nicotinamide

Small moleculeapproved

Approved

Jul 28, 1947

Niacinamide, known as nicotinamide, is an important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and pellagra. Pellagra is a nutritional disease that occurs due to insufficient dietary amounts of vitamin B3 or the chemical it is made from (tryptophan). Symptoms of pellagra include skin disease, diarrhea, dementia, and depression. In addition, was experiments, revealed, that niacinamide hydroiodide might have role in ophthalmology and parenteral use of niacinamide hydroiodide can treat arteriosclerotic syndromes. — NCATS

Clinical trial activity

227 trials · 272 clinical orgs · 9 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Apr 1, 1999 (NCT00018460)

Timeline

1940s

Jul 28, 1947
Roche — Earliest FDA Approval
Jul 28, 1947
Roche — NDA Secondary Org
Jul 28, 1947
Roche — NDA Organization

1950s

Feb 20, 1953
Hospira — NDA Secondary Org

1980s

Nov 6, 1981
Abraxis — NDA Secondary Org
Jul 13, 1982
Watson Pharmaceuticals — NDA Secondary Org

2000s

Jan 1, 2000
Earliest Phase 3 Sponsor(trial)
May 18, 2000
Sandoz — NDA Secondary Org
May 18, 2000
Novartis — NDA Secondary Org
Jan 1, 2006
Earliest Phase 1 Sponsor(trial)

2010s

Jan 1, 2010
Earliest Phase 2 Sponsor(trial)

2020s

Apr 9, 2026
Apotex — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

PARP 1, 2 and 3ANTAGONIST
PARP 1, 2 and 3 antagonist

Combination products

berocca pn
with vitamin e, folic acid, cyanocobalamin, vitamin c, thiamine, biotin, panthenol, pyridoxine, riboflavin, vitamin a, ergocalciferol
Also known as m.v.c, mvc plus
infuvite
with vitamin d3, vitamin e, folic acid, cyanocobalamin, vitamin c, thiamine, vitamin k, biotin, panthenol, pyridoxine, riboflavin, vitamin a
Also known as infuvite pediatric, infuvite pediatric (pharmacy bulk package)
m.v.i. adult (pharmacy bulk package)
with vitamin e, folic acid, cyanocobalamin, vitamin c, thiamine, vitamin k, biotin, panthenol, pyridoxine, riboflavin, vitamin a, ergocalciferol
m.v.i. pediatric
with vitamin e, folic acid, cyanocobalamin, vitamin c, thiamine, biotin, panthenol, pyridoxine, riboflavin, vitamin a, phytonadione, ergocalciferol
tpn
with tyrosine, pyridoxine
vitape
with vitamin e, folic acid, cyanocobalamin, vitamin c, thiamine, pantothenic acid, biotin, pyridoxine, riboflavin, vitamin a, phytonadione, ergocalciferol

Approval history

approvedJul 28, 1947

Chemistry & pharmacology

Loading structure…

SMILES

NC(=O)C1=CC=CN=C1

Mol. weight: 122.1246 g/mol
Lipinski Ro5: Pass
Rule of 3: Yes
Chirality: Achiral Molecule
Inorganic: No
Polymer: No
Delivery: Oral, Parenteral
Availability: Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Sources

Also known as

1,4-dihydronicotinamide adenine dinucleotide
1,4-dihydronicotinamide adenine dinucleotide
3-pyridinecarboxamide
coenzyme i
dpnh
dpnh
freederm
nad
nadh
nadh
nadh
nadide
nadide
nad reduced form
nad reduced form
niacinamide
niacinamide
niacinamide
niacinamide
niacinamide
niacinamide
niacinamide
niatin
nicam
nicobion
nicobion
nicord
nicotinamide
nicotinamide
nicotinamide
nicotinamide
nicotinamide
nicotinamide
nicotinamide
nicotinamide
nicotinamide adenine
nicotinamide adenine
nicotinamide adenine
nicotinamide adenine
nicotinamide adenine
nicotinamide adenine dinucleotide
nicotinamide adenine dinucleotide (reduced)
nicotinamide adenine dinucleotide (reduced)
nicotinamide-adenine dinucleotide, reduced
nicotinamide-adenine dinucleotide, reduced
nicotinamide riboside
nicotinic acid amide
nicotinic acid amide
nicotinic amide
nicotinic amide
nicotylamide
nicotylamide
papulex
papulex
reduced nicotinamide-adenine dinucleotide
reduced nicotinamide-adenine dinucleotide
reduced nicotinamide adenine diphosphate
reduced nicotinamide adenine diphosphate
vitamin b
vitamin b

