Aldara, Zartra(imiquimod)
Aldara, 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 carcinoma, condylomata acuminata, and keratosis. It is known to target toll-like receptor 7.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
infections | D007239 |
neoplasms | D009369 |
urogenital diseases | D000091642 |
skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
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
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
No data
Clinical
Clinical Trials
163 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 | 5 | 9 | 11 | 5 | 32 | |
Basal cell neoplasms | D018295 | — | 1 | 4 | 4 | 1 | 10 | ||
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 | 2 | ||
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 | D018290 | 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 | ||
Hepatitis b | D006509 | — | 2 | 2 | — | — | 2 | ||
Basal cell carcinoma | D002280 | — | 1 | 1 | — | — | 2 | ||
Papillomavirus infections | D030361 | — | — | 2 | — | — | 2 | ||
Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 2 | — | — | 2 |
Cutaneous leishmaniasis | D016773 | B55.1 | — | 1 | 1 | — | — | 2 | |
Localized scleroderma | D012594 | L94.0 | — | — | 2 | — | — | 2 | |
Extramammary paget disease | D010145 | — | — | 1 | — | — | 1 |
Show 5 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Melanoma | D008545 | 8 | 2 | — | — | — | 9 | ||
Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 3 | — | — | — | 5 |
Neoplasms | D009369 | C80 | 3 | 1 | — | — | 1 | 4 | |
Colorectal neoplasms | D015179 | 3 | 1 | — | — | — | 3 | ||
Uterine cervical neoplasms | D002583 | 1 | 2 | — | — | — | 3 | ||
Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | — | — | — | 2 |
Fallopian tube neoplasms | D005185 | 1 | 1 | — | — | — | 2 | ||
Prostatic neoplasms | D011471 | C61 | 2 | 1 | — | — | — | 2 | |
Carcinoma in situ | D002278 | D09.9 | — | 2 | — | — | — | 2 | |
Alphapapillomavirus | D052685 | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 4 | — | — | — | — | 4 | ||
Glioma | D005910 | EFO_0000520 | 4 | — | — | — | — | 4 | |
Glioblastoma | D005909 | EFO_0000515 | 4 | — | — | — | — | 4 | |
Stomach neoplasms | D013274 | EFO_0003897 | C16 | 2 | — | — | — | — | 2 |
Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | — | — | — | — | 2 |
Astrocytoma | D001254 | EFO_0000271 | 2 | — | — | — | — | 2 | |
Ependymoma | D004806 | 2 | — | — | — | — | 2 | ||
Renal cell carcinoma | D002292 | 1 | — | — | — | — | 1 | ||
Urinary bladder neoplasms | D001749 | C67 | 1 | — | — | — | — | 1 | |
Cholangiocarcinoma | D018281 | C22.1 | 1 | — | — | — | — | 1 |
Show 14 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 | 5ZSF |
CAS-ID | 99011-02-6 |
RxCUI | 59943 |
ChEMBL ID | CHEMBL1282 |
ChEBI ID | 36704 |
PubChem CID | 57469 |
DrugBank | DB00724 |
UNII ID | P1QW714R7M (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,194 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,229 adverse events reported
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