Prostate Cancer Pipeline 2025: MOA And ROA Insights, Clinical Trials Status, And Key Companies Involved By Delveinsight Telix Pharma, Merck, Orion Pharma, Exelixis, Ipsen Pharma And Takeda, Pfizer
“Prostate Cancer Pipeline Insight, 2025 " report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Prostate Cancer Market.
The Prostate Cancer Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.
Some of the key takeaways from the Prostate Cancer Pipeline Report:
Companies across the globe are diligently working toward developing novel Prostate Cancer treatment therapies with a considerable amount of success over the years.
Prostate Cancer companies working in the treatment market are Telix Pharmaceuticals, Merck and Orion, Exelixis, Ipsen Pharma and Takeda, Pfizer, AstraZeneca, Kangpu Biopharmaceuticals, Merus, Blue Earth Therapeutics, and others, are developing therapies for the Prostate Cancer treatment
Emerging Prostate Cancer therapies in the different phases of clinical trials are- 1 77Lu-DOTA-rosopatamab (TLX591) IV infusion, Opevesostat (MK-5684; ODM-208) Oral, CABOMETYX (cabozantinib, XL184) Oral, Mevrometostat (PF-06821497) Oral, TRUQAP (Capivasertib) Oral, KPG-121 Oral, BIZENGRI (zenocutuzumab) IV, 177Lu-rhPSMA-10.1 IV, and others are expected to have a significant impact on the Prostate Cancer market in the coming years.
In January 2026, The Alliance for Clinical Trials in Oncology is set to initiate a clinical study aimed at determining whether adjusting the timing of radiation therapy for prostate cancer can reduce side effects while preserving treatment effectiveness. The Phase III RECIPROCAL trial will enroll 1,500 patients with metastatic, castration-resistant prostate cancer, who will receive two infusions of lutetium-177 (Lu-177) prostate-specific membrane antigen (PSMA)–targeted radioligand therapy every six weeks. While this therapy enhances survival, it may also lead to side effects including dry mouth, fatigue, gastrointestinal issues, as well as blood disorders, kidney damage, or liver complications.
In June 2025, MSD and Daiichi Sankyo announced that the first patient has been dosed in the randomized Phase III IDeate-Prostate01 trial, comparing ifinatamab deruxtecan (I-DXd) with docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC). I-DXd, a potential first-in-class B7-H3-directed antibody-drug conjugate (ADC), was discovered by Daiichi Sankyo and is being co-developed with MSD. This open-label, multicenter trial is evaluating the ADC in mCRPC patients whose disease has progressed during or after treatment with an androgen receptor pathway inhibitor.
In June 2025, Novartis announced topline results from the pre-specified interim analysis of the Phase III PSMAddition trial, showing that Pluvicto (lutetium (177Lu) vipivotide tetraxetan) combined with standard of care (SoC) provided benefits in treating prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC). The open-label study met its primary endpoint, with the combination demonstrating radiographic progression-free survival (rPFS) benefits and a positive trend in overall survival (OS). In this trial, the SoC consisted of androgen receptor pathway inhibitor (ARPI) therapy plus androgen deprivation therapy (ADT).
In May 2025, Astellas Pharma Inc. (TSE: 4503) and Pfizer Inc. (NYSE: PFE) have announced long-term follow-up results from an open-label extension of the Phase 3 ARCHES (NCT02677896) study. The five-year data showed that men with metastatic hormone-sensitive prostate cancer (mHSPC) treated with XTANDI (enzalutamide), an androgen receptor pathway inhibitor (ARPI), plus androgen deprivation therapy (ADT) had a 30% lower risk of death compared to those receiving placebo plus ADT. These findings will be presented in an oral session (Abstract #5005) at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
In February 2025, Israeli pharmaceutical company RedHill Biopharma launched a placebo-controlled Phase II trial to evaluate the combination of opaganib and darolutamide for treating metastatic castration-resistant prostate cancer (mCRPC). The study, involving 80 male participants, aims to assess whether opaganib can enhance the effectiveness of standard androgen receptor pathway inhibition (ARPI) therapy. This randomized trial also incorporates the PCPro lipid biomarker test to identify mCRPC patients with poor prognosis who may benefit from the combination treatment.
In February 2025, Mevrometostat, an EZH2 inhibitor, combined with enzalutamide and androgen deprivation therapy (ADT), demonstrated improved radiographic progression-free survival (rPFS) compared to enzalutamide alone in patients with metastatic castration-resistant prostate cancer (mCRPC). These findings are from the dose expansion phase of a Phase 1b/2 clinical trial, presented at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (Abstract LBA138).
In the Phase III VISION study for PLUVICTO, the primary endpoints were Overall Survival (OS) and radiographic Progression-Free Survival (rPFS), with Overall Response Rate (ORR) by BICR included as an additional efficacy measure.
Another ongoing trial assessing capivasertib in combination with docetaxel aims to demonstrate superiority over placebo in terms of overall survival. Secondary outcome measures include radiographic Progression-Free Survival (rPFS) and Time to Pain Progression (TTPP).
Prostate Cancer Overview
Prostate cancer is a common malignancy that develops in the prostate gland, a small organ in men. It typically grows slowly and may remain asymptomatic in its early stages, though some forms can be aggressive. Risk factors include advancing age, family history, genetic predisposition, and lifestyle factors. Common symptoms, when present, may include difficulty urinating, weak urine flow, blood in urine, and pelvic discomfort. Prostate cancer is often detected through prostate-specific antigen (PSA) testing, digital rectal examination, and confirmed by biopsy. Treatment options vary based on disease stage and risk level and may include active surveillance, surgery, radiation therapy, hormone therapy, chemotherapy, and targeted or immunotherapies.
