Nicotinamide

Phase 2Small molecule

MMetro International Biotech, LLC

Nicotinamide is one of 365 small molecule programs targeting Lupus Erythematosus. It is currently in Phase 2.

Indications

Total Trials

Active Trials

364

Competitors

Pipeline

Status by Indication[3][1]

Indication

Lupus ErythematosusActive, not recruiting

Lung CancerActive, not recruiting

Friedreich AtaxiaActive, not recruiting

Skin CancerActive, not recruiting

FibrosisActive, not recruiting

Optic AtrophyActive, not recruiting

LymphopeniaActive, not recruiting

HyperphosphatemiaActive, not recruiting

PreeclampsiaActive, not recruiting

Chronic Lymphocytic LeukemiaActive, not recruiting

Lupus ErythematosusPhase 2

Active, not recruiting

Lung CancerPhase 2/Phase 3

Active, not recruiting

Friedreich AtaxiaPhase 2

Active, not recruiting

Skin CancerPhase 2

Active, not recruiting

FibrosisPhase 2

Active, not recruiting

Optic AtrophyPhase 2/Phase 3

Active, not recruiting

LymphopeniaPreclinical

Active, not recruiting

HyperphosphatemiaPhase 2

Active, not recruiting

PreeclampsiaPhase 1

Active, not recruiting

Chronic Lymphocytic LeukemiaPhase 2

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

791 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Rituxan

Roche

Preclinical

61 2

Orencia

Bristol-Myers Squibb

Preclinical

47 3

Actemra

Cimzia

30 5

Simponi

Johnson & Johnson

Preclinical

19 6

Nicotinamide

MMetro International Biotech, LLC

Phase 2

1 7

Enbrel

IImmunex

Preclinical

64 8

Remicade

OOrganon and Co

Preclinical

43 9

Arcoxia

Novartis

Preclinical

4 10

Kevzara

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2/3Recruiting

Optic Atrophy

NCT06007391

Q4 2026

Phase 1Recruiting

Tobacco-Related Carcinoma

NCT07585006

Q2 2027

Phase 1Recruiting

Sickle Cell Disease

NCT04055818

Phase 1Recruiting

Oral

NCT06882096

Q3 2027

Phase 3Recruiting

Solid Organ Transplant Recipients

NCT05955924

Clinical

Trials by Indication[1]

Nicotinamide6 trials

Pilot Trial of Supplemental Vitamin A and Nicotinamide

Recruiting·RRhode Island Hospital·Phase 1·NCT05702398·30 enrolled

Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients

Terminated·—·Phase 3·NCT01011699·176 enrolled

Safety and Pharmacokinetics of Oral Controlled-ileocolonic-release Nicotinamide (CICR-NAM)

Completed·UUniversity Hospital Schleswig-Holstein·Phase 1·NCT05258474·49 enrolled

Show 3 more trials

Topical Nicotinamide in Treatment of DLE

Completed·—·Phase 1·NCT05362188·60 enrolled

Nicotinamide Supplementation Improves Physical Performance in Older Adults at Risk of Falls

Recruiting·UUniversity of Chile·Phase 2·NCT06465602·60 enrolled

The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE

Completed·TThe Cleveland Clinic·Phase 2·NCT02258074·205 enrolled

Preeclampsia2 trials

Phase I Study of Nicotinamide for Early Onset Preeclampsia

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT02213094·10 enrolled

Study of Nicotinamide in Early Onset Preeclampsia

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT03419364·23 enrolled

Actinic Keratosis2 trials

Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients

Completed·RRhode Island Hospital·Phase 1·NCT04843553·30 enrolled

Comparison of Nicotinamide Treatments for Actinic Keratosis

Completed·FFederal University of Rio Grande do Sul·Phase 1·NCT07049068·74 enrolled

Skin Cancer1 trial

Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial

Unknown status·WWomen's College Hospital·Phase 2·NCT03769285·120 enrolled

Fibrosis1 trial

Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)

Recruiting·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 2·NCT06599918·30 enrolled

18 more indications

Hyperphosphatemia1 trial

Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

Completed·MMedice Arzneimittel Pütter GmbH & Co KG·Phase 2·NCT01200784·252 enrolled

