With Non Muscle Invasive Bladder Cancer (NMIBC) increasingly impacting populations worldwide and contributing to comorbidities such as diabetes, cardiovascular disease, and certain cancers, the need for safer and more effective treatments is rising. According to DelveInsight, the NMIBC pipeline features over 20 pharmaceutical and biotech companies actively developing more than 25 therapeutic candidates. These therapies are in various stages of clinical and preclinical development, reflecting strong innovation and dedication to tackling one of the most critical healthcare challenges today.
DelveInsight’s “Non Muscle Invasive Bladder Cancer Pipeline Insight 2025” report offers an in-depth and strategic review of the ongoing R&D landscape. It highlights clinical trial progress, emerging therapies, mechanisms of action, competitive positioning, and key company initiatives. The report is an essential resource for researchers, healthcare investors, and decision-makers seeking insights into the evolving NMIBC therapeutics market and the breakthroughs shaping its future.
Explore the Cutting-Edge Landscape of Non Muscle Invasive Bladder Cancer Drug Development @ https://www.delveinsight.com/report-store/non-muscle-invasive-bladder-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
During the ERS Congress 2025 in September 2025, several biotechnology and pharmaceutical companies shared notable advancements in pulmonary and cardiopulmonary research:
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In September 2025, Diagonal Therapeutics presented new preclinical data highlighting the potential of its lead clustering antibody, DIAG723, as a disease-modifying therapy for pulmonary arterial hypertension (PAH).
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In September 2025, a study revealed that babies raised with dogs may have a reduced risk of developing childhood asthma.
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In September 2025, Savara shared data from the Phase 3 IMPALA-2 trial of Molgramostim Inhalation Solution for patients with autoimmune pulmonary alveolar proteinosis (aPAP).
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In September 2025, AllRock Bio, Inc. reported encouraging Phase 1 results for ROC-101, a first-in-class oral pan-ROCK inhibitor for cardiopulmonary and fibrotic diseases.
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In September 2025, Gossamer Bio, Inc., in collaboration with Chiesi Group, announced five scientific presentations on seralutinib for PAH and PH-ILD.
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In September 2025, Boehringer Ingelheim presented pooled analyses from the Phase III FIBRONEER™ program on nerandomilast, an investigational oral PDE4B inhibitor, showing a nominally significant reduction in mortality risk across IPF and PPF.
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In September 2025, Kaia Health launched a pilot program of Kaia Breathe, a digital pulmonary rehabilitation solution for COPD patients, in partnership with MedImprove.
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In September 2025, aTyr Pharma, Inc. shared additional findings from the Phase 3 EFZO-FIT™ study of efzofitimod in 268 patients with pulmonary sarcoidosis, a key form of interstitial lung disease.
Key Takeaways from the Non Muscle Invasive Bladder Cancer Pipeline Report
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DelveInsight’s Non Muscle Invasive Bladder Cancer (NMIBC) pipeline report highlights a dynamic landscape with over 20 active companies developing more than 25 therapeutic candidates for NMIBC treatment.
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In February 2025, the U.S. FDA accepted Ultragenyx Pharmaceutical’s Biologics License Application (BLA) for UX111 (ABO-252), an AAV-based gene therapy targeting Non Muscle Invasive Bladder Cancer Type A. The FDA granted Priority Review, shortening the decision timeline to six months, with a Prescription Drug User Fee Act (PDUFA) action date set for August 120, 2025.
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Denali Therapeutics’ DNL126, an investigational enzyme replacement therapy capable of crossing the blood-brain barrier, was selected for the FDA’s Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program, which aims to accelerate the development of innovative rare disease treatments.
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Key NMIBC companies—including Johnson & Johnson Innovative Medicine, Asieris Pharmaceuticals, Pfizer, Theralase Technologies, Protara Therapeutics, Zhuhai Beihai Biotech Co., Ltd, Vaxiion Therapeutics, Aura Biosciences, Ractigen Therapeutics, Tyra Biosciences, Hoffmann-La Roche, SURGE Therapeutics, CG Oncology, Inc., Trigone Pharma Ltd., Merck Sharp & Dohme LLC, and others—are actively developing new therapies to advance the treatment landscape.
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Promising NMIBC pipeline candidates in various stages of development include TAR-200, APL-1202, TLD-1433, among others.
Non Muscle Invasive Bladder Cancer Overview:
Non-muscle invasive bladder cancer (NMIBC) is a type of bladder cancer that remains confined to the bladder’s inner lining and does not invade the muscle layer. It is the most commonly diagnosed form, accounting for approximately 70–80% of all bladder cancer cases. Bladder cancer ranks as the sixth most prevalent cancer in the United States, with around 81,000 new cases reported in 2020. Men are more frequently affected than women, with risk factors including tobacco use, long-term exposure to industrial chemicals, and chronic bladder inflammation. Although NMIBC generally has a better prognosis compared to muscle-invasive bladder cancer (MIBC), it poses a clinical challenge due to its high recurrence and potential for progression, making timely diagnosis and effective treatment critical.