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Emerging Prostate Cancer Drugs Under Different Phases of Clinical Development Include:
177Lu-DOTA-rosopatamab (TLX591) IV infusion: Telix Pharmaceuticals
Opevesostat (MK-5684; ODM-208) Oral: Merck and Orion
CABOMETYX (cabozantinib, XL184) Oral: Exelixis, Ipsen Pharma and Takeda
Mevrometostat (PF-06821497) Oral: Pfizer
TRUQAP (Capivasertib) Oral: AstraZeneca
KPG-121 Oral: Kangpu Biopharmaceuticals
BIZENGRI (zenocutuzumab) IV: Merus
177Lu-rhPSMA-10.1 IV: Blue Earth Therapeutics
Prostate Cancer 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 Molecule Type
Prostate Cancer Products have been categorized under various Molecule types, such as
Monoclonal Antibody
Peptides
Polymer
Small molecule
Gene therapy
Prostate Cancer Pipeline Therapeutics Assessment
Prostate Cancer Assessment by Product Type
Prostate Cancer By Stage and Product Type
Prostate Cancer Assessment by Route of Administration
Prostate Cancer By Stage and Route of Administration
Prostate Cancer Assessment by Molecule Type
Prostate Cancer by Stage and Molecule Type
DelveInsight's Prostate Cancer Report covers around 150+ products under different phases of clinical development like
Late-stage products (Phase III)
Mid-stage products (Phase II)
Early-stage product (Phase I)
Pre-clinical and Discovery stage candidates
Discontinued & Inactive candidates
Route of Administration
Further Prostate Cancer product details are provided in the report. Download the Prostate Cancer pipeline report to learn more about the emerging Prostate Cancer therapies
Some of the key companies in the Prostate Cancer Therapeutics Market include:
Key companies developing therapies for Prostate Cancer are - 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, Curium, Merck, Telix Pharmaceuticals, Exelixis, AstraZeneca, AB Science, Lantheus, Pfizer, Jiangsu Hengrui Pharmaceuticals, Modra Pharmaceuticals, Bristol-Myers Squibb, 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.
Prostate Cancer Pipeline Analysis:
The Prostate Cancer pipeline report provides insights into
The report provides detailed insights about companies that are developing therapies for the treatment of Prostate Cancer with aggregate therapies developed by each company for the same.
It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Prostate Cancer Treatment.
Prostate Cancer key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
Prostate Cancer Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Prostate Cancer market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.
Download Sample PDF Report to know more about Prostate Cancer drugs and therapies
Prostate Cancer Pipeline Market Drivers
The prostate cancer emerging pipeline consists of various novel molecules such as lorigerlimab an investigational, bispecific DART molecule that targets PD-1 and CTLA-4, CAN-2409 an oncolytic gene therapy among others.
The use of ADT primarily dominates the current treatment pattern for patients with prostate cancer. Although the sizable portion of the mCSPC market is captured by hormonal therapies, label expansion of XTANDI, NUBEQA, and ERLEADA for mCSPC are expected to help drive the overall market growth.
Prostate Cancer Pipeline Market Barriers
With a series of discouraging studies in recent years Merck's KEYTRUDA and Bristol-Myers Squibb's OPDIVO are struggling to make headway for its checkpoint inhibitors in prostate cancer.
Despite excellent double and triplet therapy options, novel targets and treatment development with enhanced prognostication for mCSPC patients is needed
Scope of Prostate Cancer Pipeline Drug Insight
Coverage: Global
Key Prostate Cancer Companies: Telix Pharmaceuticals, Merck and Orion, Exelixis, Ipsen Pharma and Takeda, Pfizer, AstraZeneca, Kangpu Biopharmaceuticals, Merus, Blue Earth Therapeutics, and others
Key Prostate Cancer Therapies: 177Lu-DOTA-rosopatamab (TLX591) IV infusion, Opevesostat (MK-5684; ODM-208) Oral, CABOMETYX (cabozantinib, XL184) Oral, Mevrometostat (PF-06821497) Oral, TRUQAP (Capivasertib) Oral, KPG-121 Oral, BIZENGRI (zenocutuzumab) IV, 177Lu-rhPSMA-10.1 IV, and others
Prostate Cancer Therapeutic Assessment: Prostate Cancer current marketed and Prostate Cancer emerging therapies
Prostate Cancer Market Dynamics: Prostate Cancer market drivers and Prostate Cancer market barriers
Request for Sample PDF Report for Prostate Cancer Pipeline Assessment and clinical trials
Table of Contents
1. Prostate Cancer Report Introduction
2. Prostate Cancer Executive Summary
3. Prostate Cancer Overview
4. Prostate Cancer- Analytical Perspective In-depth Commercial Assessment
5. Prostate Cancer Pipeline Therapeutics
6. Prostate Cancer Late Stage Products (Phase II/III)
7. Prostate Cancer Mid Stage Products (Phase II)
8. Prostate Cancer Early Stage Products (Phase I)
9. Prostate Cancer Preclinical Stage Products
10. Prostate Cancer Therapeutics Assessment
11. Prostate Cancer Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Prostate Cancer Key Companies
14. Prostate Cancer Key Products
15. Prostate Cancer Unmet Needs
16. Prostate Cancer Market Drivers and Barriers
17. Prostate Cancer Future Perspectives and Conclusion
18. Prostate Cancer Analyst Views
19. Appendix
20. About DelveInsight
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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
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