Deudomperidone
(CIN-102) - Phase 2
Deudomperidone (CIN-102) is a new chemical entity based upon deuteration and novel formulation of domperidone, a frequently prescribed first-line therapy for nausea, vomiting and gastroparesis outside of the U.S. In part due to safety concerns around QT prolongation, domperidone is not approved in the U.S. Deudomperidone has been engineered to alter the PK profile for sustained efficacy while significantly reducing cardiac liability. Multiple clinical trials of deudomperidone demonstrated it was well tolerated, including no sponsor-assessed drug related adverse events (AEs) or clinically meaningful laboratory abnormalities. CIN-102 was deemed to have no meaningful impact on QT at exposures well above a therapeutic dose in a thorough QT study and demonstrated target engagement and improvement in gastric emptying time in a previous Phase 2a trial.
Phase 2 Clinical Trials
CinDome is currently advancing two Phase 2 studies to evaluate the efficacy and safety of CIN-102 in adults:
Diabetic Gastroparesis
A randomized, double-blind, placebo-controlled trial evaluating CIN-102 over a 12-week treatment period.
View on ClinicalTrials.gov ↗
Idiopathic Gastroparesis
A randomized, double-blind, placebo-controlled trial evaluating CIN-102 in adults with idiopathic gastroparesis.
View on ClinicalTrials.gov ↗Deudomperidone (CIN-102) is a new chemical entity based upon deuteration and novel formulation of domperidone, a frequently prescribed first-line therapy for nausea, vomiting and gastroparesis outside of the U.S. In part due to safety concerns around QT prolongation, domperidone is not approved in the U.S. Deudomperidone has been engineered to alter the PK profile for sustained efficacy while significantly reducing cardiac liability. Multiple clinical trials of deudomperidone demonstrated it was well tolerated, including no sponsor-assessed drug related adverse events (AEs) or clinically meaningful laboratory abnormalities. CIN-102 was deemed to have no meaningful impact on QT at exposures well above a therapeutic dose in a thorough QT study and demonstrated target engagement and improvement in gastric emptying time in a previous Phase 2a trial.
Phase 2 Clinical Trials
CinDome is currently advancing two Phase 2 studies to evaluate the efficacy and safety of CIN-102 in adults:
Diabetic Gastroparesis
A randomized, double-blind, placebo-controlled trial evaluating CIN-102 over a 12-week treatment period.
View on ClinicalTrials.gov ↗
Idiopathic Gastroparesis
A randomized, double-blind, placebo-controlled trial evaluating CIN-102 in adults with idiopathic gastroparesis.
View on ClinicalTrials.gov ↗
