DelveInsight’s, “Non Muscle Invasive Bladder Cancer Pipeline Insight 2025” report provides comprehensive insights about 20+ companies and 22+ pipeline drugs in the 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 pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Curious about the latest updates in the NMIBC Pipeline? Click here to explore the therapies and trials making headlines @ NMIBC Pipeline Outlook Report
Key Takeaways from the NMIBC Pipeline Report
- In September 2025, CG Oncology announced the completion of patient enrollment in its Phase III PIVOT-006 trial, which is evaluating cretostimogene grenadenorepvec as an adjuvant therapy for patients with intermediate-risk NMIBC.
- On the same day, the ABLE-32 study was highlighted as an ongoing Phase III randomized, controlled trial investigating Nadofaragene versus observation in patients with intermediate-risk NMIBC. The trial’s inclusion criteria cover newly diagnosed or recurrent intermediate-risk NMIBC, as defined by the AUA/SUO Guidelines (2020).
- In July 2025, the U.S. Food and Drug Administration (FDA) granted priority review to the New Drug Application (NDA) for TAR-200 in patients with high-risk non-muscle invasive bladder cancer (NMIBC) that is unresponsive to Bacillus Calmette-Guérin (BCG) and includes carcinoma in situ, with or without papillary tumors. The update was announced in a news release from Johnson & Johnson.
- DelveInsight’s Non Muscle Invasive Bladder Cancer pipeline report depicts a robust space with 20+ active players working to develop 22+ pipeline therapies for Non Muscle Invasive Bladder Cancer treatment.
- The leading Non Muscle Invasive Bladder Cancer Companies such as CG Oncology, Janssen Research & Development, LLC, Tyra Biosciences, Inc, UroGen Pharma Ltd., Prokarium Ltd, Protara Therapeutics, ImmVira Pharma Co. Ltd, Trigone Pharma Ltd., Hoffmann-La Roche, Aura Biosciences, enGene Holdings Inc., Atonco Pharma 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 and others.
Want to know which companies are leading innovation in Non-Muscle Invasive Bladder Cancer? Dive into the full pipeline insights @ NMIBC Clinical Trials Assessment
The NMIBC Pipeline Report provides disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The NMIBC Pipeline Report also highlights the unmet needs with respect to the development of Non Muscle Invasive Bladder Cancer.
NMIBC Overview
Non-muscle invasive bladder cancer (NMIBC) is cancer found in the tissue that lines the inner surface of the bladder. The bladder muscle is not involved. Bladder cancer is the 6th most common cancer in the United States. Nearly 81,000 people will be diagnosed in the United States with bladder cancer in 2020. Bladder cancer is more common in males than females.
Non Muscle Invasive Bladder Cancer Emerging Drugs Profile
- Cretostimogene grenadenorepvec: CG Oncology
Cretostimogene grenadenorepvec is an oncolytic immunotherapy with a dual mechanism of action that selectively replicates in and lyses cancer cells while simultaneously amplifying the immune response against bladder tumors. Cretostimogene enters the tumor by binding to Coxsackievirus and Adenovirus Receptors (CAR) and integrin αvβ5present in specialized intracellular junctions and tight junctions of polarized epithelial cells. There are two modifications made to cretostimogene for tumor selectivity and potency. The first modification is the insertion of an E2F-1 promoter in cretostimogene which acts as a safety mechanism to selectively replicate and lyse Rb-E2F altered tumor cells rather than healthy cells which have intact Rb-E2F pathways. The second modification is the insertion of the gene for the cytokine granulocyte-macrophage colony stimulation factor (GM-CSF).
- TAR-210: Janssen Research & Development, LLC
TAR‑210 is an innovative intravesical targeted drug delivery system designed for patients with non–muscle-invasive bladder cancer (NMIBC) harboring FGFR alterations. The therapy utilizes a small, bladder-resident device that slowly releases erdafitinib, a potent FGFR tyrosine kinase inhibitor, directly into the bladder, achieving high local drug concentrations while minimizing systemic exposure. This localized delivery approach is intended to maximize anti-tumor activity within the bladder lining and enhance bladder preservation, making TAR‑210 a promising bladder-sparing option for patients who are unresponsive to BCG and ineligible or unwilling to undergo radical cystectomy. Currently, the drug is in Phase III stage of its development for the treatment of Non Muscle Invasive Bladder Cancer.
