Overview
High levels of LDL cholesterol (LDL-C) are a major risk factor for cardiovascular events. Caused by genetic mutations or lifestyle factors, hypercholesterolemia can significantly reduce quality of life and increase the risk of mortality from cardiovascular disease. About 1 in 4 patients, or 15 million Americans with elevated LDL-C, are insufficiently managed with maximally tolerated statin therapy alone, requiring additional treatment for hypercholesterolemia. Bempedoic acid is first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor used once a day for reducing LDL cholesterol levels in statin-refractory patients. It was developed by Esperion Therapeutics Inc. and approved by the FDA on February 21, 2020. A combination product of bempedoic acid and ezetimibe was approved on February 26, 2020 for increased control of LDL cholesterol levels in patients experiencing refractory elevations despite previous statin treatment.
Indication
作为饮食和最大耐受性他汀类药物治疗的辅助药物，用于治疗患有杂合子家族性高胆固醇血症或需要额外降低LDL-C的动脉粥样硬化性心血管疾病的成人。
Associated Conditions
- Atherosclerotic Cardiovascular Diseases
- Heterozygous Familial Hypercholesterolemia (HeFH)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/19 | Phase 1 | Recruiting | |||
2024/11/13 | N/A | Recruiting | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | ||
2024/06/10 | Phase 3 | Completed | |||
2023/09/13 | Not Applicable | Recruiting | Medanta, The Medicity, India | ||
2023/01/23 | Phase 2 | Recruiting | |||
2022/08/04 | Phase 2 | Recruiting | Priscilla Hsue, MD | ||
2021/11/02 | N/A | Recruiting | |||
2017/11/08 | Phase 3 | Completed | |||
2017/03/01 | Phase 3 | Completed | |||
2016/12/22 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Esperion Therapeutics, Inc. | 72426-118 | ORAL | 180 mg in 1 1 | 3/28/2024 | |
| Esperion Therapeutics, Inc. | 72426-818 | ORAL | 180 mg in 1 1 | 3/28/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/27/2020 | ||
Authorised | 3/27/2020 | ||
Authorised | 3/27/2020 | ||
Authorised | 3/27/2020 | ||
Authorised | 4/1/2020 | ||
Authorised | 4/1/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| NILEMDO TABLETS 180MG | N/A | N/A | N/A | 4/28/2023 | |
| NUSTENDI TABLETS 180MG/10MG | N/A | N/A | N/A | 4/28/2023 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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