Overview
Acipimox is a niacin derivative used as a hypolipidemic agent. It is used in low doses and may have less marked adverse effects, although it is unclear whether the recommended dose is as effective as are standard doses of nicotinic acid. Acipimox inhibits the production of triglycerides by the liver and the secretion of VLDL, which leads indirectly to a modest reduction in LDL and increase in HDL. Long-term administration is associated with reduced mortality, but unwanted effects limit its clinical use. Adverse effects include flushing (associated with Prostaglandin D2), palpitations, and GI disturbances. Flushing can be reduced by taking aspirin 20-30 min before taking Acipimox. High doses can cause disorders of liver function, impair glucose tolerance and precipitate gout.
Background
Acipimox is a niacin derivative used as a hypolipidemic agent. It is used in low doses and may have less marked adverse effects, although it is unclear whether the recommended dose is as effective as are standard doses of nicotinic acid. Acipimox inhibits the production of triglycerides by the liver and the secretion of VLDL, which leads indirectly to a modest reduction in LDL and increase in HDL. Long-term administration is associated with reduced mortality, but unwanted effects limit its clinical use. Adverse effects include flushing (associated with Prostaglandin D2), palpitations, and GI disturbances. Flushing can be reduced by taking aspirin 20-30 min before taking Acipimox. High doses can cause disorders of liver function, impair glucose tolerance and precipitate gout.
Indication
Used in the treatment of hyperlipidemias (abnormally elevated levels of any or all lipids and/or lipoproteins in the blood).
Associated Conditions
- Fredrickson classification type IV Hyperlipidemia
- Fredrickson type IIb hyperlipidemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/19 | N/A | Recruiting | |||
2024/01/29 | Early Phase 1 | Suspended | |||
2019/01/18 | Not Applicable | Completed | |||
2017/11/09 | Phase 2 | ENROLLING_BY_INVITATION | Charles University, Czech Republic | ||
2016/06/13 | Not Applicable | Completed | |||
2016/05/25 | Not Applicable | Completed | |||
2014/10/06 | Phase 1 | Completed | |||
2013/11/11 | Phase 2 | Completed | |||
2013/03/22 | Phase 3 | Completed | |||
2012/04/19 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
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 |
|---|---|---|---|---|---|
| Acipimox Capsules | 国药准字H20253441 | 化学药品 | 胶囊剂 | 2/20/2025 | |
| Acipimox Capsules | 国药准字H20244607 | 化学药品 | 胶囊剂 | 7/30/2024 | |
| Acipimox Capsules | 国药准字H20249501 | 化学药品 | 胶囊剂 | 12/1/2024 | |
| Acipimox Capsules | 国药准字H20010801 | 化学药品 | 胶囊剂 | 1/19/2020 | |
| Acipimox Capsules | 国药准字H20010087 | 化学药品 | 胶囊剂 | 7/21/2020 | |
| Acipimox Capsules | 国药准字H20010769 | 化学药品 | 胶囊剂 | 2/6/2020 | |
| Acipimox Dispersible Tablets | 国药准字H20060318 | 化学药品 | 片剂 | 5/20/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||