Bismuth subsalicylate
As of the edition of 20 October 2026, Bismuth subsalicylate is a small molecule: marketed, first approved in 1987 (CA); acts on PTGS1 and PTGS2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1996
- Kind
- Small molecule
- Brand name
- Helidac
- First approved
- 31 December 1987 (CA)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Casper Pharma; 2 holders in all
- Registered trials
- 7, 1 stopped early
- Disease areas
- Infections; Blood and lymph; Cancer; Digestive system; Immune system; Lungs and airways
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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 4 | 3 | 2 | 0 | 1 |
| All trials | 7 |