Cholangiocarcinoma Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Cholangiocarcinoma Pipeline Insight 2025" report provides comprehensive insights about 55+ companies and 60+ pipeline drugs in Cholangiocarcinoma pipeline landscape. It covers the Cholangiocarcinoma Pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Cholangiocarcinoma pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Cholangiocarcinoma Pipeline Report

* In May 2025, Tango Therapeutics Inc . announced a study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 225 participants.
* DelveInsight's Cholangiocarcinoma pipeline report depicts a robust space with 55+ active players working to develop 60+ pipeline therapies for Cholangiocarcinoma treatment.
* The leading Cholangiocarcinoma Companies such as Merck Sharp & Dohme, Eisai, RedHill Biopharma Limited, TransThera Science, Kinnate Biopharma, Taiho Oncology, Bristol-Myers Squibb, AstraZeneca, Jiangsu Hengrui Medicine Co. Ltd., GlaxoSmithKline, Beijing InnoCare Pharma, Genoscience, 3D Medicines, Innovent Biologics (Suzhou) Co. Ltd., QED Therapeutics, Hutchison MediPharma, TriSalus Life Sciences, Relay Therapeutics, Eli Lilly and Company, Medivir, Boehringer Ingelheim, Compass Therapeutics, Intensity Therapeutics, Sirnaomics, Wellmarker Bio and others.
* Promising Cholangiocarcinoma Pipeline Therapies such as PEMAZYRE (pemigatinib), TIBSOVO (ivosidenib), LYTGOBI (futibatinib), Imfinzi (durvalumab), Melphalan, Derazantinib, Futibatinib (TAS-120), E7090, TT-0040, and others.

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Cholangiocarcinoma Emerging Drugs Profile

* Pembrolizumab: Merck Sharp & dohme

Pembrolizumab is a highly selective humanized monoclonal IgG4 antibody directed against the PD-1 receptor on the cell surface. The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells. It is currently being evaluated in Phase III stage of development to treat biliary tract cancer.

* E7090: Eisai

Discovered in-house by Eisai's Tsukuba Research Laboratories, E7090 is an orally available novel tyrosine kinase inhibitor that demonstrates selective inhibitory activity against fibroblast growth factor receptors (FGFR) FGFR1, FGFR2, and FGFR3. Distinct from prior known FGFR inhibitors, E7090 has a basic structure that lacks the dimethoxyphenyl moiety, and in a kinetic interaction analysis study, it was observed that E7090 demonstrates antitumor effects due to inhibition of kinase activity with a binding mode (Type V) that exhibits rapid and potent binding as well as high selectivity to FGFR1. A Phase II clinical trial of E7090 is underway to evaluate the efficacy and safety in patients with cholangiocarcinoma with FGFR2 gene fusion. E7090 received orphan drug designation for a prospective indication for unresectable biliary tract cancer with FGFR2 gene fusion by the Ministry of Health, Labour and Welfare, Japan.

* ABC294640: RedHill Biopharma Limited

ABC294640 (Opaganib) is a first-in-class, proprietary sphingosine kinase-2 (SK2) selective inhibitor, administered orally, with anticancer, anti-inflammatory, and antiviral activities. Opaganib inhibits SK2, a lipid kinase that catalyzes the formation of the lipid signaling molecule sphingosine 1-phosphate (S1P). S1P promotes cancer growth, and proliferation and pathological inflammation, including TNF signaling, and other inflammatory cytokine production. Specifically, by inhibiting the SK2 enzyme, opaganib blocks the synthesis of S1P, which regulates fundamental biological processes such as cell proliferation, migration, immune cell trafficking and angiogenesis, and is also involved in immune modulation and suppression of innate immune responses from T cells. Preliminary evidence suggests that because of its specificity for targeting SK2 rather than SK1, opaganib may have a better therapeutic ratio than nonspecific sphingosine kinase inhibitors or those targeting only SK1. Currently, the drug is being evaluated in the Phase II stage of its development for the treatment of cholangiocarcinoma.

