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Prostate Cancer Pipeline and Clinical Trials 2025: EMA, PDMA, FDA Approvals, Therapies, Medication, NDA Approval, IND, NICE AMechanism of Action, Route of Administration by DelveInsight
Prostate Cancer Pipeline
As per DelveInsight's assessment, globally, Prostate Cancer pipeline constitutes 150+ key companies continuously working towards developing 160+ Prostate Cancer treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.
Request a sample and discover the recent advances in prostate cancer drugs @ Prostate Cancer Pipeline Report - https://www.delveinsight.com/report-store/prostate-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Key Takeaways from the Prostate Cancer Pipeline Report
• DelveInsight's prostate cancer pipeline report depicts a robust space with 150+ active players working to develop 160+ pipeline prostate cancer drugs.
• Key prostate cancer companies such as Curium, Merck, Telix Pharmaceuticals, Exelixis, AstraZeneca, AB Science, Lantheus, Pfizer, Jiangsu Hengrui Pharmaceuticals, Modra Pharmaceuticals, Bristol-Myers Squibb, 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, 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 are evaluating new prostate cancer drugs to improve the treatment landscape.
• Promising pipeline prostate cancer such as 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 under different phases of prostate cancer clinical trials.
• In April 2025, The Nuclear Medicine Department at Ridley-Tree Cancer Center, now part of Sutter Health, announces greater capabilities to treat prostate cancer using the injectable radioligand therapy, Pluvicto which targets high dose radiation straight to metastasized prostate cancer tumors. Ridley-Tree's nuclear medicine physicians, who participated in a clinical trial for Pluvicto, are highly experienced and trained in the use of radioligand therapies, or targeted cancer treatments where a radioactive substance is attached to a molecule (ligand) that binds to cancer cells. The FDA recently expanded the indication for Pluvicto, allowing its use after one androgen receptor pathway inhibitor (ARPI) or hormone-based therapy, and now before chemotherapy in patients who have metastatic castration-resistant prostate cancer (mCRPC).
• In March 2025, Novartis announced that the US Food and Drug Administration (FDA) approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy.
• 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 cleared its investigational new drug application to evaluate NUV-1511, the first clinical candidate from the company's novel drug-drug conjugate (DDC) platform.
• In July 2024, the FDA granted fast-track designation to SYNC-T SV-102 for metastatic castrate-resistant prostate cancer (mCRPC).
• In June 2024, Kangpu Biopharmaceuticals received FDA approval for a Phase II/III trial of KPG-121 with Abiraterone for mCRPC.
• In June 2024, BioNTech SE and Duality Biologics announced that the US Food and Drug Administration granted Fast Track designation for BNT324/DB-1311 for the treatment of patients with advanced/unresectable, or metastatic castration-resistant prostate cancer ("CRPC") who have progressed on or after standard systemic regimens.
• In May 2024, Fusion Pharmaceuticals began the Phase II AlphaBreak trial of FPI-2265 in mCRPC patients.
• In February 2024, Fusion Pharmaceuticals Inc. announced that it has entered into an exclusive worldwide license agreement with Heidelberg University and Euratom represented by the European Commission, Joint Research Centre. The license agreement grants Fusion exclusive worldwide rights to utilize, develop, manufacture, and commercialize compounds covered by the patent, which includes 225Ac-PSMA I&T for the treatment of prostate-specific membrane antigen (PSMA)-expressing cancers. In addition, Fusion and the Licensors have signed an agreement to settle the parties' dispute related to an inter partes review of a U.S. patent owned by the Licensors which was instituted in August 2023 by the United States Patent and Trademark Board.
• In February 2024, BioXcel Therapeutics, Inc. announced that the FDA granted Fast Track designation for BXCL701 with a CPI to treat metastatic small cell neuroendocrine prostate cancer (SCNC) in patients progressing on chemotherapy. This designation allows for expedited development and review by the FDA.
Find out more about prostate cancer drugs @ Prostate Cancer Pipeline Analysis - https://www.delveinsight.com/sample-request/prostate-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Prostate Cancer Overview
Prostate Cancer is one of the most common types of cancer affecting men, especially those over the age of 50. Prostate Cancer begins in the prostate gland, a small walnut-shaped gland that produces seminal fluid. Prostate Cancer often develops slowly and may not cause noticeable symptoms in its early stages. However, advanced Prostate Cancer can lead to difficulties in urination, blood in urine or semen, pelvic discomfort, and erectile dysfunction.
Prostate Cancer diagnosis typically involves prostate-specific antigen (PSA) blood tests, digital rectal exams (DRE), imaging studies, and biopsies to confirm the presence and stage of the disease. Prostate Cancer risk factors include age, family history, race, and lifestyle choices.
Prostate Cancer treatment options vary depending on the stage and aggressiveness of the disease and may include active surveillance, surgery, radiation therapy, hormone therapy, chemotherapy, and immunotherapy. Prostate Cancer patients are also increasingly benefiting from precision medicine and targeted therapies designed to minimize side effects and improve outcomes.
Prostate Cancer awareness and early detection through regular screening play a critical role in improving survival rates. Ongoing research in Prostate Cancer continues to explore advanced diagnostic tools and more effective treatment approaches to enhance patient care.
Currently approved drugs for metastatic prostate cancer include XTANDI by Astellas/Pfizer and ZYTIGA by Janssen, both available for over a decade. Despite the introduction of ZYTIGA generics in the US in 2019 and in the EU since late 2022, causing a significant revenue drop, particularly in the US, ZYTIGA is still being actively studied in combination with emerging therapies, boosting its use with the compound abiraterone acetate.
