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Comparator: niacin
Comparator: niacin is a Lipid-modifying agent; B vitamin Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Dyslipidemia; elevated triglycerides and/or low HDL cholesterol, Cardiovascular risk reduction in patients with established coronary artery disease. Also known as: Niaspan.
Niacin (vitamin B3) raises HDL cholesterol and lowers triglycerides and LDL cholesterol by inhibiting hepatic VLDL production and increasing apolipoprotein A-I.
Niacin (vitamin B3) raises HDL cholesterol and lowers triglycerides and LDL cholesterol by inhibiting hepatic VLDL production and increasing apolipoprotein A-I. Used for Dyslipidemia; elevated triglycerides and/or low HDL cholesterol, Cardiovascular risk reduction in patients with established coronary artery disease.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Comparator: niacin |
|---|---|
| Also known as | Niaspan |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Lipid-modifying agent; B vitamin |
| Target | GPR109A (hydroxycarboxylic acid receptor 2) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Niacin acts as a lipid-modifying agent that decreases the synthesis and secretion of very low-density lipoprotein (VLDL) from the liver, thereby reducing circulating triglycerides and LDL cholesterol while simultaneously increasing HDL cholesterol levels. It also reduces free fatty acid mobilization from adipose tissue. These combined effects improve the lipid profile and may reduce cardiovascular risk.
Approved indications
- Dyslipidemia; elevated triglycerides and/or low HDL cholesterol
- Cardiovascular risk reduction in patients with established coronary artery disease
Common side effects
- Flushing
- Pruritus
- Nausea
- Hyperglycemia
- Hyperuricemia
- Hepatotoxicity
Key clinical trials
- Nicotinic Acid for the Treatment of Alzheimer's Disease (PHASE1, PHASE2)
- Supplementation With Sirtuin Activators in Women With Increased Body Weight (NA)
- A Randomized Controlled Trial of Nicotinamide Riboside Supplementation in Early Parkinson's Disease (PHASE3)
- 5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder (PHASE2)
- Metabolic Cofactor Supplementation and Hydroxychloroquine Combination in Covid-19 Patients (PHASE2, PHASE3)
- Crossover Trial for Nicotinamide Riboside in Subjective Cognitive Decline and Mild Cognitive Impairment (NA)
- To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED) (PHASE3)
- IV Administration of ChromaDex's Niagen® as Compared to NAD+ (NA)
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:
- Comparator: niacin CI brief — competitive landscape report
- Comparator: niacin updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Comparator: niacin
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Related
- Drug class: All Lipid-modifying agent; B vitamin drugs
- Target: All drugs targeting GPR109A (hydroxycarboxylic acid receptor 2)
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Dyslipidemia; elevated triglycerides and/or low HDL cholesterol
- Indication: Drugs for Cardiovascular risk reduction in patients with established coronary artery disease
- Also known as: Niaspan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing