Wednesday, July 8, 2026

Drug profile · INN

imiquimod

imiquimod (ALDARA) is a toll-like receptor 7 agonist. Associated with Lacuna Pharma Pty Ltd. Route of administration: topical. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Dermatologicals (D06) D06BB10
US status approved
Patents linked 0
Pipeline programs 9
News articles 0
Drug details — imiquimod
US status
approved
Class
Dermatologicals (D06)
Route
TOPICAL
Patents
0
Programs
9
Data quality
0.89

Quick answer

imiquimod (ALDARA) is a toll-like receptor 7 agonist. Associated with Lacuna Pharma Pty Ltd. Route of administration: topical. Current US regulatory status: approved.

Key facts

INN imiquimod
Brand ALDARA
Mechanism Toll-like receptor 7 agonist
Target Toll-like receptor 7
Therapeutic class Dermatologicals (D06)
Route TOPICAL
Formulation CREAM
ATC code D06BB10

Mechanism of action

Toll-like receptor 7 agonist

Primary target: Toll-like receptor 7

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. Imiquimod Phase 3 · Elan Pharmaceuticals · Lentigo Maligna
  2. Imiquimod Phase 3 · United Therapeutics Europe · Cervical Intraepithelial Neoplasia
  3. Imiquimod 5% cream Phase 3 · Grace Therapeutics · Superficial Basal Cell Carcinoma
  4. Imiquimod Cream, 3.75% Phase 3 · Teva Pharma · Actinic Keratosis
  5. ALDARA 5% cream, Keramod® gel Phase 2 · Anaxis Pharma · Actinic keratosis
  6. Imiquimod Approved · United Therapeutics Europe · Lentigo Maligna
  7. imiquimod Approved · United Therapeutics Europe · Anal Dysplasia
  8. imiquimod 5% cream Approved · RIGEL PHARMACEUTICALS · Actinic Keratoses

Related & competitor drugs

  1. beremagene geperpavec Dermatologicals (D03)
  2. dupilumab Dermatologicals (D11)
  3. lebrikizumab Dermatologicals (D11)
  4. retapamulin Dermatologicals (D06)
  5. tacrolimus Dermatologicals (D11)
  6. tirbanibulin Dermatologicals (D06)

Frequently asked questions

What is imiquimod?

imiquimod (ALDARA) is a toll-like receptor 7 agonist. Associated with Lacuna Pharma Pty Ltd. Route of administration: topical. Current US regulatory status: approved.

What is the brand name for imiquimod?

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

What is the US approval status of imiquimod?

imiquimod 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.