PUBLISHER: DelveInsight | PRODUCT CODE: 1776681
PUBLISHER: DelveInsight | PRODUCT CODE: 1776681
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.
Non Muscle Invasive Bladder Cancer: Understanding
Non Muscle Invasive Bladder Cancer: Overview
Non-muscle invasive bladder cancer (NMIBC) refers to bladder tumors that are confined to the inner layers of the bladder wall and have not invaded the detrusor muscle. It includes stages Ta (non-invasive papillary carcinoma), T1 (tumor invades the subepithelial connective tissue), and carcinoma in situ (CIS), which is a flat, high-grade lesion. NMIBC accounts for approximately 70-80% of newly diagnosed bladder cancers and is often characterized by a high recurrence rate but relatively low risk of progression to muscle-invasive disease. Early detection and appropriate risk stratification are critical for effective management and long-term surveillance. Management typically involves transurethral resection of bladder tumor (TURBT) followed by intravesical therapy, such as Bacillus Calmette-Guerin (BCG) or chemotherapy. Risk-adapted strategies are essential to balance recurrence prevention with overtreatment avoidance. Regular cystoscopic monitoring remains a cornerstone of follow-up due to the high likelihood of tumor recurrence.
Non-muscle invasive bladder cancer (NMIBC) commonly presents with painless hematuria, which may be visible (gross) or detected microscopically. Other symptoms can include increased urinary frequency, urgency, dysuria (painful urination), and nocturia, especially when the tumor irritates the bladder lining. In some cases, these symptoms mimic urinary tract infections, leading to delayed diagnosis. Patients may also experience lower abdominal discomfort or a persistent sensation of incomplete bladder emptying. In rare cases, blood clots can cause urinary retention. Symptoms may fluctuate over time, contributing to underdiagnosis in early stages. Routine urinalysis and cystoscopy are essential for timely detection and evaluation of NMIBC.
The pathophysiology of non-muscle invasive bladder cancer (NMIBC) involves the uncontrolled proliferation of urothelial cells lining the bladder, often triggered by genetic mutations and prolonged exposure to carcinogens such as tobacco smoke and industrial chemicals. These mutations lead to alterations in key regulatory pathways, including the FGFR3, RAS-MAPK, and PI3K-AKT pathways, promoting abnormal cell growth and survival. NMIBC typically arises from the inner epithelial layer without invading the detrusor muscle, hence the term "non-muscle invasive." Chronic inflammation and impaired immune surveillance may also contribute to tumor development and progression. The recurrence and progression risk is influenced by tumor grade, stage, and molecular characteristics.
The treatment and management of non-muscle invasive bladder cancer (NMIBC) focus on eradicating visible tumors, preventing recurrence, and reducing the risk of progression. The primary treatment is transurethral resection of bladder tumor (TURBT), which removes superficial tumors endoscopically. This is often followed by intravesical therapy, such as Bacillus Calmette-Guerin (BCG) immunotherapy or intravesical chemotherapy, to destroy residual cancer cells and prevent recurrence. Regular cystoscopic surveillance is essential due to the high recurrence rate. Risk stratification based on tumor grade, stage, and recurrence history guides individualized management, with higher-risk patients receiving more aggressive adjuvant therapy and follow-up.
"Non Muscle Invasive Bladder Cancer- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Non Muscle Invasive Bladder Cancer pipeline landscape is provided which includes the disease overview and Non Muscle Invasive Bladder Cancer treatment guidelines. The assessment part of the report embraces, in depth Non Muscle Invasive Bladder Cancer commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Non Muscle Invasive Bladder Cancer collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
Non Muscle Invasive Bladder Cancer Emerging Drugs Chapters
This segment of the Non Muscle Invasive Bladder Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
Non Muscle Invasive Bladder Cancer Emerging Drugs
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 avB5present 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). GM-CSF is widely recognized as a potent stimulator of longer-term anti-tumor activity. Replication of the virus within these cancer cells leads to their lysis, releasing both viral and tumor-specific antigens into the local environment over a sustained period, strengthening an immune response. 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 grenadenorepvec works in two important and complementary ways. First, it replicates inside the tumor's cells causing tumor cell lysis and immunogenic cell death. Then, the rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a systemic anti-tumor immune response that involves the body's immune system. Currently, the drug is in Phase III stage of its development for the treatment of Non Muscle Invasive Bladder Cancer.
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 is the 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 Phase II stage of its development for the treatment of Non Muscle Invasive Bladder Cancer.
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.
Non Muscle Invasive Bladder Cancer: Therapeutic Assessment
This segment of the report provides insights about the different Non Muscle Invasive Bladder Cancer drugs segregated based on following parameters that define the scope of the report, such as:
DelveInsight's report covers around 21+ products under different phases of clinical development like
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
Products have been categorized under various Molecule types such as
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
Non Muscle Invasive Bladder Cancer: Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Non Muscle Invasive Bladder Cancer therapeutic drugs key players involved in developing key drugs.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Non Muscle Invasive Bladder Cancer drugs.
Current Treatment Scenario and Emerging Therapies:
Key Players
Key Products
Introduction
Executive Summary
Non Muscle Invasive Bladder Cancer: Overview
Pipeline Therapeutics
Therapeutic Assessment
Non Muscle Invasive Bladder Cancer- DelveInsight's Analytical Perspective
Late Stage Products (Phase III)
Cretostimogene grenadenorepvec: CG Oncology
Mid Stage Products (Phase II)
TYRA-300: Tyra Biosciences, Inc
Early Stage Products (Phase I)
UGN-301: UroGen Pharma Ltd.
Preclinical and Discovery Stage Products
Drug Name: Company Name
Inactive Products
Non Muscle Invasive Bladder Cancer Key Companies
Non Muscle Invasive Bladder Cancer Key Products
Non Muscle Invasive Bladder Cancer- Unmet Needs
Non Muscle Invasive Bladder Cancer- Market Drivers and Barriers
Non Muscle Invasive Bladder Cancer- Future Perspectives and Conclusion
Non Muscle Invasive Bladder Cancer Analyst Views
Non Muscle Invasive Bladder Cancer Key Companies