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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 keratosisD055623L57.0
basal cell carcinomaD002280
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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Mock data
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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 neoplasmsD018295144110
Condylomata acuminataD003218EFO_0007147A63.01214
Hutchinson's melanotic freckleD01832712114
KeratosisD007642314
PapillomaviridaeD027383112
WartsD014860B07112
Alopecia areataD000506EFO_0004192L6322
HivD006678O98.711
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cervical intraepithelial neoplasiaD018290D06235412
Human influenzaD007251EFO_0007328J11.11214
Squamous intraepithelial lesionsD0000814831214
Hepatitis bD006509222
Basal cell carcinomaD002280112
Papillomavirus infectionsD03036122
Hiv infectionsD015658EFO_0000764B2022
Cutaneous leishmaniasisD016773B55.1112
Localized sclerodermaD012594L94.022
Extramammary paget diseaseD01014511
Show 5 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD008545829
Breast neoplasmsD001943EFO_0003869C50335
NeoplasmsD009369C803114
Colorectal neoplasmsD015179313
Uterine cervical neoplasmsD002583123
Ovarian neoplasmsD010051EFO_0003893C56112
Fallopian tube neoplasmsD005185112
Prostatic neoplasmsD011471C61212
Carcinoma in situD002278D09.922
AlphapapillomavirusD052685112
Show 11 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients44
GliomaD005910EFO_000052044
GlioblastomaD005909EFO_000051544
Stomach neoplasmsD013274EFO_0003897C1622
Brain neoplasmsD001932EFO_0003833C7122
AstrocytomaD001254EFO_000027122
EpendymomaD00480622
Renal cell carcinomaD00229211
Urinary bladder neoplasmsD001749C6711
CholangiocarcinomaD018281C22.111
Show 14 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic diseaseD00290811
PruritusD011537HP_0000989L2911
Mycosis fungoidesD009182C84.011
Vulvar neoplasmsD014846C5111
PsoriasisD011565EFO_0000676L4011
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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