DelveInsight’s, “Non Muscle Invasive Bladder Cancer Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 22+ pipeline drugs in Non Muscle Invasive Bladder Cancer pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Non Muscle Invasive Bladder Cancer Pipeline Report

• In August 2025, Protara Therapeutics announced a Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and anti-tumor activity of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease (defined as disease present at last tumor evaluation prior to signing ICF).
• In August 2025, ImmunityBio Inc. conducted a study includes a dose escalation phase (phase Ib) and an expansion phase (phase IIb). In the phase Ib, patients will be treated with intravesical N-803 in combination with BCG. The purpose of the phase Ib portion of the study is to evaluate the safety, identify the Maximum Tolerated Dose (MTD) of N-803 and determine the Recommended Dose (RD) level of N-803 in combination with BCG for the phase IIb expansion.
• In August 2025, Merck Sharp & Dohme LLC organized a study of High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. HR NMIBC can also include carcinoma in situ (CIS). CIS is bladder cancer that appears flat and is only in the inner layer (surface) of the bladder. CIS is not raised and is not growing toward the center of the bladder.
• In August 2025, Janssen Research & Development LLC conducted a study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator’s Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy.
• 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.

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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.

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.

From early-stage research to late-phase Non Muscle Invasive Bladder Cancer Clinical Trials, our analysis covers key companies, innovative treatment approaches, and the next wave of Emerging Drugs. Don’t miss this opportunity to stay informed—download now! @ Non Muscle Invasive Bladder Cancer 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

Stay updated with the latest Non Muscle Invasive Bladder Cancer Pipeline Insights—download our report for a deep dive into the next generation of therapeutics! @ 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- 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 Therapies- PF-06801591, Bacillus Calmette-Guerin, CG0070, Gemcitabine, APL-1202 treatment, Durvalumab, eRapa, Epirubicin Hydrochloride, Cabazitaxel, Gemcitabine, Cisplatin and others.
• 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

Find answers in our latest Non Muscle Invasive Bladder Cancer Pipeline Insights report, featuring in-depth coverage of Clinical Trials, regulatory trends, and upcoming breakthroughs. Download now to stay at the forefront of pharmaceutical innovation!” @ Non Muscle Invasive Bladder Cancer Emerging Drugs and Companies

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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