The Muscle Invasive Bladder Cancer (MIBC) pipeline is rapidly expanding, with more than 10 global companies including Merck, Janssen, Aura Biosciences, AstraZeneca, Roche, and RemeGen advancing novel therapies. Key investigational candidates such as AU-011, TAR-200, KEYNOTE-905/EV-303, RC48-ADC + JS001, and Imfinzi (durvalumab) are progressing through Phase I–III trials. Several major developments emerged in 2024-2025, including positive Phase III results from Merck and AstraZeneca evaluating immunotherapy combinations alongside cystectomy. Additionally, Roche and Janssen have reported promising advancements in both adjuvant and intravesical treatment approaches, signaling a strong future for MIBC therapy innovation.
The Muscle Invasive Bladder Cancer Pipeline Insight, 2025 report by DelveInsight provides an extensive evaluation of the therapeutic landscape, highlighting 10+ key companies advancing over 10 investigational therapies. The analysis encompasses clinical trial progress, mechanisms of action, routes of administration, and ongoing development activities. The report offers a comprehensive commercial and clinical assessment of candidates from preclinical to marketed stages, with detailed insights into drug mechanisms, study outcomes, regulatory milestones, and product development strategies. It further covers technology platforms, collaborations, mergers and acquisitions, funding initiatives, designations, and other relevant updates shaping the Muscle Invasive Bladder Cancer pipeline.
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Some of the key takeaways from the Muscle Invasive Bladder Cancer Pipeline Report:
- Muscle Invasive Bladder Cancer Companies across the globe are diligently working toward developing 10+ Muscle Invasive Bladder Cancer treatment therapies with a considerable amount of success over the years.
- Muscle Invasive Bladder Cancer companies working in the treatment market are Merck Sharp & Dohme LLC, Aura Biosciences, Janssen Research & Development, LLC, Asieris Pharmaceuticals, RemeGen Co., Ltd. and others, are developing therapies for the Muscle Invasive Bladder Cancer treatment
- Emerging Muscle Invasive Bladder Cancer therapies such as AU-011, TAR-200, KEYNOTE-905/EV-303, RC48-ADC Combined with JS001, and others are expected to have a significant impact on the Muscle Invasive Bladder Cancer market in the coming years.
- In October 2025, Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV™ (enfortumab vedotin-ejfv) in combination with KEYTRUDA® (pembrolizumab) as a neoadjuvant treatment (before surgery) and then continued after radical cystectomy as adjuvant treatment (after surgery) for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
- In September 2025, Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) approved INLEXZO™ (gemcitabine intravesical system), a new, potentially practice-changing approach for treating patients with certain types of bladder cancer, addressing the need for additional options following unsuccessful BCG therapy and for patients refusing or ineligible for bladder removal surgery (radical cystectomy). INLEXZO™, previously referred to as TAR-200, is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
- In August 2025, Health Canada has granted a Notice of Compliance (NOC) for Imfinzi® (durvalumab) for the treatment of patients with resectable muscle invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by adjuvant Imfinzi monotherapy treatment after radical cystectomy. The approval is based on results from the NIAGARA Phase III trial, which were published in The New England Journal of Medicine.
- In July 2025, Merck has announced results of its Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)
- In June 2025, Hoffmann-La Roche has announced results of a Phase III, Double-Blind, Multicenter, Randomized Study of Atezolizumab (Anti-PDL1 Antibody) Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy
- In May 2025, AstraZeneca’s Imfinzi (durvalumab) has been recommended for approval in the European Union (EU) for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy (surgery to remove the bladder).
- In March 2025, AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapyafter radical cystectomy (surgery to remove the bladder) has been approved in the US for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).
- In June 2024, Janssen Research & Development announced results of a Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator’s Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High-risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
- In May 2024, Merck Sharp & Dohme LLC announced results of a Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)
- In February 2024, RemeGen Co., Ltd announced results of an Open-label, Single-arm, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of RC48-ADC Combined With JS001 in Perioperative Treatment of Muscle-Invasive Bladder Cancer
Muscle Invasive Bladder Cancer Overview
Muscle-invasive bladder cancer (MIBC) is an aggressive form of bladder cancer in which tumors penetrate the muscular layer of the bladder wall, increasing the risk of metastasis. It commonly arises from urothelial carcinoma and is associated with risk factors such as smoking, chemical exposure, and chronic inflammation. Symptoms include hematuria, pelvic pain, and urinary difficulties. Standard management typically involves radical cystectomy, neoadjuvant or adjuvant chemotherapy, and radiation therapy, with immunotherapies increasingly integrated into treatment protocols. Despite advances, recurrence rates remain high, highlighting the need for improved therapeutic strategies and personalized approaches to enhance survival and quality of life.
