Ambroxol
As of the edition of 20 October 2026, Ambroxol is a small molecule: marketed, first approved in 1983 (ES); acts on GBA1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1984
- Kind
- Small molecule
- Brand name
- Mucosan Pediatrico
- First approved
- 1 March 1983 (ES)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- OPELLA HEALTHCARE FRANCE; 2 holders in all
- Registered trials
- 27, 0 stopped early
- Disease areas
- Nervous system; Lungs and airways; Infections; Nutrition and metabolism; Inherited and neonatal; Ear, nose and throat
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 |
|---|---|---|
| GBA1 | Lysosomal acid glucosylceramidase | P04062 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 1 | 1 | 0 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 11 | 5 | 2 | 0 |
| Phase 3 | 5 | 3 | 1 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 27 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Boehringer Ingelheim | Lead sponsor of trials | 1999 to now |
| Hanmi Pharmaceutical | Lead sponsor of trials | 2012 to now |
| Exsar | Lead sponsor of trials | 2012 to now |
| Grand Johamu Pharmaceutical | Lead sponsor of trials | 2020 to now |
| Agyany Pharma | Lead sponsor of trials | 2023 to now |