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niacin

Small moleculeapproved

Approved

Jul 24, 1957

Niacin (also known as vitamin B3 and nicotinic acid) is bio converted to nicotinamide which is further converted to nicotinamide adenine dinucleotide (NAD+) and the hydride equivalent (NADH) which are coenzymes necessary for tissue metabolism, lipid metabolism, and glycogenolysis. Niacin (but not nicotinamide) in gram doses reduces LDL-C, Apo B, Lp(a), TG, and TC, and increases HDL-C. The increase in HDL-C is associated with an increase in apolipoprotein A-I (Apo A-I) and a shift in the distribution of HDL subfractions. These shifts include an increase in the HDL2:HDL3 ratio, and an elevation in lipoprotein A-I (Lp A-I, an HDL-C particle containing only Apo A-I). The mechanism by which niacin alters lipid profiles is not completely understood and may involve several actions, including partial inhibition of release of free fatty acids from adipose tissue, and increased lipoprotein lipase activity (which may increase the rate of chylomicron triglyceride removal from plasma). Niacin decreases the rate of hepatic synthesis of VLDL-C and LDL-C, and does not appear to affect fecal excretion of fats, sterols, or bile acids. As an adjunct to diet, the efficacy of niacin and lovastatin in improving lipid profiles (either individually, or in combination with each other, or niacin in combination with other statins) for the treatment of dyslipidemia has been well documented. The effect of combined therapy with niacin and lovastatin on cardiovascular morbidity and mortality has not been determined. In addition, preliminary reports suggest that niacin causes favorable LDL particle size transformations, although the clinical relevance of this effect is not yet clear. April 15, 2016: Based on several large cardiovascular outcome trials including AIM-HIGH, ACCORD, and HPS2-THRIVE, the FDA decided that "scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events" Consistent with this conclusion, the FDA has determined that the benefits of niacin ER tablets for coadministration with statins no longer outweigh the risks, and the approval for this indication should be withdrawn. — NCATS

Clinical trial activity

217 trials · 207 clinical orgs · 33 marketing orgs

Phase 1
35
Phase 2
88
Phase 3
52
Phase 4
34

Earliest trial started Apr 1, 1965 (NCT00000482)

Timeline

1950s

  1. Jul 24, 1957

    Medpointe — Earliest FDA Approval

  2. Jul 24, 1957

    Medpointe — NDA Secondary Org

  3. Jul 24, 1957

    Medpointe — NDA Organization

1960s

  1. Jan 1, 1965

    Earliest Phase 3 Sponsor(trial)

1970s

  1. Sep 15, 1972

    Teva — Marketing Organization

  2. Jan 4, 1973

    Watson Pharmaceuticals — Marketing Organization

  3. Aug 1, 1973

    MK Labs — Marketing Organization

  4. Nov 26, 1973

    Sanofi-Aventis — Marketing Organization

  5. Jan 7, 1974

    Hikma — Marketing Organization

1980s

  1. Jan 1, 1986

    Earliest Phase 2 Sponsor(trial)

