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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
infectionsD007239
neoplasmsD009369
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
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
ZYCLARABausch Health CompaniesN-022483 RX2010-03-25
2 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
aldaraNew Drug Application2018-04-12
imiquimodANDA2023-04-03
zyclaraNew Drug Application2018-02-08
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
actinic keratosis—D055623L57.0
basal cell carcinoma—D002280—
condylomata acuminataEFO_0007147D003218A63.0
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Imiquimod, Zyclara, Bausch
109186352030-04-30U-172, U-1455
112027522030-04-30U-172, U-1455
82222702029-12-11U-68
82368162029-12-11U-68
82991092029-12-11U-68
102386442029-12-11U-68
113181302029-12-11U-68
85981962029-08-18U-172, U-1455
102386452029-08-18U-172, U-1455
Imiquimod, Aldara, Bausch
76961592024-04-01DPU-1047, U-1048
ATC Codes
D: Dermatologicals
— D06: Antibiotics and chemotherapeutics for dermatological use
— D06B: Chemotherapeutics for topical use
— D06BB: Antivirals, topical
— D06BB10: Imiquimod
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 keratosisD055623L57.025911532
Basal cell neoplasmsD018295—144110
Condylomata acuminataD003218EFO_0007147A63.0—121—4
Hutchinson's melanotic freckleD018327—12114
KeratosisD007642———314
PapillomaviridaeD027383———112
WartsD014860B07—1—1—2
Alopecia areataD000506EFO_0004192L63———2—2
HivD006678O98.7———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cervical intraepithelial neoplasiaD018290D06235—412
Human influenzaD007251EFO_0007328J11.11—2—14
Squamous intraepithelial lesionsD000081483—12—14
Hepatitis bD006509—22——2
Basal cell carcinomaD002280—11——2
Papillomavirus infectionsD030361——2——2
Hiv infectionsD015658EFO_0000764B20——2——2
Cutaneous leishmaniasisD016773B55.1—11——2
Localized sclerodermaD012594L94.0——2——2
Extramammary paget diseaseD010145——1——1
Show 5 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD00854582———9
Breast neoplasmsD001943EFO_0003869C5033———5
NeoplasmsD009369C8031——14
Colorectal neoplasmsD01517931———3
Uterine cervical neoplasmsD00258312———3
Ovarian neoplasmsD010051EFO_0003893C5611———2
Fallopian tube neoplasmsD00518511———2
Prostatic neoplasmsD011471C6121———2
Carcinoma in situD002278D09.9—2———2
AlphapapillomavirusD05268511———2
Show 11 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—4————4
GliomaD005910EFO_00005204————4
GlioblastomaD005909EFO_00005154————4
Stomach neoplasmsD013274EFO_0003897C162————2
Brain neoplasmsD001932EFO_0003833C712————2
AstrocytomaD001254EFO_00002712————2
EpendymomaD0048062————2
Renal cell carcinomaD0022921————1
Urinary bladder neoplasmsD001749C671————1
CholangiocarcinomaD018281C22.11————1
Show 14 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic diseaseD002908————11
PruritusD011537HP_0000989L29————11
Mycosis fungoidesD009182C84.0————11
Vulvar neoplasmsD014846C51————11
PsoriasisD011565EFO_0000676L40————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIMIQUIMOD
INNimiquimod
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 classimmunomodulators
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(C)Cn1cnc2c(N)nc3ccccc3c21
Identifiers
PDB5ZSF
CAS-ID99011-02-6
RxCUI59943
ChEMBL IDCHEMBL1282
ChEBI ID36704
PubChem CID57469
DrugBankDB00724
UNII IDP1QW714R7M (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
TLR7
TLR7
Organism
Homo sapiens
Gene name
TLR7
Gene synonyms
NCBI Gene ID
Protein name
toll-like receptor 7
Protein synonyms
toll-like receptor 7-like
Uniprot ID
Mouse ortholog
Tlr7 (170743)
toll-like receptor 7 (Q923I1)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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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
Mock data
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6,229 adverse events reported
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