Ireland
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Priya Life Science Compound trial record
Compound · clinical trials

Nicotinamide clinical trials

Also listed in trial records as Tetrahydrouridine, Niacinamide
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 6 trials in our USA, France, Spain, Canada and Brazil registers that name Nicotinamide as an intervention. Synced 9 Nov 2026
6Current trials
5Recruiting now
6Lead sponsors
5Country registers
At a glance

Nicotinamide is named as an intervention in 6 current clinical trials in our USA, France, Spain, Canada and Brazil registers. 5 are recruiting patients now. The most common phase is Phase 1. The sponsor with the most trials is EpiDestiny, Inc (1). The most-studied condition is Sickle Cell Disease.

Where Nicotinamide is approved

All regulators →
USUnited States (FDA)
No FDA approval of a single-substance product in Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

What health systems spend on Nicotinamide

All medicines →
ENNHS England
£629k
5,478 items dispensed, Sep 2025 to Aug 2026
-10% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
No single-ingredient product reimbursed by Medicaid in 2025
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Nicotinamide works

All drug targets →
Diseases it has been tested for in clinical trials, by furthest phase
  • Alzheimer diseasePhase 3
  • Acute kidney injuryPhase 3
  • Bladder transitional cell carcinomaPhase 3
  • Brain injuryPhase 3
  • CholelithiasisPhase 3
  • Diabetic autonomic neuropathyPhase 3
  • Diabetic polyneuropathyPhase 3
  • HyperphosphatemiaPhase 3
  • Open-angle glaucomaPhase 3
  • Type 2 diabetes mellitusPhase 3
36 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1140, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Nicotinamide

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • IE
    Ireland: 1 product on the HPRA list
    Each product record links to the HPRA, which publishes the leaflet and SmPC.
  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Nicotinamide

ATC code
A11HA01
ChEMBL
CHEMBL1140
DrugBank
DB02701
PubChem CID
936
CAS number
98-92-0
FDA UNII
25X51I8RD4
Wikidata
Q192423
Wikipedia
Nicotinamide

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

Trials by status

  • Recruiting583%
  • Active, closed117%

Trials by phase

  • Phase 1233%
  • Phase 2233%
  • Phase 2/3117%
  • Phase 3117%
01

Clinical trials of Nicotinamide

6 trials
StudyPhaseStatusLead sponsorRegisters
Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
NCT05955924 · ClinicalTrials.gov ↗ · Non-melanoma Skin Cancer, Carcinoma, Squamous Cell, Carcinoma, Basal Cell
Phase 3 Recruiting Women's College Hospital Canada
Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)
NCT06599918 · ClinicalTrials.gov ↗ · Fatty Liver, Obesity, Hepatic Fibrosis
Phase 2 Recruiting Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Spain
Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Antiretrovirals
NCT06805656 · ClinicalTrials.gov ↗ · Hiv, HIV I Infection
Phase 2 Recruiting Federal University of São Paulo Brazil
A Study of Nicotinamide With Oral Tetrahydrouridine and Decitabine to Treat High Risk Sickle Cell Disease
NCT04055818 · Sickle Cell Disease
Phase 1 Recruiting EpiDestiny, Inc USA
Tracing the Metabolic Flux of Orally Administered NAD+ Precursors
NCT06882096 · ClinicalTrials.gov ↗ · Healthy Adults
Phase 1 Recruiting Metro International Biotech, LLC USA
Tolerance and Efficacy Nicotinamide (Vitamin B3) in Dominant Optic Atrophy OPA1
NCT06007391 · ClinicalTrials.gov ↗ · Nicotinamide Adverse Reaction
Phase 2/3 Active, closed University Hospital, Angers France

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Nicotinamide across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

1 single-substance product containing Nicotinamide on the HPRA medicines list.

  • Nicam 4% w/w GelDermal Laboratories (Ireland) Limited · PA23128/012/001 · Not marketed
All 1 Irish product →

Supply shortages

No entry for Nicotinamide in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Nicotinamide

13 conditions
Sickle Cell Disease1Healthy Adults1Nicotinamide Adverse Reaction1Fatty Liver1Obesity1Hepatic Fibrosis1NAFLD1Non-melanoma Skin Cancer1Carcinoma, Squamous Cell1Carcinoma, Basal Cell1Keratinocyte Carcinoma1Hiv1
All 13 conditions
Condition (as registered)Trials
Sickle Cell Disease1
Healthy Adults1
Nicotinamide Adverse Reaction1
Fatty Liver1
Obesity1
Hepatic Fibrosis1
NAFLD1
Non-melanoma Skin Cancer1
Carcinoma, Squamous Cell1
Carcinoma, Basal Cell1
Keratinocyte Carcinoma1
Hiv1
HIV I Infection1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
EpiDestiny, Inc1
Metro International Biotech, LLC1
University Hospital, Angers1
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1
Women's College Hospital1
Federal University of São Paulo1
05

By country register

RegisterTrialsRecruiting
Clinical trials in USA22
Clinical trials in France10
Clinical trials in Spain11
Clinical trials in Canada11
Clinical trials in Brazil11

A trial with sites in more than one country appears in each of those registers.

06

Related compounds

07

Questions about Nicotinamide trials

How many clinical trials are testing Nicotinamide?

6 current trials in our USA, France, Spain, Canada and Brazil registers name Nicotinamide as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Nicotinamide trials recruiting patients?

Yes. 5 of the 6 trials are recruiting: 2 with sites in USA, 1 with sites in Spain, 1 with sites in Canada and 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Nicotinamide clinical trials?

EpiDestiny, Inc (1), Metro International Biotech, LLC (1), University Hospital, Angers (1) and Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (1), among 6 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Is Nicotinamide licensed in Ireland?

Yes. The HPRA medicines list includes 1 single-substance product containing Nicotinamide, for example Nicam 4% w/w Gel (Dermal Laboratories (Ireland) Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Nicotinamide shortage?

Not in the lists we track: Nicotinamide has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Nicotinamide works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Nicotinamide works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Nicotinamide (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.