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Urothelial Carcinoma Drug Pipeline Analysis Report 2025

Publisher Expert Market Research
Published May 25, 2025
Length 200 Pages
SKU # EMAR20146956

Description

Urothelial carcinoma is the most common type of bladder cancer, comprising more than 90% of the cases in industrialized countries. It is the 10th most common cancer worldwide and is reported to have nearly 4 times higher prevalence in men than in women. Studies indicate that metastatic urothelial carcinoma shows an overall poor prognosis with limited long-term survival rates, reflecting the critical need for more effective treatment options.

Report Coverage

The Urothelial Carcinoma Drug Pipeline Insight Report by Expert Market Research gives comprehensive insights into urothelial carcinoma drugs currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for urothelial carcinoma. The report includes the analysis of over 100 pipeline drugs and 50+ companies . The urothelial 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 urothelial carcinoma.

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 urothelial carcinoma.

Urothelial Carcinoma Drug Pipeline Outlook

Urothelial carcinoma or transitional carcinoma originates in the urothelium, the tissue that lines parts of the urinary system. It accounts for 90% and 7% of all cases of bladder cancer and kidney cancer, respectively. High-grade urothelial carcinoma often comes back even after treatment and may spread into the bladder’s muscle layer. On the other hand, low-grade urothelial carcinoma may be recurrent but the chances of it spreading into the muscle layer of the bladder are rare.

Common treatments for urothelial cancer include immunotherapy, targeted therapy, chemotherapy, and surgery, among others. In 2023, a two-drug combination of enfortumab vedotin and pembrolizumab (EV/pembro) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic urothelial bladder cancer. With the growing focus on immunotherapies and drugs targeting specific molecular pathways, the pipeline for urothelial cancer is poised for robust growth and innovation in the coming years. Additionally, the continued development of antibody-drug conjugates (ADCs) and combination regimens are expected to bring further advancements in the pipeline.

Urothelial Carcinoma – Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of urothelial carcinoma drugs 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
  • Immune Checkpoint Inhibitors
  • Targeted Therapies
  • Antibody-Drug Conjugates (ADCs)
  • Chemotherapeutic Agents
  • PARP Inhibitors
  • Tyrosine Kinase Inhibitors (TKIs)
By Route of Administration
  • Oral
  • Parenteral
  • Others
Urothelial 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 EMR analysis , phase II covers a major share of the total clinical trials for urothelial carcinoma. There are around 234 drugs in phase II of urothelial carcinoma.

Urothelial Carcinoma – Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under urothelial carcinoma pipeline analysis include immune checkpoint inhibitors, targeted therapies, antibody-drug conjugates (ADCs), chemotherapeutic agents, PARP inhibitors, and tyrosine kinase inhibitors (TKIs). These drug classes comprise the major categories of therapies being developed for urothelial carcinoma. The choice of treatment varies depending on the specific type of patient population and the stage of the disease.

Urothelial Carcinoma Clinical Trials Therapeutic Assessment – Competitive Dynamics

The EMR report for the urothelial carcinoma drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. Below is the list of a few players involved in urothelial carcinoma clinical trials:
  • Bristol-Myers Squibb
  • Bayer
  • Hoffmann-La Roche
  • Merck KGaA
  • Novartis Pharmaceuticals
  • UroGen Pharma Ltd.
  • Cadila Pharnmaceuticals
  • Jazz Pharmaceuticals
  • Boehringer Ingelheim
  • Eli Lilly and Company
  • Incyte Corporation
Urothelial Carcinoma – Emerging Drugs Profile

Leading drugs in the pipeline are as follows:

UGN-102

Sponsored by UroGen Pharma Ltd., UGN-102 is currently involved in a Phase 3 multicenter study that will assess its efficacy and safety profile as a primary chemoablative therapy in non-muscle-invasive patients.

Nivolumab

Bristol-Myers Squibb is sponsoring a Phase 3 clinical trial in which this drug is investigated for its effectiveness and safety compared to placebo in patients with radical surgery for invasive urothelial cancer.

Ipilimumab + nivolumab

Ipilimumab + nivolumab is in a Phase 2 study to evaluate the response of this induction therapy followed by chemoradiotherapy as a bladder-sparing treatment in urothelial bladder cancer.

KIN-3248

Currently, in Phase 1 of a multi-center, dose escalation and dose expansion study, the oral small molecule FGFR inhibitor KIN-3248 is under investigation for its safety, tolerability, pharmacokinetics (PK), and preliminary efficacy in advanced tumors participants harboring FGFR2 and/or FGFR3 gene alterations.

Reasons To Buy This Report

The Urothelial Carcinoma Drug Pipeline Insight Report provides a strategic overview of the latest and future landscape of treatments for urothelial 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 urothelial carcinoma pipeline insights.

Key Questions Answered in the Urothelial Carcinoma – Pipeline Insight Report
  • What is the current landscape of urothelial carcinoma pipeline drugs?
  • How many companies are developing urothelial carcinoma drugs?
  • How many phase III and phase IV drugs are currently present in urothelial carcinoma pipeline drugs?
  • Which companies/institutions are leading the urothelial carcinoma drug development?
  • What is the efficacy and safety profile of urothelial carcinoma pipeline drugs?
  • What are the opportunities and challenges present in the urothelial carcinoma drug pipeline landscape?
  • Which company is conducting major trials for urothelial carcinoma drugs?
  • What geographies are covered for urothelial carcinoma clinical trials?
  • What are emerging trends in urothelial carcinoma clinical trials?
Related Reports

Global Bladder Cancer Treatment Market

Global Clinical Trials Market

Table of Contents

200 Pages
1 Preface
1.1 Introduction
1.2 Objectives of the Study
1.3 Research Methodology & Assumptions
2 Executive Summary
3 Overview of Urothelial Carcinoma
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Types of Urothelial Carcinoma
3.5 Diagnosis
3.6 Treatment
4 Patient Profile: Urothelial Carcinoma
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Urothelial Carcinoma: Epidemiology Snapshot
5.1 Urothelial Carcinoma Incidence by Key Markets
5.2 Urothelial Carcinoma – Patients Seeking Treatment in Key Markets
6 Urothelial Carcinoma: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Urothelial 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 Urothelial Carcinoma, Drug Pipeline Assessment
8.1 Assessment by Treatment Type
8.2 Assessment by Route of Administration
8.3 Assessment by Drug Class
9 EMR Drug Pipeline Comparative Analysis
9.1 List of Urothelial 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 EMR Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
10 Urothelial 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 UGN-102
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 Nivolumab
10.2.3 Avelumab
10.2.4 Other Drugs
11 Urothelial 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 Gemcitabine & Cisplatin
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 Ipilimumab & Nivolumab
11.2.3 Other Drugs
12 Urothelial 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 KIN-3248
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 RC 198
12.2.3 Other Drugs
13 Urothelial 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 Daratumumab
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 Urothelial Carcinoma, Key Drug Pipeline Companies
14.1 Astellas Institute for Regenerative Medicine
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 Ascidian Therapeutics, Inc.
14.2.1 Company Snapshot
14.2.2 Pipeline Product Portfolio
14.2.3 Financial Analysis
14.2.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region
16 Terminated or Suspended Pipeline Products

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