Niacinamide

Summary

Niacinamide (CHEMBL1140) is an approved small-molecule EC 2.4.2.30 (NAD+ ADP-ribosyltransferase) inhibitor (ATC A11HA01); indicated across 38 conditions including anemia and iron deficiency anemia; with CIViC clinical evidence for 1 variant-indication association (e.g. SIRT1 Overexpression in pancreatic cancer).

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: A11HA01
• Indications: 38 conditions
• Clinical trials: 84
• Precision-oncology evidence (CIViC): 1 variant–indication association
• Chemistry: 122.12 Da · C6H6N2O

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1140
Name	Niacinamide
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	936
ChEBI	CHEBI:17154
ATC	A11HA01
Molecular formula	C6H6N2O
Molecular weight	122.12
InChIKey	DFPAKSUCGFBDDF-UHFFFAOYSA-N

SMILES: C1=CC(=CN=C1)C(=O)N

IUPAC name: pyridine-3-carboxamide

ChEBI definition: A pyridinecarboxamide that is pyridine in which the hydrogen at position 3 is replaced by a carboxamide group.

Pharmacological roles (ChEBI): EC 2.4.2.30 (NAD+ ADP-ribosyltransferase) inhibitor, cofactor, antioxidant, neuroprotective agent, EC 3.5.1.98 (histone deacetylase) inhibitor, anti-inflammatory agent, Sir2 inhibitor, geroprotector.

Other ChEBI roles (chemical / environmental): metabolite, Saccharomyces cerevisiae metabolite, Escherichia coli metabolite, mouse metabolite, human urinary metabolite.

Also known as: Freederm, Niacin (as niacinamide), Niacinamid, Niacinamide, Niacinamide component of tpn, Niacinamide component of vitaped, Niatin, Nicam, Nicobion, Nicotinamida, Nicotinamide, Nicotinamidum

Patent coverage: 99,076 distinct patent families (231,688 SureChEMBL compound mentions), from 3 matched compound structure(s). One matched structure accounts for 231,019 (100%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 10 (assay-derived). Sample: Coagulation factor VII/tissue factor, NAD-dependent protein deacylase sirtuin-6, NAD-dependent protein deacylase sirtuin-5, mitochondrial, NAD-dependent protein lipoamidase sirtuin-4, mitochondrial, Fatty-acid amide hydrolase 1, NAD-dependent protein deacetylase sirtuin-3, mitochondrial, NAD-dependent protein deacetylase sirtuin-2, NAD-dependent protein deacetylase sirtuin-1, NAD(+) hydrolase SARM1, NAD-dependent protein deacetylase HST2.

Bioactivity

ChEMBL activities: 6 potent at pChembl ≥ 5 of 37 total. Top 100 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
SIRT2	5.92	IC50	1200	nM	CHEMBL_ACT_12178807
SIRT2	5.92	IC50	1200	nM	CHEMBL_ACT_16483900
P97612	5.48	IC50	3300	nM	CHEMBL_ACT_1744811
SIRT3	5.21	IC50	6200	nM	CHEMBL_ACT_15082633
SIRT2	5.2	IC50	6300	nM	CHEMBL_ACT_15203742
SIRT3	5	IC50	10000	nM	CHEMBL_ACT_18850642

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

3 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
anemia	4	MONDO:0002280	EFO:0004272
iron deficiency anemia	4	MONDO:0001356	HP:0001891
acne	4	MONDO:0011438	EFO:0003894

25 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
obstructive jaundice	3	MONDO:0006874	EFO:1001068
diabetic neuropathy	3	MONDO:0006626	EFO:1000783
stroke disorder	3	MONDO:0005098	EFO:0000712
chronic kidney disease	3	MONDO:0005300	MONDO:0024327
brain injury	3	MONDO:0043510	MONDO:0043510
psoriasis	2	MONDO:0005083	EFO:0000676
preeclampsia	2	MONDO:0005081	EFO:0000668
non-small cell lung carcinoma	2	MONDO:0005233	EFO:0003060
neurodegenerative disease	2	MONDO:0005559	EFO:0005772
squamous cell carcinoma	2	MONDO:0005096	EFO:0000707
basal cell carcinoma	2	MONDO:0020804	EFO:0004193
polycystic kidney disease	2	MONDO:0020642	EFO:0008620
cutaneous lupus erythematosus	2	MONDO:0005282	EFO:0003834
depressive disorder	2	MONDO:0002050	MONDO:0002050
B-cell chronic lymphocytic leukemia	2	MONDO:0004948	EFO:0000095
ataxia telangiectasia	2	MONDO:0008840	Orphanet:100
Friedreich ataxia	2	MONDO:0100339	MONDO:0100339
open-angle glaucoma	2	MONDO:0005338	EFO:0004190
systemic lupus erythematosus	2	MONDO:0007915	MONDO:0007915
Hodgkins lymphoma	1	MONDO:0004952	EFO:0000183
non-Hodgkin lymphoma	1	MONDO:0018908	EFO:0005952
Alzheimer disease	1	MONDO:0004975	MONDO:0004975
multiple sclerosis	1	MONDO:0005301	MONDO:0005301
sickle cell disease	1	MONDO:0011382	MONDO:0011382
hyperphosphatemia	1	MONDO:0000328	MONDO:0000328

6 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 84.