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Muscle Invasive Bladder Cancer Route of Administration
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
Muscle Invasive Bladder Cancer Molecule Type
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
Muscle Invasive Bladder Cancer Pipeline Therapeutics Assessment
- Muscle Invasive Bladder Cancer Assessment by Product Type
- Muscle Invasive Bladder Cancer By Stage and Product Type
- Muscle Invasive Bladder Cancer Assessment by Route of Administration
- Muscle Invasive Bladder Cancer By Stage and Route of Administration
- Muscle Invasive Bladder Cancer Assessment by Molecule Type
- Muscle Invasive Bladder Cancer by Stage and Molecule Type
DelveInsight’s Muscle Invasive Bladder Cancer Pipeline Report covers around 10+ products under different phases of clinical development like-
- Late-stage products (Phase III)
- Mid-stage products (Phase II)
- Early-stage product (Phase I)
- Pre-clinical and Discovery stage candidates
- Discontinued & Inactive candidates
- Route of Administration
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Muscle Invasive Bladder Cancer Pipeline Analysis:
TAR-200 (Janssen Research & Development, LLC)
TAR-200 is an advanced, investigational intravesical drug-delivery platform engineered to provide continuous, localized release of gemcitabine within the bladder over an extended period. This sustained-release mechanism enables prolonged intratumoral drug exposure, potentially enhancing therapeutic efficacy while minimizing systemic toxicity. TAR-200 is being evaluated in multiple Phase II and Phase III clinical studies, including the SunRISe-2 and SunRISe-4 trials, for patients with muscle-invasive bladder cancer (MIBC). It is currently in Phase III development for MIBC.
AU-011 (Aura Biosciences)
AU-011 is a first-in-class, virus-like particle–based targeted therapy in development for both muscle-invasive and non–muscle-invasive bladder cancer. The agent acts as a tumor-selective photosensitizer and cytotoxic inducer by generating reactive oxygen species (ROS) upon activation, leading to localized cancer cell death. AU-011 is presently under investigation in Phase I clinical trials for MIBC.
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Scope of Muscle Invasive Bladder Cancer Pipeline Drug Insight
- Coverage: Global
- Key Muscle Invasive Bladder Cancer Companies: Afimmune, MediciNova, Mariposa Health Limited, MedWell Laboratories, BioElectron Technology, CSPC Ouyi Pharmaceutical, Veralox Therapeutics, Qurient Therapeutics, PTC Therapeutics and others.
- Key Muscle Invasive Bladder Cancer Therapies: Epeleuton, Tipelukast, TA 270, MW 001, PTC 857, Baicalein, VLX 1005, Research programme: 5-Muscle Invasive Bladder Cancer Inhibitor (LOX Inhibitor), and others.
- Muscle Invasive Bladder Cancer Therapeutic Assessment: Muscle Invasive Bladder Cancer current marketed and Muscle Invasive Bladder Cancer emerging therapies
- Muscle Invasive Bladder Cancer Market Dynamics: Muscle Invasive Bladder Cancer market drivers and Muscle Invasive Bladder Cancer market barriers
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Table of Contents
- Muscle Invasive Bladder Cancer Report Introduction
- Muscle Invasive Bladder Cancer Executive Summary
- Muscle Invasive Bladder Cancer Overview
- Muscle Invasive Bladder Cancer- Analytical Perspective In-depth Commercial Assessment
- Muscle Invasive Bladder Cancer Pipeline Therapeutics
- Muscle Invasive Bladder Cancer Late Stage Products (Phase II/III)
- Muscle Invasive Bladder Cancer Mid Stage Products (Phase II)
- Muscle Invasive Bladder Cancer Early Stage Products (Phase I)
- Muscle Invasive Bladder Cancer Preclinical Stage Products
- Muscle Invasive Bladder Cancer Therapeutics Assessment
- Muscle Invasive Bladder Cancer Inactive Products
- Company-University Collaborations (Licensing/Partnering) Analysis
- Muscle Invasive Bladder Cancer Companies
- Muscle Invasive Bladder Cancer Key Products
- Muscle Invasive Bladder Cancer Unmet Needs
- Muscle Invasive Bladder Cancer Market Drivers and Barriers
- Muscle Invasive Bladder Cancer Future Perspectives and Conclusion
- Muscle Invasive Bladder Cancer Analyst Views
- Appendix
- About DelveInsight
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
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