DelveInsight’s, “Metastatic Prostate Cancer Pipeline Insights 2026” report provides comprehensive insights about 80+ companies and 85+ pipeline drugs in Metastatic Prostate Cancer pipeline landscape. It covers the Metastatic Prostate Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Metastatic Prostate Cancer pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Metastatic Prostate Cancer Pipeline Report

• On June 30, 2026- AstraZeneca conducted a phase Ib/II study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of multiple anti-cancer agents in participants with metastatic prostate cancer.
• On June 26, 2026- Novartis Pharmaceuticals initiated a Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + lutetium (177Lu) vipivotide tetraxetan (hereafter referred as AAA617) compared with AAA617 (control) in participants with metastatic Castration Resistant Prostate Cancer (mCRPC) with prior exposure to at least 1 Androgen Receptor Pathway Inhibitor (ARPI) and 0-2 taxane regimens and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and pharmacokinetic (PK) data from participants randomized in the study will be evaluated.
• On June 26, 2026- Halda Therapeutics OpCo Inc. announced a Phase 1/2 study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of oral single-agent HLD-0915. The study includes an initial Phase 1 open-label portion to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) of HLD-0915 as monotherapy, followed by Phase 2 expansion cohorts to further evaluate the safety and efficacy of HLD-0915.
• On June 24, 2026- H. Lee Moffitt Cancer Center and Research Institute initiated a phase II study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastases would enhance the activation of antigen presenting cells (APC) by sipuleucel-T.
• DelveInsight’s Metastatic Prostate Cancer Pipeline report depicts a robust space with 80+ active players working to develop 85+ pipeline therapies for Metastatic Prostate Cancer treatment.
• The leading Metastatic Prostate Cancer Companies such as Telix Pharmaceuticals, Candel Therapeutics, Astellas Pharma, ORIC Pharmaceuticals, Roche, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Geode Therapeutics Inc, Cullgen, AstraZeneca, TYK Medicines, Inc, K36 Therapeutics, Inc., Bristol-Myers Squibb, Kyntra Bio, ARTBIO Inc., Acerand Therapeutics, Janux Therapeutics, Evopoint Biosciences Inc., AbbVie, Arsenal Biosciences, Inc., Fusion Pharmaceuticals Inc. and others.
• Promising Metastatic Prostate Cancer Pipeline Therapies such as Enzalutamide, Cabazitaxel, Ifinatamab Deruxtecan, MK-5684, Aflibercept, HLD-0915, Prednisone, Quinacrine, SR31747A anad others.

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Metastatic Hormone Refractory Prostate Cancer Overview

Metastatic prostate cancer (MPC) is an advanced form of Prostate Cancer in which malignant cells spread from the prostate gland to distant organs, most frequently the bones, lymph nodes, liver, and lungs. It represents stage IV disease and is often categorized into stage IVA (spread to nearby tissues or lymph nodes) and stage IVB (spread to distant organs). Initially, many patients develop metastatic hormone-sensitive prostate cancer (mHSPC), which responds to androgen deprivation therapy (ADT). Over time, the disease may progress to metastatic castration-resistant prostate cancer (mCRPC) despite low testosterone levels, making it more aggressive and difficult to treat. Bone metastases occur in more than 70% of patients, while visceral metastases are seen in fewer than 30%. Survival varies depending on disease burden, reaching about 92 months in low-volume disease but dropping to roughly 55 months in high-volume cases.

Metastatic Prostate Cancer Emerging Drugs Profile

• TLX591: Telix Pharmaceuticals

TLX591 is an investigational radio antibody-drug conjugate (rADC) being developed for the treatment of metastatic castration-resistant Prostate Cancer (mCRPC). The therapy consists of a highly specific PSMA-targeting monoclonal antibody linked through a chelator to the radioactive isotope lutetium-177 (¹⁷⁷Lu), enabling targeted delivery of radiation to prostate cancer cells expressing PSMA. Administered intravenously in a two-dose fractionated regimen, the approach is designed to deliver a potent and localized radiation dose while minimizing exposure to healthy organs. Compared with small-molecule radioligand therapies, the antibody-based platform may provide improved tumor selectivity, longer retention time, and enhanced internalization within cancer cells. This targeted strategy aims to increase therapeutic efficacy while limiting off-target toxicity. TLX591 is currently being evaluated in Phase III clinical development for the treatment of metastatic prostate cancer.

• CAN-2409: Candel Therapeutics

CAN-2409 is an investigational gene-mediated immunotherapy being developed for the treatment of metastatic prostate cancer (MPC). The therapy uses a replication-deficient adenoviral vector to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene directly into tumor cells. Following administration of an antiviral prodrug such as Valacyclovir, the modified tumor cells convert the drug into a toxic metabolite, leading to selective cancer cell death. This process also stimulates a systemic immune response against tumor antigens, potentially enhancing antitumor activity beyond the treated site. The drug is currently being evaluated in Phase III clinical development for metastatic prostate cancer.