In 2019, Janssen expanded its portfolio with ERLEADA for mHSPC, following its 2018 approval for nmCRPC. Bayer's NUBEQA has also rapidly gained momentum, becoming a key competitor. PARP inhibitors have been making strides for patients with HRR gene mutations (BRCA1/2). AstraZeneca's LYNPARZA was introduced for first-line prostate cancer treatment, while Pharma& Schweiz's RUBRACA became available for 3L mCRPC patients in 2020. Additionally, in 2023, Pfizer's TALZENNA, Janssen's AKEEGA, and AstraZeneca/Merck's LYNPARZA were approved for first-line use. Myovant Sciences' ORGOVYX and Sanofi's JEVTANA have also been approved in the US for treating mCRPC.
In 2022, Novartis' radioligand therapy, PLUVICTO, was approved for mCRPC treatment, resulting in higher-than-expected revenue in the third-line mCRPC segment. Novartis now plans to expand its presence into earlier-line mCRPC by 2024 and mHSPC by 2025 within the US market.
For further information on the prostate cancer pipeline therapeutics, reach out @ Prostate Cancer Therapeutics Market - https://www.delveinsight.com/sample-request/prostate-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
A snapshot of the Pipeline Prostate Cancer Drugs mentioned in the report:
• 177Lu-PSMA-I&T: Curium
• Opevesostat (MK-5684; ODM-208): Merck/ Orion
• Mevrometostat (PF-06821497): Pfizer
• TRUQAP (capivasertib, AZD5363): AstraZeneca
• 177Lu-PNT2002: Lantheus
• 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
Learn more about the emerging prostate cancer therapies @ Prostate Cancer Clinical Trials and FDA Approvals - https://www.delveinsight.com/report-store/prostate-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Prostate Cancer Therapeutics Assessment
The prostate cancer pipeline report proffers an integral view of the emerging prostate cancer segmented by stage, product type, molecule type, route of administration, and mechanism of action.
Scope of the 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, Parenteral, Topical
• Therapeutics Assessment By Molecule Type: Monoclonal antibody, Peptides, Polymer, Small molecule, Gene therapy
• Therapeutics Assessment By Mechanism of Action: PSMA inhibitors (Prostate-specific Membrane Antigen Inhibitors), CYP11A1 inhibitor, EZH2 inhibitor, Proto-oncogene protein c-akt inhibitor, PSMA-targeted therapy, Ionising radiation emitter, Steroidal inhibitor of CYP17A1, Poly(ADP-ribose) polymerase-1 inhibitor, Thymidine kinase expression stimulants, Poly(ADP-ribose) polymerase 2 inhibitors
• Key Prostate Cancer Companies: Merck & Co., Inc. (NYSE: MRK), Telix Pharmaceuticals Limited (ASX: TLX), Exelixis, Inc. (NASDAQ: EXEL), AstraZeneca PLC (NASDAQ: AZN), AB Science S.A. (EPA: AB), Lantheus Holdings, Inc. (NASDAQ: LNTH), Pfizer Inc. (NYSE: PFE), Bristol-Myers Squibb Company (NYSE: BMY), MacroGenics, Inc. (NASDAQ: MGNX), Xencor, Inc. (NASDAQ: XNCR), Merus N.V. (NASDAQ: MRUS), Arvinas, Inc. (NASDAQ: ARVN), Candel Therapeutics, Inc. (NASDAQ: CADL), Ipsen S.A. (EPA: IPN), LAVA Therapeutics N.V. (NASDAQ: LVTX), ESSA Pharma Inc. (NASDAQ: EPIX), Poseida Therapeutics, Inc. (NASDAQ: PSTX), Janux Therapeutics, Inc. (NASDAQ: JANX), AbbVie Inc. (NYSE: ABBV), Sorrento Therapeutics, Inc. (OTC: SRNEQ), Avacta Group plc (LSE: AVCT), BeiGene, Ltd. (NASDAQ: BGNE), Duality Biologics (HKEX: 6988), Curium, Modra Pharmaceuticals, Syntrix Pharmaceuticals, Zenith Epigenetics, Phosplatin Therapeutics, Laekna Therapeutics, Tavanta Therapeutics, Madison Vaccines, Taiho Pharmaceutical, Kangpu Biopharmaceuticals, Blue Earth Therapeutics, Aurigene Oncology, Sathgen Therapeutics, Full-Life Technologies, NextPoint Therapeutics, SL VAXiGEN, Nammi Therapeutics, and 858 Therapeutics, and others
• Key Prostate Cancer Pipeline 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
Dive deep into rich insights for new prostate cancer treatments, visit @ Prostate Cancer Drugs and Therapies - https://www.delveinsight.com/sample-request/prostate-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Table of Contents
1. Prostate Cancer Pipeline Report Introduction
2. Prostate Cancer Pipeline Report Executive Summary
3. Prostate Cancer Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Prostate Cancer Clinical Trial Therapeutics
6. Prostate Cancer Pipeline: Late-Stage Products (Pre-registration)
7. Prostate Cancer Pipeline: Late-Stage Products (Phase III)
8. Prostate Cancer Pipeline: Mid-Stage Products (Phase II)
9. Prostate Cancer Pipeline: Early-Stage Products (Phase I)
10. Prostate Cancer Pipeline Therapeutics Assessment
11. Inactive Products in the Prostate Cancer Pipeline
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products in the Prostate Cancer Pipeline
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix
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About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.
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