Imiquimod

Overview

Imiquimod is an immune response modifier that acts as a toll-like receptor 7 agonist. Imiquimod is commonly used topically to treat warts on the skin of the genital and anal areas. Imiquimod does not cure warts, and new warts may appear during treatment. Imiquimod does not fight the viruses that cause warts directly, however, it does help to relieve and control wart production. Miquimod is also used to treat a skin condition of the face and scalp called actinic keratoses and certain types of skin cancer called superficial basal cell carcinoma.

Indication

For the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults. Also indicated for the treatment of external genital and perianal warts/condyloma acuminata in individuals 12 years old and above.

Associated Conditions

Actinic Keratoses of the face
Actinic Keratoses of the scalp
Condylomata Acuminata
Herpes Simplex Infections
Molluscum Contagiosum
Superficial Basal Cell Carcinoma

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia	2025/03/25	NCT06840470	Phase 4	Recruiting	University of Michigan
Deep Phenotyping of Cutaneous Lupus Erythematosus	2024/05/13	NCT06411106	Not Applicable	Recruiting	Centre for Human Drug Research, Netherlands
Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod	2024/04/10	NCT06356012	Phase 4	Recruiting	Barretos Cancer Hospital
Real-world Evaluation of Diagnostic and Treatment Strategies in Low-Risk Basal Cell Carcinoma	2024/02/12	NCT06252857	N/A	Recruiting	Maastricht University Medical Center
Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides	2023/05/01	NCT05838599	Early Phase 1	Recruiting	Northwestern University
Gene and Protein Expression Profiles After Treatment of Actinic Keratoses	2023/02/23	NCT05740969	Phase 2	Recruiting	Ismail Gögenur
Coadministration of GA2 Sporozoites With Adjuvants	2022/07/21	NCT05468606	Early Phase 1	Recruiting	Leiden University Medical Center
Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment	2022/06/06	NCT05405270	N/A	Recruiting	Catharina Ziekenhuis Eindhoven
Influenza Vaccine With Topical Imiquimod in Influenza Vaccine Non-responsive Children	2022/04/07	NCT05315024	Not Applicable	UNKNOWN	The University of Hong Kong
Efficacy of Tazarotene in Treatment of Verruca Plana	2022/04/06	NCT05314127	Phase 2	UNKNOWN	Zagazig University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Aldara	Bausch Health US LLC	99207-260	TOPICAL	50 mg in 1 g	10/5/2023
Imiquimod	Taro Pharmaceuticals U.S.A., Inc.	51672-4145	TOPICAL	50 mg in 1 g	5/23/2016
IMIQUIMOD 5% / TRETINOIN 0.025%	Sincerus Florida, LLC	72934-1129	TOPICAL	5 g in 100 g	5/6/2019
Imiquimod	Bryant Ranch Prepack	63629-8818	TOPICAL	37.5 mg in 1 g	9/15/2021
IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%	Sincerus Florida, LLC	72934-1126	TOPICAL	5 g in 100 g	4/23/2019
Imiquimod	Padagis Israel Pharmaceuticals Ltd	45802-368	TOPICAL	12.5 mg in 0.25 g	10/31/2018
Imiquimod	Taro Pharmaceuticals U.S.A., Inc.	51672-4174	TOPICAL	37.5 mg in 1 g	4/2/2024
Imiquimod	Physicians Total Care, Inc.	54868-6179	TOPICAL	50 mg in 1 g	9/30/2010
Zyclara	Bausch Health US, LLC	99207-271	TOPICAL	37.5 mg in 1 g	1/8/2024
Zyclara	Bausch Health US, LLC	99207-276	TOPICAL	2.5 mg in 1 g	1/8/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Aldara	Viatris Healthcare Limited,Damastown Industrial Park,Mulhuddart,Dublin 15,Dublin,Ireland	Authorised	9/18/1998
Aldara	Viatris Healthcare Limited,Damastown Industrial Park,Mulhuddart,Dublin 15,Dublin,Ireland	Authorised	9/18/1998
Zyclara	Viatris Healthcare Limited,Damastown Industrial Park,Mulhuddart,Dublin 15,Dublin,Ireland	Authorised	8/23/2012
Zyclara	Viatris Healthcare Limited,Damastown Industrial Park,Mulhuddart,Dublin 15,Dublin,Ireland	Authorised	8/23/2012

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ALDARA CREAM 5%	3M HEALTH CARE LIMITED, Ensign Laboratories Pty Ltd	SIN10105P	CREAM	5%	9/17/1998

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
ALDARA CREAM 5%	N/A	iNOVA Pharmaceuticals (Hong Kong) Limited	N/A	N/A	12/28/1998

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ALDARA PUMP imiquimod 50 mg/g cream pump	191815	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	1/10/2012
ALDIQ imiquimod 50 mg/g cream sachet	201801	Strides Pharma Science Pty Ltd	Medicine	A	7/19/2013
IMIQUAD Imiquimod 50mg/g cream sachet	160484	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	11/19/2009
APOTEX-IMIQUIMOD imiquimod 50 mg/g cream sachet	168099	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/16/2011
ALDARA Imiquimod 50mg/g cream sachet	64798	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	8/18/1998

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
APO-IMIQUIMOD	Apotex Inc	02407825	Cream - Topical	5 % / W/W	12/31/2013
VYLOMA	bausch health, canada inc.	02365561	Cream - Topical	3.75 % / W/W	4/19/2011
TARO-IMIQUIMOD PUMP	Taro Pharmaceuticals Inc	02482983	Cream - Topical	5 % / W/W	1/23/2019
ZYCLARA	bausch health, canada inc.	02340445	Cream - Topical	3.75 % / W/W	1/27/2010
ZYCLARA	bausch health, canada inc.	02392054	Cream - Topical	2.5 % / W/W	N/A
TARO-IMIQUIMOD	Taro Pharmaceuticals Inc	02482975	Cream - Topical	5 % / W/W	N/A
IMIQUIMOD	bausch health, canada inc.	02413582	Cream - Topical	5 % / W/W	N/A
ALDARA P	bausch health, canada inc.	02239505	Cream - Topical	5 %	7/5/1999

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ALDARA 5% CREMA	Viatris Healthcare Limited	98080001	CREMA	Medicamento Sujeto A Prescripción Médica	Commercialized
IMIKERADERM 50 MG/G CREMA	Mibe Pharma Espana S.L.	88034	CREMA	Medicamento Sujeto A Prescripción Médica	Commercialized
ALDARA 5% CREMA	Viatris Healthcare Limited	98080002	CREMA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ZYCLARA 3,75% CREMA	Viatris Healthcare Limited	12783002	CREMA	Medicamento Sujeto A Prescripción Médica	Commercialized
IMUNOCARE 50 MG/G CREMA	Industrial Farmaceutica Cantabria S.A.	78406	CREMA	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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