DelveInsight’s, “Nonalcoholic Steatohepatitis Pipeline Insight, 2023” report provides comprehensive insights about 100+ companies and 150+ pipeline drugs in the Nonalcoholic Steatohepatitis pipeline landscape. It covers the pipeline drug profiles, including Nonalcoholic Steatohepatitis clinical trials 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.
Key Takeaways from the Nonalcoholic Steatohepatitis Pipeline Report
- DelveInsight’s Nonalcoholic Steatohepatitis pipeline report depicts a robust space with 100+ active players working to develop 150+ pipeline therapies for Nonalcoholic Steatohepatitis treatment.
- The leading Nonalcoholic Steatohepatitis companies include Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, and others
- Promising nonalcoholic steatohepatitis pipeline therapies include TERN-101, SNP-610, LJN452 (tropifexor + licogliflozin), PXL065, ALS-L1023, PF-06865571 + PF-05221304, PF-06835919, PF-06865571, ORMD-0801, Norucholic acid, NNC0194-0499, MN-001, MK-3655, MET642, MET409, LPCN 1144, LIK066, Leronlimab, ALN-HSD, MT-3995, CM101, Leu-Mit-Sil (NS-0200), IN-A010, Efruxifermin (EFX), Efinopegdutide, EDP-305, JKB-122, CS0159 (Linafexor), CRV431, Chiglitazar sodium, BOS-580, BMS-986263, HEC96719, GSK4532990, FM101, Firsocostat, EPY001a, Emricasan, BMS-986036, BIO89-100, BI 456906, BFKB8488A, AXA1125, ASC 41, GS-9674 (Cilofexor), ZSP1601, and others.
- The Non-Alcoholic Steatohepatitis Companies and academics are working to assess challenges and seek opportunities that could influence Non-Alcoholic Steatohepatitis R&D. The Non-Alcoholic Steatohepatitis pipeline therapies under development are focused on novel approaches to treat/improve Non-Alcoholic Steatohepatitis.
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Non-Alcoholic Steatohepatitis Overview
Nonalcoholic steatohepatitis (NASH) is liver inflammation and damage caused by a fat buildup in the liver. It is part of a group of conditions called nonalcoholic fatty liver disease. Nonalcoholic fatty liver disease can be divided into the isolated fatty liver in which there is only accumulation of fat, and nonalcoholic steatohepatitis (NASH), in which there is fat, inflammation, and damage to liver cells.
Recent Developmental Activities in the Non-Alcoholic Steatohepatitis Treatment Landscape
- In November 2022, Sagimet Biosciences announced positive interim data from its Phase IIb clinical trial (FASCINATE-2) with denifanstat, a fatty acid synthase (FASN) inhibitor, in non-alcoholic steatohepatitis patients. Data showed statistically significant improvements across key markers of NASH, reinforcing results observed in earlier studies, including statistically significant reductions in markers of liver fat, inflammation, and fibrosis. There were no treatment-related serious adverse events, with the majority of adverse events mild to moderate in nature (Grade 1 and 2). Additional interim data are expected in early 2023.
- In November 2022, Inventiva announced that the United States Patent and Trademark Office granted a patent (U.S. Patent No. 11,504,380) that protects the use of lanifibranor for the treatment of cirrhotic patients at risk of progressing from compensated stage to decompensated stage. This patent will expire on November 8, 2039. This patent further expands the intellectual property protection of lanifibranor in the United States for use in patients with cirrhotic NASH.
- In October 2022, Galectin Therapeutics, Inc. reported the positive outcome of its second data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, phase IIb/III study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). The objective of this second independent DSMB was further to review the emerging tolerance and safety profiles of belapectin. Based on its deliberation, the DSMB concluded that NAVIGATE could continue as designed, without modifications.
- In September 2022, Inventiva and Chia Tai-Tianqing Pharmaceutical Group entered into a licensing and collaboration agreement to develop and commercialize lanifibranor, if approved, for the treatment of nonalcoholic steatohepatitis and potentially other metabolic diseases in mainland China, Hong Kong, Macau, and Taiwan.