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07258667	Phase 1	Apr 30, 2026	University of Angers
NCT07278492	Phase 1	Apr 1, 2026	Harvard University, National Institutes of Health (NIH)
NCT07286318	Early Phase 1 (Phase 1)	Jan 1, 2026	University of Pittsburgh
NCT07284225	N/A	Dec 20, 2025	Fudan University
NCT07013591	Phase 2	Dec 15, 2025	Harvard University, National Institute on Aging (NIA)
NCT06971224	Phase 2	Oct 13, 2025	University of Bergen
NCT07132801	N/A	Oct 13, 2025	Qualia Life Sciences
NCT07006194	N/A	Oct 1, 2025	D'Annunzio University of Chieti–Pescara, University of Pisa, University of Sassari
NCT07251608	Phase 1	Oct 1, 2025	ChromaDex
NCT07121439	N/A	Sep 15, 2025	University of Indonesia
NCT07144527	N/A	Sep 15, 2025	Concordia University
NCT07024966	N/A	Aug 1, 2025	Circe, S.L., Eurecat
NCT06991712	Phase 2	May 19, 2025	The University of Hong Kong
NCT06889142	N/A	Apr 30, 2025	DoNotAge.org, TriHealth
NCT06882096	Phase 1	Apr 28, 2025	Harvard University, Metro International Biotech, LLC
NCT06805656	N/A	Apr 1, 2025	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Sao Paulo
NCT06853743	Phase 2	Mar 31, 2025	Elysium Health, South-Eastern Norway Regional Health Authority, The Dam Foundation, University of Bergen, University of Oslo
NCT07073352	N/A	Mar 27, 2025	University of Iowa
NCT06815991	Phase 1	Feb 11, 2025	Harvard University, Metro International Biotech, LLC
NCT06567717	Phase 2	Jan 31, 2025	Cedars-Sinai Medical Center

Showing 20 of 227 trials

Page 1 / 12

Organizations

Research & Development (272)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
University of Bergen	Academic/Hospital	15	13	2	2018
Harvard University	Academic/Hospital	12	7	4	2016
Elysium Health	For profit	11	2	4	2018
ChromaDex	For profit	10	2	3	2014
National Heart, Lung, and Blood Institute (NHLBI)	Government	9	5	2	2015
Polysan, Ltd.	For profit	7	7	1	2017
Department of Veteran Affairs	Government	6	3	2	1999
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Government	6	1	3	2015
National Institutes of Health (NIH)	Government	6	0	4	2015
University of Copenhagen	Academic/Hospital	6	3	3	2014
University of Pennsylvania	Academic/Hospital	6	4	4	2018
Metro International Biotech, LLC	For profit	5	5	2	2021
University of Oslo	Academic/Hospital	5	2	1	2019
University of Washington	Academic/Hospital	5	5	2	2015
Duke University	Academic/Hospital	4	0	2	2010
Gamida Cell	For profit	4	4	2	2010
Mayo Clinic	Academic/Hospital	4	4	2	2016
National Institute on Aging (NIA)	Government	4	0	2	2018
Oslo Metropolitan University	Academic/Hospital	4	3	1	2019
University of Iowa	Academic/Hospital	4	3	2	2016

272 organizations

Page 1 / 14

Marketing (10)

Organization	Org type	Relationship	Date
Abraxis	For profit	NDA2	Nov 6, 1981
Apotex	For profit	MKTG	Apr 9, 2026
Hospira	For profit	NDA2	Feb 20, 1953
International Minerals and Chemical Corporation	For profit	NDA2	—
Novartis	For profit	NDA2	May 18, 2000
Roche	For profit	NDA2	Jul 28, 1947
Roche	For profit	NDA	Jul 28, 1947
Sandoz	For profit	NDA2	May 18, 2000
Teligent Pharmaceuticals	For profit	NDA2	—
Watson Pharmaceuticals	For profit	NDA2	Jul 13, 1982