Wednesday, July 8, 2026

Drug profile · INN

amlexanox

amlexanox (APHTHASOL) is a phosphodiesterase 4 inhibitor. Route of administration: dental. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 5
Pipeline programs 20
News articles 0
Drug details — amlexanox
US status
approved
Class
Route
DENTAL
Patents
5
Programs
20
Data quality
0.84

Quick answer

amlexanox (APHTHASOL) is a phosphodiesterase 4 inhibitor. Route of administration: dental. Current US regulatory status: approved.

Key facts

INN amlexanox
Brand APHTHASOL
Mechanism Phosphodiesterase 4 inhibitor
Target Phosphodiesterase 4
Route DENTAL
Formulation PASTE

Mechanism of action

Phosphodiesterase 4 inhibitor

Primary target: Phosphodiesterase 4

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Cytarabine Phase 3 · Chinese Academy of · AML
  2. Venetoclax Phase 3 · Chinese Academy of · AML
  3. Cytarabine Phase 2 · Hospital Authority · AML
  4. Cytarabine (Phase 1 only) Phase 2 · Actinium Pharmaceuticals · AML
  5. Decitabine Phase 2 · Chinese Academy of · AML
  6. IIT2024067 Phase 2 · Chinese Academy of · AML
  7. Obatoclax Phase 2 · Teva Pharma · AML
  8. REFRaME-P1 Phase 2 · SUTRO BIOPHARMA · Acute Myeloid Leukemia (AML)

Related & competitor drugs

  1. apremilast Antineoplastic and immunomodulating agents (L04)
  2. roflumilast Respiratory system (R03)
  3. crisaborole Dermatologicals (D11)
  4. difamilast Phosphodiesterase 4 inhibitor
  5. flavoxate hydrochloride Phosphodiesterase 4 inhibitor

Related patents

  1. US 10590142

    Deuterated amlexanox

    Expires Mon Mar 12 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 10214536

    Amlexanox analogs

    Expires Mon Feb 21 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 9944652

    Deuterated amlexanox

    Expires Mon Apr 12 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 9365581

    Deuterated amlexanox

    Expires Mon Jun 09 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 8946424

    Deuterated amlexanox

    Expires Mon Jan 29 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is amlexanox?

amlexanox (APHTHASOL) is a phosphodiesterase 4 inhibitor. Route of administration: dental. Current US regulatory status: approved.

What is the brand name for amlexanox?

APHTHASOL is a marketed brand name for amlexanox. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of amlexanox?

amlexanox has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.