Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4, sponsored by academic and industrial entities, evaluate the therapeutic effects of nicotinic acid across various conditions. Completed late-phase studies primarily address cardiovascular and metabolic disorders—such as dyslipidemia, atherosclerosis, and diabetes mellitus—to evaluate vascular and lipid outcomes. Furthermore, early-phase trials are actively recruiting for novel indications including Alzheimer's disease and glaucoma, while additional studies assess solid tumors and pharmacokinetics across completed, recruiting, and terminated cohorts.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03540758 RECRUITING
Diabetes Mellitus; Glucose Metabolism Disorders
Albert Einstein College of Medicine
 2018-08-01 PHASE2
NCT06582706 RECRUITING
Alzheimer Disease
Indiana University
 2024-12-19 PHASE1; PHASE2
NCT06991712 RECRUITING
Glaucoma
Christopher Kai Shun Leung
 2025-05-19 PHASE2
NCT06378125 COMPLETED
Safety Issues; Pharmacokinetic
University Hospital Schleswig-Holstein
 2022-12-19 PHASE1
NCT05846373 COMPLETED
Migraine Prophylaxis
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2022-11-25 PHASE2
NCT03685773 WITHDRAWN
Diabetes Mellitus, Type 2; Glucose, High Blood; Glucose Metabolism Disorders
Albert Einstein College of Medicine
 2019-04-21 PHASE2
NCT05092945 COMPLETED
Type 2 Diabetes
Université de Sherbrooke
 2021-05-18
NCT03510884 COMPLETED
Hypercholesterolaemia
Sanofi
 2018-05-31 PHASE3
NCT03510715 COMPLETED
Hypercholesterolemia
Sanofi
 2018-08-31 PHASE3
NCT02890992 COMPLETED
Hypercholesterolaemia
Sanofi
 2016-09-15 PHASE2
NCT00493064 COMPLETED
Retinal Vein Occlusion
Palo Alto Medical Foundation
 2006-10 PHASE2; PHASE3
NCT00500045 TERMINATED
Central Retinal Vein Occlusion; Branch Retinal Vein Occlusion
Palo Alto Medical Foundation
 2007-02 PHASE2; PHASE3
NCT02836184 UNKNOWN
Hyperphosphatemia
Jiujiang No.1 People's Hospital
 2016-07 PHASE4
NCT02702492 Terminated
Solid Tumors|NHL
Karyopharm Therapeutics Inc
 2016-06 Phase 1
NCT01450410 TERMINATED
Dyslipidemias
Xavier Pinto Sala
 2012-07 PHASE4
NCT01803594 COMPLETED
Dyslipidemia
University of California, Davis
 2012-08
NCT01118598 COMPLETED
Polycystic Ovary Syndrome
Hull University Teaching Hospitals NHS Trust
 2010-06 PHASE4
NCT00633698 UNKNOWN
Elevated Lipoprotein(a) Levels
Charite University, Berlin, Germany
 2008-01 PHASE3
NCT01216956 COMPLETED
Insulin Sensitivity; Lipoproteins Metabolism; Non Esterified Fatty Acid Kinetics; Lipid Profile
Centre de Recherche en Nutrition Humaine Rhone-Alpe
 2006-09
NCT00943124 COMPLETED
Dyslipidemia
Merck Sharp & Dohme LLC
 2007-07 PHASE1
NCT01258491 COMPLETED
Healthy Subjects
Heidelberg University
 2005-05 PHASE1
NCT00712049 UNKNOWN
Dyslipidemia; Atherosclerosis
Medical University of Vienna
 2008-06 PHASE4
NCT00238004 UNKNOWN
HDL Cholesterol; Coronary Arteriosclerosis; Lipoproteins
Craigavon Area Hospital
 2005-11 PHASE4
NCT00176020 UNKNOWN
Healthy
Heidelberg University
 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-28)

Check the Nicotinic Acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nicotinic acid serves as a precursor for the biosynthesis of nicotinamide adenine dinucleotide (NAD) and NADP, which act as vital coenzymes in cellular redox reactions to regulate tissue respiration and substrate metabolism. This enhancement of cellular energy pathways and modulation of lipid metabolic cascades inhibits pathogenic lipid accumulation, providing the mechanistic rationale for its clinical investigation in dyslipidemia, atherosclerosis, and metabolic disorders.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.