Drugs / Imiquimod
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Imiquimod

Other / unclassified targets TLR7 via activation

Developed for
actinic keratosis · cervical intraepithelial neoplasia · basal cell carcinoma · anogenital human papillomavirus infection · cervical intraepithelial neoplasia grade 2/3 · skin basal cell carcinoma · cervical cancer · cutaneous melanoma
+62 more · hepatitis B virus infection · human papilloma virus infection · lentigo maligna melanoma · melanoma · actinic cheilitis · alopecia areata · breast cancer · capillary malformation · cutaneous leishmaniasis · influenza · localized scleroderma · metastatic melanoma · mycosis fungoides · precancerous condition · skin carcinoma · squamous cell intraepithelial neoplasia · vulvar intraepithelial neoplasia · Bowen disease of the skin · breast carcinoma · capillary hemangioma · cervical carcinoma · colorectal carcinoma · diffuse intrinsic pontine glioma · dysplasia of cervix · fallopian tube cancer · grade II glioma · human papillomavirus-related squamous cell carcinoma · hyperpigmentation of the skin · in situ carcinoma · intraepithelial neoplasia · keloid · lentigo · male breast carcinoma · malignant glioma · metastatic malignant neoplasm · neurofibroma · neurofibromatosis type 1 · nodular basal cell carcinoma · non-invasive bladder urothelial carcinoma · non-small cell lung carcinoma · oral cavity squamous cell carcinoma · oral mucosa leukoplakia · ovarian cancer · peritoneum cancer · plantar wart · Plasmodium falciparum malaria · primary cutaneous T-cell lymphoma · prostate adenocarcinoma · prostate carcinoma · psoriasis · sebaceous gland disorder · skin cancer · skin disorder caused by infection · superficial multifocal basal cell carcinoma · uterine cervix carcinoma in situ · vaginal carcinoma · vulva cancer · vulval Paget disease · vulvar carcinoma · vulvar squamous cell carcinoma · anus disorder · herpes simplex infectious disease
Investigated by
National Cancer Institute (NCI) · MEDA Pharma GmbH & Co. KG · Graceway Pharmaceuticals, LLC · The University of Hong Kong · 3M · Maastricht University Medical Center
+137 more · Medical University of Graz · AIDS Malignancy Consortium · Barretos Cancer Hospital · Bausch Health Americas, Inc. · Catharina Ziekenhuis Eindhoven · Erasmus Medical Center · Farmoquimica S.A. · Hordinsky, Maria K., MD · Leiden University Medical Center · Massachusetts General Hospital · Mayo Clinic · Medical University Innsbruck · Medical University of Vienna · Melanoma Institute Australia · Moberg Pharma AB · NYU Langone Health · National Alopecia Areata Foundation · National Cancer Institute (NCI) · Providence Health & Services · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · The Emmes Company, LLC · UbiVac · University Hospital Tuebingen · University of Arkansas · University of Michigan · VA Office of Research and Development · Aalborg University · Accovion GmbH · Actavis Inc. · Albert Schweitzer Hospital · Alliance for Clinical Trials in Oncology · Apotex Inc. · Assistance Publique - Hôpitaux de Paris · Austrian Science Fund (FWF) · Barretos Cancer Hospital · Baylor College of Medicine · Baylor St. Luke's Medical Center · Beckman Laser Institute University of California Irvine · Beth Israel Deaconess Medical Center · Brigham and Women's Hospital · Brooke Army Medical Center · CES University · CLL Topics, Inc. · Cancer Research Institute, New York City · Cedars-Sinai Medical Center · Central Hospital, Nancy, France · Centre Leon Berard · Centre for Human Drug Research, Netherlands · Clinical Trial Center Maastricht B.V. · Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Craig L Slingluff, Jr · Cytos Biotechnology AG · Dan L Duncan Comprehensive Cancer Center · Dana-Farber Cancer Institute · Department of Health, United Kingdom · Derm Research @ 888 Inc. · Drugs for Neglected Diseases · Federal University of Rio Grande do Sul · Foundation Fader · Frank Lieberman · Frankel, Amylynne, M.D. · Genexine, Inc. · Glasgow Western Infirmary · Harris Health · Henry Vasconez · Hospital de Clinicas de Porto Alegre · Icahn School of Medicine at Mount Sinai · Immatics Biotechnologies GmbH · Inovio Pharmaceuticals · Instituto Oncológico Dr Rosell · James J. Peters Veterans Affairs Medical Center · Jerry Marsden · Krankenhaus Barmherzige Schwestern Linz · Louisiana State University Health Sciences Center in New Orleans · all 143 on the full record

