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Transitional Cell Carcinoma Drug Pipeline Analysis Report 2025

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    Drug Pipelines

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102658
Transitional cell carcinoma refers to a cancer that originates in the urothelial cells lining the urinary tract and other organs. It can occur in the ureters, bladder, renal pelvis, or other organs. Upper urinary tract transitional cell carcinoma makes up 5% of urothelial cancers and less than 10% of kidney tumors, with the evidence indicating an increasing incidence. Thus, the rising burden of transitional cell carcinoma along with the growing regulatory support in the form of faster approval pathways and incentives for orphan drugs is anticipated to expedite the drug pipeline growth in the coming years.

Report Coverage

The Transitional Cell Carcinoma Drug Pipeline Insight Report by the publisher gives comprehensive insights into transitional cell carcinoma therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for transitional cell carcinoma. The transitional cell carcinoma report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The transitional cell carcinoma pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials including their adverse effects on patients suffering from the condition, and alignment with transitional cell carcinoma treatment guidelines to ensure optimal care practices.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to transitional cell carcinoma.

Transitional Cell Carcinoma Drug Pipeline Outlook

Transitional cell carcinoma accounts for the majority of bladder cancer cases and primarily affects the lining of the urinary tract, including the bladder, ureters, and renal pelvis. Smoking, exposure to industrial chemicals, chronic bladder inflammation, and certain genetic predispositions include the risk factors of transitional cell carcinoma. The prognosis depends on the stage and grade of the tumor.

Transitional cell carcinoma treatments include a combination of chemotherapy, surgery, radiation, and immunotherapy. Drugs like pembrolizumab (anti-PD-1) and atezolizumab (anti-PD-L1) that enhance the ability of the immune system to attack cancer cells are increasingly being used by patients. Further, the rising focus on the development of drugs targeting specific genetic mutations or molecular pathways is expected to support the pipeline expansion in the coming years.

Transitional Cell Carcinoma Epidemiology

Studies show that transitional cell carcinoma of the renal pelvis accounts for about 7% of all kidney tumor cases. On the other hand, transitional cell carcinoma of the ureter represents nearly 4% of upper urinary tract tumors. It is estimated that 90% of patients can be cured if their tumors are superficial and confined to the ureter or renal pelvis.

Transitional Cell Carcinoma - Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of transitional cell carcinoma drug candidates based on several segmentations including:

By Phase

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

By Drug Class

  • Small Molecules
  • Monoclonal Antibodies
  • Antibody-Drug Conjugates (ADCs)
  • Peptides
  • Cell and Gene Therapies
  • RNA-based Therapies
  • Viral-Based Therapies

By Route of Administration

  • Oral
  • Parenteral
  • Others

Transitional Cell Carcinoma - Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to analysis, phase I covers a major share of the total clinical trials, with a substantial number of transitional cell carcinoma drugs undergoing clinical development.

Transitional Cell Carcinoma - Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under transitional cell carcinoma pipeline analysis include small molecules, monoclonal antibodies, antibody-drug conjugates (ADCs), peptides, cell and gene therapies, RNA-based therapies, and viral-based therapies. The transitional cell carcinoma report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for transitional cell carcinoma.

Transitional Cell Carcinoma Clinical Trials Therapeutic Assessment - Competitive Dynamics

The report for the transitional cell carcinoma drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed transitional cell carcinoma therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in transitional cell carcinoma clinical trials:
  • UroGen Pharma Ltd.
  • Mabwell (Shanghai) Bioscience Co., Ltd.
  • Sichuan Baili Pharmaceutical Co., Ltd.
  • Merck Sharp & Dohme LLC
  • Janssen Research & Development, LLC
  • ALX Oncology Inc.

Transitional Cell Carcinoma - Emerging Drugs Profile

Major drugs currently in the drug pipeline are as follows:

Drug: UGN-103

Sponsored by UroGen Pharma Ltd., the objective of this multicenter clinical trial is to investigate the efficacy and safety of the transitional cell carcinoma drug candidate UGN-103 in patients with low-grade intermediate-risk non-muscle invasive bladder cancer. The study is under Phase III clinical development and has an estimated 87 participants.