• ASP5541: Astellas Pharma

ASP5541 is an investigational small-molecule therapy being explored for the treatment of metastatic prostate cancer (MPC). The drug functions as a selective androgen receptor (AR) antagonist designed to inhibit androgen-mediated signaling that drives tumor growth and progression. By blocking activation of the androgen receptor, ASP5541 aims to suppress prostate cancer cell proliferation even in advanced or treatment-resistant disease. This mechanism is particularly relevant in metastatic castration-resistant prostate cancer, where AR signaling remains a key driver despite reduced testosterone levels. ASP5541 is being evaluated in Phase II stage of clinical trials for the treatment of advanced prostate cancer.

• ORIC-944: ORIC Pharmaceuticals

ORIC-944 is an investigational small-molecule therapy being developed for the treatment of metastatic prostate cancer (MPC). The drug acts as a selective inhibitor of PRC2/EZH2, an epigenetic regulator that contributes to tumor progression and resistance to androgen receptor–targeted therapies. By blocking EZH2 activity, ORIC-944 aims to suppress cancer cell growth and restore sensitivity to hormonal treatments. The therapy is being explored particularly in combination with androgen receptor inhibitors for patients with metastatic castration-resistant prostate cancer (mCRPC). ORIC-944 is currently in Phase I/II stage of its clinical development for the treatment of advanced prostate cancer.

• RO7656594: Roche

RO7656594 is an investigational therapeutic candidate being studied for the treatment of metastatic prostate cancer (MPC). The drug is designed to modulate immune activity within the tumor microenvironment, aiming to enhance antitumor immune responses against prostate cancer cells. By targeting immune regulatory pathways, RO7656594 may help overcome immune suppression commonly observed in advanced prostate tumors. This mechanism could potentially improve the effectiveness of immune-mediated tumor clearance in metastatic disease. RO7656594 is currently in Phase I stage of its clinical development.

The Metastatic Prostate Cancer Pipeline Report Provides Insights into-

• The report provides detailed insights about companies that are developing therapies for the treatment of Metastatic 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 Metastatic Prostate Cancer Treatment.
• Metastatic Prostate Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Metastatic 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 Metastatic Prostate Cancer market

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Metastatic Prostate Cancer Companies

Telix Pharmaceuticals, Candel Therapeutics, Astellas Pharma, ORIC Pharmaceuticals, Roche, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Geode Therapeutics Inc, Cullgen, AstraZeneca, TYK Medicines, Inc, K36 Therapeutics, Inc., Bristol-Myers Squibb, Kyntra Bio, ARTBIO Inc., Acerand Therapeutics, Janux Therapeutics, Evopoint Biosciences Inc., AbbVie, Arsenal Biosciences, Inc., Fusion Pharmaceuticals Inc. and others.

Metastatic 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
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Metastatic Prostate Cancer Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

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Scope of the Metastatic Prostate Cancer Pipeline Report

• Coverage- Global
• Metastatic Prostate Cancer Companies- Telix Pharmaceuticals, Candel Therapeutics, Astellas Pharma, ORIC Pharmaceuticals, Roche, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Geode Therapeutics Inc, Cullgen, AstraZeneca, TYK Medicines, Inc, K36 Therapeutics, Inc., Bristol-Myers Squibb, Kyntra Bio, ARTBIO Inc., Acerand Therapeutics, Janux Therapeutics, Evopoint Biosciences Inc., AbbVie, Arsenal Biosciences, Inc., Fusion Pharmaceuticals Inc. and others.
• Metastatic Prostate Cancer Pipeline Therapies- Enzalutamide, Cabazitaxel, Ifinatamab Deruxtecan, MK-5684, Aflibercept, HLD-0915, Prednisone, Quinacrine, SR31747A anad others.
• Metastatic Prostate Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Metastatic Prostate Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Contents

1. Introduction
2. Executive Summary
3. Metastatic Prostate Cancer: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Metastatic Prostate Cancer– DelveInsight’s Analytical Perspective
7. Late Stage Products (Phase III)
8. TLX591: Telix Pharmaceuticals
9. Mid Stage Products (Phase II)
10. ASP5541: Astellas Pharma
11. Early Stage Products (Phase I)
12. RO7656594: Roche
13. Preclinical and Discovery Stage Products
14. Drug Name: Company Name
15. Inactive Products
16. Metastatic Prostate Cancer Key Companies
17. Metastatic Prostate Cancer Key Products
18. Metastatic Prostate Cancer- Unmet Needs
19. Metastatic Prostate Cancer- Market Drivers and Barriers
20. Metastatic Prostate Cancer- Future Perspectives and Conclusion
21. Metastatic Prostate Cancer Analyst Views
22. Metastatic Prostate Cancer Key Companies
23. Appendix

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