Non-Alcoholic Steatohepatitis: Limited Available Treatment Options but Promising Drugs in Development and Recent Progress Towards a Regulatory Approval Pathway

Catalyzing the critical path initiative: FDA's progress in drug development activities

(2015) A Parekh et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients

(2015) H-G Eichler et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Challenges and opportunities in drug and biomarker development for nonalcoholic steatohepatitis: Findings and recommendations from an American Association for the Study of Liver Diseases-U.S. Food and Drug Administration Joint Workshop

(2015) Arun J. Sanyal et al.   HEPATOLOGY

Fibrosis stage is the strongest predictor for disease-specific mortality in NAFLD after up to 33 years of follow-up

(2015) Mattias Ekstedt et al.   HEPATOLOGY

O047 : Remogliflozin etabonate reduces insulin resistance and liver function enzymes: Role for treatment of nash

(2015) W. Wilkison et al.   JOURNAL OF HEPATOLOGY

LP37 : A placebo-controlled, multicenter, double-blind, randomised trial of emricasan in subjects with non-alcoholic fatty liver disease (NAFLD) and raised transaminases

(2015) M. Shiffman et al.   JOURNAL OF HEPATOLOGY

Farnesoid X nuclear receptor ligand obeticholic acid for non-cirrhotic, non-alcoholic steatohepatitis (FLINT): a multicentre, randomised, placebo-controlled trial

(2015) Brent A Neuschwander-Tetri et al.   LANCET

Determining the association between adipokine expression in multiple tissues and phenotypic features of non-alcoholic fatty liver disease in obesity

(2015) M G M Wolfs et al.   Nutrition & Diabetes

Accelerated Access to Innovative Medicines for Patients in Need

(2014) L G Baird et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Clinical differences between alcoholic liver disease and nonalcoholic fatty liver disease

(2014) Nobuyuki Toshikuni   WORLD JOURNAL OF GASTROENTEROLOGY

Bariatric Surgery and Non-Alcoholic Fatty Liver Disease: Current and Potential Future Treatments

(2014) Akira Sasaki et al.   Frontiers in Endocrinology

Systematic review with meta-analysis: non-invasive assessment of non-alcoholic fatty liver disease - the role of transient elastography and plasma cytokeratin-18 fragments

(2013) R. Kwok et al.   ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Nonalcoholic Fatty Liver Disease: Current Issues and Novel Treatment Approaches

(2013) Romina Lomonaco et al.   DRUGS

Utility of magnetic resonance imaging versus histology for quantifying changes in liver fat in nonalcoholic fatty liver disease trials

(2013) Mazen Noureddin et al.   HEPATOLOGY

Non-alcoholic fatty liver disease as an independent manifestation of the metabolic syndrome: Results of a US national survey in three ethnic groups

(2013) Mark M Smits et al.   JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY

1319 SIMTUZUMAB, AN ANTIFIBROTIC MONOCLONAL ANTIBODY AGAINST LYSYL OXIDASE-LIKE 2 (LOXL2) ENZYME, APPEARS SAFE AND WELL TOLERATED IN PATIENTS WITH LIVER DISEASE OF DIVERSE ETIOLOGY

(2013) A.H. Talal et al.   JOURNAL OF HEPATOLOGY

Cannabinoid signaling and liver therapeutics

(2013) Ariane Mallat et al.   JOURNAL OF HEPATOLOGY

Safety and efficacy of liraglutide in patients with type 2 diabetes and elevated liver enzymes: individual patient data meta-analysis of the LEAD program

(2012) M. J. Armstrong et al.   ALIMENTARY PHARMACOLOGY & THERAPEUTICS

The Diagnosis and Management of Non-alcoholic Fatty Liver Disease: Practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology and the American Gastroenterological Association

(2012) Naga Chalasani et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

Farnesoid X receptor targeting to treat nonalcoholic steatohepatitis

(2012) Luciano Adorini et al.   DRUG DISCOVERY TODAY

The Diagnosis and Management of Non-alcoholic Fatty Liver Disease: Practice Guideline by the American Gastroenterological Association, American Association for the Study of Liver Diseases, and American College of Gastroenterology

(2012) Naga Chalasani et al.   GASTROENTEROLOGY

Nonalcoholic fatty liver disease (NAFLD): Is it really a serious condition?

