DelveInsight’s, “Non-Alcoholic Fatty Liver Disease Pipeline Insight” report provides comprehensive insights about 110+ Non-Alcoholic Fatty Liver Disease companies and 160+ pipeline drugs in Non-Alcoholic Fatty Liver Disease pipeline landscape. It covers the Non-Alcoholic Fatty Liver Disease pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Non-Alcoholic Fatty Liver Disease pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Key Takeaways from the Non-Alcoholic Fatty Liver Disease Pipeline Report
- DelveInsight’s Non-Alcoholic Fatty Liver Disease pipeline report depicts a robust space with 110+ active players working to develop 160+ pipeline therapies for Non-Alcoholic Fatty Liver Disease treatment.
- The leading Non-Alcoholic Fatty Liver Disease Companies working in the market include BeiGene, Inventiva Pharma, Cirius Therapeutics, Inventiva Pharma, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Dr.Falk Pharma GmbH, Sagimet Biosciences, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Afimmune, PoxelSA, AngioLab, Pfizer, Oramed Pharmacetuicals, CanFite Biopharma, MediciNova, Metacrine Inc., Lipocine Inc., Novartis, CytoDyn,Inc., Alnylam Pharmaceuticals Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HKinno.N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, and others.
- Promising Non-Alcoholic Fatty Liver Disease Pipeline Therapies in the various stages of development include SAMe 1000 mg, LY3849891, CB4211 Dose 1, AMG 609, Resmetirom, K-877, ALT-801, and others.
- January 2024: Eli Lilly and Company announced a study of Phase 1 clinical trials for LY3849891. The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3849891 in participants with nonalcoholic fatty liver disease who have the patatin-like phospholipase domain-containing protein 3 (PNPLA3) I148M genotype. Blood tests and magnetic resonance imaging of the liver will be performed to determine the effects of LY3849891 on fatty liver disease. Blood tests will also determine how long it takes the body to eliminate LY3849891. This is a 2-part study and may last up to 32 weeks for each participant and may include 12 and 13 visits in parts A and B, respectively.
- January 2024: Zydus Therapeutics Inc. announced a study of Phase 2 clinical trials for Saroglitazar magnesium 1 mg. This is a randomized, double-blind, placebo-controlled study in up to 104 patients with a diagnosis of NAFLD and/or NASH. The study will be conducted over a period of up to 22 weeks and will include an optional Prescreening, Screening (Days -35 to -7) Phase, a 16-week Treatment Phase following randomization on Day 1. Patients will be randomly assigned in a ratio of 1:1:1:1 to receive Saroglitazar Magnesium 1mg or 2 mg or 4 mg or matching placebo once daily in the morning before breakfast for 16 Weeks. The primary endpoint of the study is percentage change from baseline in serum ALT levels at Week 16 in the Saroglitazar Magnesium groups as compared to the placebo group.
- January 2024: GlaxoSmithKline announced a study of Phase 2 clinical trials for GSK4532990. The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced (F3) fibrosis. The study duration will be up to 76 weeks including the screening period. The treatment duration will be up to 52 weeks.
- January 2024: Haisco Pharmaceutical announced a study of Phase 2 clinical trials for HSK31679 low dose and Ezetimibe 10mg. The purpose of this study is to assess the efficacy and safety of HSK31679 tablets compared with placebo in reducing low-density lipoprotein cholesterol (LDL-C) and MRI-PDFF after 12 weeks of treatment in patients with hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD).
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In the Non-Alcoholic Fatty Liver Disease Pipeline Report, detailed description of the drug is given which includes mechanism of action of the drug, Non-Alcoholic Fatty Liver Disease clinical trials studies, NDA approvals (if any), and product development activities comprising the technology, Non-Alcoholic Fatty Liver Disease collaborations, licensing, mergers and acquisition, funding, designations and other product related details. The assessment part of the report embraces, in depth Non-Alcoholic Fatty Liver Disease commercial assessment and clinical assessment of the Non-Alcoholic Fatty Liver Disease pipeline products under development.
Non-Alcoholic Fatty Liver Disease 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.
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Non-Alcoholic Fatty Liver Disease Emerging Drugs Profile
Lanifibranor: Inventiva Pharma
Lanifibranor 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 PPARα, PPARδ, and PPARɣ. 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 PPARα and PPARɣ and partial activation of PPARɣ. It is currently in the Phase III stage of development and is being developed by Inventiva Pharma.
