Prostate Cancer Pipeline

Prostate Cancer Pipeline Summary

The Prostate Cancer pipeline is rapidly evolving, with over 150 companies exploring novel therapies across all clinical stages. Recent developments include FDA fast-track designations, new companion diagnostic approvals, and promising trial outcomes for drugs like NUBEQA®, Xtandi™, and Cabometyx®. Emerging therapies such as Janssen’s Niraparib (Phase III), Zenith’s ZEN-3694 (Phase II), Seagen’s Ladiratuzumab vedotin (Phase II), Fortis’ FOR46 (Phase I/II), and Regeneron’s REGN5678 (Phase I/II) highlight diverse mechanisms, from PARP inhibition to antibody-drug conjugates and bispecifics. Collectively, these advances reflect growing innovation and investment in prostate cancer treatment, aiming to improve survival and outcomes.

DelveInsight’s “Prostate Cancer Pipeline Insight 2025” report offers an in-depth analysis of the global prostate cancer pipeline, covering therapies in various stages of clinical development and highlighting the efforts of leading pharmaceutical companies to advance this space. According to DelveInsight’s assessment, the prostate cancer pipeline comprises more than 150 key companies actively engaged in developing over 160 therapeutic candidates. The report provides detailed insights into clinical trials, mechanisms of action, routes of administration, and recent developmental activities, while also evaluating the future growth potential of the prostate cancer treatment landscape.

Get your free sample of the Prostate Cancer Pipeline Report today and gain strategic insights to identify opportunities, assess competitors, and strengthen your pipeline decisions @ Prostate Cancer Pipeline Report

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 August 2025, Halda Therapeutics, a clinical-stage biotechnology company developing a novel class of therapies called RIPTAC™ Therapeutics, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to HLD-0915, the company’s lead development candidate, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
• In July 2025, Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class therapies for cancer and autoimmune diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its novel drug, TRE-515, in the treatment of prostate cancer. TRE-515 is currently in phase 1 clinical trials for solid tumors. The FTD to TRE-515 in combination with radioligand therapy for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration resistant prostate cancer (mCRPC), a condition impacting thousands of patients. PSMA, an important disease biomarker, is detected in over 80% of prostate cancer cases, enabling earlier identification and intervention.
• In July 2025, AB Science SA (Euronext – FR0010557264 – AB) announced that a confirmatory phase 3 trial of masitinib in metastatic castrate resistant prostate cancer (study AB22007) has been authorized by FDA and EMA (harmonized protocol approved through step 1 of Clinical Trials Information System), with a biomarker that targets patients with less advanced metastatic disease.
• In June 2025, Orion’s collaboration partner Bayer announced that the U.S. Food and Drug Administration (FDA) has approved the oral androgen receptor inhibitor (ARi) darolutamide in combination with androgen deprivation therapy (ADT) for use in patients with metastatic castration-sensitive prostate cancer (mCSPC), which is also known as metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001) in patients with mHSPC.
• In May 2025, Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to CAN-2409 (aglatimagene besadenovec), the Company’s biological immunotherapy lead candidate, for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. CAN-2409 was also previously granted FDA Fast Track designation for the same indication.
• March 2025: The FDA approved Telix Pharmaceuticals’ NDA for TLX007-CDx (Gozellix), a diagnostic imaging agent for prostate cancer.
• March 2025: Quibim received FDA 510(k) clearance for its QP-Prostate® CAD solution, designed to enhance prostate cancer lesion detection, supporting more accurate diagnosis and treatment planning.
• February 2025: Ibex Medical Analytics secured FDA 510(k) clearance for Ibex Prostate Detect, an AI-driven diagnostic tool that generates heatmaps to help pathologists identify small or rare prostate cancers that may otherwise be overlooked.
• January 2025: The FDA granted Fast Track Designation (FTD) to Clarity Pharmaceuticals’ 64Cu-SAR-bisPSMA, a PET imaging agent for detecting PSMA-positive prostate cancer lesions in patients experiencing biochemical recurrence (BCR) after definitive therapy.
• January 2025: Clarity Pharmaceuticals also announced another FTD approval for 64Cu-SAR-bisPSMA, enabling expedited clinical development and regulatory review, potentially speeding up its availability for prostate cancer 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.

