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Bile Duct Neoplasms Pipeline Analysis Report 2025

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    Report

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102850
Bile duct neoplasms are abnormal growths in the bile ducts. These growths can be benign (bile duct adenomas) or malignant (cholangiocarcinoma). Cholangiocarcinoma is the most prevalent type of cancer that develops from glandular cells that line the bile ducts and is divided into three locations, namely, intrahepatic, perihilar, and distal. Bile duct adenomas and other benign tumors are uncommon and frequently discovered by accident after surgery or autopsy. The bile duct neoplasms pipeline analysis by the publisher focuses on various treatment options for this disease.

Report Coverage

The Bile Duct Neoplasms Pipeline Analysis Report by the publisher gives comprehensive insights into bile duct neoplasms currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for Bile Duct Neoplasms therapeutics. The bile duct neoplasms report assessment includes the analysis of over 15 pipeline drugs and 10+ companies. The bile duct neoplasms 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 bile duct neoplasms 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 bile duct neoplasms.

Bile Duct Neoplasms Pipeline Outlook

Cholangiocytes give rise to bile duct neoplasms, which frequently entail chronic inflammation (from cholestasis, infections, or stones). It leads to genetic alterations which promote carcinogenesis, such as KRAS (early) and TP53 (late). Biliary intraepithelial neoplasia (BilIN) and intraductal papillary neoplasm (IPNB) are examples of premalignant lesions that show mucin production and papillary development. Long-term inflammation causes dysplasia, which damages the bile duct epithelium and creates a "vicious cycle" of cell division and DNA damage.

The resectable nature of bile duct neoplasm determines the course of treatment. The main treatment option is surgery, which may include resection of the liver or pancreas as well as excision of the bile duct. Chemotherapy (such as gemcitabine-cisplatin) and immunotherapy (such as pembrolizumab) aid in regulating tumor growth in situations that cannot be cured. Radiation therapy and photodynamic therapy relieve symptoms, whereas targeted therapies target mutations. Stent insertion is one palliative surgery that reduces jaundice and enhances quality of life.

Bile Duct Neoplasms Epidemiology

Rare, bile duct neoplasm varies greatly in geography and demographics. About 8,000 cases of bile duct cancer are detected in the United States each year. Intrahepatic cancer is more common (1.49 per 100,000) than extrahepatic cancer (0.96 per 100,000). Infections with liver flukes are more common in Southeast Asia. Males and older persons are more likely to be impacted, and all groups continue to have low survival rates.

Bile Duct Neoplasms - Pipeline Therapeutic Assessment

This section of the report covers the analysis of bile duct neoplasms 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

  • Monoclonal antibody
  • Peptides
  • Small molecule
  • Gene Therapy

By Route of Administration

  • Oral
  • Parenteral
  • Others

Bile Duct Neoplasms - 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 II covers a major share of the total bile duct neoplasms clinical trials.

In the bile duct neoplasms pipeline, most candidates are in Phase II with 47% of the projects, followed by 35% in Phase I and 18% in Phase III demonstrating a broad spectrum of development stages and diverse progress toward potential treatments.

Bile Duct Neoplasms - Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the bile duct neoplasms pipeline analysis include monoclonal antibody, peptides, small molecule and gene therapy. The bile duct neoplasms report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for Bile Duct Neoplasms.

Bile Duct Neoplasms Clinical Trials - Key Players

The report for the bile duct neoplasms pipeline analysis 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 bile duct neoplasms clinical trials:
  • Merck Sharp & Dohme LLC
  • Endeavor Biomedicines, Inc.
  • Carisma Therapeutics Inc.
  • Elicio Therapeutics
  • OncoC4, Inc.

Bile Duct Neoplasms Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for bile duct neoplasms. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of bile duct neoplasms drug candidates.

Drug: Pembrolizumab

Pembrolizumab, developed by Merck Sharp & Dohme LLC, is in Phase 3 of a clinical trial for treating biliary duct neoplasm. The trial evaluates its safety and efficacy, particularly in combination with chemotherapy, aiming to improve progression-free and overall survival. Pembrolizumab is an anti-PD-1 monoclonal antibody that boosts the immune system's ability to detect and fight cancer cells.

Drug: ENV- 101

Endeavor Biomedicines’ ENV-101 is currently in Phase 2 of a clinical trial to treat bile duct neoplasms. In patients with solid tumors that have progressed, the trial assesses its safety, tolerability, and initial effectiveness. To reduce tumor growth and improve patient outcomes, ENV-101, an inhibitor of the hedgehog pathway, targets and blocks aberrant cell signaling.

Key Questions Answered in the Bile Duct Neoplasms Pipeline Analysis Report

  • Which companies/institutions are leading the bile duct neoplasms drug development?
  • What is the efficacy and safety profile of bile duct neoplasms pipeline drugs?
  • Which company is leading the bile duct neoplasms pipeline development activities?
  • What is the current bile duct neoplasms commercial assessment?
  • What are the opportunities and challenges present in the bile duct neoplasms pipeline landscape?
  • Which company is conducting major trials for bile duct neoplasms drugs?
  • Which companies/institutions are involved in bile duct neoplasms collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in bile duct neoplasms?

Reasons To Buy This Report

The Bile Duct Neoplasms Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for bile duct neoplasms. 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 bile duct neoplasms collaborations, regulatory environments, and potential growth opportunities.

This product will be delivered within 3-5 business days.

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 Bile Duct Neoplasms
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Diagnosis
3.5 Treatment
4 Patient Profile: Bile Duct Neoplasms
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Bile Duct Neoplasms: Epidemiology Snapshot
5.1 Bile Duct Neoplasms Incidence by Key Markets
5.2 Bile Duct Neoplasms - Patients Seeking Treatment in Key Markets
6 Bile Duct Neoplasms: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Bile Duct Neoplasms: 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 Bile Duct Neoplasms, 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 Bile Duct Neoplasms 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 Bile Duct Neoplasms 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: Pembrolizumab
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 Other Drugs
11 Bile Duct Neoplasms 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: ENV-101
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 Other Drugs
12 Bile Duct Neoplasms 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: CT-0508
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: ELI-002
12.2.3 Other Drugs
13 Bile Duct Neoplasms, Key Drug Pipeline Companies
13.1 Merck Sharp & Dohme LLC
13.1.1 Company Snapshot
13.1.2 Pipeline Product Portfolio
13.1.3 Financial Analysis
13.1.4 Recent News and Developments
13.2 Endeavor Biomedicines, Inc.
13.2.1 Company Snapshot
13.2.2 Pipeline Product Portfolio
13.2.3 Financial Analysis
13.2.4 Recent News and Developments
13.3 Carisma Therapeutics Inc
13.3.1 Company Snapshot
13.3.2 Pipeline Product Portfolio
13.3.3 Financial Analysis
13.3.4 Recent News and Developments
13.4 Elicio Therapeutics
13.4.1 Company Snapshot
13.4.2 Pipeline Product Portfolio
13.4.3 Financial Analysis
13.4.4 Recent News and Developments
13.5 OncoC4, Inc.
13.5.1 Company Snapshot
13.5.2 Pipeline Product Portfolio
13.5.3 Financial Analysis
13.5.4 Recent News and Developments
14 Regulatory Framework for Drug Approval, By Region15 Terminated or Suspended Pipeline Products