Metastatic Prostate Cancer Clinical Trials 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, MOA, ROA, and Companies by DelveInsight | Curium, Merck/ Orion, Pfizer, AstraZeneca, Telix Pharmaceuticals, Tavanta Therapeutics, Candel Therapeutics

(Albany, United States) As per DelveInsight's assessment, globally, Metastatic Prostate Cancer pipeline constitutes 80+ key companies continuously working towards developing 85+ Metastatic Prostate Cancer treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Metastatic Prostate Cancer Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Metastatic Prostate Cancer Market.

The Metastatic Prostate Cancer Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Download sample report to know in detail about emerging drugs @ https://www.delveinsight.com/sample-request/metastatic-prostate-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Some of the key takeaways from the Metastatic Prostate Cancer Pipeline Report:
• Companies across the globe are diligently working toward developing novel Metastatic Prostate Cancer treatment therapies with a considerable amount of success over the years.
• Metastatic Prostate Cancer companies working in the treatment market are Curium, Merck/ Orion, Pfizer, AstraZeneca, Telix Pharmaceuticals, Tavanta Therapeutics, Candel Therapeutics, Jiangsu Hengrui Pharmaceuticals, and others, are developing therapies for the Metastatic Prostate Cancer treatment
• Emerging Metastatic Prostate Cancer therapies in the different phases of clinical trials are- 177Lu-PSMA-I&T, Opevesostat (MK-5684), 177Lu-DOTA-rosopatamab, Cabozantinib, Capivasertib, Masitinib, FPI-2265, 177Lu-PNT2002, Mevrometostat (PF-06821497), Fuzuloparib, ModraDoc006, BMS-986218, Lorigerlimab, SX-682, ZEN-3694, Vudalimab, OPDIVO (nivolumab), Zenocutuzumab, Vobramitamab Duocarmazine, PT-112, LAE201, TAVT-45, pTVG-HP (MVI-816), TAS-115, KPG-121, ARV-766, CAN-2409, Saruparib (AZD5305), 177Lu-rhPSMA-10.1, Tazemetostat (Tazverik), KEYTRUDA, LAVA-1207, Masofaniten (EPI-7386), P PSMA 101, JANX 007, AUR107, MSP008-22, 225Ac-FL-020, NPX267, ABBV-969, SL-T10, Abivertinib, ETX-19477, AVA 6000, QXL138AM, BG-68501, DB-1311, and others are expected to have a significant impact on the Metastatic Prostate Cancer market in the coming years.
• In July 2025, Trethera Corporation, a clinical-stage biopharmaceutical company focused on innovative cancer and autoimmune therapies, announced that the FDA granted Fast Track designation to its drug TRE-515 for prostate cancer treatment. TRE-515 is currently undergoing Phase 1 clinical trials for solid tumors.
• In July 2025, Artera, a developer of multimodal AI-based cancer prognostic and predictive tests, announced that the FDA granted Breakthrough Device Designation to ArteraAI Prostate, an AI tool designed to help clinicians make risk-based decisions for patients with localized prostate cancer.
• In July 2025, AB Science announced that the FDA and EMA had authorized a confirmatory Phase III trial of masitinib for metastatic castrate-resistant prostate cancer, focusing on patients with less advanced metastatic disease using a specific biomarker.
• In June 2025, Archeus Technologies received FDA clearance for its IND application for ART-101, a novel receptor-targeting small molecule for imaging and treating metastatic castration-resistant prostate cancer (mCRPC), enabling the start of a Phase I trial later this year.
• In June 2025, Bayer announced FDA approval of NUBEQA (darolutamide) with androgen deprivation therapy (ADT) for treating metastatic castration-sensitive prostate cancer (mCSPC). The approval is based on Phase III ARANOTE trial results, where the combination reduced the risk of radiological progression or death by 46% versus placebo plus ADT.
• In May 2025, the FDA's Oncologic Drugs Advisory Committee (ODAC) unanimously voted against approving talazoparib (Talzenna) combined with enzalutamide (Xtandi) for non-HRR-mutant metastatic castration-resistant prostate cancer (mCRPC), based on phase III TALAPRO-2 trial data.
• In September 2024, Ipsen announced that the Phase III CONTACT-02 trial for Cabometyx and atezolizumab in mCRPC showed a non-significant improvement in overall survival but met the progression-free survival (PFS) endpoint.
• In August 2024, Nuvation Bio announced that the US Food and Drug Administration has approved its investigational new drug application to assess NUV-1511, the first clinical candidate developed from the company's innovative drug-drug conjugate (DDC) platform.
• In July 2024, The FDA has awarded fast-track designation to SYNC-T SV-102 for the treatment of metastatic castrate-resistant prostate cancer (mCRPC).
• In June 2024, Kangpu Biopharmaceuticals obtained FDA approval to conduct a Phase II/III trial of KPG-121 in combination with Abiraterone for metastatic castrate-resistant prostate cancer (mCRPC).
• In June 2024, BioNTech SE and Duality Biologics announced that the US Food and Drug Administration has granted Fast Track designation to BNT324/DB-1311 for treating patients with advanced, unresectable, or metastatic castration-resistant prostate cancer (CRPC) who have experienced progression following standard systemic treatments.
• In May 2024, Fusion Pharmaceuticals has launched the Phase II AlphaBreak trial to evaluate FPI-2265 in patients with metastatic castrate-resistant prostate cancer (mCRPC).
• In February 2024, Fusion Pharmaceuticals Inc. announced that it has entered into an exclusive worldwide licensing agreement with Heidelberg University and Euratom, represented by the European Commission, Joint Research Centre. This agreement grants Fusion exclusive global rights to use, develop, manufacture, and commercialize compounds covered by the patent, including 225Ac-PSMA I&T for treating prostate-specific membrane antigen (PSMA)-expressing cancers. Additionally, Fusion and the Licensors have reached an agreement to resolve a dispute regarding an inter partes review of a U.S. patent owned by the Licensors, initiated in August 2023 by the United States Patent and Trademark Office.
• In February 2024, BioXcel Therapeutics, Inc. announced that the FDA has granted Fast Track designation to BXCL701 in combination with a CPI for the treatment of metastatic small cell neuroendocrine prostate cancer (SCNC) in patients who are progressing on chemotherapy. This designation facilitates faster development and review by the FDA.

