A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Itraconazole on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants

Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer.
The purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to opevesostat in the body when it is given with and without another medicine called itraconazole.

Start Date11 May 2026

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT06979596

/ RecruitingPhase 2

A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)

Researchers want to learn if MK-5684 (the study medicine) can treat breast cancer, ovarian cancer, and endometrial cancer. MK-5684, the study medicine, is designed to treat cancer by blocking the body from making steroid hormones.
Researchers will compare MK-5684 to the standard treatments for each cancer type in this study.
The goal of this study is to learn if people who receive MK-5684 live longer without the cancer growing or spreading compared to people who receive a standard treatment.

Start Date11 Aug 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT06863272

/ RecruitingPhase 1/2

MK-2400-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)

The purpose of this substudy is to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd), given alone or with other treatments in participants with metastatic castration-resistant prostate cancer (mCRPC). The goals of this study are to learn about:
* The safety of the study treatment and if people tolerate it.
* A safe dose level of I-DXd that can be used with other treatments.
* Participant levels of prostate specific antigen (PSA) during treatment.

Start Date03 Jul 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

[+1]

100 Clinical Results associated with Opevesostat

100 Translational Medicine associated with Opevesostat

100 Patents (Medical) associated with Opevesostat

Literatures (Medical) associated with Opevesostat

01 Jun 2026·BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

Design, synthesis, and biological evaluation of cytochrome P450 CYP11A1 inhibitors

Article

Author: Tang, Chunlei ; Fan, Weizheng ; Li, Yuyang ; Cui, Shengkai ; Zhang, Yuao ; Wang, Dongyu ; Yuan, Jingyi ; Zhang, Yujie

This study addresses drug resistance in castration-resistant prostate cancer by developing novel inhibitors of CYP11A1, the key rate-limiting enzyme in androgen synthesis. Based on the clinical candidate Opevesostat, two series of 23 new compounds were designed and synthesized using a 4H-pyran-4-one core to explore structure-activity relationships at the C2 and C6 positions.Compound II-4 exhibited potent inhibitory activity (95.2% at 100 nM; IC₅₀ = 26.7 nM), comparable to Opevesostat (IC₅₀ = 20.4 nM). Importantly, II-4 showed superior selectivity against CYP1A2, 2C9, and 2D6 (2- to 4-fold improvement), attributed to hydrophobic interactions between its C6 methyl group and Ile 84.These results highlight II-4 as a promising lead compound with optimized activity and selectivity, providing valuable insights for overcoming resistance in prostate cancer therapy.

16 Mar 2026·Future Oncology

Steroidogenesis inhibitor opevesostat (MK-5684) for metastatic castration-resistant prostate cancer: OMAHA-003 and OMAHA-004 trial designs

Article

Author: Poehlein, Christian ; Yu, Evan Y. ; Antonarakis, Emmanuel S. ; Zhang, Alison Y. ; Todoric, Jelena ; Vile, Donald ; Lévesque, Eric ; Gratzke, Christian ; Chen, Zheng Hong ; Ortega, Francisco ; Fizazi, Karim ; Song, Yue ; Burotto, Mauricio ; Garratt, Chris ; Peer, Avivit ; Schloss, Charles

Treatment options for metastatic castration-resistant prostate cancer (mCRPC) include androgen receptor pathway inhibitors (ARPIs), taxanes, radium-223, Lu-PSMA, poly (ADP-ribose) polymerase inhibitors, and immunotherapy in select patients. Resistance to ARPIs and hormone-based therapies has been associated with AR-ligand-binding domain mutations that can lead to promiscuous stimulation by other steroid hormones. There is a need to explore alternative targets and develop next-generation ARPIs or combination therapies that overcome this resistance. We describe the rationale and design of the randomized phase III trials OMAHA-003 (NCT06136624) and OMAHA-004 (NCT06136650), which will evaluate the efficacy and safety of opevesostat, a steroidogenesis inhibitor, versus ARPI switch in previously treated mCRPC. Results may support opevesostat as a potential new treatment option for mCRPC.Clinical trial registration: www.clinicaltrials.gov identifiers are NCT06136624 and NCT06136650.

