DelveInsight’s “Intrahepatic Cholangiocarcinoma – Pipeline Insight, 2025” provides a detailed analysis of the therapeutic development landscape for iCCA, a rare but highly lethal form of bile duct cancer with limited curative options. The majority of patients are diagnosed at an advanced stage, and median survival remains poor, underscoring the need for targeted and immune-based innovations.
Several promising therapies are in late-stage clinical trials, including futibatinib (TAS-120), a next-generation irreversible FGFR inhibitor, and ivosidenib for IDH1-mutant iCCA. Immunotherapies such as durvalumab, nivolumab, and anti-PD-1/CTLA-4 combinations are also being explored, either alone or in synergy with chemotherapy. Novel multi-kinase inhibitors, antibody-drug conjugates, and tumor microenvironment modulators are expanding the treatment armamentarium.
The FDA continues to grant orphan drug designations and breakthrough therapy status to accelerate development in this underserved space. Biomarker testing and molecular profiling are increasingly being integrated into standard diagnostic algorithms, enhancing trial enrollment and personalization of therapy.
As 2025 approaches, the iCCA pipeline is shifting from empirical treatment to targeted, biology-driven approaches—empowered by molecular diagnostics, real-world evidence, and strong academic-industry collaboration. With multiple registrational trials underway, the landscape is poised for significant progress in improving survival and quality of life for patients with this challenging disease.
Interested in learning more about the current treatment landscape and the key drivers shaping the Intrahepatic Cholangiocarcinoma pipeline? Click here
Key Takeaways from the Intrahepatic Cholangiocarcinoma Pipeline Report
• DelveInsight’s Intrahepatic cholangiocarcinoma pipeline analysis depicts a strong space with 18+ active players working to develop 20+ pipeline drugs for Intrahepatic cholangiocarcinoma treatment.
• The leading Intrahepatic cholangiocarcinoma companies include Zymeworks, Basilea Pharmaceuticals, Medivir AB, Amgen, Kinnate Biopharma, Tyra Biosciences, Trisalus Life Sciences, and others are evaluating their lead assets to improve the Intrahepatic cholangiocarcinoma treatment landscape.
• Key Intrahepatic cholangiocarcinoma pipeline therapies in various stages of development include Zanidatamab, Derazantinib, MIV-818, Bemarituzumab, KIN-3248, TYRA-200, Nelitolimod, and others.
• In April 2025, researchers published results linking molecular resistance mechanisms in FGFR2-altered iCCA to futibatinib treatment, showing genomic correlates and evolving resistance pathways identified through ctDNA profiling and tissue biopsies; the analysis aims to guide future sequencing of FGFR inhibitors.
• In May 2024, the FDA announced the final withdrawal of its accelerated approval for infigratinib (Truseltiq) in FGFR2-positive cholangiocarcinoma. The withdrawal was requested by the sponsor due to challenges in conducting the required confirmatory trial for clinical benefit
Intrahepatic Cholangiocarcinoma Overview
Intrahepatic cholangiocarcinoma (ICC) is a rare and aggressive form of liver cancer that originates in the bile ducts within the liver. It often presents at an advanced stage due to its subtle symptoms, making early diagnosis challenging. ICC is characterized by rapid tumor growth and poor prognosis, with limited treatment options available. Current therapies include surgical resection for eligible patients, chemotherapy, targeted therapies, and emerging immunotherapies aimed at improving outcomes. Research is ongoing to better understand the molecular mechanisms driving ICC to develop more effective treatments.
Find out more about Intrahepatic cholangiocarcinoma medication at https://www.delveinsight.com/report-store/intrahepatic-cholangiocarcinoma-pipeline-insight
Intrahepatic Cholangiocarcinoma Treatment Analysis: Drug Profile
Zanidatamab: Zymeworks
Zanidatamab is an investigational bispecific antibody developed using Zymeworks’ proprietary Azymetric platform, designed to simultaneously bind two distinct HER2 epitopes through biparatopic binding. This unique approach enables multiple mechanisms of action, including dual HER2 signaling blockade, HER2 protein removal from the cell surface, and immune-mediated cytotoxicity, resulting in promising antitumor effects. Zanidatamab is currently in Phase III clinical trials as a targeted therapy for patients with HER2-expressing solid tumors, including intrahepatic cholangiocarcinoma.
HMPL-453: Hutchmed
HMPL-453 is a novel, highly selective small molecule inhibitor targeting FGFR 1, 2, and 3. Preclinical studies have shown that HMPL-453 offers superior potency and kinase selectivity compared to other FGFR inhibitors, along with a favorable safety profile. It is currently being evaluated in Phase II clinical trials for the treatment of intrahepatic cholangiocarcinoma.
Learn more about the novel and emerging intrahepatic cholangiocarcinoma pipeline therapies.
Intrahepatic Cholangiocarcinoma Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.
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
By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
Scope of the Intrahepatic Cholangiocarcinoma Pipeline Report
• Coverage: Global
• Key Intrahepatic Cholangiocarcinoma Companies: Zymeworks, Basilea Pharmaceuticals, Medivir AB, Amgen, Kinnate Biopharma, Tyra Biosciences, Trisalus Life Sciences, and others.
• Key Intrahepatic Cholangiocarcinoma Pipeline Therapies: Zanidatamab, Derazantinib, MIV-818, Bemarituzumab, KIN-3248, TYRA-200, Nelitolimod, and others.
Explore detailed insights on drugs used in the treatment of intrahepatic cholangiocarcinoma here.
Table of Contents
1. Introduction
2. Executive Summary
3. Intrahepatic Cholangiocarcinoma Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Intrahepatic Cholangiocarcinoma Pipeline Therapeutics
6. Intrahepatic Cholangiocarcinoma Pipeline: Late-Stage Products (Phase III)
7. Intrahepatic Cholangiocarcinoma Pipeline: Mid-Stage Products (Phase II)
8. Intrahepatic Cholangiocarcinoma Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix
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