Last reviewed · How we verify
Niacin Extended Release/Lovastatin
Niacin reduces triglycerides and LDL cholesterol while raising HDL cholesterol, and lovastatin inhibits HMG-CoA reductase to further lower LDL cholesterol.
Niacin reduces triglycerides and LDL cholesterol while raising HDL cholesterol, and lovastatin inhibits HMG-CoA reductase to further lower LDL cholesterol. Used for Hyperlipidemia and dyslipidemia for cardiovascular risk reduction, Primary and secondary prevention of coronary heart disease.
At a glance
| Generic name | Niacin Extended Release/Lovastatin |
|---|---|
| Sponsor | In His Image |
| Drug class | Statin/Niacin combination; Lipid-modifying agent |
| Target | HMG-CoA reductase (lovastatin); GPR109A/PUMA-G receptor (niacin) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Niacin (vitamin B3) acts as a lipid-modifying agent that decreases hepatic triglyceride synthesis and VLDL production, while also increasing HDL cholesterol through multiple pathways. Lovastatin is a statin that competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels. The combination provides complementary lipid-lowering effects for cardiovascular risk reduction.
Approved indications
- Hyperlipidemia and dyslipidemia for cardiovascular risk reduction
- Primary and secondary prevention of coronary heart disease
Common side effects
- Flushing
- Pruritus
- Myalgia
- Elevated liver enzymes
- Hyperglycemia
- Gastrointestinal upset
Key clinical trials
- To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED) (PHASE3)
- Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2) (PHASE1)
- Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study) (PHASE4)
- MK-0524B Lipid Study (MK-0524B-063) (PHASE3)
- Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143) (PHASE3)
- Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024) (PHASE3)
- A Study to Evaluate Efficacy and Safety of Extended-Release Niacin + Laropiprant + Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118) (PHASE3)
- Plaque Inflammation and Dysfunctional HDL in AIM-HIGH
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Niacin Extended Release/Lovastatin CI brief — competitive landscape report
- Niacin Extended Release/Lovastatin updates RSS · CI watch RSS
- In His Image portfolio CI