Non-Muscle Invasive Bladder Cancer Pipeline Insight 2025: 22+ Emerging Therapies, Immunotherapies, and Targeted Innovations Redefine Treatment Outlook | DelveInsight

DelveInsight's "Non-Muscle Invasive Bladder Cancer - Pipeline Insight, 2025" highlights more than 22+ therapies in development for non-muscle invasive bladder cancer (NMIBC). In this prevalent bladder cancer subtype, high recurrence rates and progression risks remain critical challenges. While intravesical BCG and chemotherapy remain the standard of care, resistance and limited long-term efficacy create a substantial unmet need in the NMIBC treatment market.

The NMIBC pipeline is expanding with checkpoint inhibitors, oncolytic viruses, and intravesical gene therapies, aiming to improve outcomes in patients unresponsive to BCG. Novel approaches targeting tumor microenvironment modulation, cancer vaccines, and drug-device combinations are also advancing clinical evaluation. Additionally, antibody-drug conjugates and targeted therapies are being explored to reduce recurrence and delay progression to muscle-invasive disease.

With a robust clinical trial landscape spanning immunotherapies, biologics, and precision medicine strategies, the NMIBC pipeline reflects a paradigm shift toward bladder-sparing approaches and long-term disease control. As late-stage candidates mature, the NMIBC treatment landscape is expected to evolve beyond conventional intravesical regimens into a new era defined by immuno-oncology and targeted innovation, bringing hope for improved survival and quality of life for patients.

Interested in learning more about the current treatment landscape and the key drivers shaping the Non-Muscle Invasive Bladder Cancer pipeline? Click here: https://www.delveinsight.com/report-store/non-muscle-invasive-bladder-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Non-Muscle Invasive Bladder Cancer Pipeline Report
• DelveInsight's Non-Muscle Invasive Bladder Cancer pipeline analysis depicts a strong space with 20+ active players working to develop 22+ pipeline drugs for Non-Muscle Invasive Bladder Cancer treatment.
• The leading Non-Muscle Invasive Bladder Cancer companies include Prokarium Ltd, Vaxiion Therapeutics, Tyra Biosciences, Lipac Oncology, SURGE Therapeutics, Jiangsu Simcere Pharmaceutical, Shanghai Hengrui Pharmaceutical Co., enGene, and others are evaluating their lead assets to improve the Non-Muscle Invasive Bladder Cancer treatment landscape.
• Key Non-Muscle Invasive Bladder Cancer pipeline therapies in various stages of development include ZH9, VAX014, TYRA-300, TSD-001, STM-416, SIM0237, SHR-1501, EG-70, and others.
• In September 2025, Johnson & Johnson (NYSE: JNJ) announced FDA approval of INLEXZOTM (gemcitabine intravesical system) for BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), offering a new option for patients after failed BCG therapy or those ineligible for bladder removal surgery.
• In June 2025, Hamlet BioPharma held a successful first in-person meeting with the FDA, receiving clear guidance on Phase III trial design for its Alpha1H program in non-muscle invasive bladder cancer (NMIBC). Following positive Phase II results, the FDA's feedback will be incorporated into the Phase III protocol, keeping the company on track for trial initiation pending final approvals. CEO Catharina Svanborg highlighted the milestone as a key step toward providing a new bladder cancer treatment.
• In June 2025, enGene Holdings Inc. (Nasdaq: ENGN) announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid, its lead therapy for high-risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
• In May 2025, the FDA's Oncologic Drugs Advisory Committee (ODAC) narrowly voted 5-4 against approving UGN-102 (mitomycin intravesical solution) for treating recurrent, low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC).
• In May 2025, UroGen (Nasdaq: URGN) announced that the FDA scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting for May 21, 2025, to review the new drug application (NDA) for UGN-102 (mitomycin) intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC.

Request a sample and discover the recent breakthroughs happening in the Non-Muscle Invasive Bladder Cancer pipeline landscape at https://www.delveinsight.com/report-store/non-muscle-invasive-bladder-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Non-Muscle Invasive Bladder Cancer Overview
Non-Muscle Invasive Bladder Cancer (NMIBC) refers to bladder cancers that are confined to the inner lining of the bladder and have not penetrated the muscular layer of the bladder wall. This type includes stages Ta (non-invasive papillary carcinoma), T1 (invading the connective tissue beneath the lining but not the muscle), and carcinoma in situ (CIS), which is a flat, high-grade, and aggressive form. NMIBC accounts for approximately 70-80% of newly diagnosed bladder cancers and is often detected early due to symptoms such as painless blood in the urine (hematuria).

Treatment typically involves transurethral resection of the bladder tumor (TURBT), followed by intravesical therapy, most commonly Bacillus Calmette-Guérin (BCG) or chemotherapy, to reduce recurrence and progression risk. Despite being non-muscle invasive, NMIBC has a high recurrence rate, necessitating long-term surveillance with regular cystoscopies. The prognosis is generally favorable if managed appropriately, although high-grade tumors carry a higher risk of progression to muscle-invasive disease.

Find out more about Non-Muscle Invasive Bladder Cancer medication at https://www.delveinsight.com/report-store/non-muscle-invasive-bladder-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Non-Muscle Invasive Bladder Cancer Treatment Analysis: Drug Profile
Cretostimogene Grenadenorepvec: CG Oncology
Cretostimogene is an oncolytic immunotherapy designed to selectively infect and destroy bladder cancer cells while stimulating an anti-tumor immune response. It targets tumor cells by binding to CAR and integrin αvβ5 receptors and is engineered with two key modifications: an E2F-1 promoter for selective replication in Rb-E2F pathway-altered tumor cells, and a GM-CSF gene to boost immune activation. As the virus replicates, it causes tumor cell lysis and releases tumor antigens and GM-CSF, triggering a sustained systemic immune response. It is currently in Phase III trials for NMIBC.

TAR-210: Janssen R&D
TAR-210 is a bladder-insertable drug delivery system that slowly releases erdafitinib, an FGFR inhibitor, directly into the bladder. This approach targets FGFR-altered NMIBC with high local drug levels and minimal systemic exposure, offering a bladder-sparing option for patients unresponsive to BCG or not eligible for surgery. It is in Phase III development.

TYRA-300: Tyra Biosciences
TYRA-300 is an oral FGFR3-selective inhibitor developed via Tyra's SNÅP platform. It's being studied for cancers with FGFR3 mutations, including intermediate-risk NMIBC and metastatic urothelial cancer. Currently, it is in Phase II trials for NMIBC.

Learn more about the novel and emerging Non-Muscle Invasive Bladder Cancer pipeline therapies at https://www.delveinsight.com/report-store/non-muscle-invasive-bladder-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Non-Muscle Invasive Bladder Cancer Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the Non-Muscle Invasive Bladder Cancer Pipeline Report
• Coverage: Global
• Key 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.
• Key Non-Muscle Invasive Bladder Cancer Pipeline Therapies: ZH9, VAX014, TYRA-300, TSD-001, STM-416, SIM0237, SHR-1501, EG-70, and others.

To dive deep into rich insights for drugs used for Non-Muscle Invasive Bladder Cancer treatment, visit: https://www.delveinsight.com/report-store/non-muscle-invasive-bladder-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Non-Muscle Invasive Bladder Cancer Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Non-Muscle Invasive Bladder Cancer Pipeline Therapeutics
6. Non-Muscle Invasive Bladder Cancer Pipeline: Late-Stage Products (Phase III)
7. Non-Muscle Invasive Bladder Cancer Pipeline: Mid-Stage Products (Phase II)
8. Non-Muscle Invasive Bladder Cancer Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

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This release was published on openPR.