esomeprazole magnesium dihydrate (YYD601) / Yooyoung Pharma - LARVOL DELTA

A Pharmacokinetic/Pharmacodynamic Study of Esomeprazole Comparing a Dual Delayed-Release Formulation (YYD601) to a Conventional Formulation Following Multiple Administrations in Healthy Adult Subjects. (PubMed, Drug Des Devel Ther) - P1 | "YYD601 20 mg was safe and well tolerated following single and multiple oral administrations, supporting its use as an effective alternative to conventional esomeprazole therapy. http://clinicaltrials.gov, NCT03985319 (Date of registration: May 29, 2019; Study period: between July 2019 and March 2020)."

Clinical • Journal • PK/PD data • GAST

Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fed Condition (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Bio-innova Co., Ltd

New P1 trial

Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fasting Condition (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Bio-innova Co., Ltd

New P1 trial

Pharmacokinetics and Pharmacodynamics of YYD601, a Dual Delayed-Release Formulation of Esomeprazole, Following Single and Multiple Doses in Healthy Adult Volunteers Under Fasting and Fed Conditions. (PubMed, Drug Des Devel Ther) - P1 | "Single and multiple oral dosing of YYD601 up to 60 mg were safe and well-tolerated throughout the study. http://clinicaltrials.gov, NCT03558477 (date of registration: June 15, 2018; study period: between October 2017 and February 2018)."

Journal • PK/PD data

Clinical Trial to Assess the PK/PD of YYD601 20mg After Oral Administration if Healthy Adult Subjects (Phase1) (clinicaltrials.gov) - P1; N=28; Completed; Sponsor: Yooyoung Pharmaceutical Co., Ltd.; Not yet recruiting ➔ Completed

Clinical • Trial completion • Gastroesophageal Reflux Disease

Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (clinicaltrials.gov) - P3; N=170; Completed; Sponsor: Yooyoung Pharmaceutical Co., Ltd.; Not yet recruiting ➔ Completed; Trial completion date: Oct 2019 ➔ May 2020

Clinical • Trial completion • Trial completion date • Gastroesophageal Reflux Disease

Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD) (clinicaltrials.gov) - P3; N=170; Completed; Sponsor: Yooyoung Pharmaceutical Co., Ltd.; Not yet recruiting ➔ Completed; Trial completion date: Jun 2019 ➔ Jul 2020

Clinical • Head-to-Head • Trial completion • Trial completion date • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

Clinical Trial to Assess the PK/PD of YYD601 20mg After Oral Administration if Healthy Adult Subjects (Phase1) (clinicaltrials.gov) - P1; N=28; Not yet recruiting; Sponsor: Yooyoung Pharmaceutical Co., Ltd.

Clinical • New P1 trial

Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (clinicaltrials.gov) - P3; N=166; Not yet recruiting; Sponsor: Yooyoung Pharmaceutical Co., Ltd.

Clinical • New P3 trial