01 May 2024·Current opinion in oncology

Targeting androgen biosynthesis in prostate cancer: implications on endocrine physiology

Review

Author: Arif Hussain ; Rana Malek ; Heather Mannuel ; Ghazal Kango

Purpose of review:

Targeting specific steroidogenic enzymes is effective in decreasing testosterone synthesis, resulting in significant antitumor effects in prostate cancer. Such treatments result in disruptions of complicated and intertwining pathways with systemic physiologic consequences via effects on the adrenal gland and renin–angiotensin–aldosterone axis. This review highlights some of these aspects that need to be taken into consideration when treating patients with androgen biosynthesis inhibitors.

Recent findings:

Targeting CYP17A1, a key enzyme involved in androgen biosynthesis, is a well established treatment in prostate cancer. More recently, efforts are underway to target a gatekeeper enzyme of steroidogenesis, CYP11A1. This enzyme mediates conversion of cholesterol to pregnenolone, the first step in steroid hormone biogenesis. Studies are beginning to demonstrate antitumor effects of ODM-208, a CYP11A1 inhibitor in prostate cancer. Although anticipated to have a therapeutic role in prostate cancer, there are potential downstream effects of CYP11A1 targeting arising from suppression of the entire adrenal cortex, including long-term adrenal insufficiency and possibly cardiovascular dysregulation.

Summary:

Agents targeting androgen biosynthesis can have systemic implications. Balancing management of prostate cancer with better understanding of the mechanisms associated with potential side effects will allow for patients to obtain improved antitumor benefit while mitigating against treatment-associated adverse effects.

News (Medical) associated with Opevesostat

05 Jun 2025

·pipelinereview.com

Acerand Therapeutics Initiates First-in-Human Phase I Clinical Trial of ACE-232, a Novel CYP11A1 Inhibitor for Advanced Prostate Cancer

SHANGHAI, China & INDIANAPOLIS, IN, USA I June 04, 2025 I Acerand Therapeutics, a clinical-stage biotech company focusing on the discovery and development of innovative small-molecule therapies in oncology, today announced the dosing of the first patient in its first-in-human Phase I clinical trial (NCT06801236) of ACE-232, a novel oral inhibitor of CYP11A1. The trial is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC). This multicenter Phase I study is being conducted in both the United States and China. The study comprises two parts: a dose-escalation phase (Phase IA) and a dose-optimization phase (Phase IB). The primary objectives are to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), as well as preliminary clinical activity of ACE-232, and to determine the recommended Phase II dose (RP2D). Professor Emmanuel Antonarakis, Director of Genitourinary Oncology at Masonic Cancer Center, University of Minnesota, is serving as the global coordinating Principal Investigator for the study. “I would like to congratulate the Acerand team, the research staff, and the first patient for helping us to reach this important milestone,” says Dr. Antonarakis. Preclinical data demonstrated that ACE-232 possesses superior potency, efficacy, and pharmacokinetic properties (flat PK curve and long half-life profile) compared to other investigational CYP11A1 inhibitors, including MK-5684 (Opevesostat, formerly known as ODM-208). ACE-232 showed excellent tolerability in preclinical models, presenting a wide therapeutic window for clinical development. The initiation of this trial marks a significant milestone for Acerand, representing its first clinical study in the United States and highlighting its strategic commitment to the global development of innovative cancer therapies that address major unmet medical needs. About ACE-232 ACE-232 is a highly potent and selective small-molecule inhibitor of CYP11A1, a key adrenal enzyme involved in the first and rate-limiting step of steroid hormone biosynthesis. By targeting CYP11A1, ACE-232 aims to suppress the production of androgens and other steroid hormones, offering a novel therapeutic mechanism for the treatment of androgen-dependent (including enzalutamide or abiraterone-resistant) prostate cancer. About Acerand Therapeutics Acerand Therapeutics is a biotech company dedicated to discovering and developing novel small-molecule therapies for oncology and metabolic diseases. With research and development hubs in Shanghai, China, and Indianapolis, USA, ACE-232 leverages its proprietary innovation platform and operational efficiency to deliver a highly differentiated pipeline of drug candidates from discovery to clinical trials. http://acerand.com/ SOURCE: Acerand Therapeutics