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) ZYCLARA — 2011-03-24 – 2011-07-15 fda.gov ↗
Label expansions (3) US (FDA) ALDARA — 2004-03-02 – 2007-03-22 fda.gov ↗
Approved EU (EMA) Aldara — 1998-09-18 europa.eu ↗
Approved US (FDA) ALDARA — 1997-02-27 fda.gov ↗

Trials 124 · started per year

today
US approved 1997
EU approved 1998
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19971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 07 trials · 1 met primary
Phase 0 NCT05838599 Jul 2023 → Jun 2027 expected mycosis fungoides Northwestern University Recruiting No outcome recorded
Phase 0 NCT05468606 Feb 2023 → Dec 2024 Plasmodium falciparum malaria Leiden University Medical Center Unknown Met primary
Phase 0 NCT04883645 Apr 2022 → Jun 2023 oral cavity squamous cell carcinoma Medical University of South Carolina Completed No outcome recorded
Phase 0 NCT03196180 Oct 2019 → Nov 2020 cervical intraepithelial neoplasia grade 2/3, uterine cervix carcinoma in situ National Cancer Institute (NCI) Completed No outcome recorded
Phase 0 NCT03116659 Feb 2018 → Dec 2020 primary cutaneous T-cell lymphoma James J. Peters Veterans Affairs Medical Center Unknown No outcome recorded
Phase 0 NCT03276832 Dec 2017 → Oct 2019 cutaneous melanoma, metastatic melanoma Mayo Clinic Completed No outcome recorded
Phase 0 NCT01678352 Oct 2012 → Nov 2017 grade II glioma Frank Lieberman Completed No outcome recorded
Phase 117 trials
Phase 1 NCT03982004 Sep 2020 → Mar 2021 breast cancer Washington University School of Medicine Terminated No outcome recorded Stop: Business
Phase 1 NCT04219358 Mar 2019 → Jun 2020 actinic cheilitis Hospital de Clinicas de Porto Alegre Terminated No outcome recorded
Phase 1 NCT03472976 Jun 2018 → Mar 2019 avian influenza National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT03071679 Feb → Mar 2017 — Maruho Co., Ltd. Completed No outcome recorded
Phase 1 NCT02889159 Jun 2016 → Feb 2023 skin disorder University of Michigan Completed No outcome recorded
Phase 1 NCT02234921 Oct 2014 → Aug 2018 prostate adenocarcinoma UbiVac Completed No outcome recorded
Phase 1 NCT02052687 Jan → Jun 2014 — Novartis Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01400672 Jul 2012 → Mar 2016 diffuse intrinsic pontine glioma Masonic Cancer Center, University of Minnesota Terminated No outcome recorded
Phase 1 NCT01792505 Oct 2009 → Nov 2014 malignant glioma Cedars-Sinai Medical Center Completed No outcome recorded
Phase 1 NCT00988559 Sep 2009 → Jul 2016 cervical intraepithelial neoplasia grade 2/3, virus associated tumor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed No outcome recorded
Phase 1/27 trials
Phase 1/2 NCT07679841 Sep 2026 → Sep 2029 expected vulvar squamous cell carcinoma Centre Leon Berard Not yet recruiting No outcome recorded
Phase 1/2 NCT07251413 Oct 2025 → Dec 2028 expected skin basal cell carcinoma Instituto Oncológico Dr Rosell Recruiting No outcome recorded
Phase 1/2 NCT07210775 Oct 2025 → Oct 2027 expected oral mucosa leukoplakia University of Southern California Recruiting No outcome recorded
Phase 1/2 NCT01421017 Aug 2011 → Jul 2016 breast carcinoma NYU Langone Health Completed No outcome recorded
Phase 1/2 NCT01191034 Aug 2010 → Aug 2012 metastatic melanoma Cliniques universitaires Saint-Luc- Université Catholique de Louvain Terminated No outcome recorded
Phase 1/2 NCT00785122 Jun 2008 → Jan 2011 colorectal carcinoma Immatics Biotechnologies GmbH Completed No outcome recorded
Phase 1/2 NCT02452307 Apr 2004 → Oct 2017 prostate carcinoma University Hospital Tuebingen Unknown No outcome recorded
Phase 224 trials · 1 met primary · 2 missed
