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

High-Intensity Statin versus Upfront Equivalent-Dose Combination of Moderate-Intensity Statin with Ezetimibe Following Acute Myocardial Infarction (ROSUZET-AMI): protocol of a multicentre, open-label, randomised non-inferiority trial. (PubMed, BMJ Open) - P4 | "Patients with AMI who underwent percutaneous coronary intervention were randomised 1:1 to receive either moderate-intensity statin with ezetimibe (rosuvastatin 5 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg). The results of this study will be submitted for publication in international peer-reviewed journals, and the key findings will be presented at international scientific conferences. NCT04499859."

Clinical protocol • Head-to-Head • Journal • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Heart Failure • Myocardial Infarction

Effectiveness and Safety of Very-Low-Dose Rosuvastatin-Ezetimibe Therapy in Korean Patients with Dyslipidaemia: A Multicentre Prospective Observational Study. (PubMed, Clin Drug Investig) - "Very-low-dose rosuvastatin-ezetimibe combination therapy significantly lowered LDL-C levels and improved lipid profiles across various risk groups, demonstrating a favourable safety profile. These findings support its use as an effective, well-tolerated option for managing dyslipidaemia. Longer-term studies are warranted to evaluate sustained lipid control and cardiovascular outcomes."

Journal • Observational data • Atherosclerosis • Cardiovascular • Dyslipidemia

Efficacy and safety of quadruple-drug fixed-dose single-pill combination therapy for hypertension and dyslipidemia: a prospective, multicenter, observational study (ESC-WCC 2025) - "Purpose: This study aimed to evaluate the efficacy and safety of a quadruple-drug fixed-dose SPC (QFDC) therapy combining losartan, amlodipine, rosuvastatin, and ezetimibe (L/A/R/E) in these patients. The L/A/R/E QFDC regimen is an effective and safe treatment option for patients with concurrent hypertension and dyslipidemia."

Clinical • Combination therapy • Observational data • Cardiovascular • Dyslipidemia • Hypertension

Efficacy and Safety of Quadruple-Drug Fixed-Dose Single-Pill Combination Therapy for Hypertension and Dyslipidemia: A Prospective, Multicenter, Observational Study. (PubMed, Clin Ther) - "The L/A/R/E QFDC regimen is an effective and safe treatment option for patients with concurrent hypertension and dyslipidemia."

Journal • Observational data • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

REMBRANDT: Efficacy and Safety of EzetimiBe/Rosuvastatin in Diabetic Dislipidemia With Hypertriglyceridaemia (clinicaltrials.gov) - P4 | N=146 | Completed | Sponsor: Seoul National University Hospital | Recruiting ➔ Completed | N=240 ➔ 146

Enrollment change • Trial completion • Diabetes • Dyslipidemia • Endocrine Disorders • Metabolic Disorders • Type 2 Diabetes Mellitus • APOB

Rosuzet-IVUS: Randomized Controlled Trial of Moderate-Intensity Rosuvastatin With Ezetimibe Combination Therapy Versus High-Intensity Rosuvastatin on Progression of Coronary Atherosclerotic Plaque (clinicaltrials.gov) - P4 | N=280 | Active, not recruiting | Sponsor: Samsung Medical Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Atherosclerosis • Cardiovascular • Coronary Artery Disease

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 | Active, not recruiting ➔ Recruiting

Enrollment open • Atherosclerosis • Cardiovascular • Coronary Artery Disease

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