Phase distribution

Phase	Trials
Not specified	27
PHASE2	21
PHASE1	12
PHASE3	10
EARLY_PHASE1	7
PHASE2/PHASE3	3
PHASE4	2
PHASE1/PHASE2	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00140166	PHASE4	COMPLETED	Treatment of Acute Schizophrenia With Vitamin Therapy
NCT01542138	PHASE4	COMPLETED	Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation
NCT04589546	PHASE3	ACTIVE_NOT_RECRUITING	Does High-dose Vitamin B3 Supplementation Prevent Major Adverse Kidney Events During Septic Shock?
NCT05955924	PHASE3	RECRUITING	Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
NCT06007391	PHASE2/PHASE3	ACTIVE_NOT_RECRUITING	Tolerance and Efficacy Nicotinamide (Vitamin B3) in Dominant Optic Atrophy OPA1
NCT06731582	PHASE3	ENROLLING_BY_INVITATION	Nicotinamide Supplementation in Glaucoma
NCT00033436	PHASE3	COMPLETED	Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer
NCT01011699	PHASE3	TERMINATED	Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients
NCT02416739	PHASE2/PHASE3	UNKNOWN	Anticancer Activity of Nicotinamide on Lung Cancer
NCT03268902	PHASE2/PHASE3	COMPLETED	Early Life Interventions for Childhood Growth and Development In Tanzania
NCT04631484	PHASE3	COMPLETED	International Trial of Efficacy of Cytoflavin in Head Trauma
NCT04649203	PHASE3	COMPLETED	Cytoflavin in the Treatment of Patients With Diabetic Polyneuropathy
NCT05513807	PHASE3	COMPLETED	Graft Acute Kidney Injury: Vitamin B3 to Facilitate Renal Recovery In the Early Life of a Transplant
NCT05935787	PHASE3	COMPLETED	Cytoflavin in the Complex Rehabilitation of Stroke Patients
NCT05958277	PHASE3	COMPLETED	Vitamin B12 vs B3 for Nerve Regeneration and Functional Recovery After Pediatric Traumatic Brain Injury
NCT04750616	PHASE2	RECRUITING	NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
NCT04844528	PHASE2	RECRUITING	Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia With History of Non-melanoma Skin Cancers
NCT06599918	PHASE2	RECRUITING	Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)
NCT06640309	PHASE2	RECRUITING	The Effect of Nicotinamide on the Clinical Outcome of Rheumatoid Arthritis Patients
NCT06991712	PHASE2	RECRUITING	Comparisons of NAD Precursors for Neuroenhancement in Glaucoma Patients
NCT07517445	PHASE2	RECRUITING	Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis
NCT00508885	PHASE1/PHASE2	COMPLETED	The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
NCT00580931	PHASE1/PHASE2	COMPLETED	Safety Study of Nicotinamide to Treat Alzheimer’s Disease
NCT01200784	PHASE2	COMPLETED	Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
NCT01368887	PHASE2	SUSPENDED	Study to Test the Effectiveness of a New Treatment for Scalp Psoriasis
NCT01589809	PHASE2	UNKNOWN	Effect of Nicotinamide in Friedreich’s Ataxia
NCT02140814	PHASE2	COMPLETED	Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease
NCT02258074	PHASE2	COMPLETED	The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE
NCT02558595	PHASE2	COMPLETED	Pilot Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD2)
NCT03061474	PHASE2	COMPLETED	Nicotinamide as an Early Alzheimer’s Disease Treatment
NCT03260166	PHASE2	UNKNOWN	Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus Erythematosus
NCT03419364	PHASE2	COMPLETED	Study of Nicotinamide in Early Onset Preeclampsia
NCT03761511	PHASE2	WITHDRAWN	Study of the Efficacy and Safety of Nicotinamide in Patients With Friedreich Ataxia
NCT03769285	PHASE2	UNKNOWN	Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial
NCT03850886	PHASE2	COMPLETED	Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients
NCT03962114	PHASE2	COMPLETED	Effects of Vitamin B3 in Patients With Ataxia Telangiectasia
NCT04670081	PHASE2	COMPLETED	Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression
NCT06465602	PHASE2	UNKNOWN	Nicotinamide Supplementation Improves Physical Performance in Older Adults at Risk of Falls
NCT04055818	PHASE1	RECRUITING	A Study of Nicotinamide With Oral Tetrahydrouridine and Decitabine to Treat High Risk Sickle Cell Disease
NCT06882096	PHASE1	RECRUITING	Tracing the Metabolic Flux of Orally Administered NAD+ Precursors
NCT07119996	PHASE1	NOT_YET_RECRUITING	Clinical Trial on the Protective Role of Vitamin B3 in Enhancing Immunotherapy for Bladder Cancer Patients
NCT07258667	PHASE1	NOT_YET_RECRUITING	Pilot Study of the Efficacy of Nicotinamide (Vitamin B3) in Leber’s Hereditary Optic Neuropathy
NCT07585006	PHASE1	NOT_YET_RECRUITING	Comparative Evaluation of Nicotine Analogs
NCT00316472	PHASE1	COMPLETED	The Effect of Oral Niacinamide on Serum Phosphorus Levels in Hemodialysis Patients
NCT00691210	PHASE1	COMPLETED	Phase I Vorinostat in Combination With Niacinamide and Etoposide for Lymphoid Malignancies
NCT01381354	PHASE1	COMPLETED	Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
