Thursday, February 20, 2025

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

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

DelveInsight’s, “Metastatic Prostate Cancer Pipeline Insight” 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 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 Prostate Cancer Pipeline Report to explore emerging therapies, key Metastatic Prostate Cancer Companies, and future Metastatic Prostate Cancer treatment landscapes @ Metastatic Prostate Cancer Pipeline Outlook Report

Key Takeaways from the Metastatic Prostate Cancer Pipeline Report

  • In February 2025:- Bayer:- This study is a phase III multinational, multicenter,randomized, double blind, placebo controlled, study with a randomization allocation ratio of 1:1 (radium-223 dichloride plus abiraterone acetate plus prednisone/prednisolone: placebo plus abiraterone acetate plus prednisone/prednisolone). Until the final overall survival (OS) analysis, the study period consisted of screening / randomization, treatment, active follow-up with clinic visits, active follow-up without clinic visits, and longterm follow-up phases.
  • In February 2025:- AstraZeneca:- This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of AZD5305 when given in combination with new hormonal agents (NHAs) in patients with Metastatic Prostate Cancer. The study consists of 2 parts, Part A and Part B. Part A consists of the dose escalation cohorts and will include patients with metastatic castration resistant prostate cancer (mCRPC) or metastatic castration-sensitive prostate cancer (mCSPC); Part B consists of dose expansion cohorts and will include patients with mCSPC only.
  • In February 2025:- Novartis Pharmceuticals:- The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with mHSPC. In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy. Approximately 1126 patients will be randomized in this study. As of 31-Jan-2024, 1144 participants have been enrolled in 20 countries.
  • 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.
  • In February 2025:- Janssen Research & Development LLC:- The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).
  • In February 2025:- Halda Therapeutics OpCo 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.
  • 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 Tavanta Therapeutics, Cardiff Oncology, Oncternal Therapeutics, Valerio Therapeutics, ORIC Pharmaceuticals, Telix Pharmaceuticals (Innovations) Pty Limited, Orion Corporation, OncoC4 Inc., Bristol-Myers Squibb/Ono Pharmaceuticals, Janssen Research & Development LLC, Merck Sharp & Dohme LLC, Modra Pharmaceuticals, Minneamrita Therapeutics LLC, AB Science, Cellbion Co., Ltd., Allarity Therapeutics, Janssen Research & Development, LLC, Hansoh BioMedical R&D Company, Jiangsu HengRui Medicine Co., Ltd., Hinova Pharmaceuticals Inc., ValiRx Plc, Epizyme Inc., Astrazeneca, and others.
  • Promising Metastatic Prostate Cancer Therapies such as Androgen Deprivation Therapy, Docetaxel, Nivolumab, Tazemetostat, Abiraterone/prednisone, Enzalutamide, and others.

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

Metastatic Prostate Cancer Emerging Drugs Profile

  • TAVT-45: Tavanta Therapeutics

TAVT-45 is a novel oral suspension of abiraterone acetate. It was designed as an alternative abiraterone acetate formulation with clear benefits over branded Zytiga tablets. TAVT-45 granules are rapidly reconstituted in water or juice and easily consumed, which could aid the ~20-30% of patients who have dysphagia or difficulty swallowing.5,6 In clinical studies with TAVT-45, variability in abiraterone exposure was reduced compared to Zytiga, and bioavailability was enhanced in subjects in a fasted state. The improved absorption profile allows for a reduction in the total daily dose of TAVT-45 compared to Zytiga and may potentially improve exposure to therapeutic abiraterone concentrations over 24 h. The large food effect of Zytiga is also avoided, and it is anticipated TAVT-45 to be dosed without regard to meals.

  • Onvansertib: Cardiff Oncology

Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported. Currently, the drug is in Phase II stage of its development for the treatment of prostate cancer.

