Nicotinamide: clinical trials recruiting now
6
Recruiting trials
15
Conditions studied
2
US states with sites
5
Countries
FDA drug label
- FDA-approved
- Yes. Nicotinamide appears in the FDA drug-label database. Marketed as Nicotinamide.
- Drug class
- Copper-containing Intrauterine Device; Standardized Chemical Allergen (FDA established pharmacologic class)
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| cGMP deviations — Blossom Pharmaceuticals | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-10-31 |
| Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing — Faria Limited LLC dba Sheffield Pharmaceuticals | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2013-11-22 |
| cGMP deviations — Blossom Pharmaceuticals | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-10-31 |
| CGMP Deviations — SYNCHRONICITY SPA INC, DBA SUNTE | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2024-05-24 |
| Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold) — SYNCHRONICITY SPA INC, DBA SUNTE | Class I (FDA: reasonable probability of serious harm or death) | Ongoing | 2024-05-24 |
Phase breakdown
Phase 1 1
Phase 2 3
Phase 3 1
Not applicable 1
Conditions being studied
Recruiting trials involving Nicotinamide
- A Study of Nicotinamide With Oral Tetrahydrouridine and Decitabine to Treat High Risk Sickle Cell Disease
- Comparisons of NAD Precursors for Neuroenhancement in Glaucoma Patients
- Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia With History of Non-melanoma Skin Cancers
- Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
- Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)
- The Glaucoma Nicotinamide Trial
Common questions
Is Nicotinamide FDA-approved?
Yes, marketed as Nicotinamide.
How many recruiting trials involve Nicotinamide?
6 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.