Non Muscle Invasive Bladder Cancer – Pipeline Insight, 2026

DelveInsight’s “Non Muscle Invasive Bladder Cancer – Pipeline Insight, 2026” report provides comprehensive insights about 20+ companies developing several pipeline drugs in the Non Muscle Invasive Bladder Cancer (NMIBC) pipeline landscape. It covers the NMIBC pipeline drug profiles, including clinical and nonclinical stage products, along with therapeutics assessment by product type, stage, route of administration, and molecule type, and further highlights inactive pipeline products in this space.

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Key Takeaways from the Non Muscle Invasive Bladder Cancer Pipeline Report

• Non-muscle invasive bladder cancer (NMIBC) refers to bladder tumors confined to the inner layers of the bladder wall that have not invaded the detrusor muscle, encompassing stages Ta, T1, and carcinoma in situ (CIS). NMIBC accounts for approximately 70–80% of newly diagnosed bladder cancers and is characterized by a high recurrence rate.

• The primary treatment for NMIBC involves transurethral resection of bladder tumor (TURBT) followed by intravesical therapy such as Bacillus Calmette–Guerin (BCG) immunotherapy or intravesical chemotherapy, with regular cystoscopic surveillance essential due to the high recurrence rate.

• DelveInsight’s Non Muscle Invasive Bladder Cancer Pipeline Insight report depicts a robust space with 20+ active players working to develop 22+ pipeline therapies for NMIBC treatment.

• The leading Non Muscle Invasive Bladder Cancer companies include 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 include Cretostimogene grenadenorepvec, TAR-210, TYRA-300, UGN-301, and others spanning Phase I through Phase III clinical development.

• On March 24, 2026, the FDA approved a label update for Ferring Pharmaceuticals’ ADSTILADRIN (nadofaragene firadenovec-vncg), the first FDA-approved non-replicating intravesical gene therapy for high-risk, BCG-unresponsive non-muscle invasive bladder cancer. The update allows for an accelerated water-bath thawing method, reducing the time required to prepare the drug to approximately 25 minutes.

Download for updates and the latest revolution in Non Muscle Invasive Bladder Cancer care @ NMIBC Pipeline Insight Report

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 αvβ5 present in specialized intracellular junctions and tight junctions of polarized epithelial cells. 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. The second modification is the insertion of the gene for the cytokine granulocyte-macrophage colony stimulation factor (GM-CSF), a potent stimulator of longer-term anti-tumor activity. Replication of the virus within cancer cells leads to lysis, releasing both viral and tumor-specific antigens into the local environment, strengthening an immune response. Currently, the drug is in a Phase III clinical trial for the treatment of Non Muscle Invasive Bladder Cancer.

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 a Phase III clinical trial for the treatment of Non Muscle Invasive Bladder Cancer.

TYRA-300: Tyra Biosciences, Inc.

TYRA-300 is Tyra Biosciences’ lead precision medicine program stemming from its in-house SNAP 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 a Phase II clinical trial 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, UroGen’s 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 as monotherapy and in combination with other agents for high-grade NMIBC (HG-NMIBC). Currently, the drug is in a Phase I clinical trial for the treatment of Non Muscle Invasive Bladder Cancer.

For more information on the Non Muscle Invasive Bladder Cancer Emerging Drugs Profile, download DelveInsight’s comprehensive Non Muscle Invasive Bladder Cancer Pipeline Insight report.

The Non Muscle Invasive Bladder Cancer Pipeline Report Provides

• Detailed insights about companies developing therapies for Non Muscle Invasive Bladder Cancer, with aggregate therapies developed by each company.

• 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 that 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 and company-academia), licensing agreements, and financing details for future advancement of the Non Muscle Invasive Bladder Cancer market.

Learn more about Non Muscle Invasive Bladder Cancer Drugs opportunities in our comprehensive NMIBC pipeline report @ Non Muscle Invasive Bladder Cancer Unmet Needs

Non Muscle Invasive Bladder Cancer Companies

There are 20+ key 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, developing therapies for Non Muscle Invasive Bladder Cancer, with CG Oncology having its NMIBC drug candidate in the most advanced Phase III stage.

DelveInsight’s 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

Discover the latest advancements in Non Muscle Invasive Bladder Cancer treatment @ 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: Cretostimogene grenadenorepvec, TAR-210, TYRA-300, UGN-301, 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

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. Mid Stage Products (Phase II)

9. Early Stage Products (Phase I)

10. Preclinical and Discovery Stage Products

11. Inactive Products

12. Non Muscle Invasive Bladder Cancer Key Companies

13. Non Muscle Invasive Bladder Cancer Key Products

14. Non Muscle Invasive Bladder Cancer Unmet Needs

15. Non Muscle Invasive Bladder Cancer Market Drivers and Barriers

16. Non Muscle Invasive Bladder Cancer Future Perspectives and Conclusion

17. Non Muscle Invasive Bladder Cancer Analyst Views

18. Appendix

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