Phase 1

21 May 2025

·www.globenewswire.com

Orion’s collaborator, MSD, expands clinical development program for opevesostat to women’s cancers

ORION CORPORATION INVESTOR NEWS 21 MAY 2025 at 07.30 EEST Orion’s collaborator, MSD, expands clinical development program for opevesostat to women’s cancers Orion’s collaborator, MSD, has expanded the development program for opevestostat (MK-5684) to now include women’s cancers. A new Phase 2 clinical trial evaluating the safety and efficacy of opevesostat for the treatment of breast, endometrial and ovarian cancers has been posted to ClinicalTrials.gov database. The study is not yet recruiting patients. Further information is available on ClinicalTrials.gov: A Study of MK-5684 in People With Certain Solid Tumors (study identifier: NCT06979596) MSD has global exclusive rights to opevesostat which is an oral, non-steroidal and selective inhibitor of CYP11A1 discovered and developed by Orion. MSD is currently evaluating opevesostat in several clinical trials, including two Phase 3 trials, for the treatment of metastatic castration-resistant prostate cancer. Contact person:Tuukka Hirvonen, Investor Relations, Orion Corporation tel. +358 10 426 2721 Publisher:Orion CorporationCommunicationsOrionintie 1A, FI-02200 Espoo, Finlandwww.orionpharma.com Orion is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. In 2024 Orion's net sales amounted to EUR 1,542 million and the company employed about 3,700 professionals worldwide, dedicated to building well-being. Orion's A and B shares are listed on Nasdaq Helsinki.

