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
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Zyclara (generic drugs available since 2010-02-25, discontinued: Aldara)
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 |
|---|---|---|
| aldara | New Drug Application | 2023-10-05 |
| imiquimod | NDA authorized generic | 2024-01-11 |
| 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 | 2024-01-08 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| actinic keratosis | — | D055623 | L57.0 |
| basal cell carcinoma | — | D002280 | — |
| 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
187 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 | 11 | 6 | 34 |
| Basal cell neoplasms | D018295 | — | — | 1 | 1 | 5 | 4 | 2 | 13 |
| Basal cell carcinoma | D002280 | — | — | 1 | 1 | 5 | 2 | 3 | 12 |
| Condylomata acuminata | D003218 | EFO_0007147 | A63.0 | — | 1 | 2 | 1 | — | 4 |
| Hutchinson's melanotic freckle | D018327 | — | — | — | 1 | 2 | 1 | 1 | 4 |
| Keratosis | D007642 | — | — | — | — | — | 3 | 1 | 4 |
| Papillomaviridae | D027383 | — | — | — | 1 | — | 1 | 1 | 3 |
| Warts | D014860 | — | B07 | — | 1 | — | 1 | — | 2 |
| Alopecia areata | D000506 | EFO_0004192 | L63 | — | — | — | 2 | — | 2 |
| Hiv | D006678 | — | O98.7 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cervical intraepithelial neoplasia | — | — | D06 | 2 | 3 | 5 | — | 4 | 12 |
| Human influenza | D007251 | EFO_0007328 | J11.1 | 1 | — | 2 | — | 1 | 4 |
| Squamous intraepithelial lesions | D000081483 | — | — | — | 1 | 2 | — | 1 | 4 |
| Papillomavirus infections | D030361 | — | — | — | — | 3 | — | — | 3 |
| Hepatitis b | D006509 | — | — | — | 2 | 2 | — | — | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 2 | — | — | 2 |
| Cutaneous leishmaniasis | D016773 | — | B55.1 | — | 1 | 1 | — | — | 2 |
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | — | — | 2 | — | — | 2 |
| Extramammary paget disease | D010145 | — | — | — | — | 1 | — | — | 1 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | 1 | 1 | — | — | 1 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | — | — | 8 | 3 | — | — | — | 10 |
| Glioblastoma | D005909 | EFO_0000515 | — | 5 | 1 | — | — | — | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 3 | — | — | — | 5 |
| Neoplasms | D009369 | — | C80 | 3 | 1 | — | — | 1 | 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 |
| Uterine cervical neoplasms | D002583 | HP_0030159 | — | 1 | 2 | — | — | — | 3 |
Show 12 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | — | 5 | — | — | — | — | 5 |
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 2 | — | — | — | — | 2 |
| Mycosis fungoides | D009182 | — | C84.0 | 1 | — | — | — | 1 | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | — | — | — | — | 2 |
| Astrocytoma | D001254 | EFO_0000271 | — | 2 | — | — | — | — | 2 |
| Ependymoma | D004806 | — | — | 2 | — | — | — | — | 2 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | — | — | — | — | 1 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 1 | — | — | — | — | 1 |
Show 18 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 | HP_0000989 | L29 | — | — | — | — | 1 | 1 |
| Vulvar neoplasms | D014846 | — | C51 | — | — | — | — | 1 | 1 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 1 | 1 |
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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2,023 adverse events reported
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