Active Ingredient History
Niacin (also known as vitamin B3 and nicotinic acid) is bio converted to nicotinamide which is further converted to nicotinamide adenine dinucleotide (NAD+) and the hydride equivalent (NADH) which are coenzymes necessary for tissue metabolism, lipid metabolism, and glycogenolysis. Niacin (but not nicotinamide) in gram doses reduces LDL-C, Apo B, Lp(a), TG, and TC, and increases HDL-C. The increase in HDL-C is associated with an increase in apolipoprotein A-I (Apo A-I) and a shift in the distribution of HDL subfractions. These shifts include an increase in the HDL2:HDL3 ratio, and an elevation in lipoprotein A-I (Lp A-I, an HDL-C particle containing only Apo A-I). The mechanism by which niacin alters lipid profiles is not completely understood and may involve several actions, including partial inhibition of release of free fatty acids from adipose tissue, and increased lipoprotein lipase activity (which may increase the rate of chylomicron triglyceride removal from plasma). Niacin decreases the rate of hepatic synthesis of VLDL-C and LDL-C, and does not appear to affect fecal excretion of fats, sterols, or bile acids. As an adjunct to diet, the efficacy of niacin and lovastatin in improving lipid profiles (either individually, or in combination with each other, or niacin in combination with other statins) for the treatment of dyslipidemia has been well documented. The effect of combined therapy with niacin and lovastatin on cardiovascular morbidity and mortality has not been determined. In addition, preliminary reports suggest that niacin causes favorable LDL particle size transformations, although the clinical relevance of this effect is not yet clear. April 15, 2016: Based on several large cardiovascular outcome trials including AIM-HIGH, ACCORD, and HPS2-THRIVE, the FDA decided that "scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events" Consistent with this conclusion, the FDA has determined that the benefits of niacin ER tablets for coadministration with statins no longer outweigh the risks, and the approval for this indication should be withdrawn. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Carotid Artery Diseases (approved 1997)
Myocardial Infarction (approved 1997)
Acute Coronary Syndrome (Phase 3)
Acute Kidney Injury (Phase 1)
Anemia, Sickle Cell (Phase 2)
Aortic Stenosis, Subvalvular (Early Phase 1)
Arterial Occlusive Diseases (Phase 3)
Ataxia Telangiectasia (Phase 2)
Atherosclerosis (Phase 4)
Autoimmune Diseases (Phase 2)
Blood Glucose (Phase 2)
Cardiovascular Diseases (Phase 4)
Carotid Artery Diseases (Phase 4)
Cerebrovascular Disorders (Phase 3)
Cholesterol, HDL (Phase 4)
Cognitive Dysfunction (Phase 2)
Coronary Disease (Phase 4)
Depression (Phase 2)
Depressive Disorder, Major (Phase 2)
Dermatology (Phase 2)
Diabetes Mellitus (Phase 4)
Diabetes Mellitus, Type 1 (Phase 2)
Diabetes Mellitus, Type 2 (Phase 4)
Dyslipidemias (Phase 4)
Endocrine System Diseases (Phase 2)
Flushing (Phase 3)
Glioblastoma (Phase 1/Phase 2)
Glucose Metabolism Disorders (Phase 2)
Growth and Development (Phase 1/Phase 2)
Growth Hormone (Phase 1/Phase 2)
Hallucinogens (Phase 1)
Healthy Volunteers (Phase 2)
Heart Diseases (Phase 3)
Heart Failure, Systolic (Phase 2)
HIV (Phase 4)
HIV Infections (Phase 2)
Hyperlipoproteinemias (Phase 4)
Hyperlipoproteinemia Type II (Phase 3)
Hyperphosphatemia (Phase 4)
Hypertriglyceridemia (Phase 4)
Hypoalphalipoproteinemias (Phase 4)
Hypolipoproteinemias (Phase 4)
Immune System Diseases (Phase 2)
Insulin Resistance (Phase 4)
Intermittent Claudication (Phase 3)
Intracranial Arteriosclerosis (Phase 3)
Ischemic Stroke (Phase 2)
Ketosis (Phase 2)
Kidney Failure, Chronic (Phase 3)
Latent Autoimmune Diabetes in Adults (Phase 2)
Lipoproteins (Phase 4)
Lymphoma, Non-Hodgkin (Phase 1)
Metabolic Diseases (Phase 2)
Metabolic Syndrome (Phase 4)
Metabolism (Early Phase 1)
Mutation (Phase 2)
Mycobacterium tuberculosis (Phase 3)
Myocardial Infarction (Phase 3)
Myocardial Ischemia (Phase 3)
Neoplasms (Phase 1)
Obesity (Phase 4)
Obsessive-Compulsive Disorder (Phase 1)
Opioid-Related Disorders (Phase 2)
Osteoporosis (Phase 3)
Pain (Phase 3)
Perception (Phase 1)
Peripheral Arterial Disease (Phase 4)
Peripheral Vascular Diseases (Phase 3)
Physiological Effects of Drugs (Phase 2)
Psychotic Disorders (Phase 3)
Renal Insufficiency, Chronic (Phase 4)
Retinal Vein Occlusion (Phase 2/Phase 3)
Schizophrenia (Phase 2/Phase 3)
Stress Disorders, Post-Traumatic (Phase 1)
Stroke (Phase 4)
Vascular Diseases (Phase 3)
Vascular Grafting (Phase 2)
Visual Pathways (Phase 1)
Vitamin D (Phase 2)
| Trial | Phase | Start Date | Organizations | Indications |
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