Ranitidine
As of the edition of 20 October 2026, Ranitidine is a small molecule: marketed, first approved in 1983 (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 1983
- Kind
- Small molecule
- Brand name
- Zantac 150
- First approved
- 9 June 1983 (US)
- Approvals on record
- 16 in 1 region
- Holder of the most recent approval
- Sanofi; 4 holders in all
- Registered trials
- 43, 7 stopped early
- Disease areas
- Digestive system; Cancer; Immune system; Heart and blood vessels; Lungs and airways; Nervous system
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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Ranitidine.
See the 1 company 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 | 7 | 7 | 0 | 0 |
| Phase 1 | 15 | 13 | 1 | 1 |
| Phase 2 | 7 | 4 | 0 | 2 |
| Phase 3 | 5 | 2 | 0 | 3 |
| Phase 4 | 9 | 7 | 0 | 1 |
| All trials | 43 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Applicant, Earlier holder and Lead sponsor of trials | 1983 to now |
| Pfizer | Later holder | 2004 to now |
| Sanofi | Acquired holder and Lead sponsor of trials | 2012 to now |
| Pharmaceutical Associates | Acquired holder | 2022 to now |