Metastatic Prostate Cancer Overview
Metastatic prostate cancer is an advanced stage of prostate cancer in which cancer cells spread from the prostate gland to other parts of the body, such as the bones, lymph nodes, liver, or lungs. This occurs when cancer cells break away from the primary tumor and travel through the bloodstream or lymphatic system to form secondary tumors. Symptoms may include bone pain, difficulty urinating, fatigue, and weight loss. Treatment for metastatic prostate cancer focuses on slowing the cancer's progression, managing symptoms, and improving quality of life, using options like hormone therapy, chemotherapy, immunotherapy, and targeted therapies.

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Emerging Metastatic Prostate Cancer Drugs Under Different Phases of Clinical Development Include:
• 177Lu-PSMA-I&T: Curium
• Opevesostat (MK-5684; ODM-208): Merck/ Orion
• Mevrometostat (PF-06821497): Pfizer
• TRUQAP (capivasertib, AZD5363): AstraZeneca
• 177Lu-DOTA-rosopatamab (TLX591): Telix Pharmaceuticals
• TAVT-45 (abiraterone acetate): Tavanta Therapeutics
• Saruparib (AZD5305): AstraZeneca
• CAN-2409 (aglatimagene besadenovec): Candel Therapeutics
• Fuzuloparib: Jiangsu Hengrui Pharmaceuticals

Metastatic Prostate Cancer Route of Administration
Metastatic Prostate Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

Metastatic Prostate Cancer Molecule Type
Metastatic Prostate Cancer Products have been categorized under various Molecule types, such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Metastatic Prostate Cancer Pipeline Therapeutics Assessment
• Metastatic Prostate Cancer Assessment by Product Type
• Metastatic Prostate Cancer By Stage and Product Type
• Metastatic Prostate Cancer Assessment by Route of Administration
• Metastatic Prostate Cancer By Stage and Route of Administration
• Metastatic Prostate Cancer Assessment by Molecule Type
• Metastatic Prostate Cancer by Stage and Molecule Type

DelveInsight's Metastatic Prostate Cancer Report covers around 85+ products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Metastatic Prostate Cancer product details are provided in the report. Download the Metastatic Prostate Cancer pipeline report to learn more about the emerging Metastatic Prostate Cancer therapies at:
https://www.delveinsight.com/sample-request/metastatic-prostate-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Some of the key companies in the Metastatic Prostate Cancer Therapeutics Market include:
Key companies developing therapies for Metastatic Prostate Cancer are - MacroGenics, Syntrix Pharmaceuticals, Zenith Epigenetics, Xencor, Bristol Myers Squibb, Merus, Phosplatin Therapeutics, Laekna Therapeutics, Tavanta Therapeutics, Madison Vaccines, Taiho Pharmaceutical, Kangpu Biopharmaceuticals, Arvinas, Candel Therapeutics, Blue Earth Therapeutics, Ipsen Biopharmaceuticals, LAVA Therapeutics, Curium, Merck, Telix Pharmaceuticals, Exelixis, AstraZeneca, AB Science, Lantheus, Pfizer, Jiangsu Hengrui Pharmaceuticals, Modra Pharmaceuticals, Bristol-Myers Squibb, Essa Pharma, Poseida Therapeutics, Janux Therapeutics, Aurigene Oncology, Sathgen Therapeutics, Full-Life Technologies, NextPoint Therapeutics, AbbVie, SL VAXiGEN, Sorrento Therapeutics, Inc., 858 Therapeutics, Avacta Life Sciences Ltd, Nammi Therapeutics, BeiGene, DualityBio, and others.

Metastatic Prostate Cancer Pipeline Analysis:
The Metastatic Prostate Cancer pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Metastatic Prostate Cancer with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Metastatic Prostate Cancer Treatment.
• Metastatic Prostate Cancer key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Metastatic Prostate Cancer Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Metastatic Prostate Cancer market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Metastatic Prostate Cancer drugs and therapies- https://www.delveinsight.com/sample-request/metastatic-prostate-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Metastatic Prostate Cancer Pipeline Market Drivers
• Growing Incidence of Prostate Cancer, Innovative Therapeutic Developments, Government and Non-Profit Funding Support, Aging Population, are some of the important factors that are fueling the Metastatic Prostate Cancer Market.

Metastatic Prostate Cancer Pipeline Market Barriers
• However, High Cost of Drug Development, Complex Disease Mechanism, Regulatory Hurdles, Adverse Side Effects of Treatments, and other factors are creating obstacles in the Metastatic Prostate Cancer Market growth.

Scope of Metastatic Prostate Cancer Pipeline Drug Insight
• Coverage: Global
• Key Metastatic Prostate Cancer Companies: Curium, Merck/ Orion, Pfizer, AstraZeneca, Telix Pharmaceuticals, Tavanta Therapeutics, Candel Therapeutics, Jiangsu Hengrui Pharmaceuticals, and others
• Key Metastatic Prostate Cancer Therapies: 177Lu-PSMA-I&T, Opevesostat (MK-5684), 177Lu-DOTA-rosopatamab, Cabozantinib, Capivasertib, Masitinib, FPI-2265, 177Lu-PNT2002, Mevrometostat (PF-06821497), Fuzuloparib, ModraDoc006, BMS-986218, Lorigerlimab, SX-682, ZEN-3694, Vudalimab, OPDIVO (nivolumab), Zenocutuzumab, Vobramitamab Duocarmazine, PT-112, LAE201, TAVT-45, pTVG-HP (MVI-816), TAS-115, KPG-121, ARV-766, CAN-2409, Saruparib (AZD5305), 177Lu-rhPSMA-10.1, Tazemetostat (Tazverik), KEYTRUDA, LAVA-1207, Masofaniten (EPI-7386), P PSMA 101, JANX 007, AUR107, MSP008-22, 225Ac-FL-020, NPX267, ABBV-969, SL-T10, Abivertinib, ETX-19477, AVA 6000, QXL138AM, BG-68501, DB-1311, and others
• Metastatic Prostate Cancer Therapeutic Assessment: Metastatic Prostate Cancer current marketed and Metastatic Prostate Cancer emerging therapies
• Metastatic Prostate Cancer Market Dynamics: Metastatic Prostate Cancer market drivers and Metastatic Prostate Cancer market barriers

Request for Sample PDF Report for Metastatic Prostate Cancer Pipeline Assessment and clinical trials- https://www.delveinsight.com/sample-request/metastatic-prostate-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Table of Contents
1. Metastatic Prostate Cancer Report Introduction
2. Metastatic Prostate Cancer Executive Summary
3. Metastatic Prostate Cancer Overview
4. Metastatic Prostate Cancer- Analytical Perspective In-depth Commercial Assessment
5. Metastatic Prostate Cancer Pipeline Therapeutics
6. Metastatic Prostate Cancer Late Stage Products (Phase II/III)
7. Metastatic Prostate Cancer Mid Stage Products (Phase II)
8. Metastatic Prostate Cancer Early Stage Products (Phase I)
9. Metastatic Prostate Cancer Preclinical Stage Products
10. Metastatic Prostate Cancer Therapeutics Assessment
11. Metastatic Prostate Cancer Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Metastatic Prostate Cancer Key Companies
14. Metastatic Prostate Cancer Key Products
15. Metastatic Prostate Cancer Unmet Needs
16 . Metastatic Prostate Cancer Market Drivers and Barriers
17. Metastatic Prostate Cancer Future Perspectives and Conclusion
18. Metastatic Prostate Cancer Analyst Views
19. Appendix
20. About DelveInsight

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