Amlexanox
As of the edition of 20 October 2026, Amlexanox is a small molecule: marketed, first approved in 1996 (US); acts on PDE4A, PDE4B and PDE4C and 1 more; 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
- Aphthasol
- First approved
- 17 December 1996 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Uluru
- Registered trials
- 3, 1 stopped early
- Disease areas
- Digestive system; Hormones; Nutrition and metabolism; Mouth and teeth
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
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Amlexanox.
See the 4 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 2 | 3 | 2 | 0 | 1 |
| All trials | 3 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Uluru | Acquired holder | 2005 to now |