Metastatic Castration-Resistant Prostate Cancer (mCRPC) - Pipeline Insight 2025: A New Wave of Precision Therapies Targeting Advanced Prostate Cancer | DelveInsight

DelveInsight's "Metastatic Castration-Resistant Prostate Cancer (mCRPC) - Pipeline Insight, 2025" offers a detailed assessment of the advancing treatment landscape for one of the most aggressive forms of prostate cancer. With more than 75+ pipeline assets in various stages of development, the mCRPC space is witnessing a surge in innovative therapies focused on improving survival outcomes and overcoming resistance to androgen receptor (AR)-targeted therapies.

The report highlights a shift toward multi-modal approaches, including next-generation AR inhibitors, radioligand therapies (RLTs), PARP inhibitors, immunotherapies, and targeted ADCs. Leading candidates include TRE-515 by Trethera, granted FDA Fast Track status in 2025 for use alongside radiation therapy, and 177Lu-PSMA-617, a radiopharmaceutical showing promising efficacy in PSMA-positive mCRPC patients. These targeted approaches aim to address key resistance mechanisms and extend the therapeutic window in late-stage disease.

Companies like Jiangsu HengRui Medicine, Eleison Pharmaceuticals, Panbela Therapeutics, SynerGene Therapeutics, and Salspera, are accelerating the development of novel agents and combination regimens, particularly in molecularly defined subgroups such as BRCA-mutated or PSMA-expressing tumors. Immunotherapy-based assets, including checkpoint inhibitors and bi-specific antibodies, are also gaining traction, especially in combination with radiation or chemotherapy.

DelveInsight's report provides insights into drug profiles, MoAs, clinical trial progress, and regulatory designations. It also outlines key unmet needs, such as limited durability of response and resistance to AR-directed therapies, along with emerging biomarkers guiding patient selection.

As we enter 2025, the mCRPC pipeline is poised to reshape the standard of care by introducing more personalized and effective treatment paradigms for patients battling this challenging late-stage prostate cancer.

Interested in learning more about the current treatment landscape and the key drivers shaping the metastatic castration-resistant prostate cancer pipeline? Click here: https://www.delveinsight.com/report-store/metastatic-castration-resistant-prostate-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Metastatic Castration-Resistant Prostate Cancer Pipeline Report
• DelveInsight's metastatic castration-resistant prostate cancer pipeline analysis depicts a strong space with 75+ active players working to develop 75+ pipeline drugs for metastatic castration-resistant prostate cancer treatment.
• The leading metastatic castration-resistant prostate cancer companies include Jiangsu HengRui Medicine, Eleison Pharmaceuticals, Panbela Therapeutics, SynerGene Therapeutics, Salspera, BioLineRx, Ocuphire Pharma, Incyte Corporation, Eli Lilly and Company, Rexahn Pharmaceuticals, AB Science, Takeda Oncology, and others are evaluating their lead assets to improve the metastatic castration-resistant prostate cancer treatment landscape.
• Key metastatic castration-resistant prostate cancer pipeline therapies in various stages of development include Fuzuloparib, Glufosfamide (Eleison Pharmaceuticals), SBP 101, SGT-53, MDB 401 B, Motixafortide, Epacadostat, Retifanlimab, Roducitabine, Olaratumab, RX 0201, Masitinib, Simurosertib, and others.
• In July 2025, Trethera Corporation, a clinical-stage biopharmaceutical company focused on innovative cancer and autoimmune therapies, announced that the FDA granted Fast Track designation to its drug TRE-515 for prostate cancer treatment. TRE-515 is currently undergoing Phase 1 clinical trials for solid tumors.
• In July 2025, Artera, a developer of multimodal AI-based cancer prognostic and predictive tests, announced that the FDA granted Breakthrough Device Designation to ArteraAI Prostate, an AI tool designed to help clinicians make risk-based decisions for patients with localized prostate cancer.
• In July 2025, AB Science announced that the FDA and EMA had authorized a confirmatory Phase III trial of masitinib for metastatic castrate-resistant prostate cancer, focusing on patients with less advanced metastatic disease using a specific biomarker.
• In June 2025, Archeus Technologies received FDA clearance for its IND application for ART-101, a novel receptor-targeting small molecule for imaging and treating metastatic castration-resistant prostate cancer (mCRPC), enabling the start of a Phase I trial later this year.
• In June 2025, Bayer announced FDA approval of NUBEQA (darolutamide) with androgen deprivation therapy (ADT) for treating metastatic castration-sensitive prostate cancer (mCSPC). The approval is based on Phase III ARANOTE trial results, where the combination reduced the risk of radiological progression or death by 46% versus placebo plus ADT.
• In May 2025, the FDA's Oncologic Drugs Advisory Committee (ODAC) unanimously voted against approving talazoparib (Talzenna) combined with enzalutamide (Xtandi) for non-HRR-mutant metastatic castration-resistant prostate cancer (mCRPC), based on phase III TALAPRO-2 trial data.

