Cholangiocarcinoma Pipeline Analysis Report 2025
Description
Cholangiocarcinoma (CCA) is a rare and aggressive cancer originating in the bile ducts, which transport bile from the liver to the digestive system. It is classified into intrahepatic, perihilar, and distal types based on its location. Symptoms often include jaundice, abdominal pain, fatigue, and unexplained weight loss. Risk factors include chronic biliary inflammation, primary sclerosing cholangitis, liver fluke infections, and exposure to toxins. Cholangiocarcinoma is typically diagnosed late due to its subtle early symptoms, making prognosis challenging. Cholangiocarcinoma pipeline analysis by Expert Market Research highlights promising drug candidates, including small molecules, gene therapies, and monoclonal antibodies.
Report Coverage
The Cholangiocarcinoma Pipeline Analysis Report by Expert Market Research gives comprehensive insights into cholangiocarcinoma therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for cholangiocarcinoma. The cholangiocarcinoma report assessment includes the analysis of over 25 pipeline drugs and 10+ companies. The cholangiocarcinoma 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 cholangiocarcinoma 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 cholangiocarcinoma.
Cholangiocarcinoma Pipeline Outlook
Chronic inflammation and cholestasis, frequently brought on by diseases like primary sclerosing cholangitis or liver fluke infections, cause biliary epithelial cells to malignantly convert into cholangiocarcinoma. Prolonged inflammation promotes unregulated proliferation and survival by causing DNA damage, epigenetic modifications, and deregulation of carcinogenic pathways such EGFR/ERB-B2 and IL-6/STAT3. Carcinogenesis is further fueled by genetic alterations (KRAS, IDH1/2, TP53), but autocrine/paracrine signaling is maintained by cytokines and growth hormones (e.g., hepatocyte growth factor). Desmoplastic stroma and cancer-associated fibroblasts are characteristics of the tumor microenvironment that promote invasion and metastasis. Adenocarcinomas with aggressive local infiltration account for most cases (>90%).
Surgery for isolated tumors is the main treatment for cholangiocarcinoma, with the goal of removing as much cancer as possible. Chemotherapy is the mainstay of palliative care for cases that cannot be cured. The first-line treatment is cisplatin plus gemcitabine, which has been demonstrated to increase overall survival when compared to gemcitabine alone. Additionally, targeted medicines that target genetic abnormalities within cancers are becoming more popular. Clinical trials are still investigating novel approaches to improve the treatment of this difficult cancer type.
Cholangiocarcinoma Epidemiology
The prevalence of cholangiocarcinoma (CCA), which currently makes up 15% of primary liver tumors and roughly 3% of gastrointestinal cancers, is rising worldwide. Although incidence rates differ greatly by area, about 8,000 new cases are detected in the US each year. In Hong Kong, for example, the rate of intrahepatic cholangiocarcinoma (ICC) is 2.3 per 100,000, while in Argentina it is 0.14 per 100,000. All things considered, improved diagnostic procedures and a greater awareness of risk factors are responsible for the rising trends in ICC and extrahepatic cholangiocarcinoma (ECC).
Cholangiocarcinoma Pipeline Therapeutic Assessment
This section of the report covers the analysis of cholangiocarcinoma drug candidates based on several segmentations including:
By Phase
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 III covers a major share of the total clinical trials, with a substantial number of cholangiocarcinoma drugs undergoing clinical development.
Cholangiocarcinoma Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under cholangiocarcinoma pipeline analysis include small molecules, biologics, peptides, and immunotherapies, among others. The cholangiocarcinoma report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for cholangiocarcinoma.
Cholangiocarcinoma Clinical Trials – Key Players
The EMR report for the cholangiocarcinoma pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed cholangiocarcinoma therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in cholangiocarcinoma clinical trials:
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 cholangiocarcinoma. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of cholangiocarcinoma drug candidates.
Drug: LY3410738
LY3410738 is an investigational, oral, covalent inhibitor targeting mutant isocitrate dehydrogenase (IDH) 1 and 2 enzymes, developed by Eli Lilly and Company. It is designed to bind irreversibly to mutant IDH1, blocking the production of the oncometabolite (R)-2-hydroxyglutarate ((R)-2HG), which is implicated in various cancers. LY3410738 is currently in Phase 1 of clinical trials to evaluate its safety, tolerability, and efficacy in patients with advanced solid tumors and hematologic malignancies harboring IDH1 or IDH2 mutations.
