Biliary Atresia Pipeline Insight

DelveInsight’s, “Biliary Atresia – Pipeline Insight, 2022,” report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Biliary Atresia 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

Biliary Atresia Understanding

Biliary Atresia: Overview

Biliary atresia is a blockage in the tubes (ducts) that carry bile from the liver to the gallbladder. This congenital condition occurs when the bile ducts inside or outside the liver do not develop normally. It is not known why the biliary system fails to develop normally. Typically, the first sign of biliary atresia is yellowing of the skin and whites of the eyes, called jaundice, which results from the buildup of bile in the body. Infants with biliary atresia typically develop jaundice by 3 to 6 weeks of age. Physical exam is performed to feel for an enlarged liver. Other tests include: Abdominal x-ray, Abdominal ultrasound, Blood tests to check total and direct bilirubin levels, Hepatobiliary iminodiacetic acid (HIDA) scan, also called cholescintigraphy, to help determine if the bile ducts and gallbladder are working properly, Liver biopsy to determine severity of cirrhosis or to rule out other causes of jaundice, and X-ray of the bile ducts (cholangiogram). Doctors treat biliary atresia with a surgery called the Kasai procedure and eventually, in most cases, a liver transplant. To make sure infants and children with biliary atresia get enough nutrients and calories, doctors may recommend a special eating plan and supplements.

"Biliary Atresia - Pipeline Insight, 2022" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Biliary Atresia pipeline landscape is provided which includes the disease overview and Biliary Atresia treatment guidelines. The assessment part of the report embraces, in depth Biliary Atresia 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, Biliary Atresia 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 Biliary Atresia R&D. The therapies under development are focused on novel approaches to treat/improve Biliary Atresia.

Biliary Atresia Emerging Drugs Chapters

This segment of the Biliary Atresia report encloses its detailed analysis of various drugs in different stages of clinical development, including phase 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.

Biliary Atresia Emerging Drugs

Odevixibat: Albireo Pharma

Bylvay is a potent, non-systemic ileal bile acid transport inhibitor. Inhibition of IBAT, which plays a main role in enterohepatic circulation, may lead to decreased bile acids returning to the liver. A4250 works through highly potent and selective inhibition and exerts minimal systemic exposure as it acts locally in the small intestine. Bylvay is currently being evaluated in the BOLD Phase III clinical trial in patients with biliary atresia. In January 2019 the Food and Drug Administration (FDA) has granted Orphan Drug designation to A4250 for the treatment of biliary atresia.

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

Biliary Atresia: Therapeutic Assessment

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

  • Major Players in Biliary Atresia

There are approx. 3+ key companies which are developing the therapies for Biliary Atresia. The companies which have their Biliary Atresia drug candidates in the most advanced stage, i.e. Phase III include, Albireo Pharma.


DelveInsight’s report covers around 3+ 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

Biliary Atresia 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
  • Molecule Type

Products have been categorized under various Molecule types such as

  • Monoclonal Antibody
  • Peptides
  • Polymer
  • Small molecule
  • Gene therapy
  • Product Type

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

Biliary Atresia: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Biliary Atresia 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 Biliary Atresia drugs.

Biliary Atresia Report Insights

  • Biliary Atresia Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Biliary Atresia 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 Biliary Atresia drugs?
  • How many Biliary Atresia drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Biliary Atresia?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Biliary Atresia 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 Biliary Atresia and their status?
  • What are the key designations that have been granted to the emerging drugs?


Executive Summary

Biliary Atresia: Overview

  • Causes
  • Mechanism of Action
  • Signs and Symptoms
  • Diagnosis
  • Disease Management

Pipeline Therapeutics

  • Comparative Analysis

Therapeutic Assessment

  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type

Late Stage Products (Pregistration)

  • Comparative Analysis

Nefecon: Calliditas Therapeutics

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Mid Stage Products (Phase II)

  • Comparative Analysis

BION-1301: Chinook therapeutics

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Early stage products (Phase I)

  • Comparative Analysis

HR19042: Jiangsu HengRui Medicine

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Inactive Products

  • Comparative Analysis

Biliary Atresia Key Companies

Biliary Atresia Key Products

Biliary Atresia- Unmet Needs

Biliary Atresia- Market Drivers and Barriers

Biliary Atresia- Future Perspectives and Conclusion

Biliary Atresia Analyst Views

Biliary Atresia Key Companies


List of Table

Table 1: Total Products for Biliary Atresia

Table 2: Late Stage Products

Table 3: Mid Stage Products

Table 4: Early Stage Products

Table 5: Pre-clinical & Discovery Stage Products

Table 6: Assessment by Product Type

Table 7: Assessment by Stage and Product Type

Table 8: Assessment by Route of Administration

Table 9: Assessment by Stage and Route of Administration

Table 10: Assessment by Molecule Type

Table 11: Assessment by Stage and Molecule Type

Table 12: Inactive Products

List of Figures

Figure 1: Total Products for Biliary Atresia

Figure 2: Late Stage Products                              

Figure 3: Mid Stage Products

Figure 4: Early Stage Products

Figure 5: Preclinical and Discovery Stage Products

Figure 6: Assessment by Product Type

Figure 7: Assessment by Stage and Product Type

Figure 8: Assessment by Route of Administration

Figure 9: Assessment by Stage and Route of Administration

Figure 10: Assessment by Molecule Type

Figure 11: Assessment by Stage and Molecule Type

Figure 12: Inactive Products    

• Mirium Pharmaceuticals

• Albireo

• Intercept Pharmaceuticals

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