Acarbose
As of the edition of 20 October 2026, Acarbose is an oligosaccharide: marketed, first approved in 1995 (US); acts on MGAM; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Oligosaccharide
- Brand name
- Precose
- First approved
- 6 September 1995 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Farmalider S.A.; 2 holders in all
- Registered trials
- 63, 8 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Heart and blood vessels; Digestive system; Cancer; Infections
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 Acarbose.
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 |
|---|---|---|
| MGAM | Maltase-glucoamylase | O43451 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 15 | 12 | 0 | 2 |
| Phase 1 | 8 | 7 | 0 | 0 |
| Phase 2 | 4 | 1 | 0 | 3 |
| Phase 3 | 11 | 9 | 0 | 1 |
| Phase 4 | 25 | 16 | 0 | 2 |
| All trials | 63 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Originator, Applicant and Lead sponsor of trials | 1995 to now |