Belapectin: Galectin Therapeutics
Belapectin (GR-MD-02) is a proprietary galactoarabino-rhamnogalacturonan polysaccharide polymer comprising galacturonic acid, galactose, arabinose, rhamnose and smaller amounts of other sugars. Structural studies have shown that belapectin binds to galectin-1 and galectin-3, with greater binding affinity to galectin-3. Belapectin targets extracellular galectins. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. It is currently in the Phase II/III stage of Clinical trial evaluation for Prevention of Esophageal Varices in NASH Cirrhosis.
ZED 1227: Dr. Falk Pharma GmbH
ZED 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. It is currently in the phase II stage of development and is being developed by Dr. Falk Pharma GmbH.
TVB-2640: Sagimet Biosciences
TVB-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. It is currently in the phase II stage of development and is being developed by Sagimet Biosciences.
ALS-L1023: AngioLab
ALS 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. The drug is currently being investigated in Phase II clinical trials for the treatment of patients with Nonalcoholic Steatohepatitis.
MN-001: MediciNova
MN-001 (tipelukast) is a novel, orally bioavailable small molecule compound which exerts its effects through several mechanisms to produce its anti-fibrotic and anti-inflammatory activity in preclinical models, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). MN-001 has been shown to down-regulate expression of genes that promote fibrosis including LOXL2, Collagen Type 1 and TIMP-1. MN-001 has also been shown to down-regulate expression of genes that promote inflammation including CCR2 and MCP-1. MN-001 has also known to reduce fibrosis in multiple animal models. The drug is currently being evaluated in Phase II stage of development for the treatment of patients with Nonalcoholic Steatohepatitis.
Non-Alcoholic Fatty Liver Disease Therapeutics Assessment
There are approx. 120+ Non-Alcoholic Fatty Liver Disease companies which are developing the Non-Alcoholic Fatty Liver Disease therapies. The Non-Alcoholic Fatty Liver Disease companies which have their Non-Alcoholic Fatty Liver Disease drug candidates in the most advanced stage, i.e. phase III include, Inventiva Pharma.
Non-Alcoholic Fatty Liver Disease 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
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Non-Alcoholic Fatty Liver Disease Products have been categorized under various Molecule types such as
- Oligonucleotide
- Peptide
- Small molecule
Scope of the Non-Alcoholic Fatty Liver Disease Pipeline Report
- Coverage- Global
- Non-Alcoholic Fatty Liver Disease Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
- Non-Alcoholic Fatty Liver Disease Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
- Non-Alcoholic Fatty Liver Disease Companies- BeiGene, Inventiva Pharma, Cirius Therapeutics, Inventiva Pharma, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Dr.Falk Pharma GmbH, Sagimet Biosciences, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Afimmune, PoxelSA, AngioLab, Pfizer, Oramed Pharmacetuicals, CanFite Biopharma, MediciNova, Metacrine Inc., Lipocine Inc., Novartis, CytoDyn,Inc., Alnylam Pharmaceuticals Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HKinno.N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, and others.
- Non-Alcoholic Fatty Liver Disease Pipeline Therapies- SAMe 1000 mg, LY3849891, CB4211 Dose 1, AMG 609, Resmetirom, K-877, ALT-801, and others.
For further information on the Non-Alcoholic Fatty Liver Disease Pipeline Therapeutics, reach out @ Non-Alcoholic Fatty Liver Disease Therapeutics Segmentation
Table of Content
- Introduction
- Executive Summary
- Non-Alcoholic Fatty Liver Disease: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Non-Alcoholic Fatty Liver Disease – DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- Lanifibranor: Inventiva Pharma
- Drug profiles in the detailed report…..
- Last Stage Products (Phase II/III)
- Belapectin: Galectin Therapeutics
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- ZED 1227: Dr. Falk Pharma GmbH
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- LB-P8: LISCure Biosciences
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Drug name : Company name
- Drug profiles in the detailed report…..
- Inactive Products
- Non-Alcoholic Fatty Liver Disease Key Companies
- Non-Alcoholic Fatty Liver Disease Key Products
- Non-Alcoholic Fatty Liver Disease – Unmet Needs
- Non-Alcoholic Fatty Liver Disease – Market Drivers and Barriers
- Non-Alcoholic Fatty Liver Disease – Future Perspectives and Conclusion
- Non-Alcoholic Fatty Liver Disease Analyst Views
- Non-Alcoholic Fatty Liver Disease Key Companies
- Appendix
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