Request a sample and discover the recent breakthroughs happening in the metastatic castration-resistant prostate cancer pipeline landscape at https://www.delveinsight.com/report-store/metastatic-castration-resistant-prostate-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Metastatic Castration-Resistant Prostate Cancer Overview
Prostate cancer (PCa) is one of the most common cancers globally and ranks as the third leading cause of cancer-related death among men in the United States. Most men diagnosed with PCa initially have localized disease and typically receive radical prostatectomy and/or radiation therapy, followed by androgen deprivation therapy (ADT). Depending on the cancer's grade, a portion of patients will progress to castration-resistant prostate cancer (CRPC) within 10 years. Previously referred to as "hormone-refractory" or "androgen-independent" prostate cancer, CRPC still depends on hormones for androgen receptor (AR) activation despite the failure of castration treatments like ADT.

Find out more about metastatic castration-resistant prostate cancer medication at https://www.delveinsight.com/report-store/metastatic-castration-resistant-prostate-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Metastatic Castration-Resistant Prostate Cancer Treatment Analysis: Drug Profile
SRF617: Surface Oncology
SRF617 is a fully human antibody that inhibits CD39 enzymatic activity in the tumor microenvironment. This dual-action mechanism reduces immunosuppressive adenosine while increasing immunostimulatory ATP levels, boosting anti-tumor immunity. The FDA has granted SRF617 Orphan Drug designation for advanced pancreatic cancer treatment.

Rucaparib: Clovis Oncology
Rucaparib is an oral small molecule that inhibits PARP1, PARP2, and PARP3. It is being developed as a monotherapy and in combination therapies for various cancers, including ovarian and metastatic castration-resistant prostate cancers, with exploratory studies ongoing in other tumor types.

HP518: Hinova Pharmaceuticals
HP518 is a highly selective, orally bioavailable chimeric degrader targeting the androgen receptor (AR). It aims to overcome prostate cancer drug resistance linked to specific AR mutations. Preclinical studies demonstrated potent degradation of wild-type AR and certain resistant mutants, along with strong antitumor effects in xenograft mouse models.

Learn more about the novel and emerging metastatic castration-resistant prostate cancer pipeline therapies at https://www.delveinsight.com/report-store/metastatic-castration-resistant-prostate-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Metastatic Castration-Resistant Prostate Cancer Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Intravenous
• Subcutaneous

By Molecule Type
• Small molecule
• Cell Therapy
• Peptides
• Polymer
• Small molecule
• Gene therapy

Scope of the Metastatic Castration-Resistant Prostate Cancer Pipeline Report
• Coverage: Global
• Key Metastatic Castration-Resistant Prostate Cancer Companies: Jiangsu HengRui Medicine, Eleison Pharmaceuticals, Panbela Therapeutics, SynerGene Therapeutics, Salspera, BioLineRx, Ocuphire Pharma, Incyte Corporation, Eli Lilly and Company, Rexahn Pharmaceuticals, AB Science, Takeda Oncology, and others.
• Key Metastatic Castration-Resistant Prostate Cancer Pipeline Therapies: Fuzuloparib, Glufosfamide (Eleison Pharmaceuticals), SBP 101, SGT-53, MDB 401 B, Motixafortide, Epacadostat, Retifanlimab, Roducitabine, Olaratumab, RX 0201, Masitinib, Simurosertib, and others.

To dive deep into rich insights for drugs used for metastatic castration-resistant prostate cancer treatment, visit: https://www.delveinsight.com/report-store/metastatic-castration-resistant-prostate-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Metastatic Castration-Resistant Prostate Cancer Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Metastatic Castration-Resistant Prostate Cancer Pipeline Therapeutics
6. Metastatic Castration-Resistant Prostate Cancer Pipeline: Late-Stage Products (Phase III)
7. Metastatic Castration-Resistant Prostate Cancer Pipeline: Mid-Stage Products (Phase II)
8. Metastatic Castration-Resistant Prostate Cancer Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

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. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve.

This release was published on openPR.