Phase 2 NCT06686043 Aug 2024 → Aug 2026 overdue cervical carcinoma, human papillomavirus-related squamous cell carcinoma, vaginal carcinoma, vulvar carcinoma Baylor College of Medicine Recruiting No outcome recorded
Phase 2 NCT05028322 Nov 2021 → Dec 2024 cirrhosis of liver, hepatitis B virus infection Central Hospital, Nancy, France Unknown No outcome recorded
Phase 2 NCT03534947 Jul 2019 → Mar 2025 invasive carcinoma, skin basal cell carcinoma Melanoma Institute Australia Completed No outcome recorded
Phase 2 NCT03760250 Feb → Sep 2019 keloid University of Pennsylvania Terminated No outcome recorded
Phase 2 NCT03233412 Jan 2018 → Jan 2020 cervical cancer, intraepithelial neoplasia Barretos Cancer Hospital Completed Met primary
Phase 2 NCT03180684 Aug 2017 → Jul 2020 human papilloma virus infection, precancerous condition, vulvar intraepithelial neoplasia Inovio Pharmaceuticals Completed No outcome recorded
Phase 2 NCT02960815 Nov 2016 → Jun 2017 — University of Lausanne Hospitals Completed No outcome recorded
Phase 2 NCT02864147 Jul 2016 → May 2022 cervical intraepithelial neoplasia Yale University Completed Missed primary
Phase 2 NCT01909752 Jul 2013 → Nov 2016 non-small cell lung carcinoma UbiVac Completed No outcome recorded
Phase 2 NCT01731652 Feb 2013 → Feb 2014 in situ carcinoma, non-invasive bladder urothelial carcinoma Telormedix SA Completed No outcome recorded
Phase 2/36 trials · 2 met primary
Phase 2/3 NCT04083157 Aug 2019 → Dec 2020 hepatitis B virus infection, inflammatory bowel disease The University of Hong Kong Completed Met primary
Phase 2/3 NCT03307902 Oct 2016 → Mar 2019 hepatitis B virus infection The University of Hong Kong Completed No outcome recorded
Phase 2/3 NCT02621112 Jan 2016 → Dec 2018 kidney failure The University of Hong Kong Completed Met primary
Phase 2/3 NCT02130323 Feb 2015 → Dec 2016 cervical intraepithelial neoplasia United States Naval Medical Center, San Diego Completed No outcome recorded
Phase 2/3 NCT01088737 Jan 2011 → Dec 2021 lentigo Medical University of Graz Unknown No outcome recorded
Phase 2/3 NCT00384124 Nov 2006 → Nov 2008 Bowen disease of the skin Brooke Army Medical Center Unknown No outcome recorded
Phase 327 trials · 3 met primary · 4 missed
Phase 3 NCT05212246 Oct 2026 → Oct 2032 expected skin basal cell carcinoma VA Office of Research and Development Not yet recruiting No outcome recorded
Phase 3 NCT03289260 Nov 2021 → Nov 2024 anogenital human papillomavirus infection Medical University Innsbruck Unknown No outcome recorded
Phase 3 NCT02669459 May 2016 → Mar 2019 cervical intraepithelial neoplasia Erasmus Medical Center Unknown No outcome recorded
Phase 3 NCT02242929 Jan 2016 → Dec 2017 nodular basal cell carcinoma Maastricht University Medical Center Unknown Missed primary
Phase 3 NCT02059499 Dec 2015 → Dec 2023 HIV infectious disease, squamous cell intraepithelial neoplasia AIDS Malignancy Consortium Completed Mixed
Phase 3 NCT02394132 Aug 2015 → Dec 2021 lentigo maligna melanoma Melanoma and Skin Cancer Trials Limited Completed No outcome recorded
Phase 3 NCT02385188 May 2015 → Mar 2018 vulval Paget disease University Medical Center Nijmegen Completed No outcome recorded
Phase 3 NCT02329171 Dec 2014 → Jun 2016 cervical intraepithelial neoplasia Maastricht University Medical Center Terminated No outcome recorded
Phase 3 NCT02135419 Sep 2014 → Aug 2021 HIV infectious disease, anal carcinoma, human papilloma virus infection, squamous cell intraepithelial neoplasia AIDS Malignancy Consortium Completed Met primary
Phase 3 NCT02103023 Mar → Nov 2014 influenza The University of Hong Kong Completed Met primary
Phase 422 trials · 1 met primary
Phase 4 NCT06840470 Mar 2025 → Dec 2026 expected sebaceous gland disorder University of Michigan Active not recruiting No outcome recorded
