Investigational Drug Details
| Drug ID: | D005 |
| Drug Name: | Aldafermin |
| Synonyms: | NGM282; (phe5>met,ser6>arg,ala8>ser,gly9>ser,his11>leu) fibroblast growth factor 19 (human fgf19) (5-194)-peptide, produced in escherichia coli; Aldafermin; Engineered variant of recombinant human fibroblast growth factor 19 |
| Type: | Biological drug |
| DrugBank ID: | DB16086 |
| DrugBank Description: | Aldafermin is under investigation in clinical trial NCT03912532 (Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)). |
| PubChem ID: | -- |
| CasNo: | 1616639-03-2 |
| Repositioning for NAFLD: | No |
| SMILES: | -- |
| InChiKey: | -- |
| Molecular Weight: | -- |
| DrugBank Targets: | -- |
| DrugBank MoA: | -- |
| DrugBank Pharmacology: | -- |
| DrugBank Indication: | -- |
| Targets: | FGF19 analog |
| Therapeutic Category: | Anti-fibrosis |
| Clinical Trial Progress: | Phase 2 completed (In a phase 2 trial of patients with NASH, aldafermin reduced liver fat and produced a trend toward fibrosis improvement. ClinicalTrials.gov, Number: NCT02443116.) |
| Latest Progress: | Under clinical trials |
| Trial ID | Source ID | Phases | Status | Study Results | Start Date | Last Update Posted |
|---|
| 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 | |
|---|---|---|---|---|
| A00500 | 35060815 | Expert Opin Investig Drugs | Nonalcoholic steatohepatitis (NASH) cirrhosis: a snapshot of therapeutic agents in clinical development and the optimal design for clinical trials. | Details |
| A01487 | 34727818 | Expert Opin Ther Targets | A short report on NGM282/aldafermin for the treatment of nonalcoholic steatohepatitis (NASH). | Details |
| A03701 | 33898959 | JHEP Rep | Potent suppression of hydrophobic bile acids by aldafermin, an FGF19 analogue, across metabolic and cholestatic liver diseases. | Details |
| A06651 | 32794259 | Hepatology | The Commensal Microbe Veillonella as a Marker for Response to an FGF19 Analog in NASH. | Details |
| A06684 | 32781086 | Gastroenterology | Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis. | Details |
| A49230 | 35814516 | J Clin Exp Hepatol | Pharmacotherapeutic Impact on Nonalcoholic Steatohepatitis Histology: A Systematic Review and Network Meta-analysis. | Details |
| A50136 | 35507280 | Curr Atheroscler Rep | Comprehensive Review and Updates on Holistic Approach Towards Non-Alcoholic Fatty Liver Disease Management with Cardiovascular Disease. | Details |
| A50613 | 35325622 | Lancet Gastroenterol Hepatol | Aldafermin in patients with non-alcoholic steatohepatitis (ALPINE 2/3): a randomised, double-blind, placebo-controlled, phase 2b trial. | Details |
| A50614 | 35325621 | Lancet Gastroenterol Hepatol | Aldafermin in non-alcoholic steatohepatitis: a cautionary tale for trial design. | Details |
| A50868 | 34749582 | Expert Opin Ther Targets | Role of hemagglutinin esterase in replication of SARS-CoV-2. | Details |