DelveInsight's "Muscle Invasive Bladder Cancer Pipeline Insight 2025" report delivers thorough information on over 10 companies and over 10 pipeline drugs in the Muscle Invasive Bladder Cancer therapeutic landscape. It encompasses profiles of Muscle Invasive Bladder Cancer pipeline drugs, including those in clinical and nonclinical phases. Additionally, it evaluates Muscle Invasive Bladder Cancer pipeline therapies by product category, development stage, administration method, and molecular structure. It also spotlights discontinued pipeline products in this field.
Interested in the newest developments in the Muscle Invasive Bladder Cancer Pipeline? Click here to examine the treatments and studies gaining attention @ Muscle Invasive Bladder Cancer Pipeline Outlook Report
Key Insights from the Muscle Invasive Bladder Cancer Pipeline Report
December 2, 2025 - The U.S. Food and Drug Administration granted approval for Padcev (enfortumab vedotin-ejfv), a Nectin-4-targeted antibody-drug conjugate, for application as both preoperative neoadjuvant therapy and postoperative adjuvant care in patients with muscle-invasive bladder cancer (MIBC). Padcev is approved alongside Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph) as neoadjuvant treatment, and continued as adjuvant therapy after cystectomy, for MIBC patients unsuitable for cisplatin-based chemotherapy.
November 25, 2025 - Protara Therapeutics disclosed a Phase 2 trial (TARA-002-101-Ph2) aimed at further evaluating the safety and effectiveness of TARA-002 at the RP2D, which was determined in the Phase 1a dose-escalation study (TARA-002-101-Ph1a).
November 25, 2025 - AstraZeneca launched a phase III trial to assess the effectiveness and safety of Durvalumab combined with BCG in managing patients with non-muscle-invasive bladder cancer.
November 24, 2025 - Merck Sharp & Dohme LLC carried out a study comparing investigational treatment to standard care for addressing HR NMIBC. Intismeran autogene is engineered to assist the immune system in targeting specific cancer cells. NMIBC refers to cancer in the bladder's inner lining that hasn't invaded the muscle or spread beyond the bladder. High-risk indicates NMIBC with a greater likelihood of worsening or recurrence post-treatment.
DelveInsight's Muscle Invasive Bladder Cancer pipeline report illustrates a vibrant arena with over 10 active entities developing over 10 pipeline therapies for Muscle Invasive Bladder Cancer management.
Leading Muscle Invasive Bladder Cancer firms include Aura Biosciences, Janssen Research & Development LLC, Asieris Pharmaceuticals, RemeGen Co., Ltd., and others.
Promising Muscle Invasive Bladder Cancer treatments encompass Pembrolizumab, Gemcitabine, TAR-210, Mitomycin C, RC48-ADC, JS001, Oncofid-P-B, Cisplatin, Tremelimumab, and more.
Want to learn which organizations are driving advancements in Muscle Invasive Bladder Cancer? Explore the complete pipeline details @ Muscle Invasive Bladder Cancer Clinical Trials Assessment
The Muscle Invasive Bladder Cancer Pipeline Report offers a disease summary, pipeline overview, and therapeutic evaluation of major pipeline therapies in this area. It also emphasizes unmet needs in Muscle Invasive Bladder Cancer development.
Muscle Invasive Bladder Cancer Overview
Muscle invasive bladder cancer (MIBC) is a bladder cancer variant that has penetrated the bladder's muscular layer. This is a more severe type compared to non-invasive forms, demanding aggressive intervention. MIBC represents roughly 25% of bladder cancer diagnoses and carries a greater risk of spread and reduced survival. Primary risk elements include tobacco use, occupational chemical exposure, persistent bladder irritation, and specific genetic factors.
Muscle Invasive Bladder Cancer Emerging Drugs Profile
TAR-200: Janssen Research & Development, LLC
TAR-200 is an innovative investigational small molecule delivery system for regulated release of gemcitabine into the bladder, maintaining prolonged local drug levels over weeks. Its safety and efficacy are under review in Phase II and Phase III trials for muscle-invasive bladder cancer patients in SunRISe-2 and SunRISe-4. The drug is currently in Phase III development for Muscle Invasive Bladder Cancer treatment.
