GV101 / Graviton Biosci, Ovid Therapeutics - LARVOL DELTA

Phase 1 Trials of Oral GV101, a Highly Selective ROCK2 Inhibitor, in Healthy Adults (OBESITY WEEK 2025) - "GV101 was associated with promising weight loss at one week. GV101 presents a novel mechanism in an oral small molecule with once-daily dosing and warrants further trials."

Clinical • P1 data • Fibrosis • Genetic Disorders • Immunology • Inflammation • Obesity • AMPK

GV101 in Healthy Obese Participants (clinicaltrials.gov) - P2 | N=130 | Active, not recruiting | Sponsor: Graviton Bioscience Corporation | Recruiting ➔ Active, not recruiting

Enrollment closed • Obesity

GV101 in Healthy Obese Participants (clinicaltrials.gov) - P2 | N=130 | Recruiting | Sponsor: Graviton Bioscience Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Obesity

GV101 in Healthy Obese Participants (clinicaltrials.gov) - P2 | N=130 | Not yet recruiting | Sponsor: Graviton Bioscience Corporation

New P2 trial • Obesity

Selectivity matters: selective ROCK2 inhibitor ameliorates established liver fibrosis via targeting inflammation, fibrosis, and metabolism. (PubMed, Commun Biol) - "GV101 treatment significantly reduces collagen levels in liver, associated with downregulation of pCofilin, pSTAT3, pAkt, while pSTAT5 and pAMPK levels are increased in tissues of treated mice. In vitro, GV101 inhibits profibrogenic markers expression in fibroblasts, adipogenesis in primary adipocytes and TLR-induced cytokine secretion in innate immune cells via targeting of Akt-mTOR-S6K signaling axis, further uncovering the ROCK2-specific complex mechanism of action and therapeutic potential of highly selective ROCK2 inhibitors in liver fibrosis."

Journal • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis

Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Dose of GV101 in Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Graviton Bioscience Corporation | Recruiting ➔ Completed | N=64 ➔ 16

Enrollment change • Trial completion