Drug intelligence / Profile preview

ini-822

Development stage
Phase 1
Lead developer
Inipharm
Modality
Small Molecules
Administration
Oral
01

Overview

INI-822 is a small molecule inhibitor of 17-beta-hydroxysteroid dehydrogenase 13 (HSD17B13), developed by Inipharm for the treatment of metabolic dysfunction-associated steatohepatitis (MASH, formerly known as non-alcoholic steatohepatitis or NASH) and other liver diseases characterized by hepatocyte lipid accumulation. HSD17B13 is a lipid droplet protein implicated in the progression of advanced fibrotic liver disease; genetic loss-of-function variants are associated with protection against fibrosis, inflammation, and cirrhosis. INI-822 potently and selectively inhibits HSD17B13 with low nanomolar potency and over 100-fold selectivity versus other family members. Preclinical studies show that INI-822 reduces fibrotic proteins, decreases markers of liver damage such as alanine transaminase (ALT), and increases hepatic phosphatidylcholines—mimicking protective effects seen in individuals with inactive HSD17B13 variants. The drug has demonstrated good oral bioavailability, low clearance across species, favorable toxicology profiles, and pharmacokinetics suitable for once-daily oral dosing. It is currently in Phase I clinical trials to assess safety, tolerability, pharmacokinetics, and target engagement in healthy volunteers and patients with MASH[1][2][3][4][5][6][7][8].

Other names
INI 822INI822INI-822
02

Targets

HSD17B13 (17β-Hydroxysteroid Dehydrogenase Type 13)

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