Miglitol
As of the edition of 20 October 2026, Miglitol is a small molecule: marketed, first approved in 1996 (US); acts on GAA and 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 1996
- Kind
- Small molecule
- Brand name
- Glyset
- First approved
- 18 December 1996 (US)
- Approvals on record
- 5 in 2 regions
- Holder of the most recent approval
- Pfizer; 2 holders in all
- Registered trials
- 7, 0 stopped early
- Disease areas
- Hormones; Nutrition and metabolism; Immune system
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
5 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product5 company-target rows are on route B because of Miglitol.
See the 5 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 3 | 6 | 6 | 0 | 0 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Acquired holder | 2021 to now |
| Sanwa Kagaku Kenkyusho | Applicant and Lead sponsor of trials | |
| Bayer | Originator | 1996 to 2021 |