Investigational Drug Details
| Drug ID: | D046 |
| Drug Name: | Pegbelfermin |
| Synonyms: | BMS-986036; PEG-FGF21; FALCON 2; FALCON 1 |
| Type: | Biological drug |
| DrugBank ID: | DB15365 |
| DrugBank Description: | Pegbelfermin is under investigation in clinical trial NCT03486899 (A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis). |
| PubChem ID: | -- |
| CasNo: | 1966977-70-7 |
| Repositioning for NAFLD: | No |
| SMILES: | -- |
| InChiKey: | -- |
| Molecular Weight: | -- |
| DrugBank Targets: | -- |
| DrugBank MoA: | -- |
| DrugBank Pharmacology: | -- |
| DrugBank Indication: | -- |
| Targets: | FGF21 analog |
| Therapeutic Category: | Improve insulin resistance; Enhance lipid metabolism; Anti-fibrosis |
| Clinical Trial Progress: | Phase 2 completed (NCT02413372: Treatment with subcutaneously administered pegbelfermin for 16 weeks was generally well tolerated and significantly reduced hepatic fat fraction in patients with non-alcoholic steatohepatitis. Further study of pegbelfermin is warranted in patients with non-alcoholic steatohepatitis. Additional studies that use liver biopsies would allow for the assessment of pegbelfermin's effects on liver histology. Moreover, further studies should allow assessments of the safety and effectiveness of pegbelfermin in a larger number of patients.) |
| Latest Progress: | Under clinical trials |
| Trial ID | Source ID | Phases | Status | Study Results | Start Date | Last Update Posted | |
|---|---|---|---|---|---|---|---|
| L0494 | JPRN-JapicCTI-184032 | Phase 2 | Not Recruiting | No Results Available | 04/07/2018 | 15 June 2020 | Details |
| Strategy ID | Strategy | Synonyms | Related Targets | Related Drugs | |
|---|---|---|---|---|---|
| S01 | Improve insulin resistance | insulin sensitizer; insulin resistance; glucose tolerance | Biguanide: increases 5-AMP activated protein kinase signaling; SGLT-2 inhibitor; Thiazalidinedione: selective PPAR-γ agonists; GLP-1 agonist | Metformin; Empagliflozin; Canagliflozin; Rosiglitazone; Pioglitazone; Liraglutide | Details |
| S02 | Enhance lipid metabolism | triglyceride-lowering; lipid tolerance; lipid metabolism | 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) inhibitor; Decreases intestinal cholesterol absorption; FXR agonist; ACC inhibitor; FAS inhibitor; DGAT2 inhibitor; SCD-1 inhibitor | Atorvastatin; Ezetimibe; Obeticholic Acid; GS-9674; GS-0976; TVB-2640; IONIS-DGAT2rx; Aramchol; | Details |
| 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 | |
|---|---|---|---|---|
| A00760 | 34977519 | JHEP Rep | Pegbelfermin selectively reduces secondary bile acid concentrations in patients with non-alcoholic steatohepatitis. | Details |
| A04343 | 33657443 | Contemp Clin Trials | The FALCON program: Two phase 2b randomized, double-blind, placebo-controlled studies to assess the efficacy and safety of pegbelfermin in the treatment of patients with nonalcoholic steatohepatitis and bridging fibrosis or compensated cirrhosis. | Details |
| A07203 | 32583961 | Clin Transl Sci | Evolving Role for Pharmacotherapy in NAFLD/NASH. | Details |
| A08900 | 31948295 | Expert Opin Investig Drugs | Fibroblast growth factor (FGF)-21 based therapies: A magic bullet for nonalcoholic fatty liver disease (NAFLD)? | Details |
| A09026 | 31899984 | Expert Opin Investig Drugs | Pegbelfermin (BMS-986036): an investigational PEGylated fibroblast growth factor 21 analogue for the treatment of nonalcoholic steatohepatitis. | Details |
| A12231 | 30554783 | Lancet | Pegbelfermin (BMS-986036), a PEGylated fibroblast growth factor 21 analogue, in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 2a trial. | Details |
| A12297 | 30520566 | Obesity (Silver Spring) | Pegbelfermin (BMS-986036), PEGylated FGF21, in Patients with Obesity and Type 2 Diabetes: Results from a Randomized Phase 2 Study. | Details |
| A29227 | 34386991 | J Labelled Comp Radiopharm | Synthesis of tritium labeled 30-KDa PEG and conjugation to form [3 H]Pegbelfermin. | Details |
| A29244 | 34364948 | Toxicol Appl Pharmacol | Pegbelfermin, a PEGylated FGF21 analogue, has pharmacology without bone toxicity after 1-year dosing in skeletally-mature monkeys. | Details |
| A31285 | 30893110 | Curr Opin Lipidol | Fibroblast growth factors in control of lipid metabolism: from biological function to clinical application. | Details |