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Drug

Niacin

Regulatory activity · FDA
Emerging researchLate-stage development
Also known as 3-Pyridinecarboxylic acid, 3-Pyridylcarboxylic acid, 3-carboxypyridine, Acide nicotinique+34 more

3-Pyridinecarboxylic acid, 3-Pyridylcarboxylic acid, 3-carboxypyridine, Acide nicotinique, Acidum Nicotinicum, Advicor, Antipellagra factor, B-3-50, B3-500-Gr, Concept OB, Endur-Acin, Endur-Amide, Endur-Thine, Folivane-F, Irospan Tablet, MVC-Fluoride, NICOTINIC ACID, Nephrocaps, Nephrocaps QT, Niacor B3, Niaspan, Nico-400, Nicobid Tempules, Nicolar, Nicotinex, Nikotinsäure, Poly-Vi-Sol, Poly-Vi-Sol with Iron, Simcor, Slo-Niacin, Vitafol-One, Vitamin B-3, anti-pellagra vitamin, m-pyridinecarboxylic acid, niacin (as nicotinic acid), ácido nicotínico, Niacina, Niacor.

RxNorm7393ChEMBLCHEMBL573ATCC10AD02ATCC04AC01ATCC10AD52UNII2679MF687A
2
Research papers
11
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

TRIP - TReatment to Improve Depression and/or Anxiety Using Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy

Clinical trial2026-07-29Results expected Q4 2026 · ClinicalTrials.gov

Stimulating Adipose Tissue Fatty Acid Disposal With Low-dose, Postprandial, Intermittent Niacin for the Treatment of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD).

Clinical trial2026-07-02Results expected Q1 2030 · ClinicalTrials.gov

5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder

Clinical trial2026-06-29Results expected Q4 2026 · ClinicalTrials.gov

Novel Pathways of Eicosanoid Metabolism

Clinical trial2026-06-05Results expected Q3 2027 · ClinicalTrials.gov

Recall (Class II): NIACIN

Regulatory2026-05-29FDA

A Randomised, Controlled Trial of MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder

Clinical trial2026-05-01Primary completion · ClinicalTrials.gov

Regulation of Endogenous Glucose Production by Central KATP Channels

Clinical trial2026-04-28Results expected Q2 2027 · ClinicalTrials.gov

A Randomized, Double-Blind Study of Single-Dose Psilocybin for Major Depressive Disorder (MDD)

Clinical trial2026-04-22Results posted · ClinicalTrials.gov

Niacin Regulation of Regional Adipose Tissue Lipolysis

Clinical trial2026-04-13Results expected Q2 2027 · ClinicalTrials.gov

Pilot Proof of Concept Study Evaluating the Potential Psilocybin Assisted Psychotherapy (PAP) as a Therapeutic Tool for Patients Suffering From Severe Irritable Bowel Syndrome.

Clinical trial2026-03-05Results expected Q4 2026 · ClinicalTrials.gov

Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial.

Research2023-09-01JAMA

Endothelial-vasoprotective effects of high-density lipoprotein are impaired in patients with type 2 diabetes mellitus but are improved after extended-release niacin therapy.

Research2009-12-21Circulation

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Niacin
Aliases & brands
3-Pyridinecarboxylic acid3-Pyridylcarboxylic acid3-carboxypyridineAcide nicotiniqueAcidum NicotinicumAdvicorAntipellagra factorB-3-50B3-500-GrConcept OBEndur-AcinEndur-AmideEndur-ThineFolivane-FIrospan TabletMVC-FluorideNICOTINIC ACIDNephrocapsNephrocaps QTNiacor B3NiaspanNico-400Nicobid TempulesNicolarNicotinexNikotinsäurePoly-Vi-SolPoly-Vi-Sol with IronSimcorSlo-NiacinVitafol-OneVitamin B-3anti-pellagra vitaminm-pyridinecarboxylic acidniacin (as nicotinic acid)ácido nicotínicoNiacinaNiacor
RxNorm CUI
7393
ChEMBL ID
CHEMBL573
ATC codes
C10AD02C04AC01C10AD52
UNII
2679MF687A
Regulatory jurisdictions
fda