Phase 2Phase 3Clinical Trial Termination

10 Oct 2024

·www.prnewswire.com

Metastatic Castration-Resistant Prostate Cancer Clinical Trial Pipeline Appears Robust With 90+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Metastatic Castration-Resistant Prostate Cancer (mCRPC) refers to prostate cancer that has spread (metastasized) to other parts of the body and continues to progress despite treatments that lower testosterone levels (androgen deprivation therapy or ADT) major pharmaceutical companies are heavily investing in research and development of new treatments, including immunotherapy (e.g., sipuleucel-T) and targeted therapies, which are seen as the next frontier in treating mCRPC. The use of precision medicine to identify genetic profiles in patients has further expanded the potential for targeted treatment. LAS VEGAS , Oct. 10, 2024 /PRNewswire/ -- DelveInsight's ' Metastatic Castration-Resistant Prostate Cancer Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline mCRPC therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the mCRPC pipeline domain. Key Takeaways from the Metastatic Castration-Resistant Prostate Cancer Pipeline Report DelveInsight's mCRPC pipeline report depicts a robust space with 90+ active players working to develop 100+ pipeline therapies for mCRPC treatment. Key mCRPC companies such as Regeneron Pharmaceuticals, AstraZeneca, Hinova Pharmaceuticals, Zenith Epigenetic, Eli Lilly and Company, Astellas Pharma, Seagen, Pfizer, Progenics Pharmaceutical, Molecular Insight Pharmaceuticals, Bayer, Accutar Biotechnology Inc, Hinova Pharmaceuticals, Forma Therapeutics, Inc., HALDA THERAPEUTICS INC., Tavanta Therapeutics, Lantheus, Pfizer, AB Science, Syntrix Pharmaceuticals, Exelixis, Laekna Therapeutics Shanghai Co. Ltd., Cardiff Oncology, Ipsen, Norroy Bioscience, Astellas Pharma, Novartis, Johnson & Johnson, Tempest Therapeutics, and others are evaluating new mCRPC drugs to improve the treatment landscape. Promising mCRPC pipeline therapies such as REGN 4336, Capivasertib, Deutenzalutamide, ZEN003694, Abemaciclib, Enfortumab vedotin, Talazoparib, I-131-1095, Pelgifatamab corixetan, AC176, HP518, FT-7051, HLD-0915, TAVT-45, PNT2002, Mevrometostat, Masitinib, SX-682, XL092, LAE001, Onvansertib, Tazemetostat, 177Lu-NYM032, PRL-02, 225 Actinium PSMA 617, ARX51, TPST-1120, and others are under different phases of mCRPC clinical trials. In October 2024, Curium announced that it had entered into a strategic partnership with PDRadiopharma Inc, a wholly-owned subsidiary of PeptiDream, for the clinical development, regulatory filing, and commercialization in Japan of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T. The two agents 177Lu-PSMA-I&T and 64Cu-PSMA-I&T target prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells and are being investigated for prostate cancer treatment and diagnostics. In July 2024, the US FDA granted fast-track designation to the prostate-specific membrane antigen (PSMA)–targeted radiopharmaceutical 225Ac-FL-020 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). In July 2024, Merck and Orion Corporation announced the mutual exercise of option providing Merck global exclusive rights to Opevesostat, an investigational CYP11A1 inhibitor, for the treatment of Metastatic Castration-Resistant Prostate Cancer. In July 2024, the US FDA granted fast-track designation to the antibody-drug conjugate (ADC) BNT324/DB-1311 to potentially treat patients with unresectable advanced or metastatic castration-resistant prostate cancer (mCRPC) whose disease had progressed on or after standard systemic regimens. In July 2024, FutureChem announced that the FC-705 