Drug

Niacinamide

In clinical development

Emerging researchLate-stage developmentSteady momentum

Also known as 3-pyridinecarboxamide, Dialyvite 800, Dialyvite 800 + Iron, Dialyvite 800 with Iron+26 more

3-pyridinecarboxamide, Dialyvite 800, Dialyvite 800 + Iron, Dialyvite 800 with Iron, Dialyvite 800 with Zinc, Eldertonic, Ellis Tonic, Ferrocite Plus, Hemocyte Plus, Infuvite, Infuvite Pediatric, Integra F, Lactocal, Multi-Delyn, NIACIN (AS NIACINAMIDE), Natafort, NicAzel, Nicomide, Nicomide-T, Nicotinamida, Nicotinamide, Nicotinamidum, Nicotinic acid amide, Nicotinic amide, Prenatal Rx 1, Rena-Vite, Tandem OB, Tandem Plus, VITAMIN B3, Vitabee with C.

RxNorm7405 ChEMBLCHEMBL1140 ATCA11HA01UNII25X51I8RD4

Research papers

Active clinical trials

Latest activity

beta

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

Randomized Phase 2 Studying the Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia (CLL) With History of Non-melanoma Skin Cancers (NMSC)

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

A Phase 2, Open-label, Randomized Controlled Trial to Assess the Safety, Bactericidal Activity, and Pharmacokinetics of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Adults With Drug-susceptible Pulmonary Tuberculosis

Clinical trial2026-07-06Results expected Q2 2027 · ClinicalTrials.gov

Comparative Evaluation of Nicotine Analogs

Clinical trial2026-06-26Results expected Q4 2026 · ClinicalTrials.gov

Evaluation of the Efficacy and Safety of Oral Nicotinamide as an Adjunctive Therapy in Patients With Sepsis

Clinical trial2026-06-18Results expected Q4 2026 · ClinicalTrials.gov

Pilot Study of Tolerance and Efficacy Nicotinamide (Vitamin B3) in Dominant Optic Atrophy OPA1

Clinical trial2026-04-01Results expected Q3 2026 · ClinicalTrials.gov

Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide

Clinical trial2026-03-20Results expected Q1 2028 · ClinicalTrials.gov

NICOLHON - Pilot Study of the Efficacy of Nicotinamide (Vitamin B3) in Leber's Hereditary Optic Neuropathy

Clinical trial2025-12-18Results expected Q2 2028 · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicentre Study of the Efficacy and Safety of Nicotinamide in Patients With Friedreich Ataxia

Clinical trial2025-12-01Withdrawn · ClinicalTrials.gov

The therapeutic perspective of NAD+ precursors in age-related diseases.

Research2024-02-02Biochemical and biophysical research communications

NAD+ Precursors and Intestinal Inflammation: Therapeutic Insights Involving Gut Microbiota.

Research2023-06-30Nutrients

NAD+ supplementation reduces neuroinflammation and cell senescence in a transgenic mouse model of Alzheimer's disease via cGAS-STING.

Research2021-09-01Proceedings of the National Academy of Sciences of the United States of America

Effects of Nicotinamide and Lanthanum Carbonate on Serum Phosphate and Fibroblast Growth Factor-23 in CKD: The COMBINE Trial.

Research2019-05-13Journal of the American Society of Nephrology : JASN

Profile

Identifiers & mechanism

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

Canonical name

Niacinamide

Aliases & brands

3-pyridinecarboxamideDialyvite 800Dialyvite 800 + IronDialyvite 800 with IronDialyvite 800 with ZincEldertonicEllis TonicFerrocite PlusHemocyte PlusInfuviteInfuvite PediatricIntegra FLactocalMulti-DelynNIACIN (AS NIACINAMIDE)NatafortNicAzelNicomideNicomide-TNicotinamidaNicotinamideNicotinamidumNicotinic acid amideNicotinic amidePrenatal Rx 1Rena-ViteTandem OBTandem PlusVITAMIN B3Vitabee with C

