Pyridostigmine
As of the edition of 20 October 2026, Pyridostigmine is a small molecule: marketed, first approved in 1953 (CH); acts on ACHE.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1990
- Kind
- Small molecule
- Brand name
- Mestinon
- First approved
- 19 December 1953 (CH)
- Approvals on record
- 12 in 4 regions
- Holder of the most recent approval
- Amneal Pharmaceuticals; 6 holders in all
- Registered trials
- 27, 1 stopped early
- Disease areas
- Nervous system; Immune system; Cancer; Heart and blood vessels; Inherited and neonatal; Nutrition and metabolism
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ACHE | Acetylcholinesterase | P22303 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 1 | 1 | 0 |
| Phase 1 | 4 | 2 | 1 | 1 |
| Phase 2 | 13 | 10 | 2 | 0 |
| Phase 3 | 2 | 0 | 1 | 0 |
| Phase 4 | 4 | 2 | 0 | 0 |
| All trials | 27 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| United States Army Office Surgeon General | Later holder | 2003 to now |
| Sandoz | Acquired holder | 2017 to now |
| Bausch Health | Acquired holder | 2019 to now |
| Amneal Pharmaceuticals | Later holder | 2024 to now |
| Organon | Later holder | |
| Roche | Earlier holder |