Liver Fibrosis - Pipeline Insight, 2024

This “Liver Fibrosis- Pipeline Insight, 2024” report provides comprehensive insights about 20+ companies and 30+ pipeline drugs in Liver Fibrosis 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

Liver Fibrosis: Understanding

Liver Fibrosis: Overview

Liver fibrosis is the excessive accumulation of extracellular matrix proteins including collagen that occurs in most types of chronic liver diseases. Advanced liver fibrosis results in cirrhosis, liver failure, and portal hypertension and often requires liver transplantation. Hepatic fibrosis is the result of the wound-healing response of the liver to repeated injury. After an acute liver injury (e.g., viral hepatitis), parenchymal cells regenerate and replace the necrotic or apoptotic cells. This process is associated with an inflammatory response and a limited deposition of ECM. If the hepatic injury persists, then eventually the liver regeneration fails, and hepatocytes are substituted with abundant ECM, including fibrillar collagen. The distribution of this fibrous material depends on the origin of the liver injury. In chronic viral hepatitis and chronic cholestatic disorders, the fibrotic tissue is initially located around portal tracts, while in alcohol-induced liver disease, it locates in pericentral and perisinusoidal areas. As fibrotic liver diseases advance, disease progression from collagen bands to bridging fibrosis to frank cirrhosis occurs. Liver fibrosis is associated with major alterations in both the quantity and composition of ECM. In advanced stages, the liver contains approximately 6 times more ECM than normal, including collagens (I, III, and IV), fibronectin, undulin, elastin, laminin, hyaluronan, and proteoglycans. Accumulation of ECM results from both increased synthesis and decreased degradation. Decreased activity of ECM-removing MMPs is mainly due to an overexpression of their specific inhibitors (TIMPs). If a doctor believes that someone has liver fibrosis, they will carefully collect a small tissue sample, or biopsy, from the liver using a large needle. A pathologist, which is a doctor who specializes in finding the root cause of disease, will then examine the sample under a microscope. They do this to assess the extent and type of damage. Determining the degree of fibrosis is difficult because pathologists only have a small sample to work with. Other doctors can also assess the same sample in different ways. People with fibrosis are usually unaware that they have it. This is because it rarely causes any obvious symptoms. However, within the liver, fibrosis can: reduce overall function, including the purifying of blood, storing of energy, and clearing of infections, limit the organ’s ability to regenerate, restrict blood flow within the organ. People usually start to experience symptoms when fibrosis progresses to cirrhosis. These initial symptoms can vary, but some of the most common indicators of early cirrhosis include: a poor appetite, feeling weak, unexplained exhaustion, unexplained weight loss, nausea and vomiting, discomfort or mild pain in the upper right abdomen. The best way to treat liver fibrosis is to address the root cause. Successfully treating the cause of early to moderate liver fibrosis may reverse most, if not all, of the damage that the fibrosis has caused.

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

Liver Fibrosis Emerging Drugs Chapters

This segment of the Liver Fibrosis 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.

Liver Fibrosis Emerging Drugs

Lanifibranor: Inventiva Pharma Lanifibranor is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory as well as beneficial metabolic changes in the body by activating each of the three PPAR isoforms, known as PPARa, PPARd and PPAR?. PPARs are ligand-activated transcription factors belonging to the nuclear hormone receptor family that regulate the expression of genes. PPARs play essential roles in the regulation of cellular differentiation, development and tumorigenesis. Currently, the drug is in Phase III stage of Clinical trial evaluation for the treatment in patients with NASH and liver fibrosis stage 2 or 3.

Aramchol meglumine: Galmed Pharmaceuticals Aramchol (arachidyl amido cholanoic acid) is a first-in-class, novel synthetic small molecule, a conjugate of cholic acid and arachidic acid, liver targeted SCD1 modulator, developed as an oral therapy for the treatment of NASH (nonalcoholic steatohepatitis) and fibrosis. Aramchol targets stearoyl-CoA desaturase 1 (SCD1), the rate-limiting step in the synthesis of monounsaturated fatty acids (MUFAs), the major fatty acid of triglycerides, cholesteryl esters, and membrane phospholipids. Aramchol also increases metabolite flux through the trans-sulfuration pathway, leading to a rise in glutathione (GSH) and the GSH/glutathione disulfide (GSSG) ratio, which preserve cellular antioxidant levels and intracellular redox status. Currently, the drug is in Phase III stage of Clinical trial evaluation for the treatment of Liver Fibrosis.

FAP-2286: Clovis Oncology FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis holds U.S. and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel. Currently, the drug is in Phase I stage of Clinical trial evaluation for the treatment of LiverFibrosis.

Liver Fibrosis: Therapeutic Assessment

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

Major Players in Liver Fibrosis

There are approx. 20+ key companies which are developing the therapies for Liver Fibrosis. The companies which have their Liver Fibrosis drug candidates in the most advanced stage, i.e. Phase III include, Inventiva Pharma.

Phases

This report covers around 30+ 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

Liver Fibrosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

Product Type

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

Liver Fibrosis: Pipeline Development Activities

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

Liver Fibrosis Report Insights

• Liver Fibrosis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Inventiva Pharma
• Galmed Pharmaceuticals
• Clovis Oncology
• Novartis
• Hepion Pharmaceuticals, Inc.
• Kowa Pharmaceutical
• Zedira GmbH
• Pfizer
• Beijing Continent Pharmaceutical Co, Ltd.
• Zydus Therapeutics Inc.
• TaiwanJ Pharmaceuticals Co., Ltd
• HEC Pharm
• Genoscience
• Ark Biosciences

Key Products

• Lanifibranor
• Aramchol meglumine
• FAP-2286
• Tropifexor
• Rencofilstat
• K-877-ER
• ZED1227
• PF-07202954
• Hydronidone
• Saroglitazar Magnesium
• JKB-122
• Yifenidone
• GNS-561
• AK 3280

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