Non Alcoholic Fatty Liver Disease (NAFLD) - Pipeline Insight, 2024

This “Non Alcoholic Fatty Liver Disease (NAFLD) - Pipeline Insight, 2024” report provides comprehensive insights about 80+ companies and 100+ pipeline drugs in Non Alcoholic Fatty Liver Disease (NAFLD) 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

Non Alcoholic Fatty Liver Disease (NAFLD): Understanding

Non Alcoholic Fatty Liver Disease (NAFLD): Overview

Non-alcoholic fatty liver disease (NAFLD) is a broad term used to cover a spectrum of conditions that are characterized by evidence of hepatic steatosis on imaging or histology (macro-vesicular steatosis), and absence of secondary causes of hepatic steatosis such as significant alcohol consumption, chronic use of medications that can cause hepatic steatosis or hereditary disorders. The prevalence of NAFLD in western countries is around 20 to 30%. Obesity, diabetes, dyslipidemias, insulin resistance, and metabolic syndrome are known to be associated with the development of non-alcoholic fatty liver disease (NAFLD). A temporal association has also been shown between inorganic arsenic exposure and the development of NAFLD reflected by elevated alanine transferase (ALT). Due to its close association with metabolic syndrome, NAFLD correlates with cardiovascular risk factors, which also contributes to mortality in these patients in addition to end-stage liver cirrhosis and hepatocellular carcinoma. NAFLD is considered to be the liver manifestation of metabolic syndrome. 50 to 70% of people with diabetes are found to have NAFLD. NAFLD has several phases of progression, which include simple steatosis, steatohepatitis, fibrosis, cirrhosis, and ultimately could even progress to hepatocellular carcinoma. The disease has a benign course; it is a silent liver disease when the only histological finding is steatosis. The presence of hepatic injury with inflammation with or without fibrosis constitutes non-alcoholic steatohepatitis (NASH). Both environmental and genetic factors are contributing to the development of non-alcoholic fatty liver disease (NAFLD) and its progression. First-degree relatives of patients with NAFLD are at higher risk than the general population. Histone amino-terminal ends, maintain the chromatin structure and gene expression that is cAMP-responsive element-binding protein H (CREBH) or sirtuin (SIRT1). Genetic studies have shown that activation of SIRT1 is thought to play a role in the development of NAFLD. The trigger of the progression of NAFLD to cancer is via abnormal DNA methylation. The majority of the patients with NAFLD do not experience any symptoms, however some of them may complain of fatigue, right upper quadrant discomfort, hepatomegaly, acanthosis nigricans, and lipomatosis. A significant amount of patients with cirrhosis can be present themselves with end-stage liver disease. In approximately 48-100% NASH can be asymptomatic and very often it is discovered during medical evaluations for other reasons. Children having NASH may develop symptoms such as abdominal pain, which may be in the center or the right upper part of the abdomen, and sometimes fatigue. However, other causes of abdominal pain and fatigue should be considered. On physical examination, the liver might be slightly enlarged, and some children may have patchy, dark discoloration of the skin present (acanthosis nigricans), most commonly over the neck and the underarm area. NASH is more common in children who have both NAFLD and type 2 diabetes. In addition, certain genes may also increase a child’s chance of developing NASH. To date, there are no established treatment guidelines and no single approved therapy for NAFLD treatment. Historically, the principal treatment for NAFLD consisted of removal of offending drugs and toxins, weight loss, and control of associated metabolic disorders as hyperlipidemia and diabetes. Lifestyle changes and dietary modification are the main methods for weight management. The focus of NAFLD management is to ameliorate the NASH risk factors (i.e., insulin resistance and obesity), with the objective of preventing disease progression or regression of already established fatty liver or NASH.

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

Non Alcoholic Fatty Liver Disease (NAFLD) Emerging Drugs Chapters

This segment of the Non Alcoholic Fatty Liver Disease (NAFLD) 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.

Non Alcoholic Fatty Liver Disease (NAFLD) Emerging Drugs

Lanifibranor: Inventiva PharmaLanifibranor is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory, and beneficial metabolic changes in the body by activating each of the three PPAR isoforms, known as PPARa, PPARd, and PPAR?. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well-balanced activation of PPARa and PPAR? and partial activation of PPAR?. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Non-Alcoholic Fatty Liver Disease.

ZED 1227: Dr. Falk Pharma GmbHZED 1227, is a synthetic peptidomimetic compound designed by Zedira scientists to specifically inhibit the enzymatic activity of human tissue transglutaminase (TG2). Dr. Falk Pharma has acquired the licensing rights to ZED1227 in Europe and several non-European countries and has assumed responsibility for pharmaceutical, preclinical, and clinical development of the new chemical entity towards a pharmaceutical product. By inhibiting TG2 in liver tissue, ZED1227 is expected to improve liver fibrosis in patients with NAFLD. Currently the drug is in Phase II stage of its clinical trial for the treatment of Non-Alcoholic Fatty Liver Disease.

TVB-2640: Sagimet BiosciencesTVB-2640 is an oral, selective, first-in-class fatty acid synthase inhibitor that directly targets the primary drivers of NASH by reducing excess liver fat (steatosis), decreasing inflammation and blunting fibrosis. In addition to the FASCINATE-2 trial, denifanstat is being tested in a Phase III clinical trial for recurrent glioblastoma and a Phase II study for moderate to severe acne. Currently the drug is in Phase II stage of clinical trial for the treatment of Non-Alcoholic Fatty Liver Disease.

ALS-L1023: AngioLabALS L1023 is a dried extract of ethyl acetate, prepared by activity-guided fractionation from Melissa leaf (lemon balm). The Angiogenesis Inhibitor ALS-L1023 from Lemon-Balm Leaves Attenuates High-Fat Diet-Induced Nonalcoholic Fatty Liver Disease through Regulating the Visceral Adipose-Tissue Function. Currently the drug is in Phase II stage of its clinical trial for the treatment of Non-Alcoholic Fatty Liver Disease.

Non Alcoholic Fatty Liver Disease (NAFLD): Therapeutic Assessment

This segment of the report provides insights about the different Non Alcoholic Fatty Liver Disease (NAFLD) drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Non-Alcoholic Fatty Liver Disease (NAFLD)

• There are approx. 80+ key companies which are developing the therapies for Non Alcoholic Fatty Liver Disease (NAFLD). The companies which have their Non Alcoholic Fatty Liver Disease (NAFLD) drug candidates in the most advanced stage, i.e. Phase II include, Inventiva Pharma.

Phases

This report covers around 100+ 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

Non Alcoholic Fatty Liver Disease (NAFLD) 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.

Non Alcoholic Fatty Liver Disease (NAFLD): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Non Alcoholic Fatty Liver Disease (NAFLD) 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 Non Alcoholic Fatty Liver Disease (NAFLD) drugs.

Non Alcoholic Fatty Liver Disease (NAFLD) Report Insights

• Non Alcoholic Fatty Liver Disease (NAFLD) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Guangdong Raynovent Biotech
• Dr. Falk Pharma GmbH
• Enyo Pharma
• Viking Therapeutics
• Sagimet Biosciences
• Terns
• Sinew Pharma
• Madrigal Pharmaceuticals
• Hepion Pharmaceuticals
• Poxel
• Inventiva Pharma
• Galectin Therapeutics
• AngioLab
• MediciNova

Key Products

• ZSP1601
• ZED1227
• Vonafexor
• VK2809
• TVB-2640
• TERN-501
• SNP-630
• Resmetirom
• Rencofilstat
• PXL065
• Lanifibranor
• Belapectin
• ALS-L1023
• MN-001

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