Prostate Cancer Pipeline Outlook 2025 - Clinical Trials, Treatment, ROA, Medication, MOA, Revenue Share, Companies by DelveInsight

The prostate cancer pipeline is experiencing unprecedented growth, driven by 150+ active players, breakthrough therapies, and recent FDA fast-track designations, signaling a transformative decade ahead in prostate cancer treatment.
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 Registered , Xtandi Trademark , and Cabometyx Registered . 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 @ [https://www.delveinsight.com/report-store/prostate-cancer-pipeline-insight?utm_source=abnewswire&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 August 2025, Halda Therapeutics, a clinical-stage biotechnology company developing a novel class of therapies called RIPTAC Trademark 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



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