Biliary Tract Cancer Pipeline 2025: Comprehensive Clinical Trials and Therapies Analysis with Key MOA and ROA Insights by DelveInsight | Agios Pharma, Servier Pharma, Merck Sharp & Dohme, AstraZeneca

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Biliary Tract Cancer pipeline constitutes 80+ key companies continuously working towards developing 80+ Biliary Tract Cancer treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The Biliary Tract Cancer Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

"Biliary Tract Cancer Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Biliary Tract Cancer Market.

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Some of the key takeaways from the Biliary Tract Cancer Pipeline Report:

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Companies across the globe are diligently working toward developing novel Biliary Tract Cancer treatment therapies with a considerable amount of success over the years.

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Biliary Tract Cancer companies working in the treatment market are Merck Sharp & Dohme, AstraZeneca, Taiho Oncology, Delcath Systems, TransThera Sciences (Nanjing), Basilea Pharmaceutica, Eisai, Zymeworks, BeiGene, Xencor, Inc., Bristol-Myers Squibb, Leap Therapeutics, Inc., Compass Therapeutics, Boehringer Ingelheim, ZielBio, Inc., GeneQuantum Healthcare (Suzhou) Co., Ltd., BioNTech SE, SOTIO Biotech, Carisma Therapeutics Inc, Rain Oncology Inc, Avacta Life Sciences Ltd, DualityBio Inc., and others, are developing therapies for the Biliary Tract Cancer treatment

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Emerging Biliary Tract Cancer therapies in the different phases of clinical trials are- Keytruda (pembrolizumab), Imfinzi (durvalumab), Futibatinib (TAS-120), Melphalan, E7090 (tasurgratinib), TT-00420, ARQ 087 (Derazantinib), Lenvima (lenvatinib), Zanidatamab, XmAb20717, Nivolumab + DKN-01, CTX-009, MEDI5752, Brigimadlin, ZB131, GQ1001, BNT141, SO-C101, CT-0508, RAIN-32, AVA6000, DB-1303, and others are expected to have a significant impact on the Biliary Tract Cancer market in the coming years.

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In January 2026, Summit Therapeutics Inc. (NASDAQ: SMMT) announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) following tyrosine kinase inhibitor (TKI) treatment. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026. In parallel, Akeso is advancing multiple Phase III clinical trials of ivonescimab beyond NSCLC, including studies in biliary tract, colorectal, breast, pancreatic, small cell lung, and head and neck cancers.

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In September 2025, Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it has received CE IVDR approval for two label extensions of its VENTANA Registered HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx* assay. HER2, a receptor protein expressed in multiple cancers, acts as a predictive biomarker to determine a patient's eligibility for HER2-targeted therapies. The VENTANA HER2 (4B5) test is the first and only companion diagnostic approved to identify HR-positive metastatic breast cancer patients with HER2-ultralow expression. Such patients may qualify for treatment with ENHERTU Registered (trastuzumab deruxtecan), a specially designed HER2-directed antibody-drug conjugate (ADC) developed by Daiichi Sankyo and co-developed and commercialized with AstraZeneca.

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In April 2025, Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage biopharmaceutical company specializing in oncology and antibody-based therapies, reported that its ongoing Phase 2/3 COMPANION-002 trial evaluating tovecimig (previously CTX-009) in combination with paclitaxel for advanced biliary tract cancer (BTC) met the primary efficacy endpoint with statistically significant top-line results.

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In January 2025, The Phase 3 SWOG S1815 trial (NCT03768414) revealed that adding nab-paclitaxel (Abraxane) to the standard chemotherapy regimen of gemcitabine and cisplatin did not lead to a statistically significant improvement in overall survival (OS) or progression-free survival (PFS) compared to gemcitabine and cisplatin alone in patients with newly diagnosed advanced biliary tract cancer.