(2012) Julia Wattacheril et al.   HEPATOLOGY

The diagnosis and management of non-alcoholic fatty liver disease: Practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association

(2012) Naga Chalasani et al.   HEPATOLOGY

Upper normal threshold of serum alanine aminotransferase in identifying individuals at risk for chronic liver disease

(2012) Ha Na Park et al.   LIVER INTERNATIONAL

Assessing the drinking status of liver transplant patients with alcoholic liver disease

(2012) John P. Allen et al.   LIVER TRANSPLANTATION

Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults

(2011) G. Vernon et al.   ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Diet-Induced Adipose Tissue Inflammation and Liver Steatosis Are Prevented by DPP-4 Inhibition in Diabetic Mice

(2011) J. Shirakawa et al.   DIABETES

Diagnosis and Evaluation of Nonalcoholic Fatty Liver Disease

(2011) Mikako Obika et al.   Experimental Diabetes Research

Sitagliptin as a Novel Treatment Agent for Non-Alcoholic Fatty Liver Disease Patients with Type 2 Diabetes Mellitus

(2011) Tomoyuki Iwasaki et al.   HEPATO-GASTROENTEROLOGY

Role of ethnicity in overweight and obese patients with nonalcoholic steatohepatitis

(2011) Romina Lomonaco et al.   HEPATOLOGY

Endpoints and clinical trial design for nonalcoholic steatohepatitis

(2011) Arun J. Sanyal et al.   HEPATOLOGY

Effect of adipose tissue insulin resistance on metabolic parameters and liver histology in obese patients with nonalcoholic fatty liver disease

(2011) Romina Lomonaco et al.   HEPATOLOGY

NASH: A global health problem

(2011) Arun J. Sanyal   HEPATOLOGY RESEARCH

Rimonabant improves cholesterol, insulin resistance and markers of non-alcoholic fatty liver in morbidly obese patients: a retrospective cohort study

(2011) A. S. Wierzbicki et al.   INTERNATIONAL JOURNAL OF CLINICAL PRACTICE

Effect of Vitamin E or Metformin for Treatment of Nonalcoholic Fatty Liver Disease in Children and Adolescents

(2011) Joel E. Lavine   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Serum ferritin is a discriminant marker for both fibrosis and inflammation in histologically proven non-alcoholic fatty liver disease patients

(2011) Pinelopi Manousou et al.   LIVER INTERNATIONAL

Effects of Combined Exenatide and Pioglitazone Therapy on Hepatic Fat Content in Type 2 Diabetes

(2011) Padma Sathyanarayana et al.   Obesity

Nonalcoholic fatty liver disease in type 2 diabetes mellitus

(2011) Kenneth Cusi   Current Opinion in Endocrinology Diabetes and Obesity

Effect of a 12-Month Intensive Lifestyle Intervention on Hepatic Steatosis in Adults With Type 2 Diabetes

(2010) M. Lazo et al.   DIABETES CARE

Transient elastography with a new probe for obese patients for non-invasive staging of non-alcoholic steatohepatitis

(2010) Mireen Friedrich-Rust et al.   EUROPEAN RADIOLOGY

Prevalence of Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis Among a Largely Middle-Aged Population Utilizing Ultrasound and Liver Biopsy: A Prospective Study

(2010) Christopher D. Williams et al.   GASTROENTEROLOGY

Disease progression of non-alcoholic fatty liver disease: a prospective study with paired liver biopsies at 3 years

(2010) V. W.-S. Wong et al.   GUT

Long-term mortality in nonalcoholic fatty liver disease: Is liver histology of any prognostic significance?

