Imiquimod
Other / unclassified targets TLR7 via activation
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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 125 · started per year
Also used as a comparator or background therapy in 42 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07077616 Background | Jul 2025 → Dec 2027 expected | glioma | Biogenea Pharmaceuticals Ltd. | Recruiting | No outcome recorded |
| Phase 114 trials | ||||||
| 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 → Jun 2026 overdue | cholangiocarcinoma, colorectal cancer, fallopian tube cancer, gastric cancer +5 | Toray Industries, Inc | Active not recruiting | 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 |
| Phase 1 | NCT02689726 Background | Aug 2015 → Aug 2016 | — | Genticel | Terminated | No outcome recorded |
| Phase 1 | NCT02276300 Background | Dec 2014 → Jul 2017 | breast cancer, gastric cancer | Technical University of Munich | Completed | No outcome recorded |
| Phase 1 | NCT01803152 Background | Jan 2014 → Sep 2019 | bone sarcoma, soft tissue sarcoma | Macarena De La Fuente, MD | Completed | No outcome recorded |
| Phase 1 | NCT01808820 Background | Aug 2013 → Nov 2018 | anaplastic astrocytoma, glioblastoma | Macarena De La Fuente, MD | Completed | No outcome recorded |
| Phase 1 | NCT01795313 Background | Aug 2012 → Dec 2025 | ependymoma | James Felker | Terminated | No outcome recorded |
| Phase 1 | NCT01403285 Background | Aug 2011 → Apr 2014 | glioblastoma | Immatics Biotechnologies GmbH | Terminated | No outcome recorded |
| Phase 1 | NCT01264731 Comparator | Jan 2011 → Jun 2012 | melanoma | University of Virginia | Completed | No outcome recorded |
| Phase 1 | NCT01171469 Background | Sep 2010 → May 2012 | anaplastic astrocytoma, ependymoma, glioblastoma, medulloblastoma | Masonic Cancer Center, University of Minnesota | Completed | No outcome recorded |
| Phase 1 | NCT00944580 Background | Jun 2009 → Aug 2010 | neuroblastoma, osteosarcoma, rhabdomyosarcoma | Penn State University | Withdrawn | No outcome recorded |
| Phase 1 | NCT00638651 Comparator | Feb 2008 → Aug 2014 | — | University of Miami | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT02224599 Background | Jul 2017 → Aug 2018 | cancer | Kiromic BioPharma Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03559413 Background | Jun 2016 → Mar 2022 | childhood acute lymphoblastic leukemia | University Children's Hospital Tuebingen | Completed | No outcome recorded |
| Phase 1/2 | NCT02078648 Background | May 2014 → Sep 2017 | adult glioblastoma | Stemline Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT05740969 Comparator | Feb 2023 → Feb 2024 | actinic keratosis | Ismail Gögenur | Unknown | No outcome recorded |
| Phase 2 | NCT05314127 Comparator | Apr → Oct 2022 | skin disorder caused by infection | Zagazig University | Unknown | No outcome recorded |
| Phase 2 | NCT02802943 Background | Oct 2016 → Sep 2022 | chronic lymphocytic leukemia/small lymphocytic lymphoma | University Hospital Tuebingen | Completed | No outcome recorded |
| Phase 2 | NCT02482428 Comparator | May 2015 → May 2016 | anogenital human papillomavirus infection | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02404389 Comparator | Mar 2015 → Jan 2016 | actinic keratosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01957878 Background | Dec 2013 → Oct 2016 | human papilloma virus infection, viral sexually transmitted disease | Genticel | Completed | No outcome recorded |
| Phase 2 | NCT01543464 Background | May 2012 → Sep 2016 | melanoma | Inge Marie Svane | Terminated | No outcome recorded |
| Phase 2 | NCT01593124 Comparator | May 2012 → Apr 2013 | infective vaginitis | CONRAD | Completed | No outcome recorded |
| Phase 2 | NCT00335179 Comparator | Jan → Jul 2003 | actinic keratosis | Graceway Pharmaceuticals, LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00941252 Comparator | Jul 2009 → Jan 2011 | cervical intraepithelial neoplasia | Medical University of Vienna | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT04143451 Comparator | Oct 2019 → Sep 2022 | influenza | The University of Hong Kong | Unknown | No outcome recorded |
| Phase 3 | NCT03901690 Comparator | Aug 2019 → Mar 2020 | anogenital human papillomavirus infection | Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri | Unknown | No outcome recorded |
| Phase 3 | NCT03073967 Comparator | May 2017 → Aug 2025 | herpes simplex infectious disease | AiCuris Anti-infective Cures AG | Completed | No outcome recorded |
| Phase 3 | NCT00894647 Comparator | May 2009 → Feb 2010 | actinic keratosis | Graceway Pharmaceuticals, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00605176 Comparator | Jan → Jul 2008 | actinic keratosis | Graceway Pharmaceuticals, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00603798 Comparator | Jan → Jul 2008 | actinic keratosis | Graceway Pharmaceuticals, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00129519 Comparator | Jan 2004 → Jan 2006 | basal cell carcinoma | Graceway Pharmaceuticals, LLC | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT01663558 Comparator | May → Dec 2015 | HIV infectious disease, anus disorder, human papilloma virus infection | United States Naval Medical Center, San Diego | Withdrawn | No outcome recorded |
| Phase 4 | NCT02281682 Comparator | Nov 2014 → Jul 2018 | actinic keratosis | Maastricht University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01926496 Comparator | Sep 2013 → Jul 2019 | actinic keratosis | LEO Pharma | Completed | No outcome recorded |
| Phase 4 | NCT01538901 Comparator | Sep 2012 → Sep 2014 | actinic keratosis | Medical University of Vienna | Terminated | No outcome recorded |
| Phase 4 | NCT01413763 Comparator | Jul 2011 → Apr 2013 | actinic keratosis | Medicis Global Service Corporation | Unknown | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05146895 Comparator | Oct 2018 → Jun 2022 | human papilloma virus infection | First Hospital of China Medical University | Unknown | No outcome recorded |
| — | NCT00707174 Comparator | Mar 2005 → Mar 2013 | lentigo maligna melanoma | University of Utah | Completed | No outcome recorded |
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 171 sources stand behind the page.
| Field | Value | Cited 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 ↗ “imiquimod cream” NCT04143451 ↗ “Imiquimod” NCT01161888 ↗ |
| 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 ↗ “Imiquimod (aldara) 0.5 % cream to site of vaccination on day 2 to 6” NCT00596336 ↗ “Topical treatment with Aldara 3 times per week.” NCT02404389 ↗ “Aldara (imiquimod) cream, 5%” NCT00115154 ↗ “imiquimod 5% cream (Aldara)” NCT00230373 ↗ “Aldara (Imiquimod)” NCT00294320 ↗ “Imiquimod, Aldara.” NCT02329171 ↗ |
| 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 | GBM6-AD | “fixed doses of 1mg GBM6-AD vaccine” NCT06305910 ↗ |
| 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 20223“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 |