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
FDA
Total events
1
fdaU.S. Food and Drug Administration· 1 event
2026-05-29RecallSafety
Recall (Class II): NIACIN
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

73 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
73
registered trials across all phases
LATEST COMPLETION 2025
11
Active studies
11
Recruiting
43
Late-stage (III+)
49
Completed
13
Discontinued
PHASE DISTRIBUTIONn = 73
Early Phase 15Phase 17Phase 1 / 21Phase 217Phase 2 / 34Phase 311Phase 415Phase N / A13

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

The Efficacy and Safety of Niacin on Hyperphosphatemia in End Stage Renal Disease Patients Undergoing Haemodialysis

Unknown statusPH IVAssiut Universityn=1502019

Carotid Plaque Composition by Magnetic Resonance Imaging During Lipid Lowering Therapy

CompletedPH IVUniversity of Washingtonn=2172019

A Randomized, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab Versus Usual Care in Patients With Type 2 Diabetes and Mixed Dyslipidemia at High Cardiovascular Risk With Non-HDL-C Not Adequately Controlled With Maximally Tolerated Statin Therapy

CompletedPH IVSanofin=4132017

Short-term Effect of Extended-release Niacin With and Without the Addition of Laropiprant on Endothelial Function

CompletedPH IVUniversity of Campinas, Braziln=182013

Efecto Del ácido nicotínico Sobre la composición de Las lipoproteínas de Alta Densidad (HDL) y la función Del Endotelio Arterial en Los Pacientes Con cardiopatía isquémica Prematura y Concentraciones Elevadas de Colesterol-HDL

TerminatedPH IVXavier Pinto Salan=122013

Recent completions

Trials that read out recently, adding to the completed evidence base.

Quantifying Brown Adipose Tissue Thermogenesis in Type 2 Diabetes

CompletedN/AUniversité de Sherbrooken=62025

Psilocybin Treatment in Obsessive-Compulsive Disorder: a Preliminary Efficacy Study and Exploratory Investigation of Neural Correlates.

CompletedPH IYale Universityn=312024

The Effect of Psilocybin on MDD Symptom Severity and Synaptic Density - A Single Dose Randomized, Double Blind, Placebo- Controlled Phase 2 Positron Emission Tomography Study

CompletedPH IISection for Affective Disorders; Northern Stockholm Psychiatryn=352024

Activation of Brown Adipose Tissue Thermogenesis in Humans Using Formoterol Fumarate, a Beta-2 Adrenergic Receptor Agonist

CompletedN/AUniversité de Sherbrooken=122023

A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

CompletedPH IIISanofin=1532022

A Randomized, Double-Blind Study of Single-Dose Psilocybin for Major Depressive Disorder (MDD)

CompletedPH IIUsona Instituten=3472022

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20102023
Major research themes3
Hallucinogens1Major Depressive Disorder1Niacin1
Journals, researchers & institutions
Top journals
  • Circulation1
  • JAMA1
Leading researchers
  • Bahlmann FH1
  • Bahr MJ1
  • Besler C1
  • Bradley E1
  • Brown C1
  • Brown RT1
  • Davis MC1
  • Doerries C1
Leading institutions
free-text, unnormalised
  • Center for Psychedelic Research1
  • Emory University School of Medicine1
  • Hassman Research Institute1
  • Johns Hopkins University School of Medicine1
  • NYU Langone Center for Psychedelic Medicine1
  • Pacific Neuroscience Institute1

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Nitric Oxide

Studied across 3 of the same disease areas as Niacin in the shared literature.

3 shared diseases1 shared paper
Psilocybin

Frequently co-studied with Niacin in the research literature.

1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.