Rosuzet (rosuvastatin/ezetimibe) / Hanmi, Merck (MSD) - LARVOL DELTA

A Study to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=66 | Completed | Sponsor: Hanmi Pharmaceutical Company Limited | Not yet recruiting ➔ Completed

Trial completion

Switching To Rosuvastatin Plus Ezetimibe In Statin-treated Stroke Patients With Low-density Lipoprotein Cholesterol Levels Above 70 mg/dL (SWITCH) (ISC 2025) - "R+E effectively reduced LDL-C level to <70 mg/dL in stroke patients on statin monotherapy with baseline level above 70 mg/dL. For achieving stricter LDL-C targets, additional therapy may be necessary."

Clinical • Cardiovascular • Diabetes • Dyslipidemia • Ischemic stroke • Metabolic Disorders

ROSUZET-AMI: Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI (clinicaltrials.gov) - P4 | N=3548 | Recruiting | Sponsor: Kiyuk Chang, MD,PhD | Trial completion date: Jul 2024 ➔ Aug 2027 | Trial primary completion date: Jan 2024 ➔ Aug 2026

Trial completion date • Trial primary completion date • Cardiovascular • Myocardial Infarction

Study on Rosuvastatin+Ezetimibe and Rosuvastatin for LDL-C Goal in Patients With Recent Ischemic Stroke (clinicaltrials.gov) - P4 | N=584 | Completed | Sponsor: Keun-Sik Hong | Unknown status ➔ Completed

Trial completion • Cardiovascular • Ischemic stroke

A Study to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Hanmi Pharmaceutical Company Limited

New P1 trial

Pharmacokinetics of a Fixed-Dose Combination Product of Amlodipine, Losartan, Ezetimibe, and Rosuvastatin and Its Comparison with Co-administration of Four Individual Components in Healthy Participants. (PubMed, Drugs R D) - P1 | "This study demonstrated that a newly developed FDCP containing amlodipine, losartan, ezetimibe, and rosuvastatin exhibited pharmacokinetic equivalence with the individual products and met the regulatory criteria. Both formulations were well tolerated."

Journal • PK/PD data • Hematological Disorders

Rosuzet-IVUS: Usual Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin on Coronary Atherosclerotic Plaque (clinicaltrials.gov) - P4 | N=280 | Active, not recruiting | Sponsor: Samsung Medical Center | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Jan 2027 | Trial primary completion date: Dec 2023 ➔ Jan 2027

Enrollment closed • Trial completion date • Trial primary completion date • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Dyslipidemia

Rosuzet-IVUS: Usual Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin on Coronary Atherosclerotic Plaque (clinicaltrials.gov) - P4 | N=280 | Recruiting | Sponsor: Samsung Medical Center | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial primary completion date • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Dyslipidemia

MODERATE-INTENSITY ROSUVASTATIN PLUS EZETIMIBE VERSUS HIGH-INTENSITY ROSUVASTATIN FOR LDL-C REDUCTION IN RECENT ISCHEMIC STROKE; A RANDOMIZED CONTROLLED TRIAL (ROSETTA-STROKE) (WSC 2022) - P4 | "Moderate-intensity rosuvastatin plus ezetimibe was superior to high-intensity rosuvastatin in LDL-C reduction, achieving LDL-C reduction >50% in more than 70% and LDL-C <70 mg/dL in 80% of patients. (Funded by Hanmi Pharm; ClinicalTrials.gov: NCT03993236)"

Clinical • Late-breaking abstract • Cardiovascular • Ischemic stroke

ROSUZET-AMI: Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI (clinicaltrials.gov) - P4 | N=3548 | Recruiting | Sponsor: Kiyuk Chang, MD,PhD | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Myocardial Infarction

Rosuzet-IVUS: Usual Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin on Coronary Atherosclerotic Plaque (clinicaltrials.gov) - P4; N=280; Recruiting; Sponsor: Samsung Medical Center; Trial completion date: Dec 2023 ➔ Dec 2024; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Dyslipidemia • CRP

Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration in Patients With Dyslipidemia in Korea (clinicaltrials.gov) - P; N=5717; Completed; Sponsor: Hanmi Pharmaceutical Company Limited

New trial • Dyslipidemia • Metabolic Disorders

REMBRANDT: Efficacy and Safety of EzetimiBe/Rosuvastatin in Diabetic Dislipidemia With Hypertriglyceridaemia (clinicaltrials.gov) - P4; N=240; Recruiting; Sponsor: Seoul National University Hospital

Clinical • New P4 trial • Diabetes • Dyslipidemia • Endocrine Disorders • Metabolic Disorders • Type 2 Diabetes Mellitus • APOA1 • APOB

A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia (clinicaltrials.gov) - P3; N=145; Completed; Sponsor: Hanmi Pharmaceutical Company Limited; Recruiting ➔ Completed

Clinical • Trial completion • Dyslipidemia • Hypertension • Metabolic Disorders

ROSUZET-AMI: Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI (clinicaltrials.gov) - P4; N=3548; Not yet recruiting; Sponsor: Kiyuk Chang, MD,PhD

Clinical • New P4 trial • Cardiovascular • Myocardial Infarction

Hanmi launches new dual-action drug for hyperlipidemia (Hanmi Press Release) - "Hanmi Pharmaceutical...had launched the world’s first dual-action drug for hyperlipidemia 'Rosuzet', which was made in combination with two anti-hyperlipidemia ingredients, Rosuvastatin and Ezetimibe...To launch Rosuzet, Hanmi recently signed a contract with MSD to share the latter’s exclusive right to use Ezetimib [sic] that will expire in April 2016."

Anticipated patent expiry • Launch • Dyslipidemia

Study on Rosuvastatin+Ezetimibe and Rosuvastatin for LDL-C Goal in Patients With Recent Ischemic Stroke (clinicaltrials.gov) - P4; N=584; Recruiting; Sponsor: Keun-Sik Hong; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

To Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Adults (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: IlDong Pharmaceutical Co Ltd

Clinical • New P1 trial

Future outlook: Treating with PCSK9 inhibitors (MD Magazine) - "In the case of PCSK9 inhibitors—particularly when the LDL cholesterol remains above 100 [mg/dL] despite the physician’s best attempt to max out the statin dose—to add on ezetimibe, of course to push weight loss and a plant-based diet…When all that hasn’t done the trick, when the LDL is still above 100 [mg/dL], the drugs really do seem to be quite cost-effective."

Video

A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia (clinicaltrials.gov) - P3; N=129; Recruiting; Sponsor: Hanmi Pharmaceutical Company Limited

Clinical • New P3 trial

Study on Rosuvastatin+Ezetimibe and Rosuvastatin for LDL-C Goal in Patients With Recent Ischemic Stroke (clinicaltrials.gov) - P4; N=584; Not yet recruiting; Sponsor: Keun-Sik Hong

Clinical • New P4 trial

Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802 (clinicaltrials.gov) - P1; N=42; Completed; Sponsor: LG Chem; Not yet recruiting ➔ Completed; Trial completion date: Sep 2018 ➔ Jan 2019

Clinical • Trial completion • Trial completion date