Imiquimod
Approved · FDA / EMAAlso known as Aldara, Zyclara, Zyclara Pump, 4-Amino-1-isobutyl-1H-imidazo(4,5-c)quinoline+1 more
Aldara, Zyclara, Zyclara Pump, 4-Amino-1-isobutyl-1H-imidazo(4,5-c)quinoline, Imiquimodum.
Recent clinical, regulatory, research and industry developments relating to this drug.
Label change: IMIQUIMOD (ANDA091308)
Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
Approval: IMIQUIMOD (ANDA091308)
Imiquimod-induced psoriasis-like skin inflammation in mice is mediated via the IL-23/IL-17 axis.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Zyclara is indicated for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp… Show full indicationShow less
Zyclara is indicated for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.
Indication: Imiquimod cream is indicated for the topical treatment of : External genital and perianal warts (condylomata acuminata) in adults. Small superficial basal cell carcinomas (sBCCs)… Show full indicationShow less
Imiquimod cream is indicated for the topical treatment of : External genital and perianal warts (condylomata acuminata) in adults. Small superficial basal cell carcinomas (sBCCs) in adults. Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
ANCHOR Study: Anal Cancer/HSIL Outcomes Research Study
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes1
Journals, researchers & institutions
- Journal of immunology (Baltimore, Md. : 1950)2
- Clinical cancer research : an official journal of the American Association for Cancer Research1
- Journal of the American Academy of Dermatology1
- Adams S2
- Bhardwaj N2
- Chiriboga L2
- Angiulli A1
- Angiulli F1
- Armstrong J1
- Axelrod D1
- Berman RS1
- Beckman Laser Institute1
- Erasmus Medical Center1
- New York University Cancer Institute1
- New York University School of Medicine1
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.