Phase 4 NCT06356012 Apr 2024 → Dec 2026 expected cervical intraepithelial neoplasia grade 2/3 Barretos Cancer Hospital Recruiting No outcome recorded
Phase 4 NCT04842422 Apr → Aug 2021 actinic keratosis Medical University of Graz Completed No outcome recorded
Phase 4 NCT01453179 Oct 2011 → Mar 2015 actinic keratosis MEDA Pharma GmbH & Co. KG Completed Met primary
Phase 4 NCT01229319 Oct 2010 → Aug 2011 actinic keratosis Frankel, Amylynne, M.D. Unknown No outcome recorded
Phase 4 NCT01203878 Sep 2010 → Nov 2011 actinic keratosis Tennessee Clinical Research Center Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT01161888 Jun 2010 → Mar 2012 lentigo maligna melanoma Jerry Marsden Completed No outcome recorded
Phase 4 NCT01059110 Feb 2010 → Jan 2015 plantar wart Assistance Publique - Hôpitaux de Paris Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT00849992 Mar 2009 → Mar 2013 actinic cheilitis Norwegian University of Science and Technology Completed No outcome recorded
Phase 4 NCT00777127 Dec 2008 → Nov 2012 actinic keratosis MEDA Pharma GmbH & Co. KG Completed No outcome recorded
Phase not applicable14 trials
— NCT06411106 Jun 2024 → Sep 2025 cutaneous lupus erythematosus Centre for Human Drug Research, Netherlands Unknown No outcome recorded
— NCT05315024 Apr 2022 → Sep 2023 influenza The University of Hong Kong Unknown No outcome recorded
— NCT02301494 Apr 2020 → Apr 2022 mycosis fungoides Rochester General Hospital Withdrawn No outcome recorded Stop: Enrollment
— NCT03943407 Nov 2019 → Jun 2021 — Aalborg University Withdrawn No outcome recorded
— NCT04859361 Nov 2018 → Apr 2020 cervical intraepithelial neoplasia University Medical Centre Maribor Unknown No outcome recorded
— NCT03206138 May 2017 → Oct 2018 cervical intraepithelial neoplasia grade 2/3 Seoul St. Mary's Hospital Unknown No outcome recorded
— NCT02917746 Nov 2016 → Jul 2018 cervical intraepithelial neoplasia Maastricht University Medical Center Unknown No outcome recorded
— NCT01508884 Jan → Dec 2012 — The University of Hong Kong Completed No outcome recorded
— NCT01935310 Jul → Nov 2010 hyperpigmentation of the skin CES University Completed No outcome recorded
— NCT00814528 Nov 2007 → Sep 2009 actinic keratosis University of Chicago Withdrawn No outcome recorded
Comparator or background therapy42 trials
Phase 0 NCT07077616 Background Jul 2025 → Dec 2027 expected glioma Biogenea Pharmaceuticals Ltd. Recruiting No outcome recorded
Phase 1 NCT06305910 Background Mar 2024 → Sep 2025 overdue diffuse midline glioma, H3 K27M-mutant OX2 Therapeutics Recruiting No outcome recorded
Phase 1 NCT04072900 Background Apr 2020 → Sep 2021 cutaneous melanoma Xiangya Hospital of Central South University Unknown No outcome recorded
Phase 1 NCT03872947 Background Apr 2019 → Jul 2026 cholangiocarcinoma, colorectal cancer, fallopian tube cancer, gastric cancer +5 Toray Industries, Inc Completed No outcome recorded
Phase 1 NCT02600949 Background May 2016 → May 2027 expected colorectal adenocarcinoma, pancreatic ductal adenocarcinoma M.D. Anderson Cancer Center Enrolling by invitation No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2020-03-30 Inovio Pharmaceuticals Results INOVIO Interim Results of an Open-Label Phase 2 Trial of VGX-3100 Show Efficacy Against HPV-associated Vulvar Dysplasia inovio.com ↗
Enrollment into the imiquimod arm was halted due to having no meaningful improvement upon the efficacy of VGX-3100 alone.
2010-09-08 Perrigo Company Regulatory Perrigo Announces FDA Approval for Imiquimod Cream - Generic Equivalent to Aldara® perrigo.com ↗
Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced it received FDA approval from the U.S. Food and Drug Administration to manufacture and market Imiquimod Cream, 5%.

