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Aphthous ulcer of mouth — Treatment Landscape & Competitive Intelligence

Aphthous ulcer of mouth (disease) competitive landscape: 4 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

4 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Aphthous ulcer of mouth, deduplicated by molecule. See the full disease page for line-of-therapy detail.

DrugGenericSponsorClassTargetLine of therapyFirst approval
Amoxanox AMLEXANOX Uluru amlexanox Inhibitor of nuclear factor kappa-B kinase subunit epsilon 1996-01-01
Cortef hydrocortisone Generic (originally Merck/Upjohn) Corticosteroid [EPC] Annexin A1, Corticosteroid-binding globulin, Nitric oxide synthase, inducible 1952-01-01
SULFUR SULFUR Poythress sulfur Carbonic anhydrase 1 1940-01-01
Cortisol Cortisol University of Zurich Annexin A1, Corticosteroid-binding globulin, Nitric oxide synthase, inducible

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this treatment set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

  1. · 2 drugs in Aphthous ulcer of mouth
  2. Generic (originally Merck/Upjohn) · 1 drug in Aphthous ulcer of mouth
  3. Poythress · 1 drug in Aphthous ulcer of mouth
  4. Uluru · 1 drug in Aphthous ulcer of mouth
  5. University of Zurich · 1 drug in Aphthous ulcer of mouth

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Every new regulatory action, PDUFA date, or trial completion in Aphthous ulcer of mouth:

Cite this brief

Drug Landscape (2026). Aphthous ulcer of mouth — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/aphthous-ulcer-of-mouth. Accessed 2026-06-10.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing