, such as long-term care facilities.19 About SCORPIO-PEP The global, double-blind, randomized, placebo-controlled Phase 3 study, SCORPIO-PEP, assessed the safety and efficacy of XOCOVA as post-exposure prophylaxis for COVID-19. The study was conducted from June 2023–September 2024. It included 2,387 study participants aged 12 years and older with a negative local screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment, who were exposed to a person living in their household with symptomatic COVID-19. The primary analysis included 2,041 household contact participants with a central laboratory-confirmed negative SARS-CoV-2 test at baseline. More than 98% of household contacts tested positive for antibodies against SARS-CoV-2 N (nucleocapsid) or S (spike) proteins, indicating that nearly all had evidence of previous SARS-CoV-2 infection or vaccination, or both.20 Study participants were randomly assigned at a 1:1 ratio to receive XOCOVA (375 mg on Day 1 and 125 mg on Days 2-5) or placebo, once daily, and began treatment within 72 hours of when the household member with COVID-19 began showing symptoms. Participants then continued XOCOVA (125 mg) or placebo for five days. In the primary analysis population, XOCOVA significantly reduced the risk of symptomatic COVID-19 by 67% in individuals following exposure to an infected individual through Day 10 compared with placebo (ensitrelvir n=1,030; placebo n=1,011).2 The most common adverse events (regardless of causality) occurring in greater than or equal to 1% of the XOCOVA group and at a greater frequency compared to placebo were headache, diarrhea, and cough.1 There were no reports of altered taste (dysgeusia) attributed to XOCOVA in the trial.2,20 Results from the SCORPIO-PEP trial were published in the New England Journal of Medicine on May 14, 2026. SCORPIO-PEP is the first and only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing COVID-19 following exposure to an infected individual. About XOCOVA XOCOVA® (ensitrelvir) is a SARS-CoV-2 main protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called the main protease, which is essential for the replication of the virus. XOCOVA suppresses the replication of SARS-CoV-2 by selectively inhibiting the main protease. XOCOVA is approved in the U.S. and Japan for post-exposure prophylaxis of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. XOCOVA received emergency regulatory approval in Japan in November 2022 and full approval in March 2024 for the treatment of COVID-19 in adults and adolescents 12 years of age and older based on results from SCORPIO-SR, a Phase 3 study conducted in Asia during the Omicron-dominant phase of the pandemic. Results from this study were published in JAMA Network Open. XOCOVA received supplemental approval in June 2026 in Japan for pediatric patients aged 6 to under 12 years who weigh at least 20 kg for the treatment of COVID-19. XOCOVA is not approved for the treatment of COVID-19 in the U.S. INDICATION XOCOVA (ensitrelvir) is a prescription medicine used to help prevent coronavirus disease 2019 (COVID-19) in adults and children aged 12 years and older following contact with a person who has COVID-19 (post-exposure prophylaxis). It is not known if XOCOVA is safe and effective in children under age 12. IMPORTANT SAFETY INFORMATION Do not take XOCOVA if you are: allergic to ensitrelvir or any of the ingredients in XOCOVA. take any of the following medicines, as these may interact with XOCOVA and may cause severe or life-threatening side effects or death: apalutamide, carbamazepine, colchicine, dihydroergotamine, enzalutamide, eplerenone, ergotamine, finerenone, ivabradine, lomitapide, lumacaftor/ivacaftor, lurasidone, methylergonovine, phenytoin, pimozide, quinidine, rifampin, St. John’s wort, simvastatin, triazolam or voclosporin. These are not the only medicines that may cause serious or life-threatening side effects if taken with XOCOVA. XOCOVA may increase or decrease the levels of many medicines in your body. Tell your healthcare provider (HCP) about all the medicines you take because additional laboratory tests or dose changes of your other medicines may be necessary during XOCOVA use. Your HCP may tell you about specific symptoms to watch for that may indicate you need to stop or decrease the dose of some of your other medicines. Before taking XOCOVA, tell your HCP about all your medical conditions, including if you: are pregnant or plan to become pregnant. XOCOVA may harm your unborn baby. For females who are able to become pregnant, your HCP will check with you to see if you are pregnant before starting XOCOVA. Use effective birth control (contraception) during XOCOVA use and for 2 weeks after the final dose. Tell your HCP right away if you become pregnant or think you may be pregnant during XOCOVA use. are breastfeeding or plan to breastfeed. It is not known if XOCOVA passes into your breast milk. Do not breastfeed during XOCOVA use and for 2 weeks after the final dose. Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your HCP can tell you if it is safe to take XOCOVA with other medicines. Do not start a new medicine without telling your HCP. What are the possible side effects of XOCOVA? XOCOVA may cause serious side effects, including: Allergic reactions, including severe allergic reactions (anaphylaxis). Stop taking XOCOVA and get medical help right away if you get any of the following allergic reaction symptoms: skin rash; hives; itching; swelling of the mouth, lips, tongue, or face; trouble swallowing or breathing; throat tightness; dizziness or feeling lightheaded; stomach-area (abdomen) pain; or vomiting. The most common side effects of XOCOVA include: headache, diarrhea, and cough. These are not all possible side effects of XOCOVA. For more info, ask your HCP or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Patient Information, for XOCOVA. About Shionogi Inc. Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global research‑driven pharmaceutical company committed to bringing to market the best possible medicines to aid the health and well-being of the patients we serve. Our global expertise in infectious disease began in the 1950s and in addition to discovering and developing multiple innovative antibiotics, today our global portfolio includes an antibiotic for the treatment of serious Gram‑negative bacterial infections, antivirals for COVID-19, HIV and influenza and a therapeutic for rare fungal infections. Our U.S. infectious disease franchise includes both approved and investigational novel anti-infectives, and investigational antivirals for COVID-19 and RSV. In parallel, we are advancing a U.S. rare disease franchise that includes an approved therapy for amyotrophic lateral sclerosis (ALS), along with clinical programs in Fragile X syndrome, Jordan’s syndrome, and Pompe disease. We are also pursuing research in additional high‑unmet need therapeutic areas, including oncology, acute ischemic stroke, sleep apnea, and other quality of life areas. Learn more at shionogi.com. About Shionogi & Co., Ltd. Shionogi & Co., Ltd. is a 148-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders and cardiovascular diseases. Shionogi’s research and development currently targets two therapeutic areas: infectious diseases and diseases with unmet medical needs in pain/CNS, including Alzheimer’s disease, oncology, rare diseases, and sleep apnea. For more information on Shionogi & Co., Ltd., please visit https://www.shionogi.com/global/en. Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. *Literature search conducted in May 2026 1 XOCOVA (ensitrelvir) Prescribing Information. Available from: https://www.shionogi.com/content/dam/shionogi/si/products/pdf/xocova.pdf. Accessed July 6, 2026. 2 Hayden FG, Shinkai M, et al. Ensitrelvir for COVID-19 postexposure prophylaxis in household contacts. N Engl J Med. 2026;394(19):1905-1915. doi:10.1056/NEJMoa2509306. 3 Centers for Disease Control and Prevention [Internet]. 2026 COVID-19 Summer Outlook. 2026. Available from: https://www-cdc-gov.libproxy1.nus.edu.sg/cfa-qualitative-assessments/php/data-research/2026covid-19outlook.html 4 Kawashima S, Matsui Y, et al. Ensitrelvir is effective against SARS-CoV-2 3CL protease mutants circulating globally. Biochem Biophys Res Commun. 2023;645:132-136. doi:10.1016/j.bbrc.2023.01.040. 5 Kuroda T, Nobori H, et al. Efficacy comparison of 3CL protease inhibitors ensitrelvir and nirmatrelvir against SARS-CoV-2 in vitro and in vivo. J Antimicrob Chemother. 2023;78(4):946-952. doi:10.1093/jac/dkad027. 6 Donnelly M [Internet]. Respiratory risk report: week ending in July 4, 2026. Biobot Analytics; 2026. Available from: https://biobotanalytics.substack.com/p/respiratory-risk-report-663 7 Tanaka M, Ruiz C, et al. SARS-CoV-2 transmission dynamics in households with children, Los Angeles, California. Front Pediatr. 2021;9:752993. doi:10.3389/fped.2021.752993. 8 Centers for Disease Control and Prevention [Internet]. Preliminary estimates of COVID-19 burden for 2024-2025. 2026. Available from: https://www-cdc-gov.libproxy1.nus.edu.sg/covid/php/surveillance/burden-estimates.html 9 Centers for Disease Control and Prevention [Internet]. Long COVID basics. 2026. Available from: https://www-cdc-gov.libproxy1.nus.edu.sg/long-covid/about/index.html. 10 Xie Y, Xu E, et al. Long-term cardiovascular outcomes of COVID-19. Nat Med. 2022;28(3):583-590. doi:10.1038/s41591-022-01689-3. 11 Xie Y, Xu E, et al. Risks of mental health outcomes in people with COVID-19: a cohort study. BMJ. 2022;376:e068993. doi:10.1136/bmj-2021-068993. 12 Srivastava S, Garg I. Post-COVID-19 infection: long-term effects on liver and kidneys. World J Meta-Anal. 2021;9(3):220-233. doi:10.13105/wjma.v9.i3.220. 13 Tenforde MW, Kim SS, et al. Symptom duration and risk factors for delayed return to usual health among outpatients with COVID-19 in a multistate health care systems network— United States, March-June 2020. MMWR Morb Mortal Wkly Rep. 2020;69(30):993-998. doi:10.15585/mmwr.mm6930e1. 14 Graham EL, Clark JR, et al. Persistent neurologic symptoms and cognitive dysfunction in non-hospitalized COVID-19 “long haulers.” Ann Clin Transl Neurol. 2021;8(5):1073-1085. doi:10.1002/acn3.51350. 15 Kwok WC, Chau CH, et al. Outcomes among patients with chronic obstructive pulmonary disease after recovery from COVID-19 infection of different severity. Sci Rep. 2024;14(1):13881. doi:10.1038/s41598-024-64670-9. 16 Conway SE, Healy BC, et al. COVID-19 severity is associated with worsened neurological outcomes in multiple sclerosis and related disorders. Mult Scler Relat Disord. 2022;63:103946. doi:10.1016/j.msard.2022.103946. 17 Chen IW, Chang LC, et al. Association between COVID-19 and the development of chronic kidney disease in patients without initial acute kidney injury. Sci Rep. 2025;15(1):10924. doi:10.1038/s41598-025-96032-4. 18 Sax PE, Draica F, et al. New onset conditions, exacerbations and worsening of underlying conditions following COVID-19 infection [poster presentation]. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI); 2026; Denver, CO, United States. 19 Gravenstein S, Cooke C, et al. Current impact of COVID-19 in long-term care facilities in the United States: a systematic literature review [poster presentation]. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI); 2026; Denver, CO, United States. 20 Hayden FG, Shinkai M, et al. Ensitrelvir for COVID-19 postexposure prophylaxis in household contacts. Supplementary Appendix. N Engl J Med. 2026;394(19). Available from: https://www-nejm-org.libproxy1.nus.edu.sg/doi/suppl/10.1056/NEJMoa2509306/suppl_file/nejmoa2509306_appendix.pdf.

Phase 3Clinical ResultDrug Approval

28 Jul 2026

·www.prnewswire.com

Galmed Announces Breakthrough Development of Dispersible Film Delivery (ODF), Brain Penetrating formulation of its SCD1 inhibitor Aramchol for Parkinson's Disease, Targeting $6 Billion Market

Aramchol meglumine is the only SCD1 inhibitor with an established clinical safety profile and confirmed blood-brain barrier (BBB) penetration. In order to improve patient convenience and long-term treatment adherence by Parkinson patients affected by dysphagia, an ODF formulation was developed demonstrating ~150% higher systemic bioavailability and ~300% significant increase in CNS exposure than conventional oral administration. Aramchol's ODF is characterized by rapid buccal and sublingual absorption and reduced first-pass hepatic metabolism, designed to maximize drug exposure within the brain. Galmed believes that the development of a clinically characterized SCD1 inhibitor with a CNS-optimized drug delivery formulation represents a differentiated strategy in a therapeutic area where disease-modifying treatment options remain limited, positioning Aramchol's PD program as an ideal out-licensing candidate. RAMAT-GAN, Israel, July 28, 2026 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on liver, cardiometabolic and oncology diseases, today announced continued advancement of Aramchol as a potential disease-modifying therapy for Parkinson's disease (PD), reporting significant progress in development of new Aramchol orally dispersible film (ODF) formulation. The data demonstrate ~150% higher systemic bioavailability and ~300% significant increase in CNS exposure than conventional oral administration. In addition to enhancing CNS drug delivery, Aramchol's proprietary ODF formulation directly addresses one of the most common clinical challenges in Parkinson's disease (PD). Up to 80% of patients develop dysphagia during disease progression, making conventional tablets and liquid formulations increasingly difficult to swallow and contributing to poor treatment adherence. Aramchol's rapidly dissolving ODF formulation dissolves within seconds without water, eliminates the need to swallow conventional tablets or liquids, thus simplifying administration and possibly improving long-term treatment adherence. The inhibition of stearoyl-CoA desaturase 1 (SCD1) is a novel disease approach in Parkinson's Disease, that targets the cause of neurodegeneration. Growing evidence identifies SCD1 as a central regulator of lipid metabolism that contributes to α-synuclein aggregation, Lewy body formation, and neuronal dysfunction. Unlike currently approved therapies that primarily improve motor symptoms through dopaminergic replacement, Aramchol targets SCD1-related biological mechanisms associated with disease progression. As previously reported, Galmed's in-vitro data demonstrated that Aramchol dose-dependently down-regulated αSyn aggregation as well as indicating that the effect was not associated with toxicity. Galmed's ODF formulation of Aramchol represents a dual innovation: a mechanism-based approach to slowing disease progression combined with patient-friendly drug delivery that addresses dysphagia affecting Parkinson's patients. Allen Baharaff, Galmed's Co-founder and CEO, commented: "We believe that combining enhanced CNS exposure to SCD1 inhibition with convenient administration creates an important competitive advantage of Aramchol ODF formulation over conventional therapies. In our view, Aramchol's potential for the treatment of PD combines several characteristics that are unique: A well-characterized mechanism of action through SCD1 inhibition, extensive human clinical experience from previous studies with an established safety and tolerability profile, demonstrated preclinical brain penetration, and proprietary ODF technology that significantly enhances CNS drug exposure. These attributes support our belief that this positions Aramchol's program for PD as an ideal candidate for co-development and out-licensing to capture significant value within the $6+ billion global Parkinson's therapeutics market, where disease-modifying options remain critically needed." About Galmed Pharmaceuticals Ltd.: Galmed Pharmaceuticals Ltd. is a biopharmaceutical and medical device company focused on developing innovative solutions for gastrointestinal, cardiometabolic and oncology indications. The Company is advancing Aramchol and related product candidates for GI oncology and other potential indications, while also exploring novel targeted delivery technologies and therapeutic approaches for cardiometabolic diseases. In addition, through its wholly owned subsidiary, Colospan Ltd., the Company is developing and commercializing CG-100, a medical device designed to address complications associated with colorectal surgery. Galmed's strategy is to build a diversified platform that leverages its expertise in drug development, medical devices and gastrointestinal disease to address significant unmet medical needs. Forward-Looking Statements: Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to the potential of of Aramchol in combination enzalutamide and docetaxel to treat prostrate cancer . Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, our inability to recognize the anticipated benefits of the acquisition of Colospan; expectations with respect to future performance and growth of Colospan; the development and approval of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of CG-100, Aramchol or any other medical device or product candidate we develop; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to CG-100, Aramchol or any other medical device or product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of CG-100, Aramchol and any future medical devices or product candidates; our ability to comply with all applicable post-market regulatory requirements for CG-100, Aramchol, or any other medical device or product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for CG-100, Aramchol, or any medical device or other product candidate; third-party payor reimbursement for CG-100, Aramchol, or any other medical device or product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of CG-100 Aramchol or any other medical device or product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of CG-100, Aramchol or any other medical device or product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our CG-100 or product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; our expectations regarding licensing, acquisitions and strategic operations; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; and the security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on March 31, 2026 in greater detail under the heading "Risk Factors." Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties. SOURCE Galmed Pharmaceuticals Ltd. 21% more press release views with Request a Demo

