Nizatidine
As of the edition of 20 October 2026, Nizatidine is a small molecule: marketed, first approved in 1988 (US); acts on HRH2; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1988
- Kind
- Small molecule
- Brand name
- Axid
- First approved
- 12 April 1988 (US)
- Approvals on record
- 4 in 1 region
- Holder of the most recent approval
- Braintree; 3 holders in all
- Registered trials
- 9, 0 stopped early
- Disease areas
- Digestive system; Lungs and airways; Infections; Mental health
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Nizatidine.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| HRH2 | Histamine H2 receptor | P25021 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 5 | 4 | 0 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 9 |