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Nicotinic Acid (NIACIN)
Niacin, marketed by Medpointe Pharm HLC, is a dietary vitamin supplement that enhances NAD levels, supporting metabolic processes and preventing nutritional deficiencies. The key strength of Niacin lies in its well-established mechanism and broad use in dietary supplementation, with a key composition patent expiring in 2028. However, the primary risk is the intense competition from a wide array of alternative supplements, including Garlic, Avena Sativa Flowering Top, and numerous homeopathic remedies, which may erode market share.
At a glance
| Generic name | NIACIN |
|---|---|
| Also known as | nicotinic acid |
| Sponsor | MEDPOINTE PHARM HLC |
| Drug class | Vitamin C [EPC] |
| Target | NAD synthase |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1957 |
Approved indications
- Dietary Vitamin Supplementation
- Fluoride Supplementation for Caries Prophylaxis
Pipeline indications
- Remission of prediabetes — Phase 2
- Healthspan improvement — Phase 3
Common side effects
- Allergic rash
Drug interactions
- pravastatin
- simvastatin
Key clinical trials
- Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma (PHASE1)
- Bortezomib, Sorafenib Tosylate, and Decitabine in Treating Patients With Acute Myeloid Leukemia (PHASE1)
- A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma (PHASE3)
- Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity (PHASE1)
- NAD Supplementation and Vascular Health in PAD (PHASE1, PHASE2)
- Different Anti-Spastic Therapy Strategies After CABG Using Radial Artery Grafts (PHASE4)
- A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Transplant Recipients (EARLY_PHASE1)
- Tolerance and Efficacy Nicotinamide (Vitamin B3) in Dominant Optic Atrophy OPA1 (PHASE2, PHASE3)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Nicotinic Acid CI brief — competitive landscape report
- Nicotinic Acid updates RSS · CI watch RSS
- MEDPOINTE PHARM HLC portfolio CI