Thursday, February 20, 2025

Metastatic Castration-Resistant Prostate Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

Metastatic Castration-Resistant Prostate Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight’s, “Metastatic Castration-Resistant Prostate Cancer Pipeline Insight” report provides comprehensive insights about 75+ companies and 75+ pipeline drugs in the Metastatic Castration-Resistant Prostate Cancer pipeline landscape. It covers the Metastatic Castration-Resistant Prostate Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Metastatic Castration-Resistant Prostate Cancer therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Stay ahead with the latest insights! Download DelveInsight’s comprehensive Metastatic Castration-Resistant Prostate Cancer Pipeline Report to explore emerging therapies, key Metastatic Castration-Resistant Prostate Cancer Companies, and future Metastatic Castration-Resistant Prostate Cancer treatment landscapes @ Metastatic Castration-Resistant Prostate Cancer Pipeline Outlook Report

Key Takeaways from the Metastatic Castration-Resistant Prostate Cancer Pipeline Report

  • In February 2025:- Brigham and Women's Hospital-The purpose of this research study is to see how well an imaging test, called 18FDCFPyL prostate specific membrane antigen (PSMA) positron emission tomography (PET), can show the extent of prostate cancer when comparing to 68Ga-PSMA-11 PET/CT (another type of diagnostic scan for prostate cancer).
  • In February 2025:- Halda Therapeutics Inc.:- This is a Phase 1/2, open-label study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of oral single-agent HLD-0915. Patients on the study must continue androgen deprivation therapy (ADT) unless surgically castrated. The study will include an initial Phase 1 portion to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) of HLD-0915 as monotherapy and Phase 2 expansion cohorts to further evaluate the efficacy and safety of HLD-0915.
  • In February 2025:- Amgen:- The main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy [ARDT]).
  • In February 2025:- Fusion Pharmaceuticals Inc.:- This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I&T). The dose optimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor activity of novel dosing regimens of FPI-2265 in participants with PSMA-positive mCRPC who have been previously treated with 177Lu-PSMA-617 or another 177Lu-PSMA radioligand therapy (RLT). The purpose of the dose optimization segment (Phase 2) is to determine the recommended FPI-2265 dose and regimen. Conclusions from Phase 2 will be based on safety, tolerability, and anti-tumor activity.
  • In February 2025:- AstraZeneca:- The purpose of this study is to evaluate the efficacy and safety of Olaparib compared with standard of care (Enzalutamide or Abiraterone Acetate) in Chinese men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have BRCA1/2 mutations.
  • In February 2025:- Janssen Pharmaceuticals- This is a Phase 4, non-randomized, multi-center (when more than one hospital work on a medical research study), open label (identity of study drug will be known to participant and study staff), single arm study of abiraterone acetate to investigate its efficacy and safety in participants with metastatic castration-resistant prostate cancer (mCRPC) who failed the first-line combined androgen blockade (CAB) therapy.
  • In February 2025:- Aragon Pharmaceuticals Inc.:- This Phase 3 clinical trial is an essential step in the evaluation of an investigational medication to see if it may be useful in treating prostate cancer. The purpose of the SPARTAN study is to compare the safety and effectiveness of the investigational medication to placebo in delaying prostate cancer from spreading to other parts of the body. A placebo is a pill that looks like the investigational medication but does not contain any active medication, a dummy pill.
  • DelveInsight’s Metastatic Castration-Resistant Prostate Cancer pipeline report depicts a robust space with 75+ active players working to develop 75+ pipeline therapies for Metastatic Castration-Resistant Prostate Cancer treatment.
  • The leading Metastatic Castration-Resistant Prostate Cancer Companies such as Surface Oncology, Regeneron Pharmaceuticals, Clovis Oncology, AstraZeneca, Veru Healthcare, Hinova Pharmaceuticals, Zenith Epigenetic, Eli Lilly and Company, Lantern Pharma, Astellas Pharma/Seagen, Pfizer, Progenics Pharmaceutical, Molecular Insight Pharmaceuticals, Bayer, Accutar Biotechnology Inc, Hinova Pharmaceuticals, Taiho Oncology, Inc., Forma Therapeutics, Inc., Dizal Pharmaceuticals, Amgen, and others.
  • Promising Metastatic Castration-Resistant Prostate Cancer Therapies such as JNJ-78278343, Cetrelimab, Cabazitaxel, TVB-2640, Enzalutamide, Abiraterone acetate, JNJ-56021927, Xofigo (Radium-223 dichloride, BAY88-8223), and others.

