§ 01 Overview
Overview
FDA-approved (1996) for aphthous ulcers; repurposed for obesity/T2D with modest weight loss and improved glycemia in human pilot studies.
Reilly Nat Med 2013 showed metabolic improvements in a small human trial.
§ 02 Mechanism
Mechanism of action
Amlexanox inhibits the noncanonical inflammatory kinases IKKε and TBK1. In obese/insulin-resistant states these kinases drive adipose tissue inflammation; their inhibition improves insulin signaling and lipid handling.
- 01Modest weight loss and A1C reduction in pilot trials
- 02Anti-inflammatory in adipose
§ 03 Dosing
Dosing protocol
Standard Protocol
- Dose Range
- 50 – 150 mg daily (off-label metabolic use)
- Route
- Oral
- Frequency
- Daily
- Cycle
- 8–12 weeks
§ 04 Evidence
Evidence & research
Reilly Nat Med 2013 showed metabolic improvements in a small human trial.
FDA Status
FDA-approved (Aphthasol NDA 020527) for aphthous ulcers.
§ 06 News
In the news
1 article from the last 12 months · updates hourly
Combined treatment with amlexanox and cytarabine induces apoptosis via the S100A6–Akt pathway in KMT2A::AFF1 -positive acute lymphoblastic leukemia - Nature
Combined treatment with amlexanox and cytarabine induces apoptosis via the S100A6–Akt pathway in KMT2A::AFF1 -positive acute lymphoblastic leukemia Nature
§ 07 Sourcing
Sourcing & supply
Regulatory status
FDA-approved
This compound has an FDA approval for at least one indication. Brand pharmacy channels exist. Compounding may or may not be available depending on shortage status.
No suppliers in our directory currently stock this compound. For investigational or research-only compounds, legitimate channels may not exist outside clinical trials.
Browse full supplier directory§ 09 Safety
Safety & side effects
Side effects
- 01GI upset
- 02Rash
Contraindications
None specified.
§ 10 Questions
Amlexanox FAQ
- What is Amlexanox?
- FDA-approved (1996) for aphthous ulcers; repurposed for obesity/T2D with modest weight loss and improved glycemia in human pilot studies. Amlexanox inhibits the noncanonical inflammatory kinases IKKε and TBK1. In obese/insulin-resistant states these kinases drive adipose tissue inflammation; their inhibition improves insulin signaling and lipid handling.
- What is Amlexanox used for?
- Reported uses include modest weight loss and a1c reduction in pilot trials and anti-inflammatory in adipose. Evidence strength is rated Clinical — see the evidence section for detail.
- How is Amlexanox dosed?
- Commonly referenced dosing is 50 – 150 mg daily (off-label metabolic use), administered Oral. This is educational reference only; consult a licensed clinician before use.
- What are the side effects of Amlexanox?
- Commonly reported side effects include gi upset and rash. This list is not exhaustive.
- Is Amlexanox legal?
- This compound has an FDA approval for at least one indication. Brand pharmacy channels exist. Compounding may or may not be available depending on shortage status. FDA status: FDA-approved (Aphthasol NDA 020527) for aphthous ulcers..
§ 11 References
Selected references
- 01
Reilly — obesity/T2D pilot
PMID: 23291631