Evidence & citations 20 cited values

Every value below carries the sentence it was read from. 170 sources stand behind the page.

FieldValueCited text
Known as imiquimod “An intradermal influenza vaccine preparations containing 15 μg of each of the three viral strains (Intanza®) will be administrated in the centre of the marked area after the...” NCT02960815 ↗
159

“TAMAVAQ Vaccine plus Poly-ICLC, cGAMP, Granulocyte-macrophage colony stimulating factor (GM-CSF), imiquimod, CpG oligodeoxynucleotides, saponins and monophosphoryl lipid A (MPLA)” NCT07077616 ↗

“Imiquimod cream is applied to the supraclavicular site followed by 2 supraclavicular injections of CD200AR-L each day for 2 consecutive days.” NCT06305910 ↗

“GTL001 will be adjuvanted with Aldara, 5% imiquimod cream, applied to the injection site 15 minutes and 24 hours after each vaccination.” NCT02689726 ↗

“ProCervix will be delivered with a topical agent, imiquimod, applied to the injection sites as a vaccine adjuvant.” NCT01957878 ↗

“Imiquimod cream is to be applied 5 of 7 days in a row with 2 days rest for a maximum of 2 cycles (total 6 weeks).” NCT03872947 ↗

“Imiquimod, a topical cream, will be applied to the vaccination site before and after each vaccination.” NCT00944580 ↗

“All subjects will be treated with Zyclara cream (Imiquimod 3.75%) and vehicle.” NCT03943407 ↗

“Adjuvants: 75 microgram GM-CSF + 1 application Imiquimod every 2nd week” NCT01543464 ↗

“Imiquimod 5% topical treatment, 3 times per week” NCT03073967 ↗

“250 mg imiquimod cream (12.5 mg imiquimod)” NCT00785122 ↗

Show 149 more sources

Known as Aldara “Aldara (imiquimod 5%) cream is an immune response modifier for topical administration. 250 mg of the cream, equivalent to 12.5 mg of imiquimod will be applied and rubbed into...” NCT03472976 ↗
19

“In the imiquimod and intradermal vaccine arm, intervention consists in the topical application of a single bag of Aldara™ creme 5%, containing 12.5 mg of imiquimod, on a 16 cm2...” NCT02960815 ↗

“Aldara® (imiquimod) Cream, 5% was the first imiquimod product approved by the Food and Drug Administration (FDA) for the topical treatment of AK, superficial basal cell...” NCT02120898 ↗