(2010) Paul Angulo   HEPATOLOGY

A meta-analysis of randomized trials for the treatment of nonalcoholic fatty liver disease

(2010) Giovanni Musso et al.   HEPATOLOGY

Nonalcoholic fatty liver disease (NAFLD) activity score and the histopathologic diagnosis in NAFLD: distinct clinicopathologic meanings

(2010) Elizabeth M. Brunt et al.   HEPATOLOGY

Non-alcoholic fatty liver disease progresses to hepatocellular carcinoma in the absence of apparent cirrhosis

(2010) Judith Ertle et al.   INTERNATIONAL JOURNAL OF CANCER

Generalizability of the Nonalcoholic Steatohepatitis Clinical Research Network Histologic Scoring System for Nonalcoholic Fatty Liver Disease

(2010) Ravi Juluri et al.   JOURNAL OF CLINICAL GASTROENTEROLOGY

An apoptosis panel for nonalcoholic steatohepatitis diagnosis

(2010) Tarek I. Abu-Rajab Tamimi et al.   JOURNAL OF HEPATOLOGY

Safety and efficacy of long-term statin treatment for cardiovascular events in patients with coronary heart disease and abnormal liver tests in the Greek Atorvastatin and Coronary Heart Disease Evaluation (GREACE) Study: a post-hoc analysis

(2010) Vasilios G Athyros et al.   LANCET

Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170 000 participants in 26 randomised trials

(2010)   LANCET

Pioglitazone, Vitamin E, or Placebo for Nonalcoholic Steatohepatitis

(2010) Arun J. Sanyal et al.   NEW ENGLAND JOURNAL OF MEDICINE

A Biomarker Panel for Non-alcoholic Steatohepatitis (NASH) and NASH-Related Fibrosis

(2010) Zobair M. Younossi et al.   OBESITY SURGERY

Review article: omega-3 fatty acids - a promising novel therapy for non-alcoholic fatty liver disease

(2009) G. S. MASTERTON et al.   ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Comparison of Noninvasive Markers of Fibrosis in Patients With Nonalcoholic Fatty Liver Disease

(2009) Amy G. Shah et al.   Clinical Gastroenterology and Hepatology

Role of Insulin Resistance and Lipotoxicity in Non-Alcoholic Steatohepatitis

(2009) Kenneth Cusi   Clinics in Liver Disease

Could inflammatory markers help diagnose nonalcoholic steatohepatitis?

(2009) Giovanni Tarantino et al.   EUROPEAN JOURNAL OF GASTROENTEROLOGY & HEPATOLOGY

Prospective Study of the Long-Term Effects of Bariatric Surgery on Liver Injury in Patients Without Advanced Disease

(2009) Philippe Mathurin et al.   GASTROENTEROLOGY

The Histologic Spectrum of Liver Disease in African-American, Non-Hispanic White and Hispanic Obesity Surgery Patients

(2008) Eric R Kallwitz et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

Long-Term Follow-Up of Patients With Nonalcoholic Fatty Liver

(2008) Nila Rafiq et al.   Clinical Gastroenterology and Hepatology

Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years

(2008) David C. Klonoff et al.   CURRENT MEDICAL RESEARCH AND OPINION

Magnetic Resonance Elastography for the Noninvasive Staging of Liver Fibrosis

(2008) Laurent Huwart et al.   GASTROENTEROLOGY

Rosiglitazone for Nonalcoholic Steatohepatitis: One-Year Results of the Randomized Placebo-Controlled Fatty Liver Improvement With Rosiglitazone Therapy (FLIRT) Trial

(2008) Vlad Ratziu et al.   GASTROENTEROLOGY

Orlistat for overweight subjects with nonalcoholic steatohepatitis: A randomized, prospective trial

(2008) Stephen A. Harrison et al.   HEPATOLOGY

Gene Therapy for Diabetes: Metabolic Effects of Helper-dependent Adenoviral Exendin 4 Expression in a Diet-induced Obesity Mouse Model

(2008) Susan L Samson et al.   MOLECULAR THERAPY

Diagnosis of Nonalcoholic Fatty Liver Disease: Invasive versus Noninvasive

(2008) Anna Wieckowska et al.   SEMINARS IN LIVER DISEASE