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Amoxanox (AMLEXANOX)
Amlexanox, also known as AMLEXANOX, is a small molecule inhibitor of nuclear factor kappa-B kinase subunit epsilon. It was originally developed and is currently owned by ULURU. Amlexanox is used to treat aphthous ulcers of the mouth and was FDA approved in 1996. The drug is off-patent, meaning it is no longer protected by patents, and there are no generic manufacturers. As a result, its commercial status is uncertain.
At a glance
| Generic name | AMLEXANOX |
|---|---|
| Sponsor | Uluru |
| Drug class | amlexanox |
| Target | Inhibitor of nuclear factor kappa-B kinase subunit epsilon |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1996 |
Approved indications
- Aphthous ulcer of mouth
Common side effects
Key clinical trials
- Amlexanox for Type 2 Diabetes and Obesity (PHASE2)
- Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients (PHASE2)
- Study to Determine the Effects Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Amoxanox CI brief — competitive landscape report
- Amoxanox updates RSS · CI watch RSS
- Uluru portfolio CI