Biological: Zilovertamab vedotin

Merck Sharp & Dohme LLC is conducting a Phase I/II study aimed at examining the efficacy of investigational agents with or without the combination of pembrolizumab for the treatment of PD-1/L1 refractory locally advanced or metastatic urothelial carcinoma. The interventional study has enrolled about 40 subjects and is expected to be completed by October 2028.

Reasons To Buy This Report

The Transitional Cell Carcinoma Drug Report provides a strategic overview of the latest and future landscape of treatments for transitional cell carcinoma. it provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into market trends, regulatory environments, and potential growth opportunities within transitional cell carcinoma pipeline insights.

Key Questions Answered in the Transitional Cell Carcinoma - Pipeline Insight Report

  • What is the current landscape of transitional cell carcinoma disease pipeline drugs?
  • Which companies/institutions are developing transitional cell carcinoma disease emerging drugs?
  • How many phase II drugs are currently present in transitional cell carcinoma disease pipeline drugs?
  • Which company is leading the transitional cell carcinoma disease pipeline development activities?
  • What is the current transitional cell carcinoma disease therapeutic assessment?
  • What are the opportunities and challenges present in the transitional cell carcinoma disease drug pipeline landscape?
  • What is the efficacy and safety profile of transitional cell carcinoma disease pipeline drugs?
  • Which companies/institutions are involved in transitional cell carcinoma disease collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in transitional cell carcinoma disease?

