Non-Alcoholic Fatty Liver Disease (NAFLD) Patient Pool Analysis

DelveInsight’s, “Non-alcoholic fatty liver disease - Pipeline Insight, 2026” report provides comprehensive insights about 90+ companies and 100+ pipeline drugs in the Non-alcoholic fatty liver disease 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 Understanding

Non-alcoholic fatty liver Overview

Non-alcoholic fatty liver disease (NAFLD), now increasingly referred to as metabolic dysfunction-associated steatotic liver disease (MASLD), is a chronic liver condition characterized by excessive accumulation of fat in the liver in individuals who consume little or no alcohol. It is strongly associated with metabolic risk factors such as obesity, insulin resistance, type 2 diabetes, dyslipidemia, and metabolic syndrome. NAFLD encompasses a disease spectrum ranging from simple hepatic steatosis, which is generally benign, to non-alcoholic steatohepatitis (NASH), a more severe form involving inflammation and hepatocellular injury that can progress to fibrosis, cirrhosis, and even hepatocellular carcinoma in advanced stages.

NAFLD is mainly caused by metabolic dysfunction, especially insulin resistance, which leads to excess fat accumulation in the liver. Common risk factors include obesity, type 2 diabetes, dyslipidemia, and a sedentary lifestyle. Genetic and dietary factors can also contribute to its development.

NAFLD develops primarily due to insulin resistance, which increases lipolysis in adipose tissue and delivers excess free fatty acids to the liver. This leads to triglyceride accumulation within hepatocytes (hepatic steatosis). Over time, lipid overload causes oxidative stress, mitochondrial dysfunction, and inflammatory cytokine release, promoting hepatocellular injury. These processes can progress from simple steatosis to non-alcoholic steatohepatitis (NASH), and in some cases further to fibrosis and cirrhosis due to chronic inflammation and activation of hepatic stellate cells.

NAFLD is diagnosed primarily by detecting excess fat in the liver after excluding significant alcohol intake and other causes of liver disease. It is often identified incidentally through elevated liver enzymes or imaging studies such as ultrasound, CT, or MRI showing hepatic steatosis. Ultrasound is the most commonly used first-line tool due to its accessibility and cost-effectiveness. In some cases, additional tests like FibroScan or MRI-based techniques are used to assess liver fibrosis. Liver biopsy remains the gold standard for confirming NASH and staging disease severity when needed.

Treatment of NAFLD mainly focuses on lifestyle modification rather than specific drug therapy. Weight loss through diet control and regular physical activity is the cornerstone of management, as even moderate reduction in body weight can significantly reduce liver fat and improve liver function. A balanced diet such as the Mediterranean diet is often recommended, along with avoidance of high-calorie and high-sugar foods. Management of associated conditions like obesity, type 2 diabetes, and dyslipidemia is also important to slow disease progression. In more advanced cases, bariatric surgery may be considered for sustained weight reduction.

“Non-alcoholic fatty liver disease- Pipeline Insight, 2026” report by DelveInsight outlays comprehensive insights of the present scenario and growth prospects across the indication. A detailed picture of the Non-alcoholic fatty liver disease pipeline landscape is provided, which includes the disease overview and Non-alcoholic fatty liver disease treatment guidelines. The assessment part of the report embraces in-depth Non-alcoholic fatty liver disease commercial assessment and clinical assessment of the pipeline products under development. In the report, a detailed description of the drug is given, which includes the mechanism of action of the drug, clinical 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.

Non-alcoholic fatty liver Pipeline Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Non-alcoholic fatty liver disease R&D.
• The therapies under development are focused on novel approaches to treat/improve Non-alcoholic fatty liver disease.

Non-alcoholic fatty liver Emerging Drugs Analysis

This segment of the Non-alcoholic fatty liver disease report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase II, Phase 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 Emerging Drugs

Efruxifermin: Akero Therapeutics, Inc.

