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

February 06 15:46 2025
Non Muscle Invasive Bladder Cancer Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight

DelveInsight’s, “Non Muscle Invasive Bladder Cancer Pipeline Insight” report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Non Muscle Invasive Bladder Cancer pipeline landscape. It covers the Non Muscle Invasive Bladder Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Non Muscle Invasive Bladder 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 Non Muscle Invasive Bladder Cancer Pipeline Report to explore emerging therapies, key Non Muscle Invasive Bladder Cancer Companies, and future Non Muscle Invasive Bladder Cancer treatment landscapes @ Non Muscle Invasive Bladder Cancer Pipeline Outlook Report

 

Key Takeaways from the Non Muscle Invasive Bladder Cancer Pipeline Report

  • In January 2025:- Janssen Research & Development, LLC– The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator’s choice of single agent intravesical chemotherapy.
  • In January 2025:- Zhuhai Beihai Biotech Co., Ltd- The purpose of this study is to determine the safety and tolerability of intravesical BH011 in patients with high-risk non-muscle invasive bladder cancer(NMIBC) after Bacillus Calmette-Guerin(BCG) failure and to assess the preliminary efficacy.
  • In January 2025:-CG Oncology, Inc.- To evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscle invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1 papillary disease.
  • In January 2025:- Pfizer:- The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B).
  • In January 2025:- Merck Sharp & Dohme LLC:- The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems. Researchers will then choose a dose level of Sacituzumab Tirumotecan to use in future studies to learn how well the drug works.
  • DelveInsight’s Non Muscle Invasive Bladder Cancer pipeline report depicts a robust space with 20+ active players working to develop 25+ pipeline therapies for Non Muscle Invasive Bladder Cancer treatment.
  • The leading Non Muscle Invasive Bladder Cancer Companies such as Prokarium Ltd, Vaxiion Therapeutics, Tyra Biosciences, Lipac Oncology, SURGE Therapeutics, Jiangsu Simcere Pharmaceutical, Shanghai Hengrui Pharmaceutical Co., enGene and others.
  • Promising Non Muscle Invasive Bladder Cancer Therapies such as PF-06801591, Bacillus Calmette-Guerin, CG0070, Gemcitabine, APL-1202 treatment, Durvalumab, eRapa, Epirubicin Hydrochloride, Cabazitaxel, Gemcitabine, Cisplatin andothers.

 

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

 

Non Muscle Invasive Bladder Cancer Emerging Drugs Profile

  • TAR-200: TARIS Biomedical

TAR-200 is an investigational targeted releasing system enabling controlled release of gemcitabine into the bladder, sustaining local drug exposure for weeks at a time. The safety and efficacy of TAR-200 are being evaluated in Phase II and Phase III studies in patients with muscle-invasive bladder cancer in SunRISe-2 and SunRISe-4 and NMIBC in SunRISe-1 and SunRISe-3. Currently, the drug is in Phase III stage of its clinical trial for the treatment of non muscle invasive bladder cancer.

 

  • VAX 014: Vaxiion Therapeutics

VAX014 is a novel rBMC-based oncolytic immunotherapy designed to have distinct advantages over traditional and emerging oncolytic virotherapies. VAX014’s ability to specifically target both alpha3beta1(α3β1) and alpha5beta1 (α5β1) integrins facilitates broad spectrum activity against various solid tumor types because these two integrin family members are clinically validated as being selectively expressed or overexpressed in a wide variety of solid tumor indications (and most mouse models). Currently, the drug is in the Phase I stage of its development for the treatment of Non muscle-invasive bladder cancer.

 

  • SIM0237: Simcere Pharmaceutical Group

SIM0237 is an anti-PD-L1 monoclonal antibody fused with potency-reduced IL-15/IL-15Rα sushi domain developed in-house by utilizing Simcere Zaiming’s protein engineering platform. As a bifunctional protein, the compound can block the PD-1/PD-L1 immunosuppressive pathway via binding to PD-L1 and activate the immune system through its IL-15 part, thus playing a synergistic role of relieving immunosuppression and boosting the immune activation to exhibit antitumor effect. The attenuated IL-15 part of SIM0237 increases MTD and avoids overstimulation and accompanied anergy of NK and CD8+ T cells. In the meantime, fusion of attenuated IL-15 to full anti-PD-L1 mAb further enhances the half-life of attenuated IL-15 and delivers IL-15 directly to the tumor microenvironment avoiding notorious CRS toxicity induced by systemic IL-15 exposure. Currently, the drug is in Phase I stage of its clinical trial for the treatment of non muscle invasive bladder cancer.

 

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Non Muscle Invasive Bladder Cancer Companies

Prokarium Ltd, Vaxiion Therapeutics, Tyra Biosciences, Lipac Oncology, SURGE Therapeutics, Jiangsu Simcere Pharmaceutical, Shanghai Hengrui Pharmaceutical Co., enGene and others

 

Non Muscle Invasive Bladder 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

 

Non Muscle Invasive Bladder 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 therapies and key developments @ Non Muscle Invasive Bladder Cancer Market Drivers and Barriers, and Future Perspectives

 

Scope of the Non Muscle Invasive Bladder Cancer Pipeline Report

  • Coverage- Global
  • Non Muscle Invasive Bladder Cancer Companies- Prokarium Ltd, Vaxiion Therapeutics, Tyra Biosciences, Lipac Oncology, SURGE Therapeutics, Jiangsu Simcere Pharmaceutical, Shanghai Hengrui Pharmaceutical Co., enGene and others.
  • Non Muscle Invasive Bladder Cancer Therapies- PF-06801591, Bacillus Calmette-Guerin, CG0070, Gemcitabine, APL-1202 treatment, Durvalumab, eRapa, Epirubicin Hydrochloride, Cabazitaxel, Gemcitabine, Cisplatin andothers.
  • Non Muscle Invasive Bladder Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Non Muscle Invasive Bladder Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

 

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

 

Table of Content

  1. Introduction
  2. Executive Summary
  3. Non Muscle Invasive Bladder Cancer: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Non Muscle Invasive Bladder Cancer– DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. TAR-200: TARIS Biomedical
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. Drug name: Company name
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. VAX 014: Vaxiion 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. Non Muscle Invasive Bladder Cancer Key Companies
  21. Non Muscle Invasive Bladder Cancer Key Products
  22. Non Muscle Invasive Bladder Cancer- Unmet Needs
  23. Non Muscle Invasive Bladder Cancer- Market Drivers and Barriers
  24. Non Muscle Invasive Bladder Cancer- Future Perspectives and Conclusion
  25. Non Muscle Invasive Bladder Cancer Analyst Views
  26. Non Muscle Invasive Bladder Cancer Key Companies
  27. Appendix

 

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