Drug: Pemigatinib
Pemigatinib, is a selective fibroblast growth factor receptor (FGFR) inhibitor developed by Incyte Corporation. It received accelerated FDA approval in 2020 for treating adults with previously treated unresectable locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements. The approval was based on the FIGHT-202 Phase 2 study, which demonstrated an overall response rate of 35.5% in patients with FGFR2 fusions. Pemigatinib is currently in Phase 3 clinical trials to further evaluate its safety and efficacy in treating cholangiocarcinoma and other FGFR-related malignancies.
Reasons To Buy This Report
The Cholangiocarcinoma Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for cholangiocarcinoma. 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 the cholangiocarcinoma pipeline insights.
Key Questions Answered in the Cholangiocarcinoma Pipeline Insight Report
Cholangiocarcinoma (CCA) Epidemiology Forecast
Global Cancer Therapeutics Market
Global Clinical Trials Market
Report Coverage
The Cholangiocarcinoma Pipeline Analysis Report by Expert Market Research gives comprehensive insights into cholangiocarcinoma therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for cholangiocarcinoma. The cholangiocarcinoma report assessment includes the analysis of over 25 pipeline drugs and 10+ companies. The cholangiocarcinoma 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 cholangiocarcinoma 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 cholangiocarcinoma.
Cholangiocarcinoma Pipeline Outlook
Chronic inflammation and cholestasis, frequently brought on by diseases like primary sclerosing cholangitis or liver fluke infections, cause biliary epithelial cells to malignantly convert into cholangiocarcinoma. Prolonged inflammation promotes unregulated proliferation and survival by causing DNA damage, epigenetic modifications, and deregulation of carcinogenic pathways such EGFR/ERB-B2 and IL-6/STAT3. Carcinogenesis is further fueled by genetic alterations (KRAS, IDH1/2, TP53), but autocrine/paracrine signaling is maintained by cytokines and growth hormones (e.g., hepatocyte growth factor). Desmoplastic stroma and cancer-associated fibroblasts are characteristics of the tumor microenvironment that promote invasion and metastasis. Adenocarcinomas with aggressive local infiltration account for most cases (>90%).
Surgery for isolated tumors is the main treatment for cholangiocarcinoma, with the goal of removing as much cancer as possible. Chemotherapy is the mainstay of palliative care for cases that cannot be cured. The first-line treatment is cisplatin plus gemcitabine, which has been demonstrated to increase overall survival when compared to gemcitabine alone. Additionally, targeted medicines that target genetic abnormalities within cancers are becoming more popular. Clinical trials are still investigating novel approaches to improve the treatment of this difficult cancer type.
Cholangiocarcinoma Epidemiology
The prevalence of cholangiocarcinoma (CCA), which currently makes up 15% of primary liver tumors and roughly 3% of gastrointestinal cancers, is rising worldwide. Although incidence rates differ greatly by area, about 8,000 new cases are detected in the US each year. In Hong Kong, for example, the rate of intrahepatic cholangiocarcinoma (ICC) is 2.3 per 100,000, while in Argentina it is 0.14 per 100,000. All things considered, improved diagnostic procedures and a greater awareness of risk factors are responsible for the rising trends in ICC and extrahepatic cholangiocarcinoma (ECC).
Cholangiocarcinoma Pipeline Therapeutic Assessment
This section of the report covers the analysis of cholangiocarcinoma 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
- Small Molecule
- Peptide
- Polymer
- Monoclonal Antibody
- Gene Therapy
- Others
- Oral
- Parenteral
- Others
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 III covers a major share of the total clinical trials, with a substantial number of cholangiocarcinoma drugs undergoing clinical development.
Cholangiocarcinoma Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under cholangiocarcinoma pipeline analysis include small molecules, biologics, peptides, and immunotherapies, among others. The cholangiocarcinoma report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for cholangiocarcinoma.
Cholangiocarcinoma Clinical Trials – Key Players
The EMR report for the cholangiocarcinoma pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed cholangiocarcinoma therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in cholangiocarcinoma clinical trials:
- Eli Lilly and Company
- Incyte Corporation
- Seagen
- Elevar Therapeutics
- Compass Therapeutics
- TCR2 Therapeutics
- Elicio Therapeutics
- Eisai Co., Ltd.
- Servier
- TriSalus Life Sciences, Inc.
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 cholangiocarcinoma. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of cholangiocarcinoma drug candidates.
Drug: LY3410738
LY3410738 is an investigational, oral, covalent inhibitor targeting mutant isocitrate dehydrogenase (IDH) 1 and 2 enzymes, developed by Eli Lilly and Company. It is designed to bind irreversibly to mutant IDH1, blocking the production of the oncometabolite (R)-2-hydroxyglutarate ((R)-2HG), which is implicated in various cancers. LY3410738 is currently in Phase 1 of clinical trials to evaluate its safety, tolerability, and efficacy in patients with advanced solid tumors and hematologic malignancies harboring IDH1 or IDH2 mutations.