- TYRA-300: Tyra Biosciences, Inc
TYRA-300 is the Tyra Biosciences’ lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasia, including achondroplasia and hypochondroplasia. In oncology, TYRA-300 is being evaluated in metastatic urothelial cancer (mUC) and intermediate risk non-muscle invasive bladder cancer (IR NMIBC). Currently, the drug is in Phase II stage of its development for the treatment of Non Muscle Invasive Bladder Cancer.
- UGN-301: UroGen Pharma Ltd.
UGN-301 is an anti-CTLA-4 monoclonal antibody (zalifrelimab), originally licensed from Agenus Inc. in 2019. It is formulated with RTGel, our proprietary reverse-thermal hydrogel, for intravesical administration into the bladder. Intravesical administration of UGN-301 is designed to increase drug concentrations in the bladder without significant systemic exposure, potentially diminishing the systemic toxicity associated with CTLA-4 blockade. UroGen is evaluating UGN-301 in a multi-arm Phase I study of UGN-301 as monotherapy and in combination with other agents. The safety of UGN-301 is being evaluated in the monotherapy arm of the study as combination therapy for HG-NMIBC. Currently, the drug is in Phase I stage of its development for the treatment of Non Muscle Invasive Bladder Cancer.
NMIBC Market Drivers
- Increasing NMIBC Prevalence
- Advancements in Bladder Cancer Treatment
NMIBC Market Barriers
- Increasing use of Biologics and Targeted Therapies
- High Cost associated with the disease
The Non Muscle Invasive Bladder Cancer Pipeline report provides insights into
- The report provides detailed insights about companies that are developing therapies for the treatment of Non Muscle Invasive Bladder 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 Non Muscle Invasive Bladder Cancer Treatment.
- Non Muscle Invasive Bladder Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
- Non Muscle Invasive Bladder 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 Non Muscle Invasive Bladder Cancer market.
If you’re tracking ongoing NMIBC clinical trials, this press release is a must-read. Tap to see the breakthroughs @ NMIBC Treatment Drugs
Non Muscle Invasive Bladder Cancer Companies
CG Oncology, Janssen Research & Development, LLC, Tyra Biosciences, Inc, UroGen Pharma Ltd., Prokarium Ltd, Protara Therapeutics, ImmVira Pharma Co. Ltd, Trigone Pharma Ltd., Hoffmann-La Roche, Aura Biosciences, enGene Holdings Inc., Atonco Pharma 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
From emerging drug candidates to competitive intelligence, the NMIBC Pipeline Report covers it all – check it out now @ NMIBC Market Drivers and Barriers, and Future Perspectives
Scope of the NMIBC Pipeline Report
- Coverage- Global
- NMIBC Companies- CG Oncology, Janssen Research & Development, LLC, Tyra Biosciences, Inc, UroGen Pharma Ltd., Prokarium Ltd, Protara Therapeutics, ImmVira Pharma Co. Ltd, Trigone Pharma Ltd., Hoffmann-La Roche, Aura Biosciences, enGene Holdings Inc., Atonco Pharma and others.
- NMIBC Therapies- PF-06801591, Bacillus Calmette-Guerin, CG0070, Gemcitabine, APL-1202 treatment, Durvalumab, eRapa, Epirubicin Hydrochloride, Cabazitaxel, Gemcitabine, Cisplatin and others.
- NMIBC Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
- NMIBC Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Stay ahead in oncology research – discover what’s next for the NMIBC treatment landscape in this detailed analysis @ NMIBC Emerging Drugs and Major Players
Table of Contents
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. Cretostimogene grenadenorepvec: CG Oncology
9. Mid Stage Products (Phase II)
10. TYRA-300: Tyra Biosciences, Inc
11. Early Stage Products (Phase I)
12. UGN-301: UroGen Pharma Ltd.
13. Preclinical and Discovery Stage Products
14. Drug Name: Company Name
15. Inactive Products
16. Non Muscle Invasive Bladder Cancer Key Companies
17. Non Muscle Invasive Bladder Cancer Key Products
18. Non Muscle Invasive Bladder Cancer- Unmet Needs
19. Non Muscle Invasive Bladder Cancer- Market Drivers and Barriers
20. Non Muscle Invasive Bladder Cancer- Future Perspectives and Conclusion
21. Non Muscle Invasive Bladder Cancer Analyst Views
22. Non Muscle Invasive Bladder Cancer Key Companies
23. Appendix
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