atorvastatin/ezetimibe / Generic mfg. - LARVOL DELTA

Comparison of pharmacokinetics of a fixed-dose combination of atorvastatin/ezetimibe 5 mg/10 mg versus separate tablets in healthy subjects. (PubMed, Transl Clin Pharmacol) - P1 | "The FDC of atorvastatin/ezetimibe 5 mg/10 mg was safe and showed similar exposure to those of the individual components. ClinicalTrials.gov Identifier: NCT05202405."

Journal • PK/PD data • Dyslipidemia • Metabolic Disorders

A Phase III Randomized, Double-Blind, Active-Controlled, Multicenter Study on the Efficacy and Safety of Ezetimibe/Atorvastatin/Amlodipine Combination in Patients With Comorbid Primary Hypercholesterolemia and Essential Hypertension. (PubMed, Clin Ther) - "Triple combination therapy with Eze/Ato + Aml has effectively reduced the LDL-C and SBP independently, compared with either Eze/Ato or Aml therapies over 8 weeks of treatment period. In terms of safety, there were no significant differences among the 3 treatment groups. This research lays the groundwork for the development of a triple fixed-dose combination in the future, which could improve patient convenience and adherence by reducing pill burden. Clinical Research Information Service (CRIS), Republic of Korea: KCT0006283."

Clinical • Journal • P3 data • Acute Myelogenous Leukemia • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2024 (GlobeNewswire) - "Biosimilars revenue increased 12% on both an as-reported and ex-FX basis for full year 2024, compared with the prior year, primarily driven by growth in Hadlima, following its U.S. launch in July 2023. Renflexis and Ontruzant declined 1% ex-FX and 9% ex-FX, respectively, as both products are in the mature phase of their product life cycles and face significant competitive pricing pressure. Established Brands revenue grew 2% both on an as-reported basis and ex-FX in the fourth quarter of 2024, primarily related to the revenue contribution of Emgality (galcanezumab-gnlm) and Vtama (tapinarof), which together more than offset the impact of the loss of exclusivity ('LOE') of Atozet (ezetimibe and atorvastatin) in key markets in Europe and in Japan."

Commercial • Ankylosing Spondylitis • Atherosclerosis • Atopic Dermatitis • Breast Cancer • Crohn's disease • Dyslipidemia • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer • Migraine • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients (clinicaltrials.gov) - P4 | N=137 | Completed | Sponsor: Organon and Co | Active, not recruiting ➔ Completed

Trial completion • Atherosclerosis • Cardiovascular • Dyslipidemia

Phase 1 Evaluation of the Bioequivalence and Drug-Drug Interaction Potential of a Novel Fixed-Dose Combination of Ezetimibe, Atorvastatin, and Amlodipine. (PubMed, Clin Pharmacol Drug Dev) - "Geometric mean ratios (FDC to individual formulations) and 90% confidence intervals of area under the time-concentration curve at steady state during dosing interval (AUCτ, ss) and maximum concentration at steady state (Cmax, ss) or amlodipine, atorvastatin, and ezetimibe were all within the bioequivalent range (0.8-1.25), confirming bioequivalence. Moreover, the FDC of ezetimibe, atorvastatin, and amlodipine exhibited comparable tolerability to corresponding individual formulations."

Journal • P1 data • Cardiovascular

Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients (clinicaltrials.gov) - P4 | N=137 | Active, not recruiting | Sponsor: Organon and Co | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2025 ➔ Oct 2024

Enrollment closed • Trial completion date • Atherosclerosis • Cardiovascular • Dyslipidemia

A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391(2) (clinicaltrials.gov) - P1 | N=66 | Completed | Sponsor: Chong Kun Dang Pharmaceutical | Not yet recruiting ➔ Completed | Trial completion date: Apr 2024 ➔ Jan 2024

Trial completion • Trial completion date • Dyslipidemia • Metabolic Disorders

Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients (clinicaltrials.gov) - P4 | N=126 | Recruiting | Sponsor: Organon and Co | Trial primary completion date: May 2024 ➔ Nov 2024

Trial primary completion date • Atherosclerosis • Cardiovascular • Dyslipidemia

A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391(2) (clinicaltrials.gov) - P1 | N=66 | Not yet recruiting | Sponsor: Chong Kun Dang Pharmaceutical

New P1 trial • Dyslipidemia • Metabolic Disorders

A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391 (clinicaltrials.gov) - P1 | N=69 | Completed | Sponsor: Chong Kun Dang Pharmaceutical | Not yet recruiting ➔ Completed

