Last update 07 Nov 2024
Ezetimibe/Pitavastatin Calcium
Last update 07 Nov 2024
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms Pitavastatin Calcium Hydrate/Ezetimibe, 依折麦布/匹伐他汀钙, K-924 + [2] |
Target |
Mechanism CETP inhibitors(Cholesteryl ester transfer protein inhibitors), HMG-CoA reductase inhibitors(HMG-CoA reductase inhibitors) |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date KR (28 Jul 2021), |
Regulation- |
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Structure
Molecular FormulaC25H24CaFNO4 |
InChIKeyAMUDYCAFPCQTAZ-NRFPMOEYSA-N |
CAS Registry147526-32-7 |
View All Structures (2)
Related
3
Clinical Trials associated with Ezetimibe/Pitavastatin Calcium依折麦布匹伐他汀钙片的生物等效性试验
[Translation] Bioequivalence study of ezetimibe and pitavastatin calcium tablets
A Phase III, Multicenter, Randomized, Clinial Trial to Evaluate the Efficacy and Safety of K-924 in Patienta With Hypercholesterolemia.
A Multicenter, Open-label Study to Evaluate 52 Weeks Long Term Efficacy and Safety of K-924 in Patients With Hypercholesterolemia Who Were Treated With Pitavastatin 2 mg or 4 mg.
100 Clinical Results associated with Ezetimibe/Pitavastatin Calcium
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100 Translational Medicine associated with Ezetimibe/Pitavastatin Calcium
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100 Patents (Medical) associated with Ezetimibe/Pitavastatin Calcium
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1
Literatures (Medical) associated with Ezetimibe/Pitavastatin Calcium01 Mar 2024Journal of atherosclerosis and thrombosis
Long-term Efficacy and Safety of K-924 Pitavastatin/Ezetimibe Fixed-dose Combination in Patients with Hypercholesterolemia: A Phase III, Multi-center, Open-label Trial
Article
Author: Yokote, Koutaro ; Tsujita, Kenichi ; Suganami, Hideki ; Kamei, Ryo ; Ako, Junya ; Tanigawa, Ryohei
AIM:
Ezetimibe administration with ongoing statin therapy is an effective option for further lowering low-density lipoprotein cholesterol (LDL-C) levels. Thus, we investigated the long-term efficacy and safety of fixed-dose combination of pitavastatin/ezetimibe (K-924 LD: 2 mg/10 mg; K-924 HD: 4 mg/10 mg).
METHODS:
We conducted a phase III, multicenter, open-label trial involving patients with hypercholesterolemia receiving pitavastatin (2 or 4 mg) who had not achieved their LDL-C management target. Patients were enrolled into the K-924 LD and HD groups based on whether they had received pitavastatin 2 and 4 mg, respectively, and treated for 52 weeks. K-924 was administered orally once daily. The primary objective was to examine the percent change in LDL-C from baseline at week 52 with last observation carried forward imputation (LOCF) in all patients.
RESULTS:
Of the 109 patients evaluated, 62 and 47 were assigned to the K-924 LD and HD groups, respectively. In all patients, LDL-C decreased by -30.3±14.3% (p＜0.001) from baseline (134.4±37.9 mg/dL). Consequently, 91.8% and 37.5% of the patients for primary and secondary prevention reached their LDL-C management target, respectively. These results were consistent in both the K-924 LD and HD groups. In the safety analysis, a single adverse drug reaction occurred in a patient in the K-924 HD group.
CONCLUSION:
After replacing pitavastatin monotherapy, K-924 was found to be effective and well-tolerated over 52 weeks. Thus, K-924 can contribute to intensifying LDL-C-lowering therapy without increasing the number of medications.
100 Deals associated with Ezetimibe/Pitavastatin Calcium
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R&D Status
Approved
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Hypercholesterolemia | JP | 26 Sep 2022 | |
| Hyperlipoproteinemia Type II | JP | 26 Sep 2022 | |
| Primary hypercholesterolemia | KR | 28 Jul 2021 |
Developing
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Homozygous familial hypercholesterolemia | Phase 1 | CN | 20 Sep 2022 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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Phase 3 | 109 | K-924 LD: 2 mg/10 mg | deimajctup(teuzdribzo) = lrrznobewi fdrkinscxz (kltwuokjaw ) | Positive | 01 Mar 2024 | ||
K-924 HD: 4 mg/10 mg | deimajctup(teuzdribzo) = wpwhpjujoh fdrkinscxz (kltwuokjaw ) |
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