Intrahepatic Cholangiocarcinoma - Pipeline Insight, 2025

DelveInsight’s, “Intrahepatic Cholangiocarcinoma - Pipeline Insight, 2025” report provides comprehensive insights about 18+ companies and 20+ pipeline drugs in Intrahepatic Cholangiocarcinoma pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Intrahepatic Cholangiocarcinoma: Understanding

Intrahepatic Cholangiocarcinoma: Overview

Intrahepatic Cholangiocarcinoma is a subtype of a family of aggressive cholangiocarcinomas, tumors that arise from cholangiocytes of the biliary tree. Cholangiocarcinoma is defined by anatomic location and can arise throughout the biliary tree: distally, peri-hilar region, or intrahepatic. The different anatomic locations of cholangiocarcinoma correspond to varied etiologies of the disease. Specifically, extrahepatic cholangiocarcinoma likely derives from stem cells in peribiliary glands while intrahepatic cholangiocarcinoma (ICC) arises from hepatocyte stem cells. The varied anatomic locations of cholangiocarcinoma can have implications for diagnosis, surgical planning, and resectability.

Intrahepatic cholangiocarcinoma, a rare liver cancer affecting the bile ducts, often presents with vague, nonspecific symptoms in its early stages, making early detection difficult. Common early signs include abdominal pain, especially in the upper right quadrant, weight loss, and fatigue. As the disease advances, patients may develop more pronounced symptoms such as jaundice (yellowing of the skin and eyes), itchy skin, pale stools, and dark urine due to bile duct obstruction. Additional symptoms may include nausea, loss of appetite, fever, and chills. These signs can easily be mistaken for other illnesses, often leading to a late-stage diagnosis when treatment options are more limited.

The initial diagnosis of ICC is mostly made when the tumor is not eligible for resection because of locally advanced or metastatic disease. Typically, a very large mass has developed in the periphery of the liver with few clinical symptoms. Most patients present with nonspecific symptoms, such as pain in the right upper abdominal quadrant, weight loss, and high serum ALP levels. Some patients present with painless jaundice, when the tumor grows towards the biliary confluence. Small ICCs are found in screening programs for early detection of HCC. Transabdominal ultrasound is often the first imaging modality that detects a liver mass with or without dilatation of the biliary tract. The number of lesions and vascular involvement are determined using a dual-phase multi-detector CT.

Surgical resection remains the only potentially curative therapeutic option and the central cornerstone of treatment. Adjuvant systemic treatment will be recommended after resection or in the palliative setting. Increasing knowledge of phenotypic sub classification and molecular profiling allows investigation of targeted therapies as (neo-) adjuvant treatment. Neoadjuvant chemotherapy, which involves administering chemotherapy before surgical treatment, plays a limited but important role in the management of Intrahepatic Cholangiocarcinoma (ICC). While surgery is the primary curative treatment for ICC, neoadjuvant chemotherapy is considered in certain situations to enhance the chances of a successful surgical outcome.

Common chemotherapy regimens used in the adjuvant setting for ICC include combinations of drugs such as gemcitabine and cisplatin. These regimens are selected based on their effectiveness against the type of cancer and the patient's tolerance to the treatment.

""Intrahepatic Cholangiocarcinoma- Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Intrahepatic Cholangiocarcinoma pipeline landscape is provided which includes the disease overview and Intrahepatic Cholangiocarcinoma treatment guidelines. The assessment part of the report embraces, in depth Intrahepatic Cholangiocarcinoma commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Intrahepatic Cholangiocarcinoma collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Intrahepatic Cholangiocarcinoma R&D. The therapies under development are focused on novel approaches to treat/improve Intrahepatic Cholangiocarcinoma.

Intrahepatic Cholangiocarcinoma Emerging Drugs Chapters

This segment of the Intrahepatic Cholangiocarcinoma report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Intrahepatic Cholangiocarcinoma Emerging Drugs

• Zanidatamab: Zymeworks

Zanidatamab is an investigational bispecific antibody (developed using Zymeworks proprietary Azymetric platform) that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design and increased binding results in multiple mechanisms of action, including dual HER2 signal blockade, removal of HER2 protein from the cell surface, and immune-mediated cytotoxicity leading to encouraging antitumor activity in patients. Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Intrahepatic Cholangiocarcinoma.

• HMPL-453: Hutchmed

HMPL 453 is a novel, highly selective and potent small molecule inhibitor targeting FGFR 1, 2 and 3. In pre clinical studies, HMPL 453 demonstrated superior potency and better kinase selectivity as compared to other drugs in the same class, as well as a favorable safety profile. Currently the drug is in Phase II stage of its clinical trial for the treatment of Intrahepatic Cholangiocarcinoma.

• KIN-3248: Kinnate Biopharma

KIN-3248 is a small-molecule kinase inhibitor that target cancer-associated alterations in FGFR2 and FGFR3 genes, which are among the most commonly identified oncogenic drivers detected in solid tumor cancers. KIN-3248 aims to address the primary driver-alteration and clinically observed and predicted FGFR 2/3 mutations that drive resistance to current FGFR2- and FGFR3-targeted therapies in intrahepatic cholangiocarcinoma (ICC) and urothelial carcinoma (UC). In preclinical studies, we have observed inhibitory activity across a broad range of clinically relevant mutations that drive acquired resistance. We believe that by addressing these mutations and broadly covering FGFR isoforms, we may be able to meaningfully increase the duration of response (DoR).

Further product details are provided in the report……..

Intrahepatic Cholangiocarcinoma: Therapeutic Assessment

This segment of the report provides insights about the different Intrahepatic Cholangiocarcinoma drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Intrahepatic Cholangiocarcinoma
• There are approx. 18+ key companies which are developing the therapies for Intrahepatic Cholangiocarcinoma. The companies which have their Intrahepatic Cholangiocarcinoma drug candidates in the most advanced stage, i.e. Phase III include, Zymeworks.
• Phases

DelveInsight’s report covers around 20+ products under different phases of clinical development like

• 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
• Route of Administration

Intrahepatic 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
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Intrahepatic Cholangiocarcinoma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Intrahepatic Cholangiocarcinoma therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Intrahepatic Cholangiocarcinoma drugs.

Intrahepatic Cholangiocarcinoma Report Insights

• Intrahepatic Cholangiocarcinoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Intrahepatic Cholangiocarcinoma Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Intrahepatic Cholangiocarcinoma drugs?
• How many Intrahepatic Cholangiocarcinoma drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Intrahepatic Cholangiocarcinoma?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Intrahepatic Cholangiocarcinoma therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Intrahepatic Cholangiocarcinoma and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Zymeworks
• Basilea Pharmaceutical
• Medivir AB
• Amgen
• Kinnate Biopharma
• Tyra Biosciences
• Trisalus Life Sciences

Key Products

• Zanidatamab
• Derazantinib
• MIV-818
• Bemarituzumab
• KIN-3248
• TYRA-200
• Nelitolimod