{"entity":{"id":"imiquimod","kind":"drug","name":"Imiquimod","aka":[],"tldr":"Imiquimod (Aldara) is a cream that provokes the skin's own immune system to clear superficial basal cell carcinomas and the sun-damage patches (actinic keratoses) that can turn into skin cancer.","summary":"Imiquimod 5% cream was approved in 1997 for external genital warts and in 2004 for actinic keratosis and for superficial basal cell carcinoma up to 2 cm in immunocompetent adults when surgery is less appropriate, on vehicle-controlled trials with histological clearance in about three-quarters of treated sBCC lesions. Zyclara 2.5% and 3.75% (2010) offers a shorter field regimen for actinic keratosis. The EU authorised Aldara in 1998 with the same three indications. It is applied five times a week for six weeks for sBCC; local inflammation, erosion and flu-like symptoms are expected and predict response. Long-term recurrence is higher than after excision, so it is reserved for low-risk lesions.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Imiquimod","links":[{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=imiquimod"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/imiquimod"},{"label":"EPAR (Aldara)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/aldara"},{"label":"Bath-Hextall et al., surgical excision versus imiquimod 5% cream for nodular and superficial basal-cell carcinoma, SINS (Lancet Oncology 2014)","url":"https://doi.org/10.1016/S1470-2045(13)70530-8"},{"label":"Williams et al., surgery versus 5% imiquimod for nodular and superficial basal cell carcinoma, 5-year results of the SINS randomised controlled trial (J Invest Dermatol 2017)","url":"https://doi.org/10.1016/j.jid.2016.10.019"},{"label":"Jansen et al., five-year results of a randomised controlled trial comparing photodynamic therapy, topical imiquimod and topical 5-fluorouracil in superficial basal cell carcinoma (J Invest Dermatol 2018)","url":"https://doi.org/10.1016/j.jid.2017.09.033"},{"label":"Thomson et al., interventions for basal cell carcinoma of the skin: Cochrane review of 52 randomised trials and 6,690 participants (2020)","url":"https://doi.org/10.1002/14651858.CD003412.pub3"}],"tags":["nci-list"],"related":[],"cancers":["basal-cell-carcinoma","cutaneous-scc","skin-cancer"],"sections":[],"technologies":["chemoprevention"],"targets":["tlr7"],"drugs":[],"companies":["bausch-health"],"institutions":[],"pathways":[],"terms":["histology","topical-and-destructive-treatment-bcc"],"trials":["sins-trial","mal-pdt-imiquimod-fluorouracil-superficial-bcc","scin-trial"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Low-risk basal cell carcinoma, what the randomised trials show. In the UK SINS trial, 501 participants with primary nodular or superficial basal cell carcinoma at low-risk sites were randomised to imiquimod once daily (six weeks for superficial, twelve weeks for nodular) or to excision with a 4 mm margin. Success was 178 of 213 (83.6 percent) against 185 of 188 (98.4 percent) at three years and 170 of 206 (82.5 percent) against 173 of 177 (97.7 percent) at five years, and most imiquimod failures occurred in year one. The authors' conclusion was that imiquimod was inferior to surgery by their predefined criterion, and that excisional surgery remains the best treatment for low-risk basal cell carcinoma.","Among the non-surgical options, imiquimod is the one with the best evidence. In a Dutch trial of 601 patients with superficial basal cell carcinoma, five-year tumour-free survival was 80.5 percent for imiquimod, 70.0 percent for fluorouracil cream and 62.7 percent for methyl-aminolevulinate photodynamic therapy. The Cochrane review reached the same conclusion, that of the non-surgical treatments imiquimod has the best evidence to support its efficacy.","What it does to the skin while it works: in SINS the commonest adverse events were itching (211 in the imiquimod group against 129 in the surgery group) and weeping (160 against 81), and 12 of 249 participants in the imiquimod group withdrew because of adverse events against four of 229 in the surgery group."],"brand":"Aldara / Zyclara","modality":"Topical immune response modifier (TLR7 agonist)","mechanism":"Toll-like receptor 7 agonist that induces interferon-alpha, TNF and other cytokines from dendritic cells and macrophages; the label states the mechanism in basal cell carcinoma and actinic keratosis is not fully established.","approvals":[{"region":"US","year":1997,"indication":"External genital and perianal warts"},{"region":"US","year":2004,"indication":"Actinic keratosis; superficial basal cell carcinoma in immunocompetent adults"},{"region":"EU","year":1998,"indication":"Genital warts, superficial basal cell carcinoma and actinic keratosis (Aldara)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/imiquimod/","neighbours":{"cancer":[{"id":"basal-cell-carcinoma","kind":"cancer","name":"Basal cell carcinoma","route":"/cancers/basal-cell-carcinoma/"},{"id":"bowens-disease","kind":"cancer","name":"Bowen's disease (squamous cell carcinoma in situ)","route":"/cancers/bowens-disease/"},{"id":"cutaneous-scc","kind":"cancer","name":"Cutaneous squamous cell carcinoma","route":"/cancers/cutaneous-scc/"},{"id":"mycosis-fungoides","kind":"cancer","name":"Mycosis fungoides","route":"/cancers/mycosis-fungoides/"},{"id":"skin-cancer","kind":"cancer","name":"Skin cancer (all types)","route":"/cancers/skin-cancer/"}],"technology":[{"id":"chemoprevention","kind":"technology","name":"Chemoprevention & risk-reducing surgery","route":"/technologies/chemoprevention/"}],"target":[{"id":"tlr7","kind":"target","name":"Toll-like receptor 7 (TLR7)","route":"/targets/tlr7/"}],"company":[{"id":"bausch-health","kind":"company","name":"Bausch Health","route":"/companies/bausch-health/"}],"term":[{"id":"topical-and-destructive-treatment-bcc","kind":"term","name":"Creams, light and cold for basal cell carcinoma","route":"/terms/topical-and-destructive-treatment-bcc/"},{"id":"histology","kind":"term","name":"Histology","route":"/terms/histology/"},{"id":"lymphoma-tx-skin-directed-therapy","kind":"term","name":"Skin-directed therapy in mycosis fungoides: creams, light and small radiotherapy fields","route":"/terms/lymphoma-tx-skin-directed-therapy/"}],"trial":[{"id":"anchor","kind":"trial","name":"ANCHOR","route":"/trials/anchor/"},{"id":"mal-pdt-imiquimod-fluorouracil-superficial-bcc","kind":"trial","name":"Photodynamic therapy against imiquimod against fluorouracil for superficial basal cell carcinoma","route":"/trials/mal-pdt-imiquimod-fluorouracil-superficial-bcc/"},{"id":"scin-trial","kind":"trial","name":"SCIN (curettage then imiquimod against excision for nodular basal cell carcinoma)","route":"/trials/scin-trial/"},{"id":"sins-trial","kind":"trial","name":"SINS (surgical excision against imiquimod cream for basal cell carcinoma)","route":"/trials/sins-trial/"}]}}