23 Jul 2026

·www.pharmaindustrial-india.com

FDA Grants Priority Review to Pfizer's Talzenna-Xtandi Combination Advanced Prostate Cancer

Pfizer Inc. has announced that the US Food and Drug Administration (FDA) has accepted for Priority Review its supplemental New Drug Application (sNDA) for Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for the treatment of men with homologous recombination repair (HRR) gene-altered metastatic Castration-Sensitive Prostate Cancer (mCSPC), also known as metastatic Hormone-Sensitive Prostate Cancer (mHSPC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date in the last quarter of 2026. If approved, the expanded indication would allow the Talzenna-Xtandi combination to be used at an earlier stage of metastatic prostate cancer. The therapy is currently approved in the US for patients with HRR gene-mutated mCRPC. The regulatory submission is supported by findings from the Phase 3 TALAPRO-3 clinical trial, which demonstrated that Talzenna plus Xtandi reduced the risk of radiographic disease progression or death by 52 percent compared with placebo plus Xtandi. The study also reported consistent clinical benefit across patients with both BRCA and non-BRCA HRR gene alterations, while maintaining a safety profile consistent with the known characteristics of each therapy and identifying no new safety concerns. Commenting on the development, Jeff Legos, Chief Oncology Officer at Pfizer, said that treating patients during the hormone-sensitive stage provides an important opportunity to delay disease progression. He added that, if approved, the combination could offer patients with HRR-driven metastatic prostate cancer a new treatment option while highlighting the growing importance of biomarker testing to guide treatment decisions earlier in the disease course. The TALAPRO-3 results were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine. The study enrolled 599 patients across North America, Europe, South America and the Asia-Pacific region, evaluating Talzenna in combination with Xtandi against placebo plus Xtandi in patients with HRR gene-altered mCSPC. In parallel with the US review, the indication expansion is also under evaluation by the European Medicines Agency (EMA). Talzenna plus Xtandi is currently approved for the treatment of HRR gene-mutated mCRPC in more than 60 countries, with approved indications varying by market. Talzenna is an oral PARP inhibitor designed to interfere with DNA damage repair mechanisms in cancer cells, while Xtandi is an androgen receptor pathway inhibitor widely used in the treatment of advanced prostate cancer. Together, the combination represents a precision medicine approach aimed at improving outcomes for patients with genetically defined forms of metastatic prostate cancer.

