Neostigmine
As of the edition of 20 October 2026, Neostigmine is a small molecule: marketed, first approved in 1952 (CH); acts on ACHE.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Bloxiverz
- First approved
- 25 April 1952 (CH)
- Approvals on record
- 13 in 6 regions
- Holder of the most recent approval
- Exela Pharma Sciences; 9 holders in all
- Registered trials
- 55, 2 stopped early
- Disease areas
- Nervous system; Digestive system; Injuries; Cancer; Heart and blood vessels; Mental health
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.
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 Neostigmine.
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 |
|---|---|---|
| ACHE | Acetylcholinesterase | P22303 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 21 | 13 | 5 | 1 |
| Phase 1 | 6 | 3 | 0 | 1 |
| Phase 2 | 6 | 5 | 1 | 0 |
| Phase 3 | 5 | 4 | 0 | 0 |
| Phase 4 | 17 | 13 | 1 | 0 |
| All trials | 55 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder | 1988 to now |
| Omega Pharma | Later holder | 1999 to now |
| Terumo | Applicant | 2008 to now |
| Fresenius Kabi | Later holder | 2015 to now |
| Exela Pharma Sciences | Acquired holder | 2020 to now |