Efruxifermin (EFX) is an investigational Fc-FGF21 fusion protein developed for the treatment of NAFLD/NASH (MASH). The drug is engineered to mimic the biological activity of fibroblast growth factor 21 (FGF21), a hormone that regulates multiple metabolic pathways involved in glucose metabolism, lipid balance, insulin sensitivity, and energy expenditure. EFX delivers sustained and balanced signaling through FGF21 receptors in the liver and adipose tissue, enabling it to address the core drivers of MASH progression. The mechanism of action of efruxifermin involves reducing hepatic fat accumulation by suppressing de novo lipogenesis, improving insulin sensitivity, enhancing lipid oxidation, and decreasing lipotoxicity and inflammation. Currently, the drug is being evaluated in the Phase III stage of its development for the treatment of Non-alcoholic fatty liver disease.

Efimosfermin alfa: GSK plc.

Efimosfermin alfa is an investigational, once-monthly subcutaneous injection of a long-acting variant of FGF21 designed to regulate key metabolic pathways to decrease liver fat, ameliorate liver inflammation, and reverse liver fibrosis. The FGF21 domain is further stabilized through the introduction of a disulfide bond and point mutations that reduce proteolytic breakdown and increase resistance, extending its half-life to approximately 21 days, enabling once-monthly dosing. Its direct antifibrotic mechanism of action gives it potential to address more advanced stages of steatotic liver disease, where therapeutic options remain limited. Currently, the drug is being evaluated in the Phase III stage of its development for the treatment of Non-alcoholic fatty liver disease.

ALN-HSD: Regeneron Pharmaceuticals Inc. / Alnylam

ALN-HSD is an investigational, subcutaneously administered, N-acetylgalactosamine (GalNAc)-conjugated RNA interference therapeutic targeting liver-expressed HSD17B13 mRNA, in development for the treatment of NASH. The therapy works by selectively silencing HSD17B13 expression in hepatocytes through the RNAi pathway, thereby reducing production of the HSD17B13 protein, which is associated with liver inflammation and fibrosis. By mimicking naturally occurring protective HSD17B13 loss-of-function variants, ALN-HSD aims to reduce liver injury, inflammation, and fibrotic progression associated with NASH. Currently, the drug is being evaluated in the Phase II stage of its development for the treatment of Non-alcoholic fatty liver disease.

HU6: Rivus Pharmaceuticals

HU6 is an oral investigational small-molecule therapy developed for the treatment of NAFLD/NASH (MASH) and other cardiometabolic diseases. The drug belongs to a novel class called Controlled Metabolic Accelerators (CMAs), which are designed to safely increase the body’s resting metabolic rate and promote fat-selective weight loss while preserving lean muscle mass. HU6 works through a precision-controlled mitochondrial uncoupling mechanism, a natural metabolic process in which mitochondria increase energy expenditure by oxidizing fats and sugars without increasing ATP production. The drug activates proton leak and mitochondrial uncoupling in a controlled and imperceptible manner, leading to increased calorie burning primarily from fat, even while the body is at rest. Currently, the drug is being evaluated in the Phase II stage of its development for the treatment of Non-alcoholic fatty liver disease.

INI-822: Inipharm

INI-822 is an orally administered small-molecule inhibitor developed for the treatment of NAFLD/NASH (MASH) and other fibrotic liver diseases. The drug acts by selectively inhibiting HSD17B13, a liver-specific lipid droplet protein involved in lipid metabolism and liver inflammation. Excessive HSD17B13 activity contributes to lipotoxicity, inflammation, and fibrosis in fatty liver disease. INI-822 is designed to mimic the protective effects observed in individuals carrying naturally occurring inactive HSD17B13 variants, which are associated with reduced liver injury and slower disease progression. By blocking HSD17B13 activity, INI-822 aims to improve liver lipid homeostasis, reduce inflammatory signaling, and decrease fibrotic processes associated with NAFLD/NASH. Currently, the drug is being evaluated in the Phase I stage of its development for the treatment of Non-alcoholic fatty liver disease.

HEC169584: Sunshine Lake Pharma Co., Ltd.

HEC169584 is an investigational small-molecule THR-β (thyroid hormone receptor beta) agonist developed for the treatment of NAFLD/NASH (MASH). The drug is the first AI-driven small-molecule drug candidate generated using its HEC-GEN molecular design platform based on sparse graph attention neural networks. The drug acts by selectively activating THR-β, a receptor involved in regulating hepatic lipid metabolism, thereby promoting fat metabolism and reducing liver fat accumulation, inflammation, and fibrosis associated with NASH. It has demonstrated high in vitro THR-β activity, strong liver-targeting ability with a high liver-to-blood ratio, and reduced effects on the thyroid axis, heart, and other tissues. Currently, the drug is being evaluated in the Phase I stage of its development for the treatment of Non-alcoholic fatty liver disease.

