The treatment paradigm for prostate cancer is witnessing rapid transformation, with more than 150 companies advancing innovative drug candidates across diverse clinical phases. Recent milestones include multiple FDA fast-track designations, companion diagnostic approvals, and positive clinical outcomes for therapies such as NUBEQA®, Xtandi™, and Cabometyx®.
Late- and mid-stage candidates including Janssen’s Niraparib (Phase III), Zenith Epigenetics’ ZEN-3694 (Phase II), Seagen’s Ladiratuzumab Vedotin (Phase II), Fortis Therapeutics’ FOR46 (Phase I/II), and Regeneron’s REGN5678 (Phase I/II)—highlight a broad range of mechanisms, spanning PARP inhibition, antibody-drug conjugates (ADCs), and bispecific antibodies. Collectively, these advancements reflect strong investment and scientific innovation aimed at enhancing survival outcomes and quality of life for prostate cancer patients.
DelveInsight’s “Prostate Cancer Pipeline Insight 2026” provides a comprehensive evaluation of the global pipeline landscape, analyzing therapies across clinical stages and profiling the strategies of leading pharmaceutical innovators. According to DelveInsight, more than 150 major companies are developing over 160 therapeutic candidates in prostate cancer. The report delivers detailed insights into ongoing clinical trials, mechanisms of action, routes of administration, regulatory developments, and future commercial potential within this rapidly evolving market.
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 Highlights from the Prostate Cancer Pipeline Report
- The prostate cancer pipeline demonstrates remarkable depth, with 150+ active companies collectively advancing 160+ drug candidates.
- Major industry participants include Merck & Co., Inc., Telix Pharmaceuticals Limited, Exelixis, Inc., AstraZeneca PLC, Pfizer Inc., Bristol-Myers Squibb Company, AbbVie Inc., BeiGene, Ltd., and Ipsen S.A., among many others—are actively developing next-generation therapies to reshape the treatment landscape.
- Prominent pipeline therapies under clinical evaluation include 177Lu-PSMA-I&T, Opevesostat (MK-5684), Cabozantinib, Capivasertib, Masitinib, Fuzuloparib, Mevrometostat (PF-06821497), ZEN-3694, OPDIVO (nivolumab), KEYTRUDA, Saruparib (AZD5305), CAN-2409, and numerous additional investigational candidates spanning radioligands, targeted inhibitors, immunotherapies, and combination regimens.
Recent Regulatory & Clinical Developments
- August 2025: Halda Therapeutics received FDA Fast Track designation for HLD-0915 for metastatic castration-resistant prostate cancer (mCRPC).
- July 2025: Trethera Corporation secured FDA Fast Track designation for TRE-515, currently in Phase I trials, including combination strategies with PSMA-targeted radioligand therapy.
- July 2025: AB Science S.A. announced FDA and EMA authorization of a confirmatory Phase III trial of masitinib in mCRPC.
- June 2025: Bayer AG, in collaboration with Orion, received FDA approval for darolutamide plus ADT for metastatic castration-sensitive prostate cancer (mCSPC), supported by strong Phase III data from the ARANOTE study.
- May 2025: Candel Therapeutics, Inc. obtained FDA RMAT designation for CAN-2409 for localized intermediate-to-high-risk prostate cancer.
- March 2025: Telix Pharmaceuticals Limited gained FDA approval for TLX007-CDx (Gozellix), a diagnostic imaging agent.
- February 2025: Ibex Medical Analytics received FDA 510(k) clearance for Ibex Prostate Detect, an AI-based diagnostic solution.
- January 2025: Clarity Pharmaceuticals secured FDA Fast Track designation for 64Cu-SAR-bisPSMA, a PET imaging agent for detecting PSMA-positive recurrence.
Additional updates across 2024–2025 include fast-track designations, investigational new drug clearances, and pivotal trial advancements for multiple targeted and radiopharmaceutical therapies.
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 Clinical Trial Analysis
Prostate Cancer Overview
Prostate cancer remains one of the most prevalent malignancies among men, particularly those over 50. The disease originates in the prostate gland. While many cases progress slowly, aggressive forms can metastasize to bones and other organs, underscoring the importance of early detection.
Major risk factors include aging, genetic predisposition, family history, and lifestyle influences. Diagnosis typically involves PSA testing, digital rectal examination (DRE), MRI imaging, and biopsy confirmation.
Treatment approaches vary depending on disease stage and patient health status and may include active surveillance, surgery, radiation therapy, androgen deprivation therapy, chemotherapy, targeted therapies, and immunotherapies. Continued innovation in diagnostics and therapeutics is improving survival outcomes and expanding personalized care options.
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 Companies and FDA Approvals
Spotlight on Key Pipeline Therapies
- Niraparib (ZEJULA) – Developed by Janssen in collaboration with GSK, this oral PARP inhibitor is in Phase III trials for metastatic prostate cancer.
- ZEN-3694 – From Zenith Epigenetics, this BET inhibitor is in Phase II development targeting oncogenic transcription pathways.
- Ladiratuzumab Vedotin – An ADC from Seagen Inc. targeting LIV-1, currently in Phase II trials.
- FOR46 – An ADC developed by Fortis Therapeutics targeting CD46, in Phase I/II studies.
- REGN5678 – A bispecific antibody from Regeneron Pharmaceuticals designed to activate T cells against PSMA-expressing tumor cells.
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 Assessment
Clinical Development Landscape
DelveInsight’s report categorizes prostate cancer therapies across:
- Late-stage (Phase III / Pre-registration)
- Mid-stage (Phase II)
- Early-stage (Phase I)
- Preclinical and discovery phases
- Discontinued or inactive programs
The analysis further evaluates drugs by route of administration (oral, intravenous, subcutaneous, parenteral, topical), molecule type (monoclonal antibodies, peptides, polymers, small molecules, gene therapies), and mechanisms of action including PSMA inhibitors, PARP inhibitors, EZH2 inhibitors, CYP17A1 inhibitors, and radioligand emitters.
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
DelveInsight is a leading Healthcare 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.
Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Ankit Nigam
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Albany
State: New York
Country: United States
Website: https://www.delveinsight.com/consulting