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In November 2024, CTX-009 is a bispecific antibody designed to inhibit both Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which play essential roles in angiogenesis and tumor vascularization. Preclinical and early clinical research indicate that targeting these pathways simultaneously enhances anti-tumor efficacy across various solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic, and non-small cell lung cancer. Notably, partial responses have been observed in patients with advanced cancers resistant to standard anti-VEGF therapies. The ongoing COMPANION-002 Phase 2/3 clinical trial is evaluating CTX-009 in combination with paclitaxel versus paclitaxel alone in patients with previously treated, unresectable, advanced, metastatic, or recurrent biliary tract cancers (BTC).

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In April 2024, AstraZeneca has released updated exploratory findings from the TOPAZ-1 Phase III clinical trial, showing that Imfinzi (durvalumab), combined with standard-of-care chemotherapy, provided a long-term overall survival (OS) benefit in patients with advanced biliary tract cancer (BTC) at the three-year mark.

Biliary Tract Cancer Overview

Biliary tract cancer, also known as cholangiocarcinoma, is a type of cancer that arises in the bile ducts, which are the tubes that carry bile (a digestive fluid) from the liver to the gallbladder and small intestine.

Explore the latest Biliary Tract Cancer pipeline insights 2025, including emerging therapies, clinical trials, and market opportunities. Stay ahead in Biliary Tract Cancer Clinical Trials [https://www.delveinsight.com/sample-request/biliary-tract-cancers-btcs-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Emerging Biliary Tract Cancer Drugs Under Different Phases of Clinical Development Include:

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Keytruda (pembrolizumab): Merck Sharp & Dohme

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Imfinzi (durvalumab): AstraZeneca

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Futibatinib (TAS-120): Taiho Oncology

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Melphalan: Delcath Systems

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E7090 (tasurgratinib): Eisai

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TT-00420: TransThera Sciences (Nanjing)

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ARQ 087 (Derazantinib): Basilea Pharmaceutica

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Lenvima (lenvatinib): Eisai and Merck & Co

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Zanidatamab: Zymeworks and BeiGene

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XmAb20717: Xencor, Inc.

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Nivolumab + DKN-01: Bristol-Myers Squibb/Leap Therapeutics, Inc.

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CTX-009: Compass Therapeutics

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MEDI5752: AstraZeneca

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Brigimadlin: Boehringer Ingelheim

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ZB131: ZielBio, Inc.

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GQ1001: GeneQuantum Healthcare (Suzhou) Co., Ltd.

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BNT141: BioNTech SE

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SO-C101: SOTIO Biotech

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CT-0508: Carisma Therapeutics Inc

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RAIN-32: Rain Oncology Inc

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AVA6000: Avacta Life Sciences Ltd

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DB-1303: DualityBio Inc.

Biliary Tract Cancer Route of Administration

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

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Oral

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Parenteral

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Intravenous

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Subcutaneous

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Topical

Biliary Tract Cancer Molecule Type

Biliary Tract Cancer Products have been categorized under various Molecule types, such as

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Monoclonal Antibody

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Peptides

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Polymer

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Small molecule

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Gene therapy

Biliary Tract Cancer Pipeline Therapeutics Assessment

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Biliary Tract Cancer Assessment by Product Type

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Biliary Tract Cancer By Stage and Product Type

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Biliary Tract Cancer Assessment by Route of Administration

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Biliary Tract Cancer By Stage and Route of Administration

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Biliary Tract Cancer Assessment by Molecule Type

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Biliary Tract Cancer by Stage and Molecule Type

DelveInsight's Biliary Tract Cancer Report covers around 80+ products under different phases of clinical development like

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Late-stage products (Phase III)

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Mid-stage products (Phase II)

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Early-stage product (Phase I)

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Pre-clinical and Discovery stage candidates

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Discontinued & Inactive candidates

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Route of Administration

Further Biliary Tract Cancer product details are provided in the report. Download the Biliary Tract Cancer pipeline report to learn more about the emerging Biliary Tract Cancer therapies [https://www.delveinsight.com/sample-request/biliary-tract-cancers-btcs-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Some of the key companies in the Biliary Tract Cancer Therapeutics Market include:

Key companies developing therapies for Biliary Tract Cancer are - Agios Pharmaceuticals, Servier Pharmaceuticals, Merck Sharp & Dohme, AstraZeneca, Taiho Oncology, Incyte Corporation, Loxo Oncology, Bayer, Roche, Genentech, Delcath Systems, Eisai, TransThera Sciences (Nanjing), Basilea Pharmaceutica, Zymeworks, BeiGene, and others.