* TT-00420: TransThera Science

TT-00420 is a highly innovative, clinical-stage, spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells and improving the tumor microenvironment. A large number of preclinical studies have found that TT-00420 has a promising inhibitory effect on triple-negative breast cancer, cholangiocarcinoma, and other malignant tumors. TT-00420 was granted Orphan Drug Designation and fast track designation by the FDA and is currently in the Phase II stage of its development for the treatment of cholangiocarcinoma.

* KIN-3248: Kinnate Biopharma

KIN-3248 is a small molecule kinase inhibitor that targets cancer associated alterations in the FGFR2 and FGFR3 genes. KIN-3248 aims to address the primary driver alteration and clinically observed and predicted FGFR2/3 mutations. The company is currently evaluating the safety and tolerability of KIN-3248 in the Phase I stage of its development for the treatment of cholangiocarcinoma.

The Cholangiocarcinoma Pipeline Report Provides Insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Cholangiocarcinoma with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Cholangiocarcinoma Treatment.
* Cholangiocarcinoma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Cholangiocarcinoma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Cholangiocarcinoma market

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Cholangiocarcinoma Companies

Merck Sharp & Dohme, Eisai, RedHill Biopharma Limited, TransThera Science, Kinnate Biopharma, Taiho Oncology, Bristol-Myers Squibb, AstraZeneca, Jiangsu Hengrui Medicine Co. Ltd., GlaxoSmithKline, Beijing InnoCare Pharma, Genoscience, 3D Medicines, Innovent Biologics (Suzhou) Co. Ltd., QED Therapeutics, Hutchison MediPharma, TriSalus Life Sciences, Relay Therapeutics, Eli Lilly and Company, Medivir, Boehringer Ingelheim, Compass Therapeutics, Intensity Therapeutics, Sirnaomics, Wellmarker Bio and others.

Cholangiocarcinoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

* Oral
* Parenteral
* Intravenous
* Subcutaneous
* Topical.

Cholangiocarcinoma Products have been categorized under various Molecule types such as

* Monoclonal Antibody
* Peptides
* Polymer
* Small molecule
* Gene therapy

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Scope of the Cholangiocarcinoma Pipeline Report

* Coverage- Global
* Cholangiocarcinoma Companies- Merck Sharp & Dohme, Eisai, RedHill Biopharma Limited, TransThera Science, Kinnate Biopharma, Taiho Oncology, Bristol-Myers Squibb, AstraZeneca, Jiangsu Hengrui Medicine Co. Ltd., GlaxoSmithKline, Beijing InnoCare Pharma, Genoscience, 3D Medicines, Innovent Biologics (Suzhou) Co. Ltd., QED Therapeutics, Hutchison MediPharma, TriSalus Life Sciences, Relay Therapeutics, Eli Lilly and Company, Medivir, Boehringer Ingelheim, Compass Therapeutics, Intensity Therapeutics, Sirnaomics, Wellmarker Bio and others.
* Cholangiocarcinoma Pipeline Therapies- PEMAZYRE (pemigatinib), TIBSOVO (ivosidenib), LYTGOBI (futibatinib), Imfinzi (durvalumab), Melphalan, Derazantinib, Futibatinib (TAS-120), E7090, TT-0040, and others.
* Cholangiocarcinoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Cholangiocarcinoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Contents

* Introduction
* Executive Summary
* Cholangiocarcinoma: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Cholangiocarcinoma- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Pembrolizumab: Merck Sharp & dohme
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* E7090: Eisai
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* KIN-3248: Kinnate Biopharma
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* Cholangiocarcinoma Key Companies
* Cholangiocarcinoma Key Products
* Cholangiocarcinoma- Unmet Needs
* Cholangiocarcinoma- Market Drivers and Barriers
* Cholangiocarcinoma- Future Perspectives and Conclusion
* Cholangiocarcinoma Analyst Views
* Cholangiocarcinoma Key Companies
* Appendix

About Us

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