1990s

  1. Apr 28, 1992

    Wockhardt — Marketing Organization

  2. Jul 28, 1997

    AbbVie — NDA Secondary Org

2000s

  1. May 3, 2000

    Avondale Pharms — Marketing Organization

  2. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  3. Apr 14, 2005

    Barr Laboratories — Marketing Organization

2010s

  1. Mar 20, 2014

    Lupin — Marketing Organization

  2. Mar 20, 2014

    Chartwell Pharmaceuticals — Marketing Organization

  3. Apr 23, 2014

    Sun Pharmaceuticals — Marketing Organization

  4. Jul 24, 2015

    Amneal Pharmaceuticals — Marketing Organization

  5. Jun 16, 2017

    Lannett Company, Inc. — Marketing Organization

  6. Feb 1, 2018

    Aurobindo Pharma — Marketing Organization

  7. May 14, 2018

    Jubilant Innovation Ltd. — Marketing Organization

  8. Feb 22, 2019

    Mylan — Marketing Organization

  9. Feb 22, 2019

    Rising Pharmaceuticals — Marketing Organization

  10. Jun 10, 2019

    Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization

2020s

  1. Nov 22, 2021

    Beijing Pearl Biotechnology Limited Liability Company — Marketing Organization

  2. Mar 3, 2022

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  3. Mar 3, 2022

    Neogen — Marketing Organization

  4. Aug 25, 2023

    Eywa Pharma — Marketing Organization

  5. Aug 25, 2023

    HIBROW HLTHCARE — Marketing Organization

  6. Apr 28, 2025

    Zydus Discovery DMCC — Marketing Organization

  7. Jul 25, 2025

    MPP PHARMA — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJul 24, 1957

Chemistry & pharmacology

Loading structure…

SMILES

OC(=O)C1=CC=CN=C1
Mol. weight
123.1094 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 3-carboxypyridine
  • 3-carboxypyridine
  • 3-pyridinecarboxylic acid
  • 3-pyridinecarboxylic acid
  • 3-pyridinecarboxylic acid
  • 3-pyridinecarboxylic acid methyl ester
  • 3-pyridinecarboxylic acid methyl ester
  • 3-pyridylcarboxylic acid
  • 3-pyridylcarboxylic acid
  • acide nicotinique
  • acide nicotinique
  • acido nicotinico
  • acido nicotinico
  • acidum nicotinicum
  • acidum nicotinicum
  • anti-pellagra vitamin
  • anti-pellagra vitamin
  • beta-pyridinecarboxylic acid
  • beta-pyridinecarboxylic acid
  • chromium nicotinate
  • chromium nicotinate
  • complamin
  • complamin
  • complamin ret
  • hexanicit
  • hexanicotinoyl inositol
  • hexanicotol
  • inositol hexaniacinate
  • inositol hexanicotinate
  • inositol niacinate
  • inositol niacinate
  • inositol niacinate
  • inositol niacinate
  • inositol nicotinate
  • inositol nicotinate
  • inositol nicotinate
  • laropiprant mixture with niacin
  • laropiprant / nicotinic acid
  • laropiprant /nicotinic acid
  • methyl 3-pyridinecarboxylate
  • methylnicotinate
  • methylnicotinate
  • methylnicotinate
  • methyl nicotinate
  • methyl nicotinate
  • methyl nicotinate
  • methyl nicotinate
  • methyl nicotinate
  • methyl nicotinate
  • methyl nicotinate
  • m-pyridinecarboxylic acid
  • m-pyridinecarboxylic acid
  • myristyl nicotinate
  • myristyl nicotinate
  • niacin
  • niacin
  • niacin
  • niacin
  • niacin
  • niacin
  • niacin
  • niacin
  • niacin magnesium
  • niacin potassium
  • niacin potassium
  • niacin potassium
  • niacin potassium
  • niacin potassium
  • niacin potassium
  • niacin td
  • niacor
  • niacor
  • niacor
  • niaspan
  • niaspan
  • niaspan
  • niaspan
  • niaspan er
  • niaspan titration starter pack
  • niaspan titration starter pack
  • nicangin
  • nicangin
  • nicolar
  • nicolar
  • nicotinate
  • nicotinate
  • nicotinic acid
  • nicotinic acid
  • nicotinic acid
  • nicotinic acid
  • nicotinic acid
  • nicotinic acid
  • nidadd
  • nikotinsaeure
  • nikotinsaeure
  • pellagra preventive factor
  • pellagra preventive factor
  • p.p. factor
  • p.p. factor
  • pp factor
  • pp factor
  • pyridine-beta-carboxylic acid
  • pyridine-beta-carboxylic acid
  • pyridine-β-carboxylic acid
  • pyridine-β-carboxylic acid
  • simcor
  • simcor
  • tocopheryl nicotinate
  • vitamin b3
  • vitamin b3
  • vitamin b3
  • vitamin b3
  • vitamin b3
  • vitamin b3 (niacin)
  • vitathone
  • wampocap
  • wampocap
  • xanthinol niacinate
  • xanthinol niacinate
  • xanthinol niacinate
  • xanthinol nicotinate
  • xanthinol nicotinate
  • xanthinol nicotinate
  • xantinol nicotinate
  • xantinol nicotinate
  • xantinol nicotinate
  • β-pyridinecarboxylic acid
  • β-pyridinecarboxylic acid