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Table of Contents

1 Preface
1.1 Introduction
1.2 Objectives of the Study
1.3 Research Methodology & Assumptions
2 Executive Summary
3 Overview of Transitional Cell Carcinoma
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Diagnosis
3.5 Treatment
4 Patient Profile: Transitional Cell Carcinoma
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Transitional Cell Carcinoma: Epidemiology Snapshot
5.1 Transitional Cell Carcinoma Incidence by Key Markets
5.2 Transitional Cell Carcinoma - Patients Seeking Treatment in Key Markets
6 Transitional Cell Carcinoma: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Transitional Cell Carcinoma: Key Facts Covered
7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
7.2 Top Countries Contributing to Clinical Trials in Europe
7.3 Top Countries Contributing to Clinical Trials in North America
7.4 Top Countries Contributing to Clinical Trials in Other Regions
8 Transitional Cell Carcinoma, Drug Pipeline Assessment
8.1 Assessment by Treatment Type
8.2 Assessment by Route of Administration
8.3 Assessment by Drug Class
9 Drug Pipeline Comparative Analysis
9.1 List of Transitional Cell Carcinoma Pipeline Drugs
9.1.1 By Company
9.1.2 By Phase
9.1.3 By Indication
9.1.4 By Trial Status
9.1.5 By Funder Type
9.2 Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
10 Transitional Cell Carcinoma Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
10.1 Comparative Analysis for Late-Stage Drugs
10.1.1 Study Type
10.1.2 Recruitment Status
10.1.3 Company
10.1.4 Funder Type
10.2 Product Level Analysis*
10.2.1 Drug: 9MW2821, Drug: Chemotherapy
10.2.1.1 Product Description
10.2.1.2 Trial ID
10.2.1.3 Sponsor Name
10.2.1.4 Study Type
10.2.1.5 Drug Class
10.2.1.6 Eligibility Criteria
10.2.1.7 Study Record Dates
10.2.1.7.1 First Submitted
10.2.1.7.2 First Posted
10.2.1.7.3 Last Update Posted
10.2.1.7.4 Last Verified
10.2.1.8 Indication
10.2.1.9 Study Design
10.2.1.10 Recruitment Status
10.2.1.11 Enrollment (Estimated)
10.2.1.12 Location Countries
10.2.1.13 Recent Results
10.2.2 Drug: UGN-103
10.2.3 Other Drugs
11 Transitional Cell Carcinoma Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
11.1 Comparative Analysis for Mid-Stage Drugs
11.1.1 Study Type
11.1.2 Recruitment Status
11.1.3 Company
11.1.4 Funder Type
11.2 Product Level Analysis*
11.2.1 Drug: BL-B01D1, Drug: PD-1
11.2.1.1 Product Description
11.2.1.2 Trial ID
11.2.1.3 Sponsor Name
11.2.1.4 Study Type
11.2.1.5 Drug Class
11.2.1.6 Eligibility Criteria
11.2.1.7 Study Record Dates
11.2.1.7.1 First Submitted
11.2.1.7.2 First Posted
11.2.1.7.3 Last Update Posted
11.2.1.7.4 Last Verified
11.2.1.8 Indication
11.2.1.9 Study Design
11.2.1.10 Recruitment Status
11.2.1.11 Enrollment (Estimated)
11.2.1.12 Location Countries
11.2.1.13 Recent Results
11.2.2 Biological: Zilovertamab vedotin
11.2.3 Other Drugs
12 Transitional Cell Carcinoma Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
12.1 Comparative Analysis for Early-Stage Drugs
12.1.1 Study Type
12.1.2 Recruitment Status
12.1.3 Company
12.1.4 Funder Type
12.2 Product Level Analysis*
12.2.1 Drug: 9MW2821, Drug: Toripalimab
12.2.1.1 Product Description
12.2.1.2 Trial ID
12.2.1.3 Sponsor Name
12.2.1.4 Study Type
12.2.1.5 Drug Class
12.2.1.6 Eligibility Criteria
12.2.1.7 Study Record Dates
12.2.1.7.1 First Submitted
12.2.1.7.2 First Posted
12.2.1.7.3 Last Update Posted
12.2.1.7.4 Last Verified
12.2.1.8 Indication
12.2.1.9 Study Design
12.2.1.10 Recruitment Status
12.2.1.11 Enrollment (Estimated)
12.2.1.12 Location Countries
12.2.2 Drug: Evorpacept, Drug: Enfortumab Vedotin
12.2.3 Other Drugs
13 Transitional Cell Carcinoma Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
13.1.1 Study Type
13.1.2 Recruitment Status
13.1.3 Company
13.1.4 Funder Type
13.2 Product Level Analysis*
13.2.1 Drug 1
13.2.1.1 Product Description
13.2.1.2 Trial ID
13.2.1.3 Sponsor Name
13.2.1.4 Study Type
13.2.1.5 Drug Class
13.2.1.6 Eligibility Criteria
13.2.1.7 Study Record Dates
13.2.1.7.1 First Submitted
13.2.1.7.2 First Posted
13.2.1.7.3 Last Update Posted
13.2.1.7.4 Last Verified
13.2.1.8 Indication
13.2.1.9 Study Design
13.2.1.10 Recruitment Status
13.2.1.11 Enrollment (Estimated)
13.2.1.12 Location Countries
13.2.2 Other Drugs
14 Transitional Cell Carcinoma, Key Drug Pipeline Companies
14.1 UroGen Pharma Ltd.
14.1.1 Company Snapshot
14.1.2 Pipeline Product Portfolio
14.1.3 Financial Analysis
14.1.4 Recent News and Developments
14.2 Mabwell (Shanghai) Bioscience Co., Ltd.
14.2.1 Company Snapshot
14.2.2 Pipeline Product Portfolio
14.2.3 Financial Analysis
14.2.4 Recent News and Developments
14.3 Sichuan Baili Pharmaceutical Co., Ltd.
14.3.1 Company Snapshot
14.3.2 Pipeline Product Portfolio
14.3.3 Financial Analysis
14.3.4 Recent News and Developments
14.4 Merck Sharp & Dohme LLC
14.4.1 Company Snapshot
14.4.2 Pipeline Product Portfolio
14.4.3 Financial Analysis
14.4.4 Recent News and Developments
14.5 Janssen Research & Development, LLC
14.5.1 Company Snapshot
14.5.2 Pipeline Product Portfolio
14.5.3 Financial Analysis
14.5.4 Recent News and Developments
14.6 ALX Oncology Inc.
14.6.1 Company Snapshot
14.6.2 Pipeline Product Portfolio
14.6.3 Financial Analysis
14.6.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region16 Terminated or Suspended Pipeline Products