  • ONCT-534: Oncternal Therapeutics

ONCT-534, Dual-Action Androgen Receptor Inhibitor (DAARI) candidate, is a novel investigational, potentially first-in-class, orally bioavailable, dual-action androgen receptor (AR) inhibitor, designed to treat patients with metastatic castration-resistant prostate cancer and other androgen receptor-driven diseases. Currently, the drug is in Phase I/II stage of its development for the treatment of prostate cancer.

  • VIO-01: Valerio Therapeutics

VIO-01 is designed to abrogate several DNA repair pathways and trigger a robust immune response by activating the innate immune response through the STING pathway. The STING pathway plays a critical role in detecting DNA abnormalities and activating the immune system to target and destroy cancer cells. VIO-01 is currently undergoing proof-of-concept IND-enabling preclinical studies, alone and in combination with cancer immunotherapies. Currently, the drug is in Phase I/II stage of its development for the treatment of prostate cancer.

  • ORIC-944: ORIC Pharmaceuticals

ORIC-944 is a potent, orally bioavailable, highly selective allosteric small molecule inhibitor of PRC2, the complex which tri-methylates histone H3 lysine 27 (H3K27me3) via targeting the embryonic ectoderm development (EED) subunit. Currently, the drug is in Phase I stage of its development for the treatment of prostate cancer.

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.

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

Metastatic Prostate Cancer Companies

Pharmaceuticals, Telix Pharmaceuticals (Innovations) Pty Limited, Orion Corporation, OncoC4 Inc., Bristol-Myers Squibb/Ono Pharmaceuticals, Janssen Research & Development LLC, Merck Sharp & Dohme LLC, Modra Pharmaceuticals, Minneamrita Therapeutics LLC, AB Science, Cellbion Co., Ltd., Allarity Therapeutics, Janssen Research & Development, LLC, Hansoh BioMedical R&D Company, Jiangsu HengRui Medicine Co., Ltd., Hinova Pharmaceuticals Inc., ValiRx Plc, Epizyme Inc., Astrazeneca, 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

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

Scope of the Metastatic Prostate Cancer Pipeline Report

  • Coverage- Global
  • Metastatic Prostate Cancer Companies- Tavanta Therapeutics, Cardiff Oncology, Oncternal Therapeutics, Valerio Therapeutics, ORIC Pharmaceuticals, Telix Pharmaceuticals (Innovations) Pty Limited, Orion Corporation, OncoC4 Inc., Bristol-Myers Squibb/Ono Pharmaceuticals, Janssen Research & Development LLC, Merck Sharp & Dohme LLC, Modra Pharmaceuticals, Minneamrita Therapeutics LLC, AB Science, Cellbion Co., Ltd., Allarity Therapeutics, Janssen Research & Development, LLC, Hansoh BioMedical R&D Company, Jiangsu HengRui Medicine Co., Ltd., Hinova Pharmaceuticals Inc., ValiRx Plc, Epizyme Inc., Astrazeneca, and others.
  • Metastatic Prostate Cancer Therapies- Androgen Deprivation Therapy, Docetaxel, Nivolumab, Tazemetostat, Abiraterone/prednisone, Enzalutamide, and 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

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

Table of Content

  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. TAVT-45: Tavanta Therapeutics
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. Onvansertib: Cardiff Oncology
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I/II)
  14. VIO-01: Valerio Therapeutics
  15. Drug profiles in the detailed report…..
  16. Preclinical and Discovery Stage Products
  17. Drug name: Company name
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Metastatic Prostate Cancer Key Companies
  21. Metastatic Prostate Cancer Key Products
  22. Metastatic Prostate Cancer- Unmet Needs
  23. Metastatic Prostate Cancer- Market Drivers and Barriers
  24. Metastatic Prostate Cancer- Future Perspectives and Conclusion
  25. Metastatic Prostate Cancer Analyst Views
  26. Metastatic Prostate Cancer Key Companies
  27. Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Yash Bhardwaj
Email:Send Email
Phone: 09650213330
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: NV
Country: United States
Website: https://www.delveinsight.com/report-store/knee-reconstruction-devices-market