NCT02213094	PHASE1	COMPLETED	Phase I Study of Nicotinamide for Early Onset Preeclampsia
NCT03136705	PHASE1	COMPLETED	Healthy Combine Study
NCT05698771	PHASE1	COMPLETED	NAD-brain: a Pharmacokinetic Study of NAD Replenishment Therapy
NCT07049068	PHASE1	COMPLETED	Comparison of Nicotinamide Treatments for Actinic Keratosis
NCT05702398	EARLY_PHASE1	RECRUITING	Pilot Trial of Supplemental Vitamin A and Nicotinamide
NCT06983730	EARLY_PHASE1	RECRUITING	The Kidney’s Response to Exercise in Heat, and the Impact of Vitamin B3 on This Response
NCT07286318	EARLY_PHASE1	NOT_YET_RECRUITING	A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Transplant Recipients
NCT02701127	EARLY_PHASE1	COMPLETED	Molecular Effects of Vitamin B3 (Niacinamide) in Acute Kidney Injury
NCT03392623	EARLY_PHASE1	COMPLETED	DNA Methylation in Malar Melasma and Its Change by Sunscreen, Retinoic Acid and Niacinamide.
NCT04843553	EARLY_PHASE1	COMPLETED	Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients
NCT05362188	EARLY_PHASE1	COMPLETED	Topical Nicotinamide in Treatment of DLE
NCT05119166	Not specified	ACTIVE_NOT_RECRUITING	International Milk Composition (IMiC) Consortium
NCT05275738	Not specified	RECRUITING	The Glaucoma Nicotinamide Trial
NCT06868771	Not specified	RECRUITING	Study on the Effectiveness of an Emollient Cream Containing Pre and Postbiotic and Niacinamide 4% in the Treatment of Skin Xerosis and Itching in Oncological Patients Treated with Anti-EGFR
NCT06889142	Not specified	NOT_YET_RECRUITING	Impact of NMN Supplementation on CD4+ T Cell Recovery in HIV Patients With Immunological Failure
NCT07006194	Not specified	NOT_YET_RECRUITING	Nicotinamide Levels in Serum, Aqueous Humor, and Tear Film in Glaucoma and Correlations With Mitochondrial Damage-Associated Molecular Patterns (mtDAMPs) and Senescence-Associated Secretory Phenotype (SASP)
NCT00605930	Not specified	COMPLETED	A Pilot Clinical Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy.
NCT02758990	Not specified	TERMINATED	Interventional Testing of Gene-environment Interactions Via the Verifomics Mobile Application
NCT03797469	Not specified	COMPLETED	Nutritional Supplements and Performance During Visual Field Testing (B3 Vitamin)
NCT03808961	Not specified	TERMINATED	Low Dose Niacin (Vitamin B3) for Parkinson’s Disease
NCT04012177	Not specified	UNKNOWN	Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women - Mumta Pregnant Women Trial
NCT04218500	Not specified	COMPLETED	The Effectiveness and Safety of Niacinamide 4% and Virgin Coconut Oil 30% for Secondary Prevention of Occupational Hand Dermatitis
NCT04664361	Not specified	COMPLETED	Effect of NMN on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity
NCT04725253	Not specified	UNKNOWN	Nicotinamide to Prevent Delirium
NCT04751604	Not specified	COMPLETED	Improvement of the Nutritional Status Regarding Nicotinamide (Vitamin B3) and the Disease Course of COVID-19
NCT04823260	Not specified	COMPLETED	To Evaluate the Efficacy and Safety of NMN as an Anti-ageing Supplement in Middle Aged and Older (40-65 Years) Adults
NCT04910230	Not specified	COMPLETED	Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19
NCT05017428	Not specified	COMPLETED	Absorption and Digestion Kinetics of Human Metabolites
NCT05175768	Not specified	TERMINATED	Study to Evaluate the Effect of Nicotinamide Mononucleotide (NMN) As an Adjuvant to Standard of Care (SOC) On Fatigue Associated With COVID-19 Infection
NCT05297851	Not specified	COMPLETED	Cytoflavin in Combination With Reperfusion in Stroke Patients
NCT05517122	Not specified	COMPLETED	Effect of Oral NAD+ Precursors Administration on Blood NAD+ Concentration in Healthy Adults
NCT05530707	Not specified	COMPLETED	Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer
NCT05642702	Not specified	UNKNOWN	Primary Irritation Patch Test (PIPT) Study Conducted at NovoBliss Research for Shared Panel
NCT05916066	Not specified	COMPLETED	Nicotinamide and Glaucoma
NCT06214078	Not specified	UNKNOWN	Preliminary Clinical Study of NMN Intervention in Mild Ulcerative Colitis
NCT07007260	Not specified	COMPLETED	Effect of Niacinamide Supplementation in Glaucoma
NCT07062120	Not specified	COMPLETED	Efficacy and Safety of 30% Salicylic Acid and 10% Nicotinamide Combined Therapy in Melasma
NCT07337486	Not specified	COMPLETED	Evaluation of a Non-Pharmacological Skin Care Intervention for the Prevention and Treatment of Skin Toxicities Caused by Immunotherapy in Cancer Patients

Clinical evidence (CIViC)

Variant × indication × effect (1 predictive associations from 1 curated evidence items):

Variant	Indication	Effect	Therapy	Level	CIViC
SIRT1 Overexpression	Pancreatic Cancer	Resistance	Niacinamide	CIViC D	EID1294

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).