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ER-niacin
ER-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 low HDL cholesterol in patients at risk for cardiovascular disease.
ER-niacin is an extended-release formulation of niacin (vitamin B3) that raises HDL cholesterol and lowers triglycerides and LDL cholesterol.
ER-niacin is an extended-release formulation of niacin (vitamin B3) that raises HDL cholesterol and lowers triglycerides and LDL cholesterol. Used for Dyslipidemia; elevated triglycerides and low HDL cholesterol in patients at risk for cardiovascular 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 | ER-niacin |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Lipid-modifying agent; B-vitamin |
| Target | DGAT2; GPR109A (hydroxycarboxylic acid receptor 2) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Niacin works through multiple pathways: it inhibits hepatic diacylglycerol acyltransferase-2 (DGAT2) and reduces free fatty acid mobilization from adipose tissue, thereby decreasing hepatic triglyceride and VLDL production. It also increases HDL cholesterol through upregulation of apolipoprotein A-I and reduces LDL cholesterol. The extended-release formulation improves tolerability by reducing the flushing side effect associated with immediate-release niacin.
Approved indications
- Dyslipidemia; elevated triglycerides and low HDL cholesterol in patients at risk for cardiovascular disease
Common side effects
- Flushing
- Pruritus
- Gastrointestinal upset
- Hyperglycemia
- Hyperuricemia
Key clinical trials
- Effects of Niacin Therapy on Lipoprotein Composition and Function (NA)
- PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA) (PHASE1)
- Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133) (PHASE3)
- To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED) (PHASE3)
- A Study of Evaluating Dual Inhibitor of PAK4 and NAMPT ATG-019 in Advanced Solid Tumors or Non-Hodgkin's Lymphoma (PHASE1)
- QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine (PHASE1, PHASE2)
- Niacin to Improve Blood Flow in People With Sickle Cell Disease (PHASE2)
- 2nd Line Treatment With Pemetrexed and Sorafenib for Recurrent or Metastatic Triple Negative Breast Cancer (PHASE2)
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:
- ER-niacin CI brief — competitive landscape report
- ER-niacin updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about ER-niacin
What is ER-niacin?
How does ER-niacin work?
What is ER-niacin used for?
Who makes ER-niacin?
What drug class is ER-niacin in?
What development phase is ER-niacin in?
What are the side effects of ER-niacin?
What does ER-niacin target?
Related
- Drug class: All Lipid-modifying agent; B-vitamin drugs
- Target: All drugs targeting DGAT2; 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 low HDL cholesterol in patients at risk for cardiovascular disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing