DelveInsight's,“ Muscle Invasive Bladder Cancer Pipeline Insight 2025” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in the Muscle Invasive Bladder Cancer pipeline landscape. It covers the Muscle Invasive Bladder Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Muscle Invasive Bladder Cancer pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Curious about the latest updates in the Muscle Invasive Bladder Cancer Pipeline? Click here to explore the therapies and trials making headlines @ Muscle Invasive Bladder Cancer Pipeline Outlook Report

Key Takeaways from the Muscle Invasive Bladder Cancer Pipeline Report

• Dec. 2, 2025 - The U.S. Food and Drug Administration has approved Padcev (enfortumab vedotin-ejfv), a Nectin-4–directed antibody-drug conjugate, for use as both perioperative neoadjuvant therapy and post-cystectomy adjuvant treatment in adults with muscle-invasive bladder cancer (MIBC). Padcev is authorized in combination with Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph) as neoadjuvant therapy, and continued as adjuvant treatment following cystectomy, for patients with MIBC who are not eligible for cisplatin-based chemotherapy.
• On November 25, 2025- Protara Therapeutics announced a Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a).
• On November 25, 2025- AstraZeneca initiated a phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer
• On November 24, 2025- Merck Sharp & Dohme LLC conducted a study treatment, to standard treatment can help treat HR NMIBC. Intismeran autogene is designed to help a person's immune system attack their specific cancer. NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment.
• DelveInsight's Muscle Invasive Bladder Cancer pipeline report depicts a robust space with 10+ active players working to develop 10+ pipeline therapies for Muscle Invasive Bladder Cancer treatment.
• The leading Muscle Invasive Bladder Cancer Companies such as Aura Biosciences, Janssen Research & Development LLC, Asieris Pharmaceuticals, RemeGen Co., Ltd. and others.
• Promising Muscle Invasive Bladder Cancer Therapies such as Pembrolizumab, Gemcitabine, TAR-210, Mitomycin C, RC48-ADC, JS001, Oncofid-P-B, Cisplatin, Tremelimumab and others.

Want to know which companies are leading innovation in Muscle Invasive Bladder Cancer? Dive into the full pipeline insights @ Muscle Invasive Bladder Cancer Clinical Trials Assessment

The Muscle Invasive Bladder Cancer Pipeline Report provides disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The Muscle Invasive Bladder Cancer Pipeline Report also highlights the unmet needs with respect to the development of Muscle Invasive Bladder Cancer.

Muscle Invasive Bladder Cancer Overview

Muscle invasive bladder cancer (MIBC) is a type of bladder cancer that has grown into the muscle layer of the bladder wall. This is a more aggressive form of bladder cancer compared to non-muscle invasive types and requires more intensive treatment. MIBC accounts for about 25% of all bladder cancer cases and is associated with a higher risk of metastasis and lower survival rates. The main risk factors include smoking, exposure to industrial chemicals, chronic bladder inflammation, and certain genetic predispositions.

Muscle Invasive Bladder Cancer Emerging Drugs Profile

• TAR-200: Janssen Research & Development, LLC

TAR-200 is a novel investigational small molecule targeted releasing system enabling controlled release of gemcitabine into the bladder, sustaining local drug exposure for weeks at a time. The safety and efficacy of TAR-200 are being evaluated in Phase II and Phase III studies in patients with muscle-invasive bladder cancer in SunRISe-2 and SunRISe-4. Currently, the drug is in Phase III stage of its development for the treatment of Muscle Invasive Bladder Cancer.

• AU-011: Aura Biosciences

AU-011 is a first-in-class targeted therapy in development for the muscle Invasive Bladder Cancer and noninvasive muscle bladder cancer. The drug candidate is being developed by Aura Biosciences. The drug is death stimulants and photosensitisers and also works as reactive oxygen species stimulants thus having mechanism of action. Currently, the drug is in Phase I stage of its development for the treatment of Muscle Invasive Bladder Cancer.

The Muscle Invasive Bladder Cancer Pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Muscle Invasive Bladder Cancer with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Muscle Invasive Bladder Cancer Treatment.
• Muscle Invasive Bladder Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Muscle Invasive Bladder Cancer Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Muscle Invasive Bladder Cancer market.

If you're tracking ongoing Muscle Invasive Bladder Cancer clinical trials, this press release is a must-read. Tap to see the breakthroughs @ Muscle Invasive Bladder Cancer Treatment Drugs

Muscle Invasive Bladder Cancer Companies

Aura Biosciences, Janssen Research & Development LLC, Asieris Pharmaceuticals, RemeGen Co., Ltd. and others.

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 Products have been categorized under various Molecule types such as

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

From emerging drug candidates to competitive intelligence, the Muscle Invasive Bladder Cancer Pipeline Report covers it all – check it out 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 – discover what's next for the Muscle Invasive Bladder Cancer treatment landscape in this detailed analysis @ Muscle Invasive Bladder Cancer Emerging Drugs and Major Players

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