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
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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
- Introduction
- Executive Summary
- Non Muscle Invasive Bladder Cancer: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Non Muscle Invasive Bladder Cancer– DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- TAR-200: TARIS Biomedical
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- Drug name: Company name
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- VAX 014: Vaxiion Therapeutics
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Drug Name: Company Name
- Drug profiles in the detailed report…..
- Inactive Products
- Non Muscle Invasive Bladder Cancer Key Companies
- Non Muscle Invasive Bladder Cancer Key Products
- Non Muscle Invasive Bladder Cancer- Unmet Needs
- Non Muscle Invasive Bladder Cancer- Market Drivers and Barriers
- Non Muscle Invasive Bladder Cancer- Future Perspectives and Conclusion
- Non Muscle Invasive Bladder Cancer Analyst Views
- Non Muscle Invasive Bladder Cancer Key Companies
- Appendix
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