Trial completion • Dyslipidemia • Metabolic Disorders

Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients (clinicaltrials.gov) - P4 | N=126 | Recruiting | Sponsor: Organon and Co | Not yet recruiting ➔ Recruiting

Enrollment open • Atherosclerosis • Cardiovascular • Dyslipidemia

Cholesterol-Lowering Drugs as Potential Antivirals: A Repurposing Approach against Flavivirus Infections. (PubMed, Viruses) - "The combination of atorvastatin and ezetimibe showed a synergistic effect against DENV 2, an additive effect against DENV 4 and ZIKV, and an antagonistic effect against YFV. However, the combination of both drugs did not significantly affect survival. This study provides valuable insights into the potential of atorvastatin and ezetimibe as antiviral agents against flaviviruses and highlights the need for further investigations into their combined therapeutic effects."

Journal • Dengue Fever • Infectious Disease

Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients (clinicaltrials.gov) - P4 | N=126 | Not yet recruiting | Sponsor: Organon and Co

New P4 trial • Atherosclerosis • Cardiovascular • Dyslipidemia

A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia (clinicaltrials.gov) - P3 | N=228 | Recruiting | Sponsor: Chong Kun Dang Pharmaceutical

New P3 trial • Dyslipidemia • Metabolic Disorders

A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391 (clinicaltrials.gov) - P1 | N=66 | Not yet recruiting | Sponsor: Chong Kun Dang Pharmaceutical

New P1 trial • Dyslipidemia • Metabolic Disorders

A Budget Impact Analysis of Introducing a New Combination of Atorvastatin and Ezetimibe in Greece (ISPOR-EU 2022) - "The analysis suggests that the introduction of ΕΖΕ/ΑΤΟR_CH in the Greek market is expected to bring significant economic benefit for the Greek public payer."

HEOR • Dyslipidemia

Efficacy and Tolerability of Ezetimibe/Atorvastatin Fixed-Dose Combination Versus Atorvastatin Monotherapy in Hypercholesterolemia: A Phase III, Randomized, Active-Controlled Study in Chinese Patients. (PubMed, Clin Ther) - "The LDL-C level at week 12 was significantly improved with both FDCs compared with escalated doses of atorvastatin (20 or 40 mg/d) in these Chinese patients with hypercholesterolemia uncontrolled on atorvastatin 10 or 20 mg/d. Both FDCs were well tolerated, with no new tolerability-related findings. Chinadrugtrials.org.cn identifier: CTR20190172. (Clin Ther. 2022;44:XXX-XXX)"

Clinical • Journal • Monotherapy • P3 data • Atherosclerosis • Cardiovascular • Dyslipidemia • Metabolic Disorders

A Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A (clinicaltrials.gov) - P3 | N=290 | Completed | Sponsor: Addpharma Inc. | Recruiting ➔ Completed

Trial completion • Dyslipidemia • Metabolic Disorders

A Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Addpharma Inc. | Recruiting ➔ Completed | Trial completion date: Jun 2022 ➔ Mar 2022 | Trial primary completion date: Jun 2022 ➔ Mar 2022

Trial completion • Trial completion date • Trial primary completion date • Dyslipidemia

Combination glecaprevir, pibrentasvir with ezetimibe prevents HCV in transplantation (Healio) - '"We have an availability of safe, well-tolerated and highly effective hepatitis C therapies with direct acting antiviral agents,' Bashar Aqel, MD...'Use of HCV viremic grafts has been associated with a reduced wait time, good graft and patient survival, and very favorable cost effectiveness...Glecaprevir/pibrentasvir is a highly effective, pangenotypic [direct acting antiviral agent] with confirmed safety in patients with kidney disease and minimal drug-to-drug interaction.'"

Media quote

A Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: Addpharma Inc.

Clinical • New P1 trial • Dyslipidemia

"Has anyone tried the combination of ezetimibe with atorvastatin or with rosuvastatin?" (@rigotordoc)

Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439) (clinicaltrials.gov) - P3; N=454; Completed; Sponsor: Merck Sharp & Dohme Corp.; Active, not recruiting ➔ Completed

Trial completion • Dyslipidemia • Metabolic Disorders

Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439) (clinicaltrials.gov) - P3; N=450; Active, not recruiting; Sponsor: Merck Sharp & Dohme Corp.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Dyslipidemia • Metabolic Disorders

Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439) (clinicaltrials.gov) - P3; N=450; Recruiting; Sponsor: Merck Sharp & Dohme Corp.; Trial primary completion date: Jan 2021 ➔ Apr 2021

Clinical • Trial primary completion date • Dyslipidemia • Metabolic Disorders