Clinical ResultPhase 3Drug ApprovalPriority ReviewASCO

100 Deals associated with Enzalutamide

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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
Advanced Triple-Negative Breast Carcinoma	Phase 3	United States	Astellas Pharma, Inc.	01 Sep 2016
Advanced Triple-Negative Breast Carcinoma	Phase 3	United States	MediVation, Inc.	01 Sep 2016
Advanced Triple-Negative Breast Carcinoma	Phase 3	United States	Pfizer Inc.	01 Sep 2016
Adenocarcinoma of prostate	Phase 3	United States	MediVation, Inc.	22 Jan 2014
Adenocarcinoma of prostate	Phase 3	United States	Astellas Pharma US, Inc.	22 Jan 2014
Adenocarcinoma of prostate	Phase 3	Canada	MediVation, Inc.	22 Jan 2014
Adenocarcinoma of prostate	Phase 3	Canada	Astellas Pharma US, Inc.	22 Jan 2014
Recurrent Prostate Carcinoma	Phase 3	United States	MediVation, Inc.	22 Jan 2014
Recurrent Prostate Carcinoma	Phase 3	United States	Astellas Pharma US, Inc.	22 Jan 2014
Recurrent Prostate Carcinoma	Phase 3	Canada	Astellas Pharma US, Inc.	22 Jan 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03336983 (BonEnza, Pubmed \| Bone)	Phase 2	Hormone-dependent prostate cancer	89	androgen deprivation therapy + enzalutamide + zoledronic acid	cclmkpllqo(xgmpuagqsi) = xnjqcdrfff ywmjziypxk (ocatneanyz ) View more	Positive	01 Aug 2026
				androgen deprivation therapy + enzalutamide	cclmkpllqo(xgmpuagqsi) = phqnrjzdqa ywmjziypxk (ocatneanyz ) View more
NCT02319837 (EMBARK, ASCO2026)	Phase 3	-	320	Enzalutamide + Leuprolide (high-risk biochemical recurrence prostate cancer)	yzahmdvddh(mquouyefas) = gokidprcps lugrjsjcqa (zpeidrfpjo ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Castration-Resistant Prostatic Cancer	198	Enzalutamide	hwhatkulfv(gsyotmhzgs): P-Value = 1.0 View more	Positive	29 May 2026
				Darolutamide
NCT04455750 (Alliance A031902, ASCO2026)	Phase 3	Metastatic castration-resistant prostate cancer First line	61	Enzalutamide plus rucaparib	rfrfcgvwgp(sdthtfrehj) = pxjlzdfckd inlcqqxjnv (aykvvdvowo ) View more	Negative	29 May 2026
				Enzalutamide plus placebo	xddboroelo(mxhykahkce) = nijuzxoczg btaqfauggg (ukjrgxtclt ) View more
ENZAMET (ASCO2026)	Phase 3	Hormone-dependent prostate cancer BRCA1 \| BRCA2	847	ADT + NSAA (BRCA-)	fmdwcbrqfi(ojgrwwpmsa) = tgxbferywh knnajlyucg (wzrjvbbkjc, 50.0 - 62.7) View more	Positive	29 May 2026
				ADT + NSAA (BRCA+)	fmdwcbrqfi(ojgrwwpmsa) = eapdsllnhu knnajlyucg (wzrjvbbkjc, 5.4 - 94.5) View more
NCT02677896 (ARCHES, ASCO2026)	Phase 3	Hormone-dependent prostate cancer	572	Enzalutamide + ADT (short treatment duration (0-2 years))	diascfvqqo(xodvsbtoal) = ujwjuetuyf ljttjwrbuk (oitzmqosbg ) View more	Positive	29 May 2026
				Enzalutamide + ADT (medium treatment duration (2-5 years))	diascfvqqo(xodvsbtoal) = eqfzmotomm ljttjwrbuk (oitzmqosbg ) View more
NCT02555189 (RiboX, ASCO2026)	Phase 1/2	Castration-Resistant Prostatic Cancer RB expression	46	Enzalutamide	qrkrlppeom(dsswzoioue) = gtmbmfaoms svwaarhlnn (wckkhhgbpv, 43 - 95) View more	Negative	29 May 2026
				Enzalutamide + Ribociclib	qrkrlppeom(dsswzoioue) = pvudbvrbbe svwaarhlnn (wckkhhgbpv, 65 - 93) View more
NCT01949337 (Alliance A031201, ASCO2026)	Phase 3	Metastatic castration-resistant prostate cancer First line	776	enzalutamide + abiraterone acetate + prednisone	brifjobrsd(whaxyvwfdh) = uthqklofol qiguwisbxb (oruwvdjifu ) View more	Positive	29 May 2026
				enzalutamide	brifjobrsd(whaxyvwfdh) = udqbxdjqpe qiguwisbxb (oruwvdjifu )
NCT06099769 (TBCRC 058, ASCO2026)	Phase 2	Breast Cancer androgen receptor-positive	32	Enzalutamide	wyladpcref(taxjvnekdo) = tiboigasmz ysghxvdnjv (fopukajvym, 2.7 - 4.9) View more	Positive	29 May 2026
				Carboplatin, Paclitaxel, Eribulin, or Capecitabine	nqtutsvwng(iopeiqgshr) = xprwnbmvls dytmobauiq (otzqehpvxi ) View more
NCT06629779 \| NCT06551324 (MEVPRO-1, Pubmed \| Future Oncol)	Phase 3	Metastatic Prostate Carcinoma	1,500	Mevrometostat + Enzalutamide	yzwzfuirnw(jttwmorxnn) = igpieiuusa isqejhullt (pccwgsabtr ) View more	Positive	15 May 2026
				Enzalutamide or Docetaxel (physician's choice)	kpeijjmmwv(uxcmmayvrc) = sgcgiclhpw gbdvyalhpu (adssbpuvum, 8.4 - 18.8) View more

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