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07306364Phase 2Jun 30, 2026National Center for Complementary and Integrative Health (NCCIH), Yale University
NCT07286747Phase 2Jan 1, 2026Universitaetsklinikum Schleswig-Holstein
NCT06983730Early Phase 1 (Phase 1)Dec 31, 2025Boston University, Harvard University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT07119996Phase 1Oct 1, 2025Sun Yat-Sen University
NCT07004725Phase 2May 28, 2025Peking University
NCT06991712Phase 2May 19, 2025The University of Hong Kong
NCT06843148N/AApr 30, 2025University of Sherbrooke
NCT06760533Early Phase 1 (Phase 1)Jan 31, 2025New York University
NCT06697626N/ANov 14, 2024Biotechnology and Biological Sciences Research Council, Ulster University, University of Auckland, University of Leeds
NCT06582706Phase 1/Phase 2 (Phase 2)Oct 31, 2024Alzheimer's Association, Indiana University
NCT06444243Phase 2Sep 30, 2024University of Sydney
NCT06446830N/AMay 25, 2024Ain Shams University
NCT06200155Phase 2Apr 16, 2024Gateway for Cancer Research, University of Texas at Houston
NCT06406140Phase 2/Phase 3 (Phase 3)Mar 15, 2024Al Azhar University
NCT06072898Phase 2Dec 31, 2023University of Toronto
NCT06175403Early Phase 1 (Phase 1)Dec 31, 2023Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT05846880Early Phase 1 (Phase 1)Dec 31, 2023Augusta University
NCT05838716Phase 3Dec 29, 2023National Cancer Institute (NCI), University of Rochester
NCT06140953Phase 2Dec 10, 2023Beni Suef University, October 6 University
NCT06940557Phase 2/Phase 3 (Phase 3)Dec 1, 2023BREGO Life Sciences Sdn Bhd, University Putra Malaysia
Showing 20 of 217 trials
Page 1 / 11

Organizations

Research & Development (207)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit312842000
National Heart, Lung, and Blood Institute (NHLBI)Government17751965
Kos PharmaceuticalsFor profit10522000
University of PennsylvaniaAcademic/Hospital9842000
AbbottFor profit8332001
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government7142004
Department of Veteran AffairsGovernment5342005
University of WashingtonAcademic/Hospital5421984
Harvard UniversityAcademic/Hospital4331986
Johns Hopkins UniversityAcademic/Hospital4232003
McGill UniversityAcademic/Hospital4432006
RegeneronFor profit4032016
SanofiFor profit4432016
University of SherbrookeAcademic/Hospital4412017
GlaxoSmithKlineFor profit3132001
Mayo ClinicAcademic/Hospital3222018
National Institute of Allergy and Infectious Diseases (NIAID)Government3232000
National Institutes of Health (NIH)Government3112010
Radboud UniversityAcademic/Hospital3322018
University of HeidelbergAcademic/Hospital3222005
207 organizations
Page 1 / 11

Marketing (37)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2Jul 28, 1997
Amneal PharmaceuticalsFor profitMKTGJul 24, 2015
Aurobindo PharmaFor profitMKTGFeb 1, 2018
Avondale PharmsFor profitMKTGMay 3, 2000
Barr LaboratoriesFor profitMKTGApr 14, 2005
Beijing Pearl Biotechnology Limited Liability CompanyGovernmentMKTGNov 22, 2021
Chartwell PharmaceuticalsFor profitMKTGMar 20, 2014
Everylife Foundation for Rare DiseasesAcademic/HospitalMKTG—
Eywa PharmaFor profitMKTGAug 25, 2023
HIBROW HLTHCAREFor profitMKTGAug 25, 2023
HalseyFor profitMKTG—
HikmaFor profitMKTGJan 7, 1974
HikmaFor profitSYNJan 7, 1974
Impax LaboratoriesFor profitMKTG—
Jubilant Innovation Ltd.For profitMKTGMay 14, 2018
Lannett Company, Inc.For profitMKTGJun 16, 2017
LupinFor profitMKTGMar 20, 2014
MK LabsFor profitMKTGAug 1, 1973
MPP PHARMAFor profitMKTGJul 25, 2025
Macleods Pharmaceuticals, LtdFor profitMKTGMar 3, 2022
MedpointeFor profitNDA2Jul 24, 1957
MedpointeFor profitNDAJul 24, 1957
MylanFor profitMKTGFeb 22, 2019
MylanFor profitSYNFeb 22, 2019
NeogenFor profitMKTGMar 3, 2022
Puracap PharmaceuticalFor profitMKTG—
Rising PharmaceuticalsFor profitMKTGFeb 22, 2019
SandozFor profitMKTG—
Sanofi-AventisFor profitMKTGNov 26, 1973
Sun PharmaceuticalsFor profitMKTGApr 23, 2014
Sun PharmaceuticalsFor profitSYNApr 23, 2014
TablicapsFor profitMKTG—
TevaFor profitMKTGSep 15, 1972
Watson PharmaceuticalsFor profitMKTGJan 4, 1973
WockhardtFor profitMKTGApr 28, 1992
Yichang Humanwell Pharmaceutical Co.,LtdFor profitMKTGJun 10, 2019
Zydus Discovery DMCCFor profitMKTGApr 28, 2025