Biliary Tract Cancer Pipeline Analysis:

The Biliary Tract Cancer pipeline report provides insights into

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The report provides detailed insights about companies that are developing therapies for the treatment of Biliary Tract Cancer with aggregate therapies developed by each company for the same.

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It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Biliary Tract Cancer Treatment.

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Biliary Tract Cancer key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

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Biliary Tract Cancer 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.

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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Biliary Tract Cancer market.

The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Biliary Tract Cancer drugs and therapies [https://www.delveinsight.com/sample-request/biliary-tract-cancers-btcs-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Biliary Tract Cancer Pipeline Market Strengths

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The therapeutic landscape in BTCs has expanded considerably in recent years. Combined therapy with chemotherapy, immunotherapy, and modulation of immune checkpoints-mediated signaling pathways are promising strategies.

Biliary Tract Cancer Pipeline Market Opportunities

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Increasing cognizance about different mutations, pathways, and other regimens has changed the focus on curable treatment options with emerging candidates that will lead the growth of the global market.

Scope of Biliary Tract Cancer Pipeline Drug Insight

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Coverage: Global

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Key Biliary Tract Cancer Companies: Merck Sharp & Dohme, AstraZeneca, Taiho Oncology, Delcath Systems, TransThera Sciences (Nanjing), Basilea Pharmaceutica, Eisai, Zymeworks, BeiGene, Xencor, Inc., Bristol-Myers Squibb, Leap Therapeutics, Inc., Compass Therapeutics, Boehringer Ingelheim, ZielBio, Inc., GeneQuantum Healthcare (Suzhou) Co., Ltd., BioNTech SE, SOTIO Biotech, Carisma Therapeutics Inc, Rain Oncology Inc, Avacta Life Sciences Ltd, DualityBio Inc., and others

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Key Biliary Tract Cancer Therapies: Keytruda (pembrolizumab), Imfinzi (durvalumab), Futibatinib (TAS-120), Melphalan, E7090 (tasurgratinib), TT-00420, ARQ 087 (Derazantinib), Lenvima (lenvatinib), Zanidatamab, XmAb20717, Nivolumab + DKN-01, CTX-009, MEDI5752, Brigimadlin, ZB131, GQ1001, BNT141, SO-C101, CT-0508, RAIN-32, AVA6000, DB-1303, and others

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Biliary Tract Cancer Therapeutic Assessment: Biliary Tract Cancer current marketed and Biliary Tract Cancer emerging therapies

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Biliary Tract Cancer Market Dynamics: Biliary Tract Cancer market drivers and Biliary Tract Cancer market barriers

Request for Sample PDF Report for Biliary Tract Cancer Pipeline Assessment and clinical trials [https://www.delveinsight.com/sample-request/biliary-tract-cancers-btcs-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Table of Contents

1. Biliary Tract Cancer Report Introduction

2. Biliary Tract Cancer Executive Summary

3. Biliary Tract Cancer Overview

4. Biliary Tract Cancer- Analytical Perspective In-depth Commercial Assessment

5. Biliary Tract Cancer Pipeline Therapeutics

6. Biliary Tract Cancer Late Stage Products (Phase II/III)

7. Biliary Tract Cancer Mid Stage Products (Phase II)

8. Biliary Tract Cancer Early Stage Products (Phase I)

9. Biliary Tract Cancer Preclinical Stage Products

10. Biliary Tract Cancer Therapeutics Assessment

11. Biliary Tract Cancer Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Biliary Tract Cancer Key Companies

14. Biliary Tract Cancer Key Products

15. Biliary Tract Cancer Unmet Needs

16 . Biliary Tract Cancer Market Drivers and Barriers

17. Biliary Tract Cancer Future Perspectives and Conclusion

18. Biliary Tract Cancer Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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