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Drug ReportsImiquimod
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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
neoplasmsD009369
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
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
ZYCLARABausch Health CompaniesN-022483 RX2010-03-25
2 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
imiquimodANDA2025-09-25
imiquimod 5% / levocetirizine dihydrochloride 1% / niacinamide 2%unapproved drug other2019-04-23
imiquimod 5% / levocetirizine dihydrochloride 1% / tretinoin 0.05%unapproved drug other2019-04-23
imiquimod 5% / niacinamide 4%unapproved drug other2019-05-06
imiquimod 5% / salicylic acid 30% / tretinoin 0.1%unapproved drug other2019-05-06
imiquimod 5% / tretinoin 0.025%unapproved drug other2019-05-06
zyclaraNew Drug Application2025-05-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
basal cell carcinoma—D002280—
actinic keratosis—D055623L57.0
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
193 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Actinic keratosisD055623—L57.02————2
KeratosisD007642——2————2
Indications Without Phase
No data
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)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)Cn1cnc2c(N)nc3ccccc3c21
Identifiers
PDB—
CAS-ID99011-02-6
RxCUI—
ChEMBL IDCHEMBL1282
ChEBI ID36704
PubChem CID57469
DrugBankDB00724
UNII IDP1QW714R7M (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Imiquimod
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 17,544 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,501 adverse events reported
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