Non-Muscle Invasive Bladder Cancer Pipeline and Clinical Trial Analysis: 20+ Players, 22+ Assets, and Key Clinical Breakthroughs, analyses DelveInsight

DelveInsight's "Non-Muscle Invasive Bladder Cancer Pipeline Insight" report delivers an in-depth analysis of more than 20 companies and over 22 investigational therapies shaping the NMIBC pipeline landscape.

The report features comprehensive profiles of pipeline candidates, spanning both clinical and preclinical stages of development.

It also presents a detailed therapeutic evaluation of NMIBC drugs based on product category, development phase, route of administration, and molecular classification.
In addition, the study sheds light on discontinued and inactive pipeline assets within this therapeutic area.

Interested in the most recent developments in the NMIBC pipeline? Discover the therapies and clinical trials gaining attention, explore the NMIBC Pipeline Outlook Report - https://www.delveinsight.com/sample-request/non-muscle-invasive-bladder-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Key Highlights from the NMIBC Pipeline Report
• On November 21, 2025, Merck (NYSE: MRK), operating as MSD outside the U.S. and Canada, achieved a significant regulatory advancement as the U.S. Food and Drug Administration (FDA) approved two of its products-Keytruda® (pembrolizumab) and Keytruda QlexTM (pembrolizumab with berahyaluronidase alfa-pmph)-for use alongside Padcev® (enfortumab vedotin-ejfv). This combination is approved for use both prior to cystectomy as neoadjuvant therapy and following surgery as adjuvant treatment in adult patients with muscle-invasive bladder cancer (MIBC) who are not suitable candidates for cisplatin-based chemotherapy.
• On November 20, 2025, Tyra Biosciences, Inc. announced the initiation of a Phase II, multicenter, open-label clinical study designed to assess the safety and efficacy of TYRA-300 in patients with FGFR3-altered, low-grade, intermediate-risk non-muscle invasive bladder cancer.
• On November 19, 2025, Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. launched a randomized, double-blind, active-controlled, multicenter study consisting of screening, treatment, and follow-up phases.
• A total of 438 participants will be equally randomized between the experimental and control arms, with stratification based on baseline risk status (high or intermediate risk) and urine PD sample collection.
• DelveInsight's NMIBC pipeline analysis highlights a dynamic and competitive environment, with more than 20 active organizations developing over 22 therapeutic candidates for non-muscle invasive bladder cancer.
• Leading companies in the NMIBC space 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.
• Prominent NMIBC therapies under investigation include PF-06801591, Bacillus Calmette-Guérin (BCG), CG0070, Gemcitabine, APL-1202, Durvalumab, eRapa, Epirubicin Hydrochloride, Cabazitaxel, Cisplatin, and additional candidates.

Want insights into the companies driving innovation in NMIBC? Explore the complete pipeline analysis in the NMIBC Clinical Trials Assessment - https://www.delveinsight.com/sample-request/non-muscle-invasive-bladder-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

The NMIBC Pipeline Report offers a comprehensive disease overview, current pipeline landscape, and therapeutic evaluation of key candidates in development. It also identifies critical unmet needs influencing the future management of non-muscle invasive bladder cancer.

NMIBC Overview
Non-muscle invasive bladder cancer (NMIBC) refers to tumors confined to the inner lining of the bladder without involvement of the muscular wall.
Bladder cancer ranks as the sixth most commonly diagnosed cancer in the United States.
Approximately 81,000 new bladder cancer cases were diagnosed in the U.S. in 2020, with a higher incidence observed in men compared to women.

Emerging NMIBC Drug Profiles
Cretostimogene grenadenorepvec: CG Oncology
Cretostimogene grenadenorepvec is an oncolytic immunotherapy engineered with a dual mechanism that selectively replicates within tumor cells, leading to cancer cell destruction while enhancing anti-tumor immune responses. The therapy gains entry into cancer cells by binding to Coxsackievirus and Adenovirus Receptors (CAR) and integrin αvβ5 located within specialized epithelial junctions. To enhance selectivity and therapeutic potency, two genetic modifications have been incorporated. The first involves the use of an E2F-1 promoter to ensure selective replication in Rb-E2F pathway-altered tumor cells while sparing healthy tissue. The second modification introduces the GM-CSF cytokine gene to stimulate immune activation within the tumor microenvironment.

