Rashtriya Newsflash

Prostate Cancer Pipeline

The prostate cancer treatment arena is undergoing rapid transformation, with over 150 organizations actively working on novel therapies across multiple stages of clinical development. Recent advancements include FDA fast-track recognitions, approvals of companion diagnostic tools, and positive clinical outcomes for established therapies such as NUBEQA®, Xtandi™, and Cabometyx®. In parallel, late- and mid-stage investigational agents—including 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 a broad range of therapeutic strategies such as PARP inhibition, antibody–drug conjugates, and bispecific antibodies. Collectively, these developments underscore the strong innovation momentum and sustained investment focused on improving survival outcomes and quality of life for prostate cancer patients.

DelveInsight’s “Prostate Cancer Pipeline Insight” delivers a comprehensive evaluation of the global prostate cancer pipeline, encompassing therapies at various clinical stages and showcasing the initiatives of leading pharmaceutical and biotechnology players. As per DelveInsight’s analysis, more than 150 major companies are currently developing over 160 therapeutic candidates for prostate cancer. The report offers in-depth insights into clinical trial progress, mechanisms of action, administration routes, and recent developmental updates, while also assessing the long-term growth prospects of the prostate cancer treatment market.

Request your free sample of the Prostate Cancer Pipeline Report today to gain actionable intelligence, benchmark competitors, uncover opportunities, and optimize pipeline strategies @ Prostate Cancer Pipeline Report

Key Highlights from the Prostate Cancer Pipeline Report

• DelveInsight’s prostate cancer pipeline analysis reveals a highly dynamic ecosystem with over 150 active participants collectively advancing more than 160 pipeline therapies.
• Leading organizations—including Curium, Merck, Telix Pharmaceuticals, Exelixis, AstraZeneca, AB Science, Lantheus, Pfizer, Jiangsu Hengrui Pharmaceuticals, Modra Pharmaceuticals, Bristol-Myers Squibb, MacroGenics, Syntrix Pharmaceuticals, Zenith Epigenetics, Xencor, 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, 858 Therapeutics, Avacta Life Sciences, Nammi Therapeutics, BeiGene, DualityBio, and others—are actively evaluating next-generation therapies to enhance prostate cancer care.
• A diverse set of promising pipeline assets—including 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, 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, among others—are being assessed across different clinical phases.
• August 2025: Halda Therapeutics announced that the FDA granted Fast Track designation to its lead candidate HLD-0915 for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
• July 2025: Trethera Corporation received FDA Fast Track designation for TRE-515, a first-in-class agent currently in Phase I trials, for use in combination with radioligand therapy for PSMA-positive mCRPC.
• July 2025: AB Science SA confirmed FDA and EMA authorization for a confirmatory Phase III trial of masitinib (study AB22007) in metastatic castration-resistant prostate cancer, targeting patients with less advanced metastatic disease using a biomarker-driven approach.
• June 2025: Bayer, in collaboration with Orion, announced FDA approval of darolutamide in combination with androgen deprivation therapy for metastatic castration-sensitive prostate cancer, supported by positive Phase III ARANOTE trial outcomes.
• May 2025: Candel Therapeutics received FDA RMAT designation for CAN-2409 in newly diagnosed localized prostate cancer patients at intermediate-to-high risk, in addition to its previously granted Fast Track status.
• March 2025: The FDA approved Telix Pharmaceuticals’ NDA for TLX007-CDx (Gozellix), a diagnostic imaging agent for prostate cancer.
• March 2025: Quibim secured FDA 510(k) clearance for QP-Prostate® CAD, enhancing prostate lesion detection and diagnostic accuracy.
• February 2025: Ibex Medical Analytics obtained FDA 510(k) clearance for Ibex Prostate Detect, an AI-based pathology tool designed to identify subtle or rare prostate cancers.
• January 2025: The FDA granted Fast Track designation to Clarity Pharmaceuticals’ 64Cu-SAR-bisPSMA PET imaging agent for detecting PSMA-positive lesions in patients with biochemical recurrence.
• September 2024: Ipsen reported that the Phase III CONTACT-02 trial of Cabometyx plus atezolizumab met its progression-free survival endpoint despite a non-significant overall survival improvement.
• August 2024: Nuvation Bio announced FDA clearance of its IND application for NUV-1511, the first clinical candidate from its proprietary drug–drug conjugate platform.
• July 2024: The FDA granted Fast Track designation to SYNC-T SV-102 for mCRPC.
• June 2024: Kangpu Biopharmaceuticals received FDA approval to initiate a Phase II/III trial of KPG-121 in combination with abiraterone for mCRPC.
• June 2024: BioNTech and Duality Biologics received FDA Fast Track designation for BNT324/DB-1311 in advanced or metastatic castration-resistant prostate cancer.

With more than 150 active developers and over 160 pipeline assets, the prostate cancer landscape is advancing at an unprecedented pace. Access DelveInsight’s Prostate Cancer Pipeline Report to remain competitive @ Prostate Cancer Clinical Trial Analysis

Prostate Cancer Overview

Prostate cancer is among the most frequently diagnosed malignancies in men, particularly affecting those aged 50 and above. Originating in the prostate gland, which plays a key role in seminal fluid production, the disease can remain indolent for extended periods, although aggressive variants may metastasize rapidly to bones and other organs—making early diagnosis critical.

Major risk factors include aging, hereditary predisposition, genetic alterations, and lifestyle influences. Higher incidence rates are observed among African American men and individuals with a family history of prostate or breast cancer. Symptoms may involve urinary difficulties, reduced urine flow, pelvic pain, or the presence of blood in urine, though early-stage disease often remains asymptomatic.

Diagnosis typically relies on PSA testing, digital rectal examination, imaging modalities such as MRI, and confirmatory biopsy. Treatment approaches vary based on disease stage and patient health, ranging from active surveillance and surgery to radiation, hormonal therapy, chemotherapy, and emerging targeted or immunotherapies.

Improved disease awareness, technological advances in diagnostics, and innovative treatments continue to enhance survival rates and patient outcomes. Early screening and personalized care remain central to effective prostate cancer management.

Download free sample report here @ Prostate Cancer Companies and FDA Approvals

Snapshot of Selected Pipeline Therapies

• 177Lu-PSMA-I&T – Curium
• Opevesostat (MK-5684; ODM-208) – Merck / Orion
• Mevrometostat (PF-06821497) – Pfizer
• TRUQAP (capivasertib) – AstraZeneca
• 177Lu-PNT2002 – Lantheus
• 177Lu-DOTA-rosopatamab (TLX591) – Telix Pharmaceuticals
• TAVT-45 – Tavanta Therapeutics
• Saruparib (AZD5305) – AstraZeneca
• CAN-2409 – Candel Therapeutics
• Fuzuloparib – Jiangsu Hengrui Pharmaceuticals

Explore breakthrough therapies, regulatory developments, and late-stage trials shaping the future of prostate cancer care @ Prostate Cancer Companies and FDA Approvals

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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

About DelveInsight

DelveInsight is a leading 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.

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