- In June 2022, Poxel SA announced that the U.S. Patent and Trademark Office (PTO) has issued to Poxel US Patent No. 11319313, which represents a new patent for PXL065, a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone which is being investigated in Phase II stage of clinical trial evaluation for the treatment of Nonalcoholic steatohepatitis (NASH).
- In May 2022, Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) had granted Fast Track designation to Pfizer’s investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis: ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi).
- In May 2022, Hepion Pharmaceuticals, Inc. announced that it has entered into a clinical collaboration with HepQuant, a Denver-based, privately held company with novel, proprietary investigational technology for evaluating liver function and health in patients with chronic liver diseases. Hepion will incorporate the HepQuant ‘SHUNT’ test into a dedicated Phase IIb clinical trial in presumed NASH F3 subjects.
- In February 2022, the US Food and Drug Administration (FDA) granted a Fast-Track Designation to Axcella Therapeutics’ AXA1125 to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis.
- In January 2022, LISCure Biosciences announced that it had executed a research collaboration agreement with Mayo Clinic for new drug development for rare liver diseases. LISCure Biosciences Inc. has executed a research collaboration agreement with US based-Mayo Clinic for new drug development for rare liver diseases.
For further information, refer to the detailed Non-Alcoholic Steatohepatitis Drugs Launch, Non-Alcoholic Steatohepatitis Developmental Activities, and Non-Alcoholic Steatohepatitis News, click here for Non-Alcoholic Steatohepatitis Ongoing Clinical Trial Analysis
Non-Alcoholic Steatohepatitis Emerging Drugs Profile
Resmetirom: Madrigal Pharmaceuticals
Resmetirom (MGL-3196) is a first-in-class, orally-administered, small-molecule, liver-directed thyroid hormone receptor (THR) β-selective agonist. Preclinical, toxicology, Phase I, and Phase II clinical data suggest Resmetirom has an attractive, differentiated profile as a potential treatment for Nonalcoholic steatohepatitis (NASH), Nonalcoholic fatty liver disease (NAFLD) and associated dyslipidemias. THR-β selectivity also enhances the safety profile of Resmetirom, compared to non-selective agents. Resmetirom has shown neither suppression of the central thyroid axis nor THR-α effects on heart rate or bone, reducing elevated liver enzymes in NASH patients. It is currently in the Phase III stage of development for Nonalcoholic steatohepatitis and is being developed by Madrigal Pharmaceuticals.
MSDC-0602K: Cirius Therapeutics
MSDC-0602K, a second-generation oral insulin sensitizer, is designed to selectively modulate the mitochondrial pyruvate carrier (MPC) while minimizing direct PPAR-gamma activation. The MPC mediates at the cellular level the effects of over nutrition, a major cause of Nonalcoholic fatty liver disease NAFLD/NASH and Type 2 diabetes. In preclinical studies, modulation of the MPC has been shown to improve insulin sensitivity, lipid metabolism, and inflammation. Currently the drug is in Phase III stage of Clinical trial evaluation for the treatment of Nonalcoholic steatohepatitis.
ION224: Ionis Pharmaceuticals
ION224 is a ligand-conjugated (LICA) investigational antisense medicine designed to reduce the production of DGAT2, or diacylglycerol acyltransferase 2, to treat patients with NASH, or nonalcoholic steatohepatitis. NASH is a common liver disease characterized by excessive triglycerides in the liver with concurrent inflammation and cellular damage. DGAT2 is an enzyme that catalyzes the final step in triglyceride synthesis in the liver. Reducing the production of DGAT2 should therefore decrease triglyceride synthesis in the liver. In animal studies, antisense inhibition of DGAT2 significantly improved liver steatosis, lowered blood lipid levels and reversed diet-induced insulin resistance in animal models of obesity and fatty liver disease. Currently the drug is in Phase II stage of Clinical trial evaluation for the treatment of Nonalcoholic steatohepatitis.
HU 6: Rivus Pharmaceuticals
Rivus’ lead candidate HU6, a first-in-class CMA, to address a broad range of cardio-metabolic diseases by increasing fat selective weight loss and improving key markers of glycemic control and inflammation. HU6 is designed to reduce the steatosis, inflammation, and fibrosis and hepatocyte injury in Noncirrhotic Nonalcoholic Steatohepatitis (NASH). The drug is being developed by Rivus Pharmaceuticals and has completed Phase II stage of development.