has received orphan drug designation from the Ministry of Food and Drug Safety (MFDS) for the treatment of prostate cancer. In June 2024, CAR T-Cell Therapy demonstrated promising results for mCRPC according to Phase I trial results. In January 2024, Lava Therapeutics announced that it has signed a clinical trial collaboration and supply agreement with Merck to evaluate its prostate cancer therapy LAVA-1207 as a combination treatment with MSD's Keytruda (pembrolizumab). In July 2024, Blue Earth Therapeutics announced the signing of a clinical research collaboration with University College London (UCL). The collaboration is centered on a Phase I/II trial designed to evaluate the safety, tolerability, radiation dosimetry, and antitumor activity of the 225Ac-rhPSMA-10.1 in men with metastatic castrate-resistant prostate cancer who have previously responded to lutetium 177 (177Lu)-PSMA therapy. Request a sample and discover the recent advances in mCRPC treatment drugs @ Metastatic Castration-Resistant Prostate Cancer Pipeline Report The mCRPC pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage mCRPC drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the mCRPC clinical trial landscape. Metastatic Castration-Resistant Prostate Cancer Overview Metastatic castration-resistant prostate cancer (mCRPC) is an advanced stage of prostate cancer that continues to grow and spread despite hormone therapy aimed at lowering testosterone levels. The term "metastatic" refers to cancer spreading to other parts of the body, such as the bones, lymph nodes, or distant organs, while "castration-resistant" indicates that the cancer no longer responds to treatments that reduce testosterone, a key driver of prostate cancer growth. mCRPC is typically more aggressive and challenging to treat than earlier stages of prostate cancer. The causes of mCRPC stem from genetic and environmental factors. Genetic mutations in the androgen receptor pathway can make cancer cells less dependent on testosterone, allowing them to thrive even under hormone-suppressing treatments. Environmental factors like diet, lifestyle, and exposure to certain chemicals may also contribute to the development and progression of prostate cancer. Symptoms of mCRPC often include pain in bones, fatigue, difficulty urinating, weight loss, and general weakness. As the cancer spreads, it can impair the function of other organs, depending on the site of metastasis. Diagnosis of mCRPC usually involves a combination of tests, including prostate-specific antigen (PSA) blood tests, imaging studies like CT scans, MRIs, or bone scans, and sometimes biopsies to confirm the spread and resistance to treatment. Treatment options for mCRPC are more complex and may include newer hormonal therapies (e.g., abiraterone, enzalutamide), chemotherapy (docetaxel or cabazitaxel), immunotherapy (e.g., sipuleucel-T), or targeted therapies such as PARP inhibitors. Bone-targeting therapies, radiation, and palliative care can also be used to manage symptoms and improve the quality of life. Treatment is typically tailored to the individual based on the extent of the disease and the patient health. Find out more about mCRPC treatment drugs @ Drugs for Metastatic Castration-Resistant Prostate Cancer Treatment A snapshot of the mCRPC Pipeline Drugs mentioned in the report: Learn more about the emerging mCRPC pipeline therapies @ Metastatic Castration-Resistant Prostate Cancer Clinical Trials Metastatic Castration-Resistant Prostate Cancer Therapeutics Assessment The mCRPC pipeline report proffers an integral view of the mCRPC emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Metastatic