Niacinamide
As of the edition of 20 October 2026, Niacinamide is a small molecule: marketed, first approved in 1951 (CA).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1989
- Kind
- Small molecule
- Brand name
- Tpn
- First approved
- 31 December 1951 (CA)
- Approvals on record
- 29 in 4 regions
- Holder of the most recent approval
- B. Braun Medical; 13 holders in all
- Registered trials
- 51, 1 stopped early
- Disease areas
- Urinary and reproductive; Nervous system; Pregnancy and women's health; Cancer; Nutrition and metabolism; Skin and connective tissue
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 7 | 3 | 2 | 1 |
| Phase 1 | 12 | 7 | 5 | 0 |
| Phase 2 | 17 | 7 | 5 | 0 |
| Phase 3 | 14 | 9 | 4 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 51 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant | 1954 to now |
| Baxter Healthcare | Later holder | 1987 to now |
| B. Braun Medical | Later holder | 2024 to now |