Amlexanox is a small anti-allergic and anti-inflammatory molecule developed by Takeda in Japan in the 1980s.
Amounts reported for Amlexanox are listed under Reported protocols, each with its source and study kind. No amount ladder is inferred from them. This is educational source context, not a protocol or recommendation.
Enter a target amount only from your own reviewed source. The calculator can convert it into concentration, volume and device markings, but it will not infer an amount from product availability or another compound.
Only mcg or mg amounts are retained. The calculator derives mL, syringe units or pen clicks from the current vial strength, water volume and device.
Human study rows are described per source under Reported protocols; they belong to their trial populations and are not a general amount.
Verify the exact compound, formulation and amount against the product label or certificate before calculation.
Follow the product label, certificate and validated laboratory SOP; no universal storage assumption is applied here.
Label concentration and preparation date, use sterile technique where applicable, and follow a validated stability protocol.
What published studies and recent community write-ups report about amounts, timing and course length. 3 clinical, 1 preclinical and 2 community-reported rows, each linked to its source. These are descriptions of what others report, not instructions, and nothing here is medical advice.
| Context | Dose | Frequency | Route | Course | Source |
|---|---|---|---|---|---|
| Clinical3 rows | |||||
| Proof-of-concept trial in type 2 diabetes with fatty liver42 obese adults with type 2 diabetes and nonalcoholic fatty liver disease, randomised double-blind to amlexanox or placebo (NCT01975935); 38 completed 12 weeks | 50 mg (two 25 mg capsules) | Three times daily, without titration | Oral | 12 weeks, with a 4-week follow-up off drugNot applicable | Cell Metabolism (PubMed Central)2017 |
| HbA1c and fructosamine fell significantly against placebo, and a subset of treated patients, the responders, also improved insulin sensitivity and hepatic steatosis; responders had a distinct inflammatory gene expression signature in subcutaneous fat biopsies at baseline and a gene expression response consistent with higher energy expenditure. In a preceding open-label study of six patients who took 25 mg three times daily for 2 weeks then 50 mg for 10 weeks, two developed a generalised itchy rash at about four weeks that settled within two weeks despite continued dosing. The 50 mg dose was chosen because it had been used for asthma in Japan. | |||||
| Trial registration for the diabetes studyPlanned 40 adults with type 2 diabetes (HbA1c 6.5-10%) and BMI 27-45 on metformin, DPP-4 inhibitors or no medication | 25 mg to start, titrated to 50 mg | Three times daily (25 mg for 2 weeks, then 50 mg) | Oral tablets | 3 monthsSafety and efficacy repeated 4 weeks after stopping | ClinicalTrials.gov2013 |
| The registration states that the doses were those used to treat asthma in humans and that they produce serum concentrations comparable to the metabolically effective doses in rodents; HbA1c was the primary endpoint and weight a secondary one, with safety bloods at weeks 1, 2, 4, 6 and 12. The registered amlexanox came from Japan, since no oral product has ever been approved in the United States. | |||||
| Approved US label (Aphthasol 5% oral paste)Adults with aphthous ulcers and normal immune systems | A dab of 5% paste about 1/4 inch (0.5 cm) long on each ulcer | Four times daily, after oral hygiene following breakfast, lunch, dinner and at bedtime | Topical to the mouth ulcer | Until the ulcer heals; seek advice if no improvement in 10 daysNot applicable | US Food and Drug Administration2002 |
| This is the only amlexanox product the FDA has ever approved: a topical paste supplied in 5 g tubes, applied as soon as an ulcer is noticed and continued until it heals, with patients told to wash their hands after each application and to stop if a rash or contact mucositis appears. The paste was later discontinued in the United States for commercial reasons. A 2020 review records that oral tablets remained in legal use in Japan for asthma, which is the only precedent for the swallowed doses used in the diabetes trial. | |||||
| Preclinical1 row | |||||
| Obese mice (prevention and reversal of diet-induced obesity)C57BL/6 mice on a 45% fat diet and genetically obese ob/ob mice | 25 or 100 mg/kg per day | Daily by gavage | Oral | 4-8 weeks, started either with the high-fat diet or after 12 weeks of itWeight loss reversed when dosing stopped | Nature Medicine (PubMed Central)2013 |