Castration-Resistant Prostate Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous Therapeutics Assessment By Molecule Type: Small molecule, Cell therapy, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Androgen receptor degradation enhancers, Antibody-dependent cell cytotoxicity, Proto-oncogene protein c-akt inhibitors, Androgen receptor antagonists, Bromodomain and extraterminal domain protein inhibitors, Cyclin-dependent kinase 4 inhibitors, Cyclin-dependent kinase 6 inhibitors, Ionizing radiation emitters, PPAR alpha antagonists. Key Metastatic Castration-Resistant Prostate Cancer Companies: Regeneron Pharmaceuticals, AstraZeneca, Hinova Pharmaceuticals, Zenith Epigenetic, Eli Lilly and Company, Astellas Pharma, Seagen, Pfizer, Progenics Pharmaceutical, Molecular Insight Pharmaceuticals, Bayer, Accutar Biotechnology Inc, Hinova Pharmaceuticals, Forma Therapeutics, Inc., HALDA THERAPEUTICS INC., Tavanta Therapeutics, Lantheus, Pfizer, AB Science, Syntrix Pharmaceuticals, Exelixis, Laekna Therapeutics Shanghai Co. Ltd., Cardiff Oncology, Ipsen, Norroy Bioscience, Astellas Pharma, Novartis, Johnson & Johnson, Tempest Therapeutics, and others. Key Metastatic Castration-Resistant Prostate Cancer Pipeline Therapies: REGN 4336, Capivasertib, Deutenzalutamide, ZEN003694, Abemaciclib, Enfortumab vedotin, Talazoparib, I-131-1095, Pelgifatamab corixetan, AC176, HP518, FT-7051, HLD-0915, TAVT-45, PNT2002, Mevrometostat, Masitinib, SX-682, XL092, LAE001, Onvansertib, Tazemetostat, 177Lu-NYM032, PRL-02, 225 Actinium PSMA 617, ARX51, TPST-1120, and others. Dive deep into rich insights for new drugs for mCRPC treatment, visit @ Metastatic Castration-Resistant Prostate Cancer Drugs Table of Contents For further information on the mCRPC Cancer pipeline therapeutics, reach out @ Metastatic Castration-Resistant Prostate Cancer Treatment Drugs Related Reports Metastatic Castration-Resistant Prostate Cancer Market Metastatic Castration-Resistant Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key mCRPC companies including AstraZeneca, Merck Sharp & Dohme, Hinova Pharmaceuticals, Pfizer, Astellas Pharma, Modra Pharmaceuticals, AB Science, Eli Lilly and Company, Zr Pharma & GmbH, Bristol-Myers Squibb, Ipsen, Exelixis, Takeda, Janssen Research & Development, Tesaro, Lantheus Holdings, Kintor Pharmaceutical, MacroGenics, Daiichi Sankyo, Madison Vaccines, Novartis, Point Biopharma, Xencor, Essa Pharma, Telix International, Bayer, Arvinas, among others. Metastatic Prostate Cancer Market Metastatic Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key metastatic prostate cancer companies including AstraZeneca, Arvinas, Madison Vaccines, Phosplatin Therapeutics, Hinova Pharmaceuticals, Bristol Myers Squibb, Merck, MacroGenics, Daiichi Sankyo, Seagen, Taiho Pharmaceutical, Modra Pharmaceuticals, Xencor, Point Biopharma, Lantheus Holdings, Zenith Epigenetics, Essa Pharma, Telix Pharmaceuticals, Kintor Pharmaceutical, AB Science, Eli Lilly and Company, Exelixis among others. Metastatic Castration-Sensitive Prostate Cancer Market Metastatic Castration-Sensitive Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key mCSPC companies including Myovant Sciences, Pfizer, Bayer, Orion, Novartis, AstraZeneca, Pfizer, Janssen, Merck, Eli Lilly, among others. Metastatic Castration-Sensitive Prostate Cancer Pipeline Metastatic Castration-Sensitive Prostate Cancer Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key mCSPC companies, including Myovant Sciences, Pfizer, Bayer, Orion, Novartis, AstraZeneca, Pfizer, Janssen, Merck, Eli Lilly, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Fast TrackImmunotherapyPhase 1Clinical Result