Chronic Lymphocytic Leukemia1 trial

Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia With History of Non-melanoma Skin Cancers

Recruiting·UUniversity of Utah·Phase 2·NCT04844528·86 enrolled

Alzheimer's Disease1 trial

Safety Study of Nicotinamide to Treat Alzheimer's Disease

Completed·UUniversity of California, Irvine·Phase 1/2·NCT00580931·50 enrolled

Sickle Cell Disease1 trial

A Study of Nicotinamide With Oral Tetrahydrouridine and Decitabine to Treat High Risk Sickle Cell Disease

Recruiting·EEpiDestiny, Inc.·Phase 1·NCT04055818·20 enrolled

Optic Atrophy1 trial

Tolerance and Efficacy Nicotinamide (vitamin B3) in Dominant Optic Atrophy OPA1

Recruiting·UUniversity Hospital, Angers·Phase 2/3·NCT06007391·25 enrolled

Rheumatoid Arthritis1 trial

The Effect of Nicotinamide on the Clinical Outcome of Rheumatoid Arthritis Patients

Recruiting·—·Phase 2·NCT06640309·70 enrolled

Oral1 trial

Tracing the Metabolic Flux of Orally Administered NAD+ Precursors

Recruiting·MMetro International Biotech, LLC·Phase 1·NCT06882096·32 enrolled

Friedreich ataxia1 trial

Study of the Efficacy and Safety of Nicotinamide in Patients With Friedreich Ataxia

Withdrawn·RRWTH Aachen University·Phase 2·NCT03761511

Ataxia1 trial

Effect of Nicotinamide in Friedreich's Ataxia

Unknown status·IImperial College London·Phase 2·NCT01589809·40 enrolled

Early Alzheimer's Disease1 trial

Nicotinamide as an Early Alzheimer's Disease Treatment

Completed·UUniversity of California, Irvine·Phase 2·NCT03061474·46 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression

Completed·—·Phase 2·NCT04670081·144 enrolled

Pregnant Women1 trial

Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women - Mumta Pregnant Women Trial

Unknown status·VVital Pakistan Trust·N/A·NCT04012177·1,884 enrolled

Lupus Erythematosus1 trial

Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus Erythematosus

Unknown status·SSecond Xiangya Hospital of Central South University·Phase 2·NCT03260166·40 enrolled

Lymphopenia1 trial

Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19

Completed·QQiang Hu·N/A·NCT04910230·24 enrolled

Lung Cancer1 trial

Anticancer Activity of Nicotinamide on Lung Cancer

Unknown status·—·Phase 2/3·NCT02416739·110 enrolled

Solid Organ Transplant Recipients1 trial

Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial

Recruiting·WWomen's College Hospital·Phase 3·NCT05955924·396 enrolled

Tobacco-Related Carcinoma1 trial

Comparative Evaluation of Nicotine Analogs

Recruiting·OOhio State University Comprehensive Cancer Center·Phase 1·NCT07585006·70 enrolled

Unspecified1 trial

Healthy Combine Study

Completed·NNorthwestern University·Phase 1·NCT03136705·39 enrolled

Sources

References

[1]
ClinicalTrials.gov — 30 trial records for Nicotinamide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nicotinamide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nicotinamide. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Metro International Biotech, LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: MMetro International Biotech, LLC

Nicotinamide

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q2 2027

Q3 2027

Trials by Indication[1]

Nicotinamide6 trials

Preeclampsia2 trials

Actinic Keratosis2 trials

Skin Cancer1 trial

Fibrosis1 trial

Hyperphosphatemia1 trial

Chronic Lymphocytic Leukemia1 trial

Alzheimer's Disease1 trial

Sickle Cell Disease1 trial

Optic Atrophy1 trial

Rheumatoid Arthritis1 trial

Oral1 trial

Friedreich ataxia1 trial

Ataxia1 trial

Early Alzheimer's Disease1 trial

Efficacy and Safety1 trial

Pregnant Women1 trial

Lupus Erythematosus1 trial

Lymphopenia1 trial

Lung Cancer1 trial

Solid Organ Transplant Recipients1 trial

Tobacco-Related Carcinoma1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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