Bile Duct Cancer (Cholangiocarcinoma) Pipeline: Pioneering Progress with 50+ Leading Companies Developing Groundbreaking Therapies | DelveInsight

The Bile Duct Cancer market is rapidly advancing. It is fueled by groundbreaking research and innovative therapies from companies such as Tyra Biosciences, Anheart Therapeutics, Nuvalent, Array BioPharma, InnoCare Pharma, and NextPoint Therapeutics. These industry pioneers are transforming treatment strategies and redefining the future of Bile Duct Cancer, bringing new hope to patients worldwide.

DelveInsight's "Bile Duct Cancer Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the Bile Duct Cancer market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging Bile Duct Cancer drugs, the Bile Duct Cancer pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the Bile Duct Cancer Pipeline Report
• DelveInsight's Bile Duct Cancer Pipeline analysis depicts a robust space with 50+ active players working to develop 60+ pipeline drugs for Bile Duct Cancer treatment.
• The leading Bile Duct Cancer companies include Wellmarker Bio, Virogin Biotech Canada, TransThera Sciences, Tango Therapeutics, Taiho Oncology, Tyra Biosciences, Anheart Therapeutics, Nuvalent, Array BioPharma, InnoCare Pharma, NextPoint Therapeutics, and others are evaluating their lead assets to improve the Bile Duct Cancer treatment landscape.
• Key Bile Duct Cancer pipeline therapies in various stages of development include WM-S1-030, VG161, TT-00420, TNG908, TAS-120, TYRA 200, Safusidenib, NVL 655, Tucatinib, Gunagratinib, NPX267, and others.
• In December 2024, the FDA granted orphan drug designation to PLT012 (Pilatus Biosciences) for treating liver and intrahepatic bile duct cancer (HCC/ICCA). Experts highlight its potential against multiple tumors with unmet needs, with plans for its first US investigational new drug application submission and patient dosing in 2025.

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Bile Duct Cancer Overview
Cholangiocarcinoma is an aggressive cancer originating from the biliary epithelium inside or outside the liver. It is difficult to diagnose due to challenges in obtaining tissue samples, and by the time it is detected, it is often invasive or metastatic. Surgery is the only curative treatment, but chemotherapy, radiation, and targeted therapies are used alongside it. The disease is classified into intrahepatic cholangiocarcinoma (iCCA) and extrahepatic cholangiocarcinoma (eCCA), with eCCA further divided into perihilar and distal types. Most cholangiocarcinomas are adenocarcinomas and result from chronic inflammation and mutations in genes such as RAS, TP53, and K-ras.

Symptoms include jaundice, dark urine, pale stools, abdominal pain, weight loss, fever, and nausea. Diagnosis involves imaging techniques like CT, MRI, and MRCP, along with blood tests, including CA 19-9, and sometimes interventional procedures, though tissue confirmation is often difficult.

Treatment includes surgery for resection or liver transplantation, with chemotherapy and radiation as adjuncts. Preoperative biliary drainage, volumetric analysis, and portal venous embolization (PVE) are important for surgical planning. For unresectable tumors, local treatments like TACE, TARE, and ablation therapies can help manage the disease and improve survival.

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Bile Duct Cancer Treatment Analysis: Drug Profile
TT-00420: TransThera Biosciences
TT-00420 is a novel, phase III-stage, spectrum-selective kinase inhibitor that targets tumor cells and enhances the tumor microenvironment. Ongoing clinical trials in the US and China demonstrate its potential efficacy in treating various solid tumors. The FDA has granted it Orphan-Drug and Fast Track Designations for cholangiocarcinoma (CCA) treatment. In July 2023, TT-00420 received Breakthrough Therapy Designation (BTD) from the NMPA in China.

VG161: Virogin Biotech
VG161 is an oncolytic virus developed on Virogin's proprietary SynerlyticTM platform. It is an attenuated herpes simplex virus type 1 (HSV-1) engineered with IL12 and IL15/IL15Ra payloads and a PD-L1 blocking peptide. The neurovirulence of wild-type HSV-1 is reduced by the deletion of the ICP 34.5 gene. These payloads work together to stimulate both innate and adaptive immune responses in the tumor microenvironment. VG161 has shown safety and efficacy in various tumor xenograft models and GLP toxicity studies. It is currently in Phase II trials for cholangiocarcinoma treatment.

Key Bile Duct Cancer Therapies and Companies
• KEYTRUDA (pembrolizumab): Merck Sharp & Dohme
• IMFINZI (durvalumab): AstraZeneca
• Futibatinib (TAS-120): Taiho Oncology
• Tasurgratinib (E7090): Eisai
• TT-00420: TransThera Sciences (Nanjing)
• LENVIMA (lenvatinib): Eisai and Merck & Co
• Zanidatamab: Zymeworks and BeiGene
• Nab-paclitaxel: Celgene/Bristol Myer Squibb
• LONSURF (Trifluridine and Tipiracil Hydrochloride/TAS-102): Taiho Pharmaceutical/Servier
• Tinengotinib: TransThera Sciences
• Silmitasertib (CX-4945): Senhwa Biosciences
• VG161: Virogin Biotech
• NXP800: Nuvectis Pharma

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Bile Duct Cancer 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 Bile Duct Cancer Pipeline Report
• Coverage: Global
• Key Bile Duct Cancer Companies: Wellmarker Bio, Virogin Biotech Canada, TransThera Sciences, Tango Therapeutics, Taiho Oncology, Tyra Biosciences, Anheart Therapeutics, Nuvalent, Array BioPharma, InnoCare Pharma, NextPoint Therapeutics, and others.
• Key Bile Duct Cancer Pipeline Therapies: WM-S1-030, VG161, TT-00420, TNG908, TAS-120, TYRA 200, Safusidenib, NVL 655, Tucatinib, Gunagratinib, NPX267, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Bile Duct Cancer Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Bile Duct Cancer Pipeline Therapeutics
6. Bile Duct Cancer Pipeline: Late-Stage Products (Phase III)
7. Bile Duct Cancer Pipeline: Late-Stage Products (Phase III)
8. Bile Duct Cancer Pipeline: Mid-Stage Products (Phase II)
9. Bile Duct Cancer Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
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This release was published on openPR.