Aldara, Zartra(imiquimod)
Aldara, Imiquimod, Zyclara (imiquimod) is a small molecule pharmaceutical. Imiquimod was first approved as Aldara on 1997-02-27. It is used to treat actinic keratosis, basal cell carcinoma, and condylomata acuminata in the USA. It has been approved in Europe to treat actinic keratosis, basal cell neoplasms, condylomata acuminata, and keratosis.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Imiquimod, Zyclara (discontinued: Aldara, Imiquimod)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Imiquimod
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZYCLARA | Bausch Health Companies | N-022483 RX | 2010-03-25 | 2 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| imiquimod | ANDA | 2025-08-11 |
| imiquimod 5% / levocetirizine dihydrochloride 1% / niacinamide 2% | unapproved drug other | 2019-04-23 |
| imiquimod 5% / levocetirizine dihydrochloride 1% / tretinoin 0.05% | unapproved drug other | 2019-04-23 |
| imiquimod 5% / niacinamide 4% | unapproved drug other | 2019-05-06 |
| imiquimod 5% / salicylic acid 30% / tretinoin 0.1% | unapproved drug other | 2019-05-06 |
| imiquimod 5% / tretinoin 0.025% | unapproved drug other | 2019-05-06 |
| zyclara | New Drug Application | 2025-05-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| basal cell carcinoma | — | D002280 | — |
| actinic keratosis | — | D055623 | L57.0 |
| condylomata acuminata | EFO_0007147 | D003218 | A63.0 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Imiquimod, Zyclara, Bausch | |||
| 10918635 | 2030-04-30 | U-172, U-1455 | |
| 11202752 | 2030-04-30 | U-172, U-1455 | |
| 8222270 | 2029-12-11 | U-68 | |
| 8236816 | 2029-12-11 | U-68 | |
| 8299109 | 2029-12-11 | U-68 | |
| 10238644 | 2029-12-11 | U-68 | |
| 11318130 | 2029-12-11 | U-68 | |
| 8598196 | 2029-08-18 | U-172, U-1455 | |
| 10238645 | 2029-08-18 | U-172, U-1455 | |
| Imiquimod, Aldara, Bausch | |||
| 7696159 | 2024-04-01 | DP | U-1047, U-1048 |
HCPCS
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Clinical
Clinical Trials
192 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Actinic keratosis | D055623 | — | L57.0 | 2 | 6 | 9 | 13 | 7 | 37 |
| Keratosis | D007642 | — | — | 2 | 6 | 9 | 13 | 7 | 37 |
| Carcinoma | D002277 | — | C80.0 | 5 | 4 | 7 | 4 | 3 | 22 |
| Basal cell carcinoma | D002280 | — | — | 1 | 1 | 7 | 4 | 3 | 16 |
| Basal cell neoplasms | D018295 | — | — | 1 | 1 | 6 | 4 | 3 | 15 |
| Carcinoma in situ | D002278 | — | D09.9 | 3 | 5 | 6 | 1 | 2 | 15 |
| Warts | D014860 | — | B07 | — | 2 | 3 | 3 | 2 | 10 |
| Squamous cell carcinoma | D002294 | — | — | 3 | 1 | 1 | 1 | 1 | 7 |
| Squamous intraepithelial lesions of the cervix | D065310 | — | — | 1 | 2 | 2 | 1 | 1 | 7 |
| Condylomata acuminata | D003218 | EFO_0007147 | A63.0 | — | 1 | 3 | 1 | — | 5 |
Show 12 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 5 | 6 | 5 | — | 4 | 17 |
| Uterine cervical dysplasia | D002578 | EFO_1000910 | N87 | 3 | 4 | 5 | — | 4 | 14 |
| Melanoma | D008545 | — | — | 8 | 4 | 1 | — | — | 12 |
| Cervical intraepithelial neoplasia | — | — | D06 | 2 | 3 | 5 | — | 4 | 12 |
| Recurrence | D012008 | — | — | 4 | 4 | 2 | — | 1 | 9 |
| Human influenza | D007251 | EFO_0007328 | J11.1 | 1 | 1 | 2 | — | 2 | 6 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 2 | 1 | 1 | — | — | 4 |
| Hepatitis b | D006509 | — | — | — | 3 | 2 | — | — | 3 |
| Papillomavirus infections | D030361 | — | — | — | — | 3 | — | — | 3 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 2 | — | — | 3 |
Show 18 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | — | 10 | 1 | — | — | — | 10 |
| Glioblastoma | D005909 | EFO_0000515 | — | 5 | 1 | — | — | — | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 3 | — | — | — | 5 |
| Urinary bladder neoplasms | D001749 | — | C67 | 3 | 1 | — | — | — | 4 |
| Uterine cervical neoplasms | D002583 | — | — | 1 | 3 | — | — | — | 4 |
| Colorectal neoplasms | D015179 | — | — | 3 | 1 | — | — | — | 3 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | — | — | 1 | 3 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | 1 | — | — | 1 | 3 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 2 | — | — | — | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 1 | — | — | 1 | 3 |
Show 22 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 2 | — | — | — | — | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 2 | — | — | — | — | 2 |
| T-cell lymphoma | D016399 | — | — | 1 | — | — | — | 1 | 2 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | 1 | — | — | — | 1 | 2 |
| Adenocarcinoma | D000230 | — | — | 2 | — | — | — | — | 2 |
| Skin aging | D015595 | EFO_0005422 | — | 1 | — | — | — | 1 | 2 |
| Mycoses | D009181 | — | B35-B49 | 1 | — | — | — | 1 | 2 |
| Mycosis fungoides | D009182 | — | C84.0 | 1 | — | — | — | 1 | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | — | — | — | — | 2 |
Show 22 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peritoneal neoplasms | D010534 | — | — | — | — | — | — | 1 | 1 |
| Chronic disease | D002908 | — | — | — | — | — | — | 1 | 1 |
| Pruritus | D011537 | — | L29 | — | — | — | — | 1 | 1 |
| Lymphoma | D008223 | — | C85.9 | — | — | — | — | 1 | 1 |
| T-cell lymphoma peripheral | D016411 | — | — | — | — | — | — | 1 | 1 |
| Skin diseases | D012871 | — | L00-L99 | — | — | — | — | 1 | 1 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 1 | 1 |
| Fever | D005334 | — | R50.9 | — | — | — | — | 1 | 1 |
| Hyperthermia | D000084462 | — | — | — | — | — | — | 1 | 1 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | — | — | 1 | 1 |
Show 5 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Imiquimod |
| INN | imiquimod |
| Description | Imiquimod is an imidazoquinoline fused [4,5-c] carrying isobutyl and amino substituents at N-1 and C-4 respectively. A prescription medication, it acts as an immune response modifier and is used to treat genital warts, superficial basal cell carcinoma, and actinic keratosis. It has a role as an antineoplastic agent and an interferon inducer. |
| Classification | Small molecule |
| Drug class | immunomodulators |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)Cn1cnc2c(N)nc3ccccc3c21 |
Identifiers
| PDB | — |
| CAS-ID | 99011-02-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1282 |
| ChEBI ID | 36704 |
| PubChem CID | 57469 |
| DrugBank | DB00724 |
| UNII ID | P1QW714R7M (ChemIDplus, GSRS) |
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Imiquimod
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Safety
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Adverse Events
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2,462 adverse events reported
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