Drug intelligence / Profile preview

amlexanox

Development stage
Phase 2
Lead developer
GSK
Modality
Small Molecules
Administration
Topical, Inhalation, Intranasal, Ophthalmic, Oral
01

Overview

Amlexanox is a small molecule anti-inflammatory and antiallergic drug primarily used as a topical oral paste for the treatment of recurrent aphthous ulcers (canker sores) in the mouth. It accelerates ulcer healing and reduces pain by inhibiting the formation and/or release of inflammatory mediators from cells such as neutrophils and mast cells. The exact mechanism is not fully understood but includes inhibition of histamine and leukotriene release, antagonism of interleukin-3, inhibition of TBK1 and IKK-ε kinases, stabilization of fibroblast growth factor 1 (FGF1), and antagonism/inhibition at proteins S100-A12/A13 and heat shock protein HSP90-alpha. In Japan, it has also been used for allergic asthma, rhinitis, conjunctivitis, and ulcers associated with Behçet disease. Amlexanox has shown potential in metabolic diseases such as type 2 diabetes mellitus with nonalcoholic fatty liver disease due to its effects on inflammation pathways[2][5][8].

Brand names
AphthasolApthera
Other names
amlexanox oral pasteamlexanox 5% paste
02

Targets

S100A13 (S100 calcium-binding protein A13)TBK1 (TANK binding kinase 1)S100A12 (S100 calcium-binding protein A12)S100A4 (Ferroptosis suppressor protein 1)FGF1 (Fibroblast growth factor 1)IKBKE (IκB kinase epsilon)IL3 (IL-3)HSP90AA1 (Heat shock protein HSP90-alpha)

Beyond the preview

Go deeper on amlexanox.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Full profile access

Follow clinical development from study design and recruitment through results.

  • Trial phase
  • Status
  • Readouts

Indications & development

Full profile access

Explore development by indication, patient population, and geography.

  • Indications
  • Development status
  • Countries

Licensing & deals

Full profile access

Trace asset ownership, licensing agreements, and commercial partnerships.

  • Partners
  • Deal terms
  • Milestones

Patents & exclusivity

Full profile access

Explore the patent landscape and regulatory exclusivity around an asset.

  • Patents
  • Expiration dates
  • Exclusivity

Competitive landscape

Full profile access

Compare development programs by target, modality, and indication.

  • Competing assets
  • Targets
  • Development stage

Research & analysis

Full profile access

Connect source evidence and development news to your research questions.

  • Publications
  • News
  • Analysis

Bring the full picture into focus.

See how Gosset can support your research on amlexanox.

Explore the full profile

Gosset Free

Get started with Gosset.

Enter your work email and we’ll be in touch with next steps.

Work email preferred.

Book a call