HTD 1801: HighTide Biopharma
The company’s lead drug candidate, HTD1801, is a first-in-class new molecular entity (ionic salt of two active moieties). It is a novel orally active ionic salt of berberine and ursodeoxycholic acid, substantially reduced liver fat while improving glycemic control and other cardiometabolic biomarkers in adults with nonalcoholic steatohepatitis (NASH) and type 2 diabetes (T2DM). Currently, it is in Phase II trials for the treatment of primary sclerosing cholangitis (PSC), and nonalcoholic steatohepatitis (NASH).
EDP-305: Enanta Pharmaceuticals
EDP-305 is a potent Farnesoid X Receptor (FXR) agonist and Enanta’s lead product candidate being developed for the treatment of NASH and PBC. FXR is a nuclear receptor and a main regulator of bile acid levels in the liver and small intestine. It responds to bile acids by regulating gene transcription of key enzymes and transporters, many of which play important roles in lipid metabolism, insulin resistance, inflammation, and fibrosis. EDP-305 represents a new class of FXR agonists that has been designed to take advantage of increased binding interactions with the receptor. This non-bile acid class contains steroid and non-steroid components and does not contain the carboxylic acid group normally present in other classes of FXR agonists and natural bile acids that can lead to the formation of taurine and glycine conjugates. Currently the drug is in Phase II stage of Clinical trial evaluation for the treatment of Nonalcoholic steatohepatitis.
Non-Alcoholic Steatohepatitis Pipeline Therapeutics Assessment
There are approx. 100+ key companies which are developing the therapies for Nonalcoholic Steatohepatitis. The companies which have their Nonalcoholic Steatohepatitis drug candidates in the most advanced stage, i.e. phase III include, Madrigal Pharmaceuticals.
Find out more about the Non-Alcoholic Steatohepatitis Pipeline Segmentation, Therapeutics Assessment, and Non-Alcoholic Steatohepatitis Emerging Drugs @ Non-Alcoholic Steatohepatitis Treatment Landscape
Scope of the Non-Alcoholic Steatohepatitis Pipeline Report
- Coverage- Global
- Non-Alcoholic Steatohepatitis Companies- Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, and others
- Non-Alcoholic Steatohepatitis Pipeline Therapies- TERN-101, SNP-610, LJN452 (tropifexor + licogliflozin), PXL065, ALS-L1023, PF-06865571 + PF-05221304, PF-06835919, PF-06865571, ORMD-0801, Norucholic acid, NNC0194-0499, MN-001, MK-3655, MET642, MET409, LPCN 1144, LIK066, Leronlimab, ALN-HSD, MT-3995, CM101, Leu-Mit-Sil (NS-0200), IN-A010, Efruxifermin (EFX), Efinopegdutide, EDP-305, JKB-122, CS0159 (Linafexor), CRV431, Chiglitazar sodium, BOS-580, BMS-986263, HEC96719, GSK4532990, FM101, Firsocostat, EPY001a, Emricasan, BMS-986036, BIO89-100, BI 456906, BFKB8488A, AXA1125, ASC 41, GS-9674 (Cilofexor), ZSP1601, and others
- Non-Alcoholic Steatohepatitis Pipeline Segmentation: Product Type, Molecule Type, Route of Administration
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Table of Content
- Introduction
- Executive Summary
- Nonalcoholic Steatohepatitis: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Nonalcoholic Steatohepatitis– DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- Resmetirom: Madrigal Pharmaceuticals
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- ION224: Ionis Pharmaceuticals
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- AMG 609: Amgen
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Drug name : Company name
- Drug profiles in the detailed report…..
- Inactive Products
- Nonalcoholic Steatohepatitis Key Companies
- Nonalcoholic Steatohepatitis Key Products
- Nonalcoholic Steatohepatitis- Unmet Needs
- Nonalcoholic Steatohepatitis- Market Drivers and Barriers
- Nonalcoholic Steatohepatitis- Future Perspectives and Conclusion
- Nonalcoholic Steatohepatitis Analyst Views
- Nonalcoholic Steatohepatitis Key Companies
- Appendix
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