Investigational Drug Details
| Drug ID: | D200 |
| Drug Name: | Lanifibranor |
| Synonyms: | IVA337 |
| Type: | Chemical drug |
| DrugBank ID: | DB14801 |
| DrugBank Description: | Lanifibranor is under investigation in clinical trial NCT03008070 (Phase 2b Study in NASH to Assess IVA337). |
| PubChem ID: | 68677842 |
| CasNo: | 927961-18-0 |
| Repositioning for NAFLD: | No |
| SMILES: | OC(=O)CCCC1=CC2=C(C=CC(Cl)=C2)N1S(=O)(=O)C1=CC2=C(C=C1)N=CS2 |
| Structure: |
|
| InChiKey: | OQDQIFQRNZIEEJ-UHFFFAOYSA-N |
| Molecular Weight: | 434.926 |
| DrugBank Targets: | -- |
| DrugBank MoA: | -- |
| DrugBank Pharmacology: | -- |
| DrugBank Indication: | -- |
| Targets: | PPARD agonist; PPARA agonist; PPARG agonist |
| Therapeutic Category: | Dermatological drug |
| Clinical Trial Progress: | Phase 2 completed (NCT03008070: In this phase 2b trial involving patients with active NASH, the percentage of patients who had a decrease of at least 2 points in the SAF-A score without worsening of fibrosis was significantly higher with the 1200-mg dose of lanifibranor than with placebo. These findings support further assessment of lanifibranor in phase 3 trials.) Phase 3 on-going (NCT04849728) |
| Latest Progress: | Advanced in clinical trials |
| Trial ID | Source ID | Phases | Status | Study Results | Start Date | Last Update Posted | |
|---|---|---|---|---|---|---|---|
| L0341 | NCT04849728 | Phase 3 | Recruiting | No Results Available | August 19, 2021 | February 15, 2022 | Details |
| L0345 | NCT05232071 | Phase 2 | Not yet recruiting | No Results Available | June 1, 2022 | March 2, 2022 | Details |
| L0376 | EUCTR2020-004986-38-NL | Phase 3 | Authorised | No Results Available | 30/09/2021 | 13 December 2021 | Details |
| L0377 | EUCTR2020-004986-38-HU | Phase 3 | Authorised | No Results Available | 01/09/2021 | 15 November 2021 | Details |
| L0378 | EUCTR2020-004986-38-DE | Phase 3 | Authorised | No Results Available | 13/08/2021 | 2 March 2022 | Details |
| L0380 | EUCTR2020-004986-38-FR | Phase 3 | Authorised | No Results Available | 09/07/2021 | 10 January 2022 | Details |
| L0507 | NCT03459079 | Phase 2 | Recruiting | No Results Available | 02/03/2018 | 12 April 2021 | Details |
| L0569 | EUCTR2016-001979-70-BE | Phase 2 | Not Recruiting | No Results Available | 23/09/2016 | 2 June 2020 | Details |
| Target ID | Target Name | GENE | Action | Class | UniProtKB ID | Entry Name | |
|---|---|---|---|---|---|---|---|
| T03 | Peroxisome proliferator-activated receptor alpha | PPARA | agonist | Nuclear hormone receptor | Q07869 | PPARA_HUMAN | Details |
| T04 | Peroxisome proliferator-activated receptor delta | PPARD | agonist | Nuclear hormone receptor | Q03181 | PPARD_HUMAN | Details |
| T05 | Peroxisome proliferator-activated receptor gamma | PPARG | agonist | Nuclear hormone receptor | P37231 | PPARG_HUMAN | Details |
| Strategy ID | Strategy | Synonyms | Related Targets | Related Drugs | |
|---|---|---|---|---|---|
| S03 | Anti-fibrosis | fibrosis | Angiotensin Receptor Blocker (ARB); CCR2/CCR5 antagonist; Thyroid receptor β agonist; PEGylated human FGF21 analogue; Monoclonal antibody to lysyl oxidase-like 2 (LOXL2); Galectin-3 inhibitor; FGF19 variant | Losartan; Cenicriviroc; VK-2809; MGL-3196; Pegbelfermin; Simtuzumab; GR-MD-02; NGM282 | Details |
| Article ID | PMID | Source | Title | |
|---|---|---|---|---|
