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Bladder Cancer Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

Bladder Cancer Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

Globe and Mail26-03-2025
DelveInsight's, 'Bladder Cancer Pipeline Insight 2025' report provides comprehensive insights about 80+ companies and 100+ pipeline drugs in the Bladder cancer pipeline landscape. It covers the Bladder Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Bladder Cancer pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Explore our latest breakthroughs in Bladder Cancer Research. Learn more about our innovative pipeline today! @ Bladder Cancer Pipeline Outlook
Key Takeaways from the Bladder Cancer Pipeline Report
In March 2025, Janssen Research & Development LLC announced a phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy.
In March 2025, Fidia Farmaceutici announced a phase III, single-arm, multicenter, international study to assess the efficacy and safety of ONCOFID-P-B following intravesical instillation in adult patients with histologically and cytologically confirmed CIS, with or without concomitant Ta-T1, who are unresponsive to BCG therapy and unwilling or unfit to undergo radical cystectomy.
In March 2025, Merck Sharp & Dohme LLC announced a study are to learn if people who receive V940 and pembrolizumab are alive and cancer free longer than those who receive placebo and pembrolizumab, and to learn about the safety of V940, pembrolizumab, and EV, and if people tolerate them.
DelveInsight's Bladder Cancer pipeline report depicts a robust space with 80+ active players working to develop 100+ pipeline therapies for Bladder Cancer treatment.
The leading Bladder Cancer Companies such as UroGen Pharma Ltd., Asieris Pharmaceuticals, G1 Therapeutics, Inc., LintonPharm Co. Ltd., Vaxiion Therapeutics, Merck Sharp & Dohme LLC, CG Oncology, Inc., Ferring Pharmaceuticals, SURGE Therapeutics, Halozyme Therapeutics, ImmunityBio, Inc., AstraZeneca, Spectrum Pharmaceuticals, Inc., enGene, Inc., CicloMed LLC, Protara Therapeutics, Hoffmann-La Roche, Astellas Pharma Global Development, Inc., and Five Prime Therapeutics, Inc., and others.
Promising Bladder Cancer Therapies such as Atezolizumab, PGV001, VAX014, BCG Vaccine, Oncofid-P-B, Oncofid-P-B, and others.
Stay informed about the cutting-edge advancements in Bladder Cancer Treatments. Download for updates and be a part of the revolution in cancer care @ Bladder Cancer Clinical Trials Assessment
Bladder cancer Emerging Drugs Profile
UGN-102: UroGen Pharma Ltd.
UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin. It is been developed by utilizing UroGen's proprietary RTGel® technology which is a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Currently it is in Phase III stage of clinical trial for the treatment of Bladder Cancer.
APL 1202 : Asieris Pharmaceuticals
APL-1202 is an orally available reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment. It is currently in registration clinical trials in China, either as single agent as first-line treatment for patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC), or in combination with a chemotherapy as second-line treatment in patients with intermediate and high-risk chemo-refractory NMIBC. Currently, the drug is being evaluated in the Phase III stage for Bladder Cancer.
Trilaciclib: G1 Therapeutics, Inc.
Trilaciclib, is a first-in-class therapy designed to improve outcomes for people with cancer who are treated with chemotherapy. It is a transient IV-administered CDK4/6 inhibitor, a novel therapeutic approach which is given before chemotherapy that temporarily blocks progression through the cell cycle. Currently the drug is being evaluated in Phase II for the treatment of Bladder Cancer.
Catumaxomab: LintonPharm Co.,Ltd.
Catumaxomab is a bispecific antibody that binds to EpCAM (the epithelial cell adhesion molecule) on the tumor cell--and CD3 on the T cell, recruits immune accessory cells through FcγR binding at the same time. The drug kills tumor cells by engaging T cell and accessory cell mediated cytotoxicity and has the potential to induce long-term vaccinal effects which has been verified in animal models. The drug is in Phase I/II stage of clinical trials for the treatment of bladder cancer.
VAX 014: Vaxiion Therapeutics
VAX014 is a novel rBMC-based oncolytic immunotherapy. VAX014is a first-in-class tumor-targeted oncolytic agent based on Vaxiion's proprietary rBMC technology. It works by specifically targeting and delivering a novel fast-acting pre-formed oncolytic protein toxin directly to tumor cells that express either α3β1 or α5β1 integrin(s), both commonly found to be selectively expressed in many solid tumor types. The drug is in Phase I stage of clinical trials for the treatment of bladder cancer.
Learn more about Bladder Cancer Drugs opportunities in our groundbreaking Bladder Cancer Research and development projects @ Bladder Cancer Unmet Needs
Bladder Cancer Companies
UroGen Pharma Ltd., Asieris Pharmaceuticals, G1 Therapeutics, Inc., LintonPharm Co. Ltd., Vaxiion Therapeutics, Merck Sharp & Dohme LLC, CG Oncology, Inc., Ferring Pharmaceuticals, SURGE Therapeutics, Halozyme Therapeutics, ImmunityBio, Inc., AstraZeneca, Spectrum Pharmaceuticals, Inc., enGene, Inc., CicloMed LLC, Protara Therapeutics, Hoffmann-La Roche, Astellas Pharma Global Development, Inc., and Five Prime Therapeutics, Inc., and others.
Bladder cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration
Oral
Parenteral
Intravenous
Subcutaneous
Topical
Bladder Cancer Products have been categorized under various Molecule types such as
Monoclonal Antibody
Peptides
Polymer
Small molecule
Gene therapy
Discover the latest advancements in Bladder Cancer Treatment by visiting our website. Stay informed about how we're transforming the future of Oncology @ Bladder Cancer Market Drivers and Barriers, and Future Perspectives
Scope of the Bladder Cancer Pipeline Report
Coverage- Global
Bladder Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
Bladder Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Bladder Cancer Companies- UroGen Pharma Ltd., Asieris Pharmaceuticals, G1 Therapeutics, Inc., LintonPharm Co. Ltd., Vaxiion Therapeutics, Merck Sharp & Dohme LLC, CG Oncology, Inc., Ferring Pharmaceuticals, SURGE Therapeutics, Halozyme Therapeutics, ImmunityBio, Inc., AstraZeneca, Spectrum Pharmaceuticals, Inc., enGene, Inc., CicloMed LLC, Protara Therapeutics, Hoffmann-La Roche, Astellas Pharma Global Development, Inc., and Five Prime Therapeutics, Inc., and others
Bladder Cancer Therapies- Atezolizumab, PGV001, VAX014, BCG Vaccine, Oncofid-P-B, Oncofid-P-B, and others.
For a detailed overview of our latest research findings and future plans, read the full details of Bladder Cancer Pipeline on our website @ Bladder Cancer Drugs and Companies
Table of Content
Introduction
Bladder Cancer Executive Summary
Bladder Cancer: Overview
Bladder Cancer Pipeline Therapeutics
Bladder Cancer Pipeline Therapeutic Assessment
Late Stage Products (Phase III)
UGN-102: UroGen Pharma Ltd.
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
Trilaciclib: G1 Therapeutics, Inc.
Early Stage Products (Phase I)
VAX 014: Vaxiion Therapeutics
Inactive Products
Bladder Cancer Key Companies
Bladder Cancer Key Products
Bladder Cancer - Unmet Needs
Bladder Cancer - Market Drivers and Barriers
Bladder Cancer - Future Perspectives and Conclusion
Bladder Cancer Analyst Views
Bladder Cancer Key Companies
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
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/medical-marijuana-market-insight
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