Drug · Small Molecule
Imiquimod
CI-DRUG-00000781Explore in graph →CHEMBL1282 Approved
Regulatory
Approvals (4)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
emaProvenance
- Source
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-11T06:00
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | Superficial Basal Cell Carcinoma | 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. | approved | Sep 18, 1998 | ema |
| US FDA | — | Efficacy supplement 2011-07-15 (see label) | approved | Jul 15, 2011 | openfda |
| US FDA | — | Efficacy supplement 2011-03-24 (see label) | approved | Mar 24, 2011 | openfda |
| US FDA | — | ZYCLARA 2.5% and 3.75% is indicated for the topical treatment of clinically typical, visible, or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults. • ZYCLARA, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age or older. |
Data updated 6 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 7 | 3 | 28 | 108 | 4 | EU, US | Sep 18, 1998 | 1999-06 |
| Skin Carcinoma | Approved | Phase 3 | 1 | 1 | 1 | 3 | 1 | EU | Sep 18, 1998 | 2001-03 |
| Malignant Anal Neoplasm | Phase3 | Phase 3 | 0 | 0 | 1 | 1 | 0 | — | — | Sep 24, 2014 |
| Malignant Ovarian Neoplasm | Phase2 | Phase 2 | 1 | 0 | 0 | 2 | 0 | — |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
No curated evidence item mentions this therapy yet.
Clinical trials
Trials with this intervention (114)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT00674739 | Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts | completed | Phase 3 | 470 | Graceway Pharmaceuticals, LLCINDUSTRY | 1 | May 24, 2011 | clinicaltrials |
| NCT00894647 | Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery | completed | Phase 3 |