With 150+ players and 160+ pipeline drugs, the prostate cancer space is evolving rapidly. Get your copy of DelveInsight’s Prostate Cancer Pipeline Report to stay competitive @ Prostate Cancer Pipeline Analysis

Prostate Cancer Overview

Prostate cancer is one of the most common cancers affecting men, particularly those over the age of 50. It develops in the prostate gland, a small walnut-shaped organ responsible for producing seminal fluid. While many prostate cancers grow slowly and may remain asymptomatic for years, aggressive forms can spread rapidly to bones and other organs, making early detection essential.

The primary risk factors of Prostate cancer include advanced age, family history, genetic mutations, and certain lifestyle factors. African American men and those with a family history of prostate or breast cancer are at higher risk. Common symptoms may include difficulty urinating, weak urine flow, pelvic discomfort, or blood in urine. However, in early stages, prostate cancer may not cause noticeable signs.

Prostate cancer Diagnosis typically involves prostate-specific antigen (PSA) blood tests, digital rectal exams (DRE), imaging techniques like MRI, and biopsy confirmation. Prostate cancer Treatment strategies depend on the stage, aggressiveness, and overall health of the patient. Options include active surveillance, surgery, radiation therapy, hormone therapy, chemotherapy, and newer targeted or immunotherapy approaches.

Rising awareness, advanced diagnostic tools, and novel therapies are improving survival rates and patient outcomes are some of the factors affecting Prostate cancer market. Timely screening and personalized treatment remain crucial in managing prostate cancer effectively.

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

Discover key players, breakthrough therapies, regulatory updates, and late-stage clinical trials shaping the future of prostate cancer treatment. @ Prostate Cancer Clinical Trials and FDA Approvals

Prostate Cancer Therapeutics Assessment

Niraparib (Janssen Research & Development/GSK)

Niraparib is an oral PARP inhibitor marketed as ZEJULA by GSK’s oncology division. Janssen holds rights for prostate cancer development (excluding Japan) through a partnership with TESARO. Already approved in ovarian cancers, niraparib is in Phase III trials for mCRPC and mCSPC.

ZEN-3694 (Zenith Epigenetics)

ZEN-3694 is an oral BET inhibitor that blocks bromodomain proteins (BRD2, BRD3, BRD4, BRDT) involved in tumor growth and survival. By targeting oncogenic super enhancers, it may disrupt cancer proliferation, metastasis, and immune evasion. It is currently in Phase II development for prostate cancer.

Ladiratuzumab Vedotin (Seagen)

This ADC targets LIV-1, expressed in several cancers including prostate cancer. Using Seagen’s ADC technology, it links a LIV-1–directed antibody to the cytotoxic agent MMAE. It works by delivering targeted cell death and may also trigger immune responses. The therapy is under Phase II evaluation for prostate cancer.

FOR46 (Fortis Therapeutics)

FOR46 is an antibody-drug conjugate directed against CD46, a target highly expressed in prostate cancer and multiple myeloma. The drug is in Phase I/II trials for metastatic castration-resistant prostate cancer (mCRPC).

REGN5678 (Regeneron Pharmaceuticals)

REGN5678 is a bispecific antibody that binds CD28 on T cells and PSMA on tumor cells, helping T cells attack prostate cancer with reduced toxicity risk compared to CD3 bispecifics. It is in Phase I/II development.

Prostate Cancer Phases

DelveInsight’s report highlights over 150 products across multiple stages of clinical development, including:

• Late-stage therapies (Phase III)
• Mid-stage therapies (Phase II)
• Early-stage therapies (Phase I), along with details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive therapies

Stay ahead with therapeutic assessments across multiple molecule types and MoAs. For further information on the prostate cancer pipeline therapeutics, reach out @ Prostate Cancer Therapeutics Market

Prostate Cancer Drugs Route of Administration

The Prostate Cancer pipeline report evaluates drugs based on their Route of Administration (ROA). Candidates are classified into categories such as:

• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

Prostate Cancer Drugs Molecule Type

Pipeline products are also segmented by Molecule Type, including:

• Monoclonal Antibodies
• Peptides
• Polymers
• Small Molecules
• Gene Therapies

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

Explore the latest prostate cancer pipeline therapies — from PARP inhibitors to next-gen ADCs and bispecifics. Get competitive insights on Janssen, GSK, Seagen, Fortis & Regeneron. @ Prostate Cancer Drugs and Therapies

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 Prostate Cancer Companies

14. Key Products in the Prostate Cancer Pipeline15. Prostate Cancer Unmet Needs

16. Prostate Cancer Market Drivers and Barriers

17. Future Perspectives and Conclusion

18. Analyst Views

19. Appendix

About DelveInsight

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