Drug: Pemigatinib
Pemigatinib, is a selective fibroblast growth factor receptor (FGFR) inhibitor developed by Incyte Corporation. It received accelerated FDA approval in 2020 for treating adults with previously treated unresectable locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements. The approval was based on the FIGHT-202 Phase 2 study, which demonstrated an overall response rate of 35.5% in patients with FGFR2 fusions. Pemigatinib is currently in Phase 3 clinical trials to further evaluate its safety and efficacy in treating cholangiocarcinoma and other FGFR-related malignancies.
Reasons To Buy This Report
The Cholangiocarcinoma Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for cholangiocarcinoma. 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 the cholangiocarcinoma pipeline insights.
Key Questions Answered in the Cholangiocarcinoma Pipeline Insight Report
- What is the current landscape of cholangiocarcinoma pipeline drugs?
- Which companies/institutions are developing cholangiocarcinoma emerging drugs?
- How many phase II drugs are currently present in cholangiocarcinoma pipeline drugs?
- Which company is leading the cholangiocarcinoma pipeline development activities?
- What is the current cholangiocarcinoma therapeutic assessment?
- What are the opportunities and challenges present in the cholangiocarcinoma drug pipeline landscape?
- What is the efficacy and safety profile of cholangiocarcinoma pipeline drugs?
- Which companies/institutions are involved in cholangiocarcinoma collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in cholangiocarcinoma?
Cholangiocarcinoma (CCA) Epidemiology Forecast
Global Cancer Therapeutics 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 Cholangiocarcinoma
- 3.1 Signs and Symptoms
- 3.2 Causes
- 3.3 Risk Factors
- 3.4 Types of Cholangiocarcinoma
- 3.5 Diagnosis
- 3.6 Treatment
- 4 Patient Profile: Cholangiocarcinoma
- 4.1 Patient Profile Overview
- 4.2 Patient Psychology and Emotional Impact Factors
- 4.3 Risk Assessment and Treatment Success Rate
- 5 Cholangiocarcinoma: Epidemiology Snapshot
- 5.1 Cholangiocarcinoma Incidence by Key Markets
- 5.2 Cholangiocarcinoma – Patients Seeking Treatment in Key Markets
- 6 Cholangiocarcinoma: Market Dynamics
- 6.1 Market Drivers and Constraints
- 6.2 SWOT Analysis
- 7 Cholangiocarcinoma: 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 Cholangiocarcinoma, 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 Cholangiocarcinoma 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 Cholangiocarcinoma Drug Pipeline - Mid-Stage Products (Phase III & IV) (Top Drugs)
- 10.1 Comparative Analysis for Mid-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: Pemigatinib
- 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: Pembrolizumab
- 10.2.3 Other Drugs
- 11 Cholangiocarcinoma 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: LY3410738
- 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 Drug: CTX-009
- 11.2.3 Other Drugs
- 12 Cholangiocarcinoma 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: RLY-4008
- 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: Gavocabtagene autoleucel
- 12.2.3 Other Drugs
- 13 Cholangiocarcinoma, Key Drug Pipeline Companies
- 13.1 Eli Lilly and Company
- 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 Incyte Corporation
- 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 Seagen
- 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 Elevar 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 Compass Therapeutics
- 13.5.1 Company Snapshot
- 13.5.2 Pipeline Product Portfolio
- 13.5.3 Financial Analysis
- 13.5.4 Recent News and Developments
- 13.6 TCR2 Therapeutics
- 13.6.1 Company Snapshot
- 13.6.2 Pipeline Product Portfolio
- 13.6.3 Financial Analysis
- 13.6.4 Recent News and Developments
- 13.7 Elicio Therapeutics
- 13.7.1 Company Snapshot
- 13.7.2 Pipeline Product Portfolio
- 13.7.3 Financial Analysis
- 13.7.4 Recent News and Developments
- 13.8 Eisai Co., Ltd.
- 13.8.1 Company Snapshot
- 13.8.2 Pipeline Product Portfolio
- 13.8.3 Financial Analysis
- 13.8.4 Recent News and Developments
- 13.9 Servier
- 13.9.1 Company Snapshot
- 13.9.2 Pipeline Product Portfolio
- 13.9.3 Financial Analysis
- 13.9.4 Recent News and Developments
- 13.10 TriSalus Life Sciences, Inc.
- 13.10.1 Company Snapshot
- 13.10.2 Pipeline Product Portfolio
- 13.10.3 Financial Analysis
- 13.10.4 Recent News and Developments
- 14 Regulatory Framework for Drug Approval, By Region
- 15 Terminated or Suspended Pipeline Products
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