Essentiale (essential phospholipids (EPL)) / Sanofi - LARVOL DELTA

Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia (clinicaltrials.gov) - P=N/A | N=232 | Not yet recruiting | Sponsor: General Hospital of Shenyang Military Region

New trial • Hepatology • Liver Failure

Effect of Essential phospholipids on hepatic steatosis and quality of life in patients with MASLD associated with type 2 diabetes mellitus and/or hyperlipidemia and/or obesity – a Phase IV, randomized double-blind clinical trial (APASL 2025) - "Patients were randomized (1:1) to receive 1800 mg/day of Essentiale® plus SoC or a placebo with SoC, taken orally, and followed for 9 months... Treatment of EPLs with SoC reduced hepatic steatosis and improved fatigue at 6 months in MASLD patients compared to placebo, with acceptable safety profile making it a promising option for early intervention of MASLD. Table and Figure:Figure 1.Change in QoL total and fatigue scores (Change from baseline)"

Clinical • HEOR • P4 data • CNS Disorders • Depression • Diabetes • Dyslipidemia • Fatigue • Fibrosis • Genetic Disorders • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Pain • Psychiatry • Type 2 Diabetes Mellitus

Illness perceptions, medication beliefs and immunosuppression adherence in young adult kidney transplant recipients: A single-centre cohort study and comparative analysis (TTS 2024) - "Rates of overall non-adherence in our YKTR cohort are consistent with existing literature. Reported rates of intentional non-adherence were high. Importantly, we identified that medication beliefs and illness perceptions significantly affect IS adherence in YKTR."

Adherence • Clinical • Nephrology • Pediatrics • Transplantation

Effectiveness of Polyene phosphatidylcholine in metabolic-associated fatty liver disease treatment : a real-world study in China (EASL-ILC 2024) - "Previous studies showed that polyenyl phosphatidylcholine (Essentiale capsule, Ess) could be used for MAFLD due to its action of accelerating liver cell membrane regeneration... This study found that, in MAFLD patients, Ess treatment could improve liver function and might have beneficial effects on reducing the risk of fibrosis and improving lipid disorders."

Clinical • Real-world • Real-world evidence • Cardiovascular • Diabetes • Dyslipidemia • Fibrosis • Hepatology • Hypertension • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

Effect of essential phospholipids on hepatic steatosis in metabolic dysfunction-associated steatotic liver disease associated with type 2 diabetes mellitus and/or hyperlipidemia and/or obesity: study protocol of a randomized, double-blind, phase IV clinical trial. (PubMed, Trials) - P4 | "The current protocol design will allow to comprehensively explore the efficacy of EPL added to the standard of care on hepatic steatosis and QoL and its safety in patients with MASLD associated with T2DM and/or hyperlipidemia and/or obesity by assessing various outcome measures."

Clinical • Journal • P4 data • Diabetes • Dyslipidemia • Fatigue • Fibrosis • Genetic Disorders • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Pain • Type 2 Diabetes Mellitus

Antifibrotic Effect of Polyene Phosphatidylcholine in Chinese Mafld Patients: A Real-World Study. (APASL 2024) - "We aimed to conduct an observational study based on retrospective real-world data to analyze the antifibrotic effect of Polyene phosphatidylcholine (Essentiale® Capsule, Ess) in MAFLD patients... Our study found that Ess treatment for 24 weeks can significantly reduce the FIB-4 index in MAFLD patients."

Clinical • Real-world • Real-world evidence • Cardiovascular • Dyslipidemia • Fibrosis • Hypertension • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

INVESTIGATING THE EFFECT OF ESSENTIAL PHOSPHOLIPIDS ON AN IN VITRO MODEL OF HUMAN STEATOSIS (AASLD 2023) - "Inducing steatosis on differentiated HepaRG cells mimics human steatosis. Treatment with Essentiale® effectively impacted fat deposits without compromising cell viability, membrane integrity, mitochondria, or oxidative stress This suggests Essentiale® could be safe in human steatosis."

Preclinical • Addiction (Opioid and Alcohol) • Fibrosis • Gastrointestinal Cancer • Hepatology • Immunology • Liver Cancer • Liver Cirrhosis • Liver Failure • Non-alcoholic Fatty Liver Disease • Oncology • Solid Tumor

"#CHCNewsflash: @sanofi #Sanofi's OTC-registered liver & bile remedy #Essentiale has been extended in #China with two #healthfoods to support #liverhealth" (@NicholasHallCo)

Effect of Dangfei Liganning capsule on liver X receptor α/steroid regulatory element binding protein-1/fatty acid synthase signal pathway in rats with metabolic- associated fatty liver disease. (PubMed, J Tradit Chin Med) - "Dangfei Liganning capsule can slow down the increase of body weight of MAFLD rats, reduce the levels of transaminase, Lipid and inflammatory factors in MAFLD rats, promote the synthesis of liver protein and bile metabolism, and improve the liver fatty lesion of MAFLD rats, among which the Dangfei Liganning high-dose group is more effective. The mechanism of action may be through blocking LXR-SREBP-1-FAS signal pathway."