AU-011: Aura Biosciences
AU-011 is a pioneering targeted treatment being developed for muscle-invasive bladder cancer and non-invasive muscle bladder cancer. Developed by Aura Biosciences, it acts as a cell death inducer, photosensitizer, and reactive oxygen species activator. The drug is presently in Phase I development for Muscle Invasive Bladder Cancer.
The Muscle Invasive Bladder Cancer Pipeline report provides insights into
Detailed information on firms advancing therapies for Muscle Invasive Bladder Cancer, including the total therapies per company.
Various therapeutic candidates are divided into early, mid, and late development phases for Muscle Invasive Bladder Cancer care.
Muscle Invasive Bladder Cancer companies engaged in targeted therapy development, with active and inactive (dormant or halted) initiatives.
Muscle Invasive Bladder Cancer drugs in progress, categorized by development phase, delivery route, target receptor, monotherapy or combo approach, action mechanism, and molecular category.
In-depth review of partnerships (corporate-corporate and corporate-academic), licensing deals, and funding for future Muscle Invasive Bladder Cancer market growth.
If you're monitoring active Muscle Invasive Bladder Cancer clinical trials, this press release is essential. Click to view the advancements @ Muscle Invasive Bladder Cancer Treatment Drugs
Muscle Invasive Bladder Cancer Companies
Aura Biosciences, Janssen Research & Development LLC, Asieris Pharmaceuticals, RemeGen Co., Ltd., and others.
The Muscle Invasive Bladder Cancer pipeline report evaluates pipeline drugs by administration route. Products are grouped under routes like
Oral
Intravenous
Subcutaneous
Parenteral
Topical
Muscle Invasive Bladder Cancer products are classified by molecular types such as
Recombinant fusion proteins
Small molecule
Monoclonal antibody
Peptide
Polymer
Gene therapy
From novel drug prospects to competitive data, the Muscle Invasive Bladder Cancer Pipeline Report covers everything - review it now @ Muscle Invasive Bladder Cancer Market Drivers and Barriers, and Future Perspectives
Scope of the Muscle Invasive Bladder Cancer Pipeline Report
Coverage- Global
Muscle Invasive Bladder Cancer Companies- Aura Biosciences, Janssen Research & Development LLC, Asieris Pharmaceuticals, RemeGen Co., Ltd., and others.
Muscle Invasive Bladder Cancer Therapies- Pembrolizumab, Gemcitabine, TAR-210, Mitomycin C, RC48-ADC, JS001, Oncofid-P-B, Cisplatin, Tremelimumab, and others.
Muscle Invasive Bladder Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
Muscle Invasive Bladder Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Stay ahead in oncology research - uncover upcoming trends in the Muscle Invasive Bladder Cancer treatment field through this comprehensive review @ Muscle Invasive Bladder Cancer Emerging Drugs and Major Players
Table of Contents
Introduction
Executive Summary
Muscle Invasive Bladder Cancer: Overview
Comparative Analysis
Therapeutic Assessment
Muscle Invasive Bladder cancer- DelveInsight's Analytical Perspective
Late Stage Products (Phase III)
TAR-200: Janssen Research & Development, LLC
Mid Stage Products (Phase II)
Early Stage Products (Phase I)
AU-011: Aura Biosciences
Research and Development
Product Development Activities
Preclinical and Discovery Stage Products
Drug Name: Company Name
Research and Development
Product Development Activities
Inactive Products
Muscle Invasive Bladder cancer Key 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
Muscle Invasive Bladder cancer Key Companies
Appendix
About Us
DelveInsight is a premier healthcare market research and advisory firm delivering top-tier market intelligence and analysis to guide strategic business choices. With a skilled team of industry specialists and profound expertise in life sciences and healthcare, we provide tailored research services and insights worldwide. Reach out to us for precise, timely, and reliable data to maintain a competitive edge.
Kanishk
kkumar@delveinsight.comÂ