100 Deals associated with Opevesostat

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Prostate Carcinoma	Phase 3	United States	Merck Sharp & Dohme LLC	31 Dec 2023
Metastatic Prostate Carcinoma	Phase 3	Brazil	Merck Sharp & Dohme LLC	31 Dec 2023
Metastatic Prostate Carcinoma	Phase 3	Chile	Merck Sharp & Dohme LLC	31 Dec 2023
Metastatic Prostate Carcinoma	Phase 3	Taiwan Province	Merck Sharp & Dohme LLC	31 Dec 2023
Metastatic Prostate Carcinoma	Phase 3	Thailand	Merck Sharp & Dohme LLC	31 Dec 2023
Metastatic Prostate Carcinoma	Phase 3	United Kingdom	Merck Sharp & Dohme LLC	31 Dec 2023
Castration-Resistant Prostatic Cancer	Phase 3	Canada	Merck Sharp & Dohme LLC	18 Dec 2023
Castration-Resistant Prostatic Cancer	Phase 3	Malaysia	Merck Sharp & Dohme LLC	18 Dec 2023
Castration-Resistant Prostatic Cancer	Phase 3	Peru	Merck Sharp & Dohme LLC	18 Dec 2023
Castration-Resistant Prostatic Cancer	Phase 3	Singapore	Merck Sharp & Dohme LLC	18 Dec 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06136650 (OMAHA-004, ASCO2026 \| ASCO_GU2026)	Phase 3	Metastatic castration-resistant prostate cancer	1,314	Opevesostat 5 mg orally twice-daily + Dexamethasone 1.5 mg + Fludrocortisone 0.1 mg	gmczsexcbs(deddkhqsfx) = xysmaiadwg xdeuzjloyb (mwdkfwzjsk, 77 - 89) View more	Positive	29 May 2026
				Abiraterone acetate 1000 mg + Prednisone (if prior enzalutamide/darolutamide/apalutamide) OR Enzalutamide 160 mg (if prior abiraterone)	ielkxhwpyy(lixgzkhtqe) = yqffsycsdc mvgnakotxi (rfobimpwfz, 11 - 23) View more
NCT06979596 (OMAHA-015, ESGO2026)	Phase 2	Solid tumor	170	Opevesostat 5 mg BID + corticosteroids (Cohort C)	djdaemvpcj(pphymtfpib) = ytvnwhaqed pfbrlqrvdg (vlnurntutk ) View more	Positive	28 Feb 2026
NCT06353386 (OMAHA-U01, ASCO_GU2026 \| ASCO2026)	Phase 1/2	Metastatic castration-resistant prostate cancer AR-LBD mutation (AR-LBDm) status	174	Opevesostat 5 mg PO BID plus olaparib	besipnmabm(xfvutddteu) = xaoemocpqu krsgsrcnwz (ltqilfbppp, 83 - 100) View more	Positive	26 Feb 2026
				Opevesostat 5 mg PO BID plus cabazitaxel	besipnmabm(xfvutddteu) = kheokfught krsgsrcnwz (ltqilfbppp, 75 - 100) View more
NCT06136624 \| NCT06136650 (OMAHA-003, Pubmed \| Future Oncol)	Phase 3	Metastatic castration-resistant prostate cancer	468	Opevesostat	nwznbcddqe(xsksplugqq) = pphmkixcep spxikmjjrm (mikiqpxpta ) View more	Positive	23 Feb 2026
				ARPI	nwznbcddqe(xsksplugqq) = gwfptgfceg spxikmjjrm (mikiqpxpta ) View more
NCT03436485 (CYPIDES, ESMO2024) Manual	Phase 2	Metastatic castration-resistant prostate cancer Second line AR-LBD mutations	134	Opevesostat 5mg BID	uktckoznxb(aorplfyfqt) = uqmrdwsuxi uprlnjdxgf (kraficrkui ) View more	Positive	15 Sep 2024
				Opevesostat	uktckoznxb(aorplfyfqt) = uzbkqzswif uprlnjdxgf (kraficrkui ) View more
NCT03436485 (CYPIDES, ASCO_GU2024) Manual	Phase 2	Metastatic castration-resistant prostate cancer AR-LBD mutations	134	MK-5684 5mg BID (AR-LBD mutation-positive)	wxycuivxfh(acmiryckix) = msgppcdoeu flbjojevxs (oczjdefdpn ) View more	Positive	25 Jan 2024
				MK-5684 5mg BID (AR-LBD mutation-negative)	mdxirzedld(zlqhyhrwfe) = liuejmwaiq vayvchnfmy (rujrcoqpmh ) View more
NCT03436485 (CYPIDES , Pubmed) Manual	Phase 1/2	Castration-Resistant Prostatic Cancer AR Mutation	92	ODM-208+glucocorticoid/mineralocorticoid replacement+androgen deprivation therapy (ARmut in phase 1)	wnqfucumsk(rfnnutvlxy) = Treatment-related adrenal insufficiency was the most common toxicity in phase 1 (n=17, 36.2%; necessitating ODM-208 discontinuation in one patient); this toxicity occurred in six patients (13.3%) at 5 mg twice a day in phase 2. fiftjvqhew (uxjglsyipm )	Positive	26 Dec 2023
				ODM-208+glucocorticoid/mineralocorticoid replacement+androgen deprivation therapy (AR wild type in phase 1)
NCT03436485 (CYPIDES, ESMO2022) Manual	Phase 2	Metastatic castration-resistant prostate cancer AR LBD mutation	45	ODM-208+dexamethasone+fludrocortisone	lrsxsfliof(ckqpgkxntj) = eqajrmhrhi fbpdfobbkc (xmiphvrmwl ) View more	Positive	11 Sep 2022
NCT03436485 (CYPIDES, Corporate Publications) Manual	Phase 1/2	Metastatic castration-resistant prostate cancer AR LBD mutation	44	ODM-208	kxlnsmvhur(olknsqudau) = severe adrenal insufficiency 32% pqdusznssn (nxuorgiwpo )	Positive	18 Feb 2022

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

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

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

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

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis