Overview
Amlexanox is an antiallergic drug, clinically effective for atopic diseases, especially allergic asthma and rhinitis. Amlexanox as a topical paste is a well tolerated treatment of recurrent aphthous ulcers. Recurrent aphthous ulcer (RAU) is the most prevalent oral mucosal disease in humans, estimated to affect between 5% and 50% of the general population.
Background
Amlexanox is an antiallergic drug, clinically effective for atopic diseases, especially allergic asthma and rhinitis. Amlexanox as a topical paste is a well tolerated treatment of recurrent aphthous ulcers. Recurrent aphthous ulcer (RAU) is the most prevalent oral mucosal disease in humans, estimated to affect between 5% and 50% of the general population.
Indication
Used as a paste in the mouth to treat aphthous ulcers (canker sores).
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2013/11/05 | Phase 2 | Completed | |||
2013/04/29 | Phase 2 | Terminated | |||
2010/03/10 | Phase 2 | Completed | Access Pharmaceuticals, Inc. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Amlexanox Oral Mucoadhesive patch | 国药准字H20080173 | 化学药品 | 片剂 | 3/9/2023 | |
| Amlexanox Oral Mucoadhesive patch | 国药准字H20120080 | 化学药品 | 片剂 | 5/12/2022 | |
| Amlexanox Oral Paste | 国药准字H20080260 | 化学药品 | 糊剂 | 11/21/2022 | |
| Amlexanox Oral Paste | 国药准字H20110009 | 化学药品 | 糊剂 | 8/6/2020 | |
| Amlexanox Oral Paste | 国药准字H20060270 | 化学药品 | 糊剂 | 7/9/2020 | |
| Amlexanox Oral Paste | 国药准字H20050663 | 化学药品 | 糊剂 | 1/21/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||