Journal • Preclinical • Dyslipidemia • Gastrointestinal Cancer • Hepatology • Liver Cancer • Non-alcoholic Fatty Liver Disease • Oncology • Solid Tumor • FASN • IL6 • TNFA

"Dla przykładu lek reklamowany jako "ratunkowy" dla wątroby firmy @sanofi @SanofiPolska - Essentiale Forte także zawiera dwutlenek tytanu E171 jako składnik otoczki kapsułki. Tak samo pochodny np. Esseliv Forte #Aflofarm. To jest po prostu jakaś paranoja!" (@p_a_baranowski)

Atypical primary biliary cholangitis results in vanishing bile duct syndrome with cutaneous xanthomas: a case report. (PubMed, Diagn Pathol) - "This case highlights that the positivity of ANA that in PBC have a well diagnostic and prognostic significance and antinuclear antibodies giving the 'multiple nuclear dots' or the 'rim-like/membranous' pattern scan ca diagnose primary biliary cirrhosis accurately. Since the liver biopsy of PBC alone may not be sufficient to establish the diagnosis, serum antibodies should also be examined. PBC can also lead to intrahepatic cholestasis, which can cause dyslipidemia and cutaneous xanthomas."

Journal • Cholestasis • Dyslipidemia • Fibrosis • Hepatology • Immunology • Metabolic Disorders • Primary Biliary Cholangitis

Insights to molecular mechanism of Essentiale: In vitro studies in hepatic cell lines HepaRG and steatotic HepaRG (EASL-ILC 2022) - "In vitro investigations in hepatocyte cell lines provided valuable insights into the impact of EPL on pro-inflammatory cytokine release, lipid-metabolizing enzymes which may improve liver function."

Preclinical • Hepatology • Non-alcoholic Fatty Liver Disease • CXCL8 • FASN • IL6

Treatment with phosphatidylcholine of patients with non-alcoholic fatty liver disease: a prospective pilot study. (PubMed, Minerva Gastroenterol (Torino)) - "The results of the study indicate that treatment with Essentiale® Forte N for 3 months was associated with a significant decrease in transaminase levels, in the activity of lipid peroxidation markers and an increase in the level of antioxidant enzymes."

Journal • Cardiovascular • Fibrosis • Hepatology • Immunology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

"@pfizer + @moderna_tx vaccine adverse effect can be neutralize by @sanofi tablet #ESSENTIALE ..........." (@rainier_manejo)

Adverse events • Clinical

Ketogenic diet in women with polycystic ovary syndrome and liver dysfunction who are obese: A randomized, open-label, parallel-group, controlled pilot trial. (PubMed, J Obstet Gynaecol Res) - "In addition to improving the menstrual cycle, KD had the additional benefits of reducing blood glucose and body weight, improving liver function, and treating fatty liver compared to traditional pharmacological treatment in women with PCOS and liver dysfunction who were obese."

Clinical • Journal • Genetic Disorders • Hepatology • Liver Failure • Obesity • Polycystic Ovary Syndrome

[VIRTUAL] The course of toxic hepatitis at the stage of treatment consolidation acute leukemia in children (EHOC 2020) - "In the mild form of hepatitis from the intravenous use of Essentiale forte and Riboxin against the background of ongoing chemotherapy, a positive effect was obtained. With moderate severity, intravenous administration of Adeomethionine preparations (Heptral/Legend) in combination with Aevit per os turned out to be more effective. In 4 patients, upon transition to a severe form in the last course of consolidation, along with these drugs, ursodeoxycholic acid (Ursobil) + enhanced detoxification therapy was prescribed, which led to a complete recovery."

Clinical • Hematological Malignancies • Hepatology • Leukemia • Oncology

Local immune and oxidative status in exacerbated chronic apical periodontitis (PubMed, Stomatologiia (Mosk)) - "The study revealed disturbances in cytokines and complement system balance and activation of lipids peroxidation. Combination of Gepon or Vobenzim with Essentiale forte H and Kaskatol proved to be the most effective for correction of this imbalance."

Journal • Biosimilar • Immunology

Lipid Profiles of Five Essential Phospholipid Preparations for the Treatment of Nonalcoholic Fatty Liver Disease: A Comparative Study. (PubMed, Lipids) - "Lipid composition was consistent between the preparations. The high PtdCho:PtdEtn ratio composition of Essentiale Forte compared with the other PPC analyzed, as well as the presence of polyunsaturated fatty acids, suggest it could be the most clinically beneficial commercially available hepatoprotective product in the treatment of NAFLD."

Journal

Experimental justification choise to prevent hepatotoxic reactions to anti-TB drugs based on gene-phenotypic characteristics (ERS 2019) - "A benchmark assessment of the hepatoprotective effect of ropren, essentiale forte, ursosan, and heptral for rats with different acetylation phenotypes with liver damage caused by anti-tuberculosis drugs (ATD). In order to prevent hepatotoxic reactions, it is important to conduct genetic studies to identify mutations of the enzyme genes responsible for the metabolism of ATD. If the risk of reaction - use a hepatoprotector depending on the phenotype of acetylation and the changes of biocimical markers."

"@hoorahdigital has been appointed as the preferred digital marketing agency for @sanofi’s Essentiale Extreme brand ... https://t.co/V5ltwtiMNx" (@Modern_Marketin)

Linderae radix ethanol extract attenuates alcoholic liver injury via attenuating inflammation and regulating gut microbiota in rats. (PubMed, Braz J Med Biol Res) - "...Rats were divided into six groups: normal group (no treatment), model group (ALD rats), Essentiale group (ALD rats fed with Essentiale, 137 mg/kg), and LREE high/moderate/low dose groups (ALD rats fed with 4, 2, or 1 g LREE/kg)...Thus, LREE could partly ameliorate microflora dysbiosis, suppress the inflammatory response, and attenuate liver injury in ALD rats. The protective effect of LREE might be related to the LPS-TLR4-NF-κB pathway."

IO Biomarker • Journal • Preclinical

"@sanofi pls give us a box of essentiale forte. So that we can eat non stop oily food. Charot!" (@iwanderjuan)

"@sanofi Hello, I am from Hong Kong. Where your product 'Essentiale' was made in?" (@Sunny27740015)