Niacin

Overview

Niacin is a B vitamin used to treat vitamin deficiencies as well as hyperlipidemia, dyslipidemia, hypertriglyceridemia, and to reduce the risk of myocardial infarctions.

Indication

Niacin is indicated to prevent vitamin deficiencies in pediatric and adult patients receiving parenteral nutrition as part of multivitamin intravenous injections. Niacin oral tablets are indicated as a monotherapy or in combination with simvastatin or lovastatin to treat primary hyperlipidemia and mixed dyslipidemia. It can also be used to reduce the risk of nonfatal myocardial infarctions in patients with a history of myocardial infarction and hyperlipidemia. Niacin is also indicated with bile acid binding resins to treat atherosclerosis in patients with coronary artery disease and hyperlipidemia or to treat primary hyperlipidemia. Finally niacin is indicated to treat severe hypertriglyceridemia.

Associated Conditions

Atherosclerosis
High Cholesterol
High Triglyceride Level
Mixed Dyslipidemias
Nonfatal Myocardial Infarction
Pellagra
Primary Hypercholesterolemia
Severe Hypertriglyceridemia (sHTG)
Type II Hyperlipidaemia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia	2025/03/05	NCT06858332	N/A	Recruiting	Novartis Pharmaceuticals
Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver.	2025/02/24	NCT06843148	Not Applicable	Not yet recruiting	Université de Sherbrooke
Psilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS)	2025/01/07	NCT06760533	Early Phase 1	Not yet recruiting	NYU Langone Health
Nicotinic Acid for the Treatment of Alzheimer's Disease: a Phase 1b/2a Study	2024/09/03	NCT06582706	Phase 1	Recruiting	Indiana University
Psilocybin-assisted Therapy for Alcohol Use Disorder	2024/06/05	NCT06444243	Phase 2	Not yet recruiting	University of Sydney
Study the Effect of Niacin on Lipoprotein (a) Concentration and Hyperphosphatemia in Hemodialysis Patients	2024/05/09	NCT06406140	Phase 2	ENROLLING_BY_INVITATION	Al-Azhar University
A Study of Niacin Regulation	2023/12/18	NCT06175403	Early Phase 1	Recruiting	Mayo Clinic
Adipose Tissue Storage in the Rapid Remission of Hepatic and Cardiac Metabolic Dysfunction After Bariatric Surgery	2023/07/07	NCT05934409	Not Applicable	Recruiting	Université de Sherbrooke
MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder	2023/02/02	NCT05709353	Phase 2	Recruiting	University of Sydney
5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder	2022/07/11	NCT05452772	Phase 2	Recruiting	Johns Hopkins University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Multivitamin with Fluoride	Method Pharmaceuticals, LLC	58657-164	ORAL	13.5 mg in 1 1	12/9/2023
Niacin	Macleods Pharmaceuticals Limited	33342-189	ORAL	1000 mg in 1 1	12/25/2023
Simcor	Physicians Total Care, Inc.	54868-6169	ORAL	1000 mg in 1 1	8/18/2010
Niacin	Aurobindo Pharma Limited	59651-018	ORAL	500 mg in 1 1	2/15/2023
Melatonin Forte	BioActive Nutritional, Inc.	43857-0020	ORAL	6 [hp_X] in 1 mL	5/14/2025
Davimet	PureTek Corporation	59088-695	ORAL	13.5 mg in 1 1	12/13/2023
Multivitamin with fluoride	A-S Medication Solutions	50090-0356	ORAL	13.5 mg in 1 1	6/1/2017
Multivitamin with Fluoride	A-S Medication Solutions	50090-4475	ORAL	13.5 mg in 1 1	4/3/2020
RENO CAPS	Carilion Materials Management	68151-1928	ORAL	20 mg in 1 1	11/11/2013
Vita-Rx Diabetic Vitamin	MAS Management Group Inc.	69677-050	ORAL	20 mg in 1 1	8/11/2015

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
FBC FILMTAB	OLIC (THAILAND) LTD, UNICHEM PHARMACEUTICALS LTD	SIN05814P	TABLET, FILM COATED	10 mg	5/3/1991

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MaxN-Fuze Multivitamins	288444	Max Health & Living Australia Pty Ltd	Medicine	A	5/1/2017
Top Life Cellenova	330661	Homart Pharmaceuticals Pty Ltd	Medicine	A	3/3/2020
USANA HealthPak	350153	Usana Australia Pty Ltd	Medicine	A	11/30/2020
Biogency Vman Tablets	351126	Biogency Pty Ltd	Medicine	A	12/8/2020
ABC Boost NMN III	371487	Australia Biotechnology Group Pty Ltd	Medicine	A	7/22/2021
Clovra NAD +	353988	Clovra (Australia) Enterprises Pty Ltd	Medicine	A	2/1/2021
Biogency Synext Tablets	377730	Biogency Pty Ltd	Medicine	A	11/10/2021
Honey Spring NAD+Se	367059	Vastrade Meditek Pty Ltd	Medicine	A	5/25/2021
EZZ FEM Immune Support	447973	EZZ LIFE SCIENCE HOLDINGS LIMITED	Medicine	A	5/7/2024
NAD+NMN Plus	373212	Aus Nature Pharmaceuticals Pty Ltd	Medicine	A	8/20/2021

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
VASODYN TAB	nutri-dyn products ltd.	00420999	Tablet - Oral	100 MG / TAB	12/31/1978
MULTI-REGIME	regime industries ltd.	02247272	Capsule - Oral	5 MG	6/16/2003
WOMEN'S 45+	natural factors nutritional products ltd.	02244128	Tablet - Oral	5 MG	12/19/2001
FORMULA V S C TAB	creative nutrition canada corp.	01963899	Tablet - Oral	4 MG / TAB	12/31/1994
GRAND MASTER FORMULA TAB	nutrition for life international	02053349	Tablet - Oral	5 MG	12/30/1996
FORMULA CW-CAPLET	body wise international llc	02138549	Tablet - Oral	50 MG	12/31/1995
CAL M TAB	anabolic laboratories inc.	00438162	Tablet - Oral	30 MG	12/31/1978
OMNIPLEX WITH BETA CAROTENE-TAB	vita health products inc	02132001	Tablet - Oral	50 MG	12/31/1995
MAGNA B-6	nutri-west products ltd.	02001063	Tablet - Oral	10 MG	12/31/1993
VITA VIM TAB	jamieson laboratories ltd	00575895	Tablet - Oral	20 MG / TAB	12/31/1983

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
LUNAFEM CAPSULAS BLANDAS	Bayer Hispania S.L.	73818	CÁPSULA BLANDA	Sin Receta	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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