| A00305 | 35143711 | Clin Transl Sci | Hepatoprotective effects of semaglutide, lanifibranor and dietary intervention in the GAN diet-induced obese and biopsy-confirmed mouse model of NASH. | Details |
| A00609 | 35030323 | Lancet Gastroenterol Hepatol | Efficacy of peroxisome proliferator-activated receptor agonists, glucagon-like peptide-1 receptor agonists, or sodium-glucose cotransporter-2 inhibitors for treatment of non-alcoholic fatty liver disease: a systematic review. | Details |
| A00651 | 35014161 | Diabetes Obes Metab | The metabolic triad of non-alcoholic fatty liver disease, visceral adiposity and type 2 diabetes: Implications for treatment. | Details |
| A01645 | 34670042 | N Engl J Med | A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH. | Details |
| A01853 | 34588764 | Drug Des Devel Ther | Non-Alcoholic Steatohepatitis (NASH) - A Review of a Crowded Clinical Landscape, Driven by a Complex Disease. | Details |
| A02287 | 34435378 | Aliment Pharmacol Ther | Systematic review with network meta-analysis: comparative efficacy of pharmacologic therapies for fibrosis improvement and resolution of NASH. | Details |
| A03482 | 33987427 | Ann Transl Med | Non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH)-related liver fibrosis: mechanisms, treatment and prevention. | Details |
| A04749 | 33515800 | Ann Hepatol | Horizon scanning of therapeutic modalities for nonalcoholic steatohepatitis. | Details |
| A06009 | 33038502 | Contemp Clin Trials | A randomised, double-blind, placebo-controlled, multi-centre, dose-range, proof-of-concept, 24-week treatment study of lanifibranor in adult subjects with non-alcoholic steatohepatitis: Design of the NATIVE study. | Details |
| A07125 | 32613381 | Cell Biol Toxicol | Human hepatic in vitro models reveal distinct anti-NASH potencies of PPAR agonists. | Details |
| A07769 | 32360434 | J Hepatol | Differential effects of selective- and pan-PPAR agonists on experimental steatohepatitis and hepatic macrophages☆. | Details |
| A09096 | 31877771 | Cells | Anti-NASH Drug Development Hitches a Lift on PPAR Agonism. | Details |
| A09774 | 31614690 | Int J Mol Sci | Exploration and Development of PPAR Modulators in Health and Disease: An Update of Clinical Evidence. | Details |
| A12835 | 30261763 | Expert Rev Gastroenterol Hepatol | An update on the recent advances in antifibrotic therapy. | Details |
| A14362 | 29446942 | J Med Chem | Design, Synthesis, and Evaluation of a Novel Series of Indole Sulfonamide Peroxisome Proliferator Activated Receptor (PPAR) α/γ/δ Triple Activators: Discovery of Lanifibranor, a New Antifibrotic Clinical Candidate. | Details |
| A42381 | 34725496 | Nat Rev Gastroenterol Hepatol | Lanifibranor and NASH resolution. | Details |
| A49515 | 35728962 | Cas Lek Cesk | An overview of current therapy options of non-alcoholic fatty liver disease. | Details |
| A50136 | 35507280 | Curr Atheroscler Rep | Comprehensive Review and Updates on Holistic Approach Towards Non-Alcoholic Fatty Liver Disease Management with Cardiovascular Disease. | Details |
| A51112 | 35693411 | Hepatobiliary Surg Nutr | Pan-peroxisome proliferator-activated receptor agonist lanifibranor as a dominant candidate pharmacological therapy for nonalcoholic fatty liver disease. | Details |
| A51306 | 35735253 | Hepatol Commun | Combinations of an acetyl CoA carboxylase inhibitor with hepatic lipid modulating agents do not augment antifibrotic efficacy in preclinical models of NASH and fibrosis. | Details |