Further product details are provided in the report.

Non-alcoholic fatty liver Drug Therapeutic Assessment

This segment of the report provides insights about the different Non-alcoholic fatty liver disease drugs segregated based on the following parameters that define the scope of the report.

Major Non-alcoholic fatty liver Players in Non-alcoholic fatty liver  

There are approximately 90+ key companies developing therapies for Non-alcoholic fatty liver disease. The companies with drug candidates in the most advanced stage, i.e., Phase III, include Akero Therapeutics, Inc. and others.

Non-alcoholic fatty liver Clinical Trial Phases

DelveInsight’s report covers around 100+ products under different phases of clinical development, including:

• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage products (Phase I)
• Preclinical and discovery-stage candidates
• Discontinued and inactive candidates

Non-alcoholic fatty liver Drug Route of Administration

Non-alcoholic fatty liver disease pipeline report provides the therapeutic assessment of the pipeline drugs by route of administration. Products have been categorized under various ROAs such as:

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

Non-alcoholic fatty liver Product Molecule Type

Products have been categorized under various molecule types such as:

• Oligonucleotide
• Peptide
• Small molecule

Non-alcoholic fatty liver Product Type

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

Non-alcoholic fatty liver Clinical Trial Activities

The Non-alcoholic fatty liver Pipeline report provides insights into Non-alcoholic fatty liver Clinical Trials within Phase II, Phase I, preclinical, and discovery stages. It also analyzes Non-alcoholic fatty liver disease therapeutic drugs and the key players involved in developing key drugs.

Non-alcoholic fatty liver Pipeline Development Activities

The Non-alcoholic fatty liver Clinical Trial analysis report covers detailed information on collaborations, acquisitions and mergers, licensing, along with a thorough therapeutic assessment of emerging Non-alcoholic fatty liver disease drugs.

Non-alcoholic fatty liver Pipeline Report Insights

• Non-alcoholic fatty liver disease Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Non-alcoholic fatty liver Pipeline Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive Drugs Assessment
• Unmet Needs

Key Questions Answered In The Non-alcoholic fatty liver Pipeline Report

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Non-alcoholic fatty liver disease drugs?
• How many Non-alcoholic fatty liver disease drugs are developed by each company?
• How many emerging drugs are in mid-stage and late-stage development for the treatment of Non-alcoholic fatty liver disease?
• What are the key collaborations (Industry–Industry, Industry–Academia), mergers and acquisitions, and licensing activities related to the Non-alcoholic fatty liver disease therapeutics?
• What are the recent trends, drug types, and novel technologies developed to overcome the limitations of existing therapies?
• What are the clinical studies going on for Non-alcoholic fatty liver disease and their status?
• What are the key designations that have been granted to the emerging drugs?

Non-alcoholic fatty liver Key Companies

• Akero Therapeutics, Inc.
• GSK plc.
• Regeneron Pharmaceuticals Inc.
• Inipharm
• Rivus Pharmaceuticals
• Sunshine Lake Pharma Co., Ltd.
• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
• MediciNova, Inc.
• Tasly Biopharmaceuticals Co., Ltd.
• Sinew Pharma Inc.
• Hinova Pharmaceuticals Inc.
• Novo Nordisk A/S
• 89bio, Inc.
• Hanmi Pharmaceutical Company Limited
• Guangdong Raynovent Biotech Co., Ltd.
• Polaris Group
• Changchun Intellicrown Pharmaceutical Co. LTD
• OrsoBio, Inc.
• Akero Therapeutics
• Corcept Therapeutics, Incorporated
• Eccogene
• Inventiva Pharma

Non-alcoholic fatty liver Key Products

• Efruxifermin
• Efimosfermin alfa
• ALN-HSD
• INI-822
• HU6
• HEC169584
• TQA2225
• MN-001
• B1344
• SNP-610
• HP515
• NNC4005-001
• Pegozafermin
• HM15211
• ZSP1601
• ADI-PEG20
• IMMH014
• TLC-2716
• Efruxifermin
• Miricorilant
• ECC4703
• ALN-PNP