| Amlexanox raised oxygen consumption and energy expenditure, produced reversible weight loss, improved insulin sensitivity in clamp studies (at 50 mg/kg) and cleared hepatic steatosis, and 100 mg/kg also reduced weight in ob/ob mice. The authors identified the drug by screening for inhibitors of TBK1 and IKK-epsilon, kinases induced in fat and liver by high-fat feeding; mouse doses per kilogram are far higher than the 150 mg a day later given to people. | |||||
| Community-reported2 rows | |||||
| Bodybuilding-oriented dosing table (community) | 25-100 mg three times a day as the page's summary of human studies; 'no standardized bodybuilding dosing exists' | Twice daily suggested by the page on the basis of a 4-6 hour half-life | Oral capsules; sublingual troches described as rare | 8-12 weeks in the page's tableNot described | Community resource2026 |
| This 2026 physique-oriented article promotes amlexanox for fat loss and lists forum reports of gradual leaning over three to five weeks, warmer body temperature and a group of non-responders. Its table does not match the published record: the only completed trial used 50 mg three times daily for 12 weeks, there is no separate 100 mg three-times-daily fatty liver study, and no trial has tested amlexanox for weight loss in people without diabetes. The stacks it describes with GLP-1 agonists, thyroid hormone or stimulants have no study behind them. | |||||
| Vendor capsule format | 25 mg per capsule, 60 capsules per bottle; no dose stated | Not stated | Oral | Not statedNot stated | Community resource2026 |
| A vendor claim. The certificate for lot AM01 measured 28.07 mg per capsule against the 25 mg label; two capsules equal the 50 mg trial dose, so the bottle holds ten days of the trial regimen of 150 mg a day. An independent compound guide reviewed on 1 October 2026 describes such capsules as an approved topical drug repackaged for a systemic use tested once, in 42 people, for twelve weeks. | |||||
Plus 3 community resources (dosing guides, forum threads and vendor write-ups), reported above but not linked.
Amlexanox is a small anti-allergic and anti-inflammatory molecule developed by Takeda in Japan in the 1980s, where it was sold as Solfa tablets for asthma and allergic rhinitis, and approved in the United States in 1996 as Aphthasol, a 5% oral paste for canker sores that was later withdrawn for commercial rather than safety reasons. In 2013 Alan Saltiel's group found that it inhibits the kinases TBK1 and IKK-epsilon, which raised energy expenditure and reversed obesity and fatty liver in mice, and a 12-week proof-of-concept trial in 42 obese adults with type 2 diabetes and fatty liver (50 mg three times a day) lowered HbA1c, with insulin sensitivity and liver fat improving only in a responder subgroup that could be identified by an inflammatory signature in their fat. It has no approval for any metabolic use anywhere, a phase 3 programme never followed, and it is sold online as 25 mg capsules.
These themes describe recurring questions in published research. They are not claims of effectiveness or recommendations for use.
Energy balance, body composition and incretin signaling.
Innate defense, inflammatory signaling and barrier models.
HbA1c and fructosamine fell significantly against placebo, and a subset of treated patients, the responders, also improved insulin sensitivity and hepatic steatosis; responders had a distinct inflammatory gene.
The registration states that the doses were those used to treat asthma in humans and that they produce serum concentrations comparable to the metabolically effective doses in rodents; HbA1c was the primary endpoint and.
This is the only amlexanox product the FDA has ever approved: a topical paste supplied in 5 g tubes, applied as soon as an ulcer is noticed and continued until it heals, with patients told to wash their hands after.
Amlexanox raised oxygen consumption and energy expenditure, produced reversible weight loss, improved insulin sensitivity in clamp studies (at 50 mg/kg) and cleared hepatic steatosis, and 100 mg/kg also reduced weight.
Study models remain visible so laboratory and animal findings are not mistaken for established human outcomes.
3 protocol rows on this page come from human trials, trial registrations, regulator labels or reviews of human data. Approval status and populations are stated per row.
1 protocol row describe animal, cell or toxicology work. Amounts from these rows do not translate to people.
2 rows record what blogs, vendor write-ups or forums describe for Amlexanox. None has been verified against primary literature.
Sequence, synonyms and registry identifiers as recorded in PubChem, the National Library of Medicine's open chemistry database. Formula, mass and CAS number are summarized at the top of the page.
Aphthasol, Solfa, AA-673, CHX-3673, Amoxanox, Elics, UNII BRL1C2459K
SGRYPYWGNKJSDL-UHFFFAOYSA-N
2-amino-5-oxo-7-propan-2-ylchromeno[2,3-b]pyridine-3-carboxylic acid
6 curated references, each with its journal, year and study model, plus 3 community resources reported but not linked.