Autoimmune Hepatitis - Pipeline Insight, 2024

Autoimmune Hepatitis - Pipeline Insight, 2024

DelveInsight’s, “Autoimmune Hepatitis - Pipeline Insight, 2024,” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Autoimmune Hepatitis 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

Autoimmune Hepatitis Understanding

Autoimmune Hepatitis: Overview

Autoimmune hepatitis refers to chronic and progressive inflammation of the liver from an unknown cause. The proposed mechanism for the development of autoimmune hepatitis is thought to be the interplay of genetic predisposition, an environmental trigger, and failure of the native immune system resulting in chronic inflammation of hepatocytes and subsequent fibrosis of the liver. There are two known types of autoimmune hepatitis. Type 1 is distinguished by the presence of anti-smooth muscle antibodies (ASMA) with or without anti-nuclear antibodies (ANA). Type 2 autoimmune hepatitis presents with positive anti-liver/anti-kidney microsome (anti-LMK) type 1 antibodies or anti-liver cytosol (anti-LC) type 1 antibodies. There is no specific evidence of the cause. Sixty percent of patients have chronic hepatitis but without serologic evidence of a viral infection. The disease is associated with anti-smooth muscle autoantibodies.

""Autoimmune Hepatitis - Pipeline Insight, 2024"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Autoimmune Hepatitis pipeline landscape is provided which includes the disease overview and Autoimmune Hepatitis treatment guidelines. The assessment part of the report embraces, in depth Autoimmune Hepatitis 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, Autoimmune Hepatitis 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 Autoimmune Hepatitis R&D. The therapies under development are focused on novel approaches to treat/improve Autoimmune Hepatitis.

Autoimmune Hepatitis Emerging Drugs Chapters

This segment of the Autoimmune Hepatitis 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.

Autoimmune Hepatitis Emerging Drugs

• Ianalumab: Novartis

Ianalumab (VAY736) is a fully human IgG1/k mAb with a dual mode of action targeting B-cell lysis and BAFF-R blockade that is being investigated by Novartis in several indications including Sjögren’s, Autoimmune Hepatitis and Systemic Lupus Erythematosus (SLE). Novartis is conducting a randomized, placebo-controlled, double-blind dose-range Phase II/III study in autoimmune hepatitis.

• JKB-122: TaiwanJ Pharmaceuticals

JKB-122 is a small molecule and a long-acting TLR4 antagonist. This drug has demonstrated in preclinical models anti-fibrotic, immuno-modulating, and anti-inflammatory activities and improvement of liver injuries by hepatoprotectant property. JKB-122 is the lead compound of the TaiwanJ pipeline for CLD. Currently, JKB-122 has been approved by the US FDA for a couple of Phase II Clinical Trials in different indications. TaiwanJ Pharmaceuticals reported positive results from Phase II clinical trial evaluating the efficacy and safety of JKB-122 for the treatment of patients with refractory Autoimmune Hepatitis (AIH). JKB-122 has received an orphan disease designation from US FDA as well as a Phase II IND application for treating autoimmune hepatitis (AIH). The proof of concept study was demonstrated in a preclinical model of AIH. JKB-122 will be developed via FDA 505(b) (2) regulatory pathway. A new patentable slow release formulation has been developed and application will be filed soon.

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

Autoimmune Hepatitis: Therapeutic Assessment

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

• Major Players in Autoimmune Hepatitis

There are approx. 10+ key companies which are developing the therapies for Autoimmune Hepatitis. The companies which have their Autoimmune Hepatitis drug candidates in the most advanced stage, i.e. phase II/III include, Novartis.

• Phases

DelveInsight’s report covers around 10+ 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

Autoimmune Hepatitis 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.

Autoimmune Hepatitis: Pipeline Development Activities

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

Autoimmune Hepatitis Report Insights

• Autoimmune Hepatitis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Novartis
• TaiwanJ Pharmaceuticals Co., Ltd
• Kezar Life Sciences
• Jiangsu HengRui Medicine Co., Ltd.
• Revive Therapeutics
• Moderna, Inc.
• Parvus Therapeutics
• Sigilon Therapeutics, Inc.
• Orbsen Therapeutics

Key Products

• VAY736
• JKB-122
• Zetomipzomib
• HR19042
• Bucillamine
• mRNA-6981
• PVT-201