Discover how the Metastatic Castration-Resistant Prostate Cancer treatment paradigm is evolving. Access DelveInsight’s in-depth Metastatic Castration-Resistant Prostate Cancer Pipeline Analysis for a closer look at promising breakthroughs @ Metastatic Castration-Resistant Prostate Cancer Clinical Trials and Studies

Metastatic Castration-Resistant Prostate Cancer Emerging Drugs Profile

  • SRF617: Surface Oncology

SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39 in the tumor microenvironment, allowing for a dual mechanism of action to promote anti-tumor immunity via reduction of immunosuppressive adenosine in addition to increasing levels of immunostimulatory ATP. SRF617 has been granted Orphan Drug designation for the treatment of advanced pancreatic cancer by the FDA.

  • Rucaparib: Clovis Oncology

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

  • HP518: Hinova Pharmaceuticals

HP518, a highly selective and orally bioavailable chimeric degrader targeting androgen receptor (AR) with the potential to overcome the drug resistance of prostate cancer due to some specific AR mutations. In discovery and preclinical studies, HP518 showed high degradation activity against wild type AR and some specific AR mutants that are resistant to enzalutamide, and excellent antitumor activity in xenograft mouse models. HP518 is highly selective for AR.

The Metastatic Castration-Resistant Prostate Cancer pipeline report provides insights into

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

Get a detailed analysis of the latest innovations in the Metastatic Castration-Resistant Prostate Cancer pipeline. Explore DelveInsight’s expert-driven report today! @ Metastatic Castration-Resistant Prostate Cancer Unmet Needs

Metastatic Castration-Resistant Prostate Cancer Companies

Surface Oncology, Regeneron Pharmaceuticals, Clovis Oncology, AstraZeneca, Veru Healthcare, Hinova Pharmaceuticals, Zenith Epigenetic, Eli Lilly and Company, Lantern Pharma, Astellas Pharma/Seagen, Pfizer, Progenics Pharmaceutical, Molecular Insight Pharmaceuticals, Bayer, Accutar Biotechnology Inc, Hinova Pharmaceuticals, Taiho Oncology, Inc., Forma Therapeutics, Inc., Dizal Pharmaceuticals, Amgen, and others.

Metastatic Castration Resistant Prostate cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

  • Oral
  • Intravenous
  • Subcutaneous

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

  • Small molecule
  • Cell Therapy
  • Peptides
  • Polymer
  • Small molecule
  • Gene therapy

Download DelveInsight’s latest report to gain strategic insights into upcoming Metastatic Castration-Resistant Prostate Cancer Therapies and key Cervical Cancer Developments @ Metastatic Castration-Resistant Prostate Cancer Market Drivers and Barriers, and Future Perspectives

Scope of the Metastatic Castration-Resistant Prostate Cancer Pipeline Report

  • Coverage- Global
  • Metastatic Castration-Resistant Prostate Cancer Companies- Surface Oncology, Regeneron Pharmaceuticals, Clovis Oncology, AstraZeneca, Veru Healthcare, Hinova Pharmaceuticals, Zenith Epigenetic, Eli Lilly and Company, Lantern Pharma, Astellas Pharma/Seagen, Pfizer, Progenics Pharmaceutical, Molecular Insight Pharmaceuticals, Bayer, Accutar Biotechnology Inc, Hinova Pharmaceuticals, Taiho Oncology, Inc., Forma Therapeutics, Inc., Dizal Pharmaceuticals, Amgen, and others.
  • Metastatic Castration-Resistant Prostate Cancer Therapies- JNJ-78278343, Cetrelimab, Cabazitaxel, TVB-2640, Enzalutamide, Abiraterone acetate, JNJ-56021927, Xofigo (Radium-223 dichloride, BAY88-8223), and others.
  • Metastatic Castration-Resistant Prostate Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Metastatic Castration-Resistant Prostate Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Which companies are leading the race in Metastatic Castration-Resistant Prostate Cancer drug development? Find out in DelveInsight’s exclusive Metastatic Castration-Resistant Prostate Cancer Pipeline Report—access it now! @ Metastatic Castration-Resistant Prostate Cancer Emerging Drugs and Major Companies

Table of Content

  1. Introduction
  2. Executive Summary
  3. Metastatic Castration Resistant Prostate cancer: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Metastatic Castration Resistant Prostate cancer– DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Rucaparib: Clovis Oncology
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. Surface Oncology: SRF 617
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I/II)
  14. REGN 4336: Regeneron Pharamceuticals
  15. Drug profiles in the detailed report…..
  16. Early Stage Products (Phase I)
  17. HP 518: Hinova Pharmaceuticals
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Metastatic Castration Resistant Prostate cancer Key Companies
  21. Metastatic Castration Resistant Prostate cancer Key Products
  22. Metastatic Castration Resistant Prostate cancer- Unmet Needs
  23. Metastatic Castration Resistant Prostate cancer- Market Drivers and Barriers
  24. Metastatic Castration Resistant Prostate cancer- Future Perspectives and Conclusion
  25. Metastatic Castration Resistant Prostate cancer Analyst Views
  26. Metastatic Castration Resistant Prostate cancer Key Companies
  27. Appendix

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