Symptoms of bladder cancer can vary and may not appear in early stages, but early recognition is crucial for intervention. The most common symptom is hematuria, or blood in the urine, which may be painless and either visible or detectable only under a microscope. Other signs can include increased urinary frequency, a sudden or strong urge to urinate, a feeling of incomplete bladder emptying, or painful urination (dysuria). Discomfort in the lower abdomen or pelvic region may also occur. In advanced stages, back pain could indicate cancer spread. Since these symptoms can overlap with other conditions like urinary tract infections or kidney stones, it is essential for anyone experiencing them to consult a healthcare professional. Early detection greatly enhances the likelihood of successful treatment.
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Non Muscle Invasive Bladder Cancer Pipeline Analysis
The Non Muscle Invasive Bladder Cancer pipeline insights report 2025, provides insights into:
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Provides comprehensive insights into key companies developing therapies in the Non Muscle Invasive Bladder Cancer Market.
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Categorizes Non Muscle Invasive Bladder Cancer therapeutic companies by development stage: early, mid, and late-stage.
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Highlights major companies involved in targeted therapy development, including both active and inactive (paused/discontinued) projects.
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Reviews emerging Non Muscle Invasive Bladder Cancer drugs under development based on:
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Stage of development
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Non Muscle Invasive Bladder Cancer Route of administration
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Target receptor
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Monotherapy vs. combination therapy
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Non Muscle Invasive Bladder Cancer Mechanism of action
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Molecular type
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Offers detailed analysis of:
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Company-to-company and company-academia collaborations
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Non Muscle Invasive Bladder Cancer Licensing agreements
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Funding and investment activities supporting future Non Muscle Invasive Bladder Cancer market advancement.
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Unlock key insights into emerging Non Muscle Invasive Bladder Cancer therapies and market strategies here: https://www.delveinsight.com/report-store/non-muscle-invasive-bladder-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Non Muscle Invasive Bladder Cancer Emerging Drugs
TAR-200 – Johnson & Johnson Innovative Medicine
TAR-200 is an investigational intravesical drug delivery system designed to provide controlled release of gemcitabine directly into the bladder. The treatment is administered by a healthcare professional using a specially designed urinary catheter, typically taking under five minutes in an outpatient setting without the need for anesthesia. The U.S. FDA has granted TAR-200 Breakthrough Therapy Designation for adult patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS) who are either unsuitable for or decline radical cystectomy. TAR-200 is currently in the preregistration stage for NMIBC therapy.
APL-1202 – Asieris Pharmaceuticals
APL-1202 is an innovative oncology drug developed by Asieris Pharmaceuticals, built on licensed technology from Johns Hopkins University after more than ten years of research. It is a first-in-class, oral, reversible Methionine Aminopeptidase 2 (MetAP2) inhibitor and is currently in Phase III clinical trials for non-muscle invasive bladder cancer (NMIBC). Additionally, APL-1202 is being investigated as a neoadjuvant (pre-surgical) therapy for muscle-invasive bladder cancer (MIBC). Its development has been supported by China’s National Major New Drug Innovation Programs during the 12th and 13th Five-Year Plans in 2015 and 2018.
TLD-1433 – Protara Therapeutics
TLD-1433 is a ruthenium-based photosensitizing agent with potential anti-cancer effects in photodynamic therapy (PDT). Administered directly into the bladder, it binds to transferrin and is taken up by transferrin receptors, which are highly expressed on cancer cells. When activated by green light (525 nm), TLD-1433 generates reactive oxygen species (ROS) and singlet oxygen, inducing apoptosis and destroying tumor cells. Its selectivity is enhanced by the elevated presence of transferrin receptors on malignant cells. TLD-1433 is currently in Phase II clinical trials for non-muscle invasive bladder cancer.
Non Muscle Invasive Bladder Cancer Pipeline Therapeutic Assessment
Non Muscle Invasive Bladder Cancer Assessment by Product Type
• Mono
• Combination
• Mono/Combination
Non Muscle Invasive Bladder Cancer 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
Non Muscle Invasive Bladder Cancer Assessment by Route of Administration
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical
Non Muscle Invasive Bladder Cancer Assessment by Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
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Table of Contents
1. Report Introduction
2. Executive Summary
3. Non Muscle Invasive Bladder Cancer Current Treatment Patterns
20. Non Muscle Invasive Bladder Cancer – DelveInsight’s Analytical Perspective
5. Therapeutic Assessment
25. Non Muscle Invasive Bladder Cancer Late-Stage Products (Phase-III)
7. Non Muscle Invasive Bladder Cancer Mid-Stage Products (Phase-II)
20. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
25. Inactive Products
11. Dormant Products
12. Non Muscle Invasive Bladder Cancer Discontinued Products
13. Non Muscle Invasive Bladder Cancer Product Profiles
120. Non Muscle Invasive Bladder Cancer Key Companies
15. Non Muscle Invasive Bladder Cancer Key Products
125. Dormant and Discontinued Products
17. Non Muscle Invasive Bladder Cancer Unmet Needs
120. Non Muscle Invasive Bladder Cancer Future Perspectives
19. Non Muscle Invasive Bladder Cancer Analyst Review
20. Appendix
21. Report Methodology
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