Prostate Cancer Pipeline Outlook 2025 -- Investigational Therapies, Clinical Trials, Drugs and Companies, Medication, by Phase, by ROA, by MOA | DelveInsight

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, Sathgen Therapeutics, Full-Life Technologies, AbbVie, etc
Prostate Cancer Pipeline Summary

Prostate Cancer Pipeline report highlights 230+ companies developing 265+ drugs, including key players like Merck, Pfizer, AstraZeneca, Ipsen, AbbVie, BeiGene, and more. Promising candidates such as Cabozantinib, KEYTRUDA, OPDIVO, and 177Lu-PSMA agents are in trials. Recent updates include FDA fast-track designations, trial approvals, IND clearances, and global licensing deals, signaling strong innovation in advancing prostate cancer treatments.

DelveInsight's "Prostate Cancer Pipeline Insight 2025" report offers an in-depth overview of the global prostate cancer pipeline, highlighting therapies in various stages of clinical development. It emphasizes the efforts of leading pharmaceutical companies driving innovation in this space and explores the potential future growth of the prostate cancer pipeline market. According to DelveInsight's analysis, the global prostate cancer pipeline includes 230+ key companies actively engaged in developing over 265+ treatment candidates. The report further provides detailed insights into clinical trials, therapeutic approaches, mechanisms of action, routes of administration, and recent advancements in the field.

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Key Takeaways from the Prostate Cancer Pipeline Report

* DelveInsight's prostate cancer pipeline report depicts a robust space with 230+ active players working to develop 265+ 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 July 2025, the European Commission approved Nubeqa Trademark (darolutamide), an oral androgen receptor inhibitor, for use alongside androgen deprivation therapy (ADT) in treating metastatic hormone-sensitive prostate cancer (mHSPC). The approval was supported by results from the Phase III ARANOTE trial, which demonstrated a 46% reduction in the risk of radiological progression or death compared with placebo plus ADT.
* In March 2025, the FDA approved Telix Pharmaceuticals' TLX007-CDx (Gozellix) for prostate cancer imaging. That same month, Quibim received FDA 510(k) clearance for its QP-Prostate Registered CAD solution, designed to enhance detection of prostate cancer lesions.
* In February 2025, Ibex Medical Analytics gained FDA 510(k) clearance for Ibex Prostate Detect, an AI-based diagnostic tool that generates heatmaps to help pathologists identify rare or small prostate cancers, improving diagnostic accuracy.
* In January 2025, Clarity Pharmaceuticals secured FDA Fast Track Designation for its PET imaging agent 64Cu-SAR-bisPSMA, intended for patients with biochemical recurrence (BCR) of prostate cancer after definitive therapy, expediting its development and review.
* On November 1, 2024, ESSA Pharma discontinued its Phase II trial of masofaniten (EPI-7386), an investigational AR inhibitor, after an interim review showed limited benefit when combined with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) patients.
* 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.

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Prostate Cancer Overview

Prostate cancer is one of the most common cancers in men, typically affecting those over 50. It originates in the prostate gland and often progresses slowly without early symptoms, though advanced stages can cause urinary issues, blood in urine and pelvic pain. Diagnosis relies on PSA blood tests, digital rectal exams, imaging, and biopsies. Risk factors include age, family history, race, and lifestyle.

Treatment depends on disease stage and ranges from active surveillance and surgery to radiation, hormone therapy, chemotherapy, and immunotherapy. Precision medicine and targeted therapies are increasingly improving patient outcomes while reducing side effects. Awareness and early detection through regular screening remain crucial for survival.

The therapeutic landscape has evolved with established drugs like XTANDI (Astellas/Pfizer) and ZYTIGA (Janssen), alongside newer options such as ERLEADA, NUBEQA, and PARP inhibitors like LYNPARZA, RUBRACA, TALZENNA, and AKEEGA. Additional therapies include ORGOVYX and JEVTANA for advanced cases.

A major advancement came with Novartis' PLUVICTO radioligand therapy, approved in 2022 for mCRPC, with expansion planned into earlier disease stages. Ongoing research into novel therapies and combination approaches continues to strengthen treatment options and improve outcomes for prostate cancer patients worldwide.

A snapshot of some Prostate Cancer investigational drugs / candidates:

Here are a few pipeline drugs and investigational agents mentioned:

* 177Lu-PSMA-I&T (Curium)
* Opevesostat (MK-5684/ODM-208) (Orion/Merck)
* Lantheus' 177Lu-PNT2002
* Candel Therapeutics' CAN-2409
* Tavanta Therapeutics' TAVT-45
* AstraZeneca/Merck's AZD5305
* Pfizer's Mevrometostat
* Jiangsu HengRui Medicine's Fuzuloparib
* AB Science's Masitinib
* Additional agents mentioned in later-phase trials or mCRPC settings include Capivasertib, Mevrometostat again, SX-682, TAVT-45, PNT2002, Masitinib, REGN-4336, ZEN003694, HP518, FT-7051, HLD-0915, 225Ac-PSMA-617 radiopharmaceuticals, etc.
* Masofaniten (EPI-7386) is also under investigation as a next-generation androgen receptor antagonist.
* Luxdegalutamide (ARV-766) is another investigational oral androgen receptor degrader in development by Arvinas.

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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.

Prostate Cancer Companies

* Janssen Research and Development
* Sanofi
* AstraZeneca
* Merck
* Pfizer
* Astellas Pharma
* Bayer
* Novartis
* Curium
* Merck and Orion
* Janssen Pharmaceutical
* Pfizer
* Exelixis, Ipsen Pharma and Takeda
* AB Science
* Lantheus and Eli Lilly
* POINT Biopharma
* Telix Pharmaceuticals
* Tavanta Therapeutics
* Jiangsu Hengrui Pharmaceuticals
* Kangpu Biopharmaceuticals
* Fusion Pharma
* Merus
* Bristol-Myers Squibb
* Syntrix Pharmaceuticals
* Promontory Therapeutics
* Xencor
* Taiho Pharmaceutical
* Madison Vaccines
* MacroGenics
* Zenith Epigenetics
* Modra Pharmaceuticals
* Arvinas
* Laekna Therapeutics
* Blue Earth Therapeutics
* Oncternal Therapeutics
* Essa Pharma
* Clarity Pharmaceuticals
* BioNTech and DualityBio
* Daiichi Sankyo
* Fortis Therapeutics
* ORIC Pharmaceuticals
* Amgen, and others

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Prostate Cancer Drugs in different phases

DelveInsight's report covers around 265+ products under different phases of clinical development like

* Late stage products (Phase III)
* Mid-stage products (Phase II)
* Early-stage product (Phase I) along with the details of
* Pre-clinical and Discovery stage candidates
* Discontinued & Inactive candidates

Prostate Cancer Drugs by Route of Administration

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.

Prostate Cancer Drugs by Molecule Type

Products have been categorized under various Molecule types such as

* Monoclonal Antibody
* Peptides
* Polymer
* Small molecule
* Gene therapy

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

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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

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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