“Imiquimod (Aldara; 3M Pharmaceuticals) is a novel immune response-activating compound, approved by the FDA for cervical warts, that activates macrophage killing of Leishmania species.” NCT01380314 ↗

“Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients” NCT00257530 ↗

“Double-Blind, Vehicle-Controlled Study to Evaluate Apoptosis in Basal Cell Carcinoma Treated With Aldara™ (Imiquimod) Cream, 5% Applied Once or Twice a Day” NCT00079300 ↗

“Imiquimod (Aldara, 3M) is one of the better characterized imidazoquinolines and is the only one currently approved for clinical use as a topical ointment.” NCT01792505 ↗

“All patients will receive imiquimod (Aldara®) as local adjuvant, applied topically at the side of vaccination 18h to 24h prior to the vaccination.” NCT02802943 ↗

“GTL001 will be adjuvanted with Aldara, 5% imiquimod cream, applied to the injection site 15 minutes and 24 hours after each vaccination.” NCT02689726 ↗

“Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average)” NCT00803907 ↗

“5 mg imiquimod (100mg Aldara®) per treatment site with a 12mm Finn chamber” NCT06411106 ↗

Show 9 more sources

Known as Aldara (Imiquimod) “Aldara (Imiquimod)” NCT00785122 ↗
Known as Aldara (imiquimod) 5% cream - 250 mg / packet “Aldara (imiquimod) 5% cream - 250 mg / packet” NCT00189306 ↗
Known as Aldara (imiquimod) cream 5% “Aldara® (imiquimod) cream 5%” NCT00116649 ↗
Known as Aldara 5% Topical Cream ClinicalTrials.gov intervention name — accepted as the source's own label NCT04859361 ↗
Known as Aldara cream “Marketed as 5% Aldara cream topically applied; total of 12.5 mg divided between the two vaccination sites and reapplied at the vaccination sites 24 hours later.” NCT01400672 ↗
Known as IMI “5% Imiquimod (IMI) cream” NCT02281682 ↗
Known as Imiquimod 5% cream “Imiquimod 5% cream” NCT03233412 ↗
Known as Imiquimod Cream “Drug: Imiquimod Cream” NCT03872947 ↗
Known as Imiquimod Cream (generic name) “Imiquimod Cream (generic name)” NCT01686152 ↗
Known as IMQ “In a previous phase II trial, we showed that topical imiquimod (IMQ) therapy is an efficacious treatment for high-grade squamous intraepithelial lesion (HSIL).” PMID 35177279 ↗ Feb 2022
3

“This study is to find an optimal dose of Imiquimod (IMQ) in the first part (Phase I)” NCT01421017 ↗

“treatment with imiquimod (IMQ)” PMID 25885553 ↗ Apr 2015

“5% imiquimod (IMQ) 5%” PMID 31961446 ↗ Feb 2020

Known as TMX-101 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01731652 ↗
Known as Zyclara “Marketed by Medicis, Zyclara® (imiquimod) cream 2.5% is a safe and effective topical therapy for the treatment of AK of the face and scalp.” NCT02120898 ↗
2

“All subjects will be treated with Zyclara cream (Imiquimod 3.75%) and vehicle.” NCT03943407 ↗

“Zyclara® (imiquimod Cream), 3.75% (Medicis)” NCT01686152 ↗

Known as Zyclara (imiquimod 3.75% cream) “Zyclara (imiquimod 3.75% cream)” NCT01203878 ↗
Known as Zyclara, imiquimod “Zyclara, imiquimod” NCT04859361 ↗
Action Activate “topical imiquimod, a TLR7 agonist” PMID 18566444 ↗ Jul 2008
Modality Other / unclassified “Aldara is a immune-response modifier.” NCT00177021 ↗
Route Topical “Patients have topical imiquimod applied to the cervix” NCT00031759 ↗
Target TLR7 “topical imiquimod, a TLR7 agonist” PMID 18566444 ↗ Jul 2008