RxNorm CUI

7405

ChEMBL ID

CHEMBL1140

ATC codes

A11HA01

UNII

25X51I8RD4

Clinical trials

46 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

registered trials across all phases

LATEST COMPLETION 2024

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 46

Early Phase 14Phase 19Phase 1 / 22Phase 217Phase 2 / 33Phase 36Phase 43Phase N / A2

Late-stage studies

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

Evaluation of the Efficacy and Safety of Oral Nicotinamide as an Adjunctive Therapy in Patients With Sepsis

Not yet recruitingPH IVAin Shams Universityn=602027

A Double Blind, Randomized Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation

CompletedPH IVUniversidad Autonoma de San Luis Potosín=282012

The Treatment of Acute Schizophrenia With High Dose Niacinmide Plus Ascorbate Plus Pyridoxine Plus Centrum Forte vs. Centrum Forte Only as an Add-On to Risperidone and Dietary Counseling

CompletedPH IVBeersheva Mental Health Centern=552008

Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: a Multicentre, Pragmatic Randomized Trial

RecruitingPH IIIWomen's College Hospitaln=3962027

Pilot Study of Tolerance and Efficacy Nicotinamide (Vitamin B3) in Dominant Optic Atrophy OPA1

Active, not recruitingPH II/IIIUniversity Hospital, Angersn=252026

Recent completions

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

A Phase II Randomized, Double-blind, Active Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of Psilocybin in Treatment-resistant Major Depression

CompletedPH IICentral Institute of Mental Health, Mannheimn=1442024

Double-bllind, Double-dummy, Randomized Clinical Trial Comparative Between Oral Nicotinamide Versus Topical Nicotinamide in the Management of Facial Actinic Keratosis .

CompletedPH IFederal University of Rio Grande do Suln=742024

Graft Acute Kidney Injury: Vitamin B3 to Facilitate Renal Recovery In the Early Life of a Transplant - GABRIEL

CompletedPH IIIAssistance Publique - Hôpitaux de Parisn=2042024

Vitamin B12 vs B3 for Nerve Regeneration and Functional Recovery After Pediatric Traumatic Brain Injury

CompletedPH IIIKRL Hospital, Islamabadn=3002023

A Double-Blind-Randomized, Placebo-Controlled Adaptive Design Trial of Nicotinamide in Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease Dementia

CompletedPH IIUniversity of California, Irvinen=462022

Phase II Study of Nicotinamide in Early Onset Preeclampsia

CompletedPH IIUniversity of North Carolina, Chapel Hilln=232021

Research activity

8 papers

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

Publications over time

20082024

Most influential

Sorafenib in advanced hepatocellular carcinoma.

The New England journal of medicine · 2008 · 10,144 cites

Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial.

Lancet (London, England) · 2017 · 2,767 cites

Wild-type BRAF is required for response to panitumumab or cetuximab in metastatic colorectal cancer.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2008 · 1,162 cites

Enhancing mitochondrial proteostasis reduces amyloid-β proteotoxicity.

Nature · 2017 · 550 cites

NAD+ supplementation reduces neuroinflammation and cell senescence in a transgenic mouse model of Alzheimer's disease via cGAS-STING.

Proceedings of the National Academy of Sciences of the United States of America · 2021 · 387 cites

Effects of Nicotinamide and Lanthanum Carbonate on Serum Phosphate and Fibroblast Growth Factor-23 in CKD: The COMBINE Trial.

Journal of the American Society of Nephrology : JASN · 2019 · 79 cites

Related diseases

3 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Alzheimer's Disease2 Carcinoma, Hepatocellular2 Liver Neoplasms2

Related drugs

3 matches

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

Sorafenib

Studied across 4 of the same disease areas as Niacinamide in the shared literature.

4 shared diseases3 shared papers

Regorafenib

Studied across 4 of the same disease areas as Niacinamide in the shared literature.

4 shared diseases1 shared paper

Nicotinamide Mononucleotide

Frequently co-studied with Niacinamide 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