TAR-210: Janssen Research & Development, LLC
TAR-210 is a novel intravesical drug delivery platform developed for NMIBC patients with FGFR genetic alterations. The therapy employs a bladder-retentive device that continuously releases erdafitinib, a potent FGFR inhibitor, directly into the bladder. This approach enables sustained local drug exposure while minimizing systemic toxicity. TAR-210 aims to improve bladder preservation outcomes in BCG-unresponsive patients who are either ineligible for or unwilling to undergo radical cystectomy.
The candidate is currently in Phase III clinical development for NMIBC.

TYRA-300: Tyra Biosciences, Inc.
TYRA-300 represents Tyra Biosciences' flagship precision oncology program derived from its proprietary SNÅP discovery platform. It is an oral, FGFR3-selective investigational inhibitor being developed for oncology and skeletal dysplasia indications. Within oncology, TYRA-300 is under evaluation for metastatic urothelial carcinoma and intermediate-risk NMIBC. The therapy is presently in Phase II clinical development for non-muscle invasive bladder cancer.

UGN-301: UroGen Pharma Ltd.
UGN-301 is an anti-CTLA-4 monoclonal antibody (zalifrelimab) licensed from Agenus Inc. in 2019. The drug is formulated with UroGen's proprietary RTGel technology for intravesical delivery. This localized administration strategy is intended to enhance bladder drug exposure while limiting systemic immune-related toxicity. UGN-301 is being studied in a multi-arm Phase I trial both as monotherapy and in combination regimens. The monotherapy arm is focused on evaluating safety, while combination therapy is under investigation for high-grade NMIBC.

NMIBC Market Drivers
• Rising prevalence of non-muscle invasive bladder cancer
• Continued innovation in bladder cancer therapeutic approaches
NMIBC Market Barriers
• Growing reliance on costly biologics and targeted therapies
• Significant economic burden associated with NMIBC management

The NMIBC Pipeline Report provides detailed insights into:
• Companies actively developing NMIBC therapies and their cumulative pipelines
• Pipeline candidates segmented by early, mid, and late stages of development
• Active and inactive NMIBC programs across targeted therapeutic approaches
• Drug candidates categorized by development phase, route of administration, molecular class, target receptor, and treatment strategy
• In-depth evaluation of collaborations, licensing agreements, and funding activities shaping future market growth

Tracking NMIBC clinical trials? This release offers essential insights-explore ongoing advances in NMIBC treatment development - https://www.delveinsight.com/sample-request/non-muscle-invasive-bladder-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

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.

NMIBC pipeline therapies are assessed based on route of administration, including:
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Pipeline candidates are also classified by molecule type, such as:
• Recombinant fusion proteins
• Small molecules
• Monoclonal antibodies
• Peptides
• Polymers
• Gene therapies

From emerging therapeutics to competitive intelligence, the NMIBC Pipeline Report delivers comprehensive coverage explore market drivers, barriers, and future outlook now - https://www.delveinsight.com/sample-request/non-muscle-invasive-bladder-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Scope of the NMIBC Pipeline Report
• Geographic Coverage: Global
• Key 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
• Key Therapies: PF-06801591, Bacillus Calmette-Guérin, CG0070, Gemcitabine, APL-1202, Durvalumab, eRapa, Epirubicin Hydrochloride, Cabazitaxel, Cisplatin, and others
• Therapeutic Assessment: Monotherapy, combination therapy, and mono/combination approaches
• Clinical Stages Covered: Discovery, preclinical, Phase I, Phase II, and Phase III

Stay at the forefront of oncology research uncover what lies ahead for NMIBC treatments in this comprehensive pipeline assessment - https://www.delveinsight.com/sample-request/non-muscle-invasive-bladder-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Table of Contents
1. Introduction
2. Executive Summary
3. NMIBC Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. DelveInsight's Analytical Perspective
7. Late-Stage Pipeline (Phase III)
8. Cretostimogene grenadenorepvec: CG Oncology
9. Mid-Stage Pipeline (Phase II)
10. TYRA-300: Tyra Biosciences, Inc.
11. Early-Stage Pipeline (Phase I)
12. UGN-301: UroGen Pharma Ltd.
13. Preclinical and Discovery-Stage Assets
14. Drug and Company Profiles
15. Inactive Pipeline Products
16. Key NMIBC Companies
17. Key NMIBC Therapies
18. NMIBC Unmet Needs
19. Market Drivers and Barriers
20. Future Outlook and Conclusion
21. Analyst Insights
22. Key Companies Overview
23. Appendix

Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679

About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

This release was published on openPR.