{"entity":{"id":"glasdegib","kind":"drug","name":"Glasdegib","aka":[],"tldr":"Glasdegib is a hedgehog-pathway pill that, with low-dose chemotherapy, extends survival in older AML patients who cannot have intensive treatment; it has largely been displaced by venetoclax combinations.","summary":"Glasdegib inhibits smoothened (SMO), reducing hedgehog signalling in leukaemic stem cells, and is combined with low-dose cytarabine for newly diagnosed AML in adults aged 75 or over or unfit for intensive chemotherapy. In BRIGHT AML 1003 the combination gave a median overall survival of 8.8 versus 4.9 months with low-dose cytarabine alone, leading to US approval in 2018 and EU approval in 2020. The BRIGHT AML 1019 trials, which added glasdegib to intensive chemotherapy or azacitidine backbones, were negative. In the same period venetoclax with azacitidine became the preferred regimen for unfit AML, so glasdegib is now rarely chosen. Muscle spasms, dysgeusia and alopecia are class hedgehog-inhibitor effects. For a newcomer, glasdegib proved that a hedgehog pill could extend survival in older AML but was overtaken by a better combination.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Glasdegib","links":[{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=glasdegib"}],"tags":["gap-fill"],"related":[],"cancers":["aml","aml-older-unfit"],"sections":[],"technologies":["kinase-inhibitors","hedgehog-inhibitors"],"targets":["smoothened"],"drugs":[],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":["nct03416179","nct04842604","nct04093505"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Daurismo","modality":"Small-molecule smoothened (hedgehog) inhibitor","mechanism":"Inhibits SMO, reducing hedgehog signalling in leukaemic stem cells; combined with low-dose cytarabine.","approvals":[{"region":"US","year":2018,"indication":"Newly diagnosed AML in adults ≥75 or unfit for intensive chemotherapy, with low-dose cytarabine"},{"region":"EU","year":2020,"indication":"Same"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/glasdegib/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-older-unfit","kind":"cancer","name":"Acute myeloid leukaemia in older or unfit patients","route":"/cancers/aml-older-unfit/"}],"technology":[{"id":"hedgehog-inhibitors","kind":"technology","name":"Hedgehog pathway inhibitors","route":"/technologies/hedgehog-inhibitors/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"smoothened","kind":"target","name":"Smoothened (hedgehog pathway)","route":"/targets/smoothened/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}],"trial":[{"id":"nct03416179","kind":"trial","name":"A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia","route":"/trials/nct03416179/"},{"id":"nct04842604","kind":"trial","name":"Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML","route":"/trials/nct04842604/"},{"id":"nct04093505","kind":"trial","name":"Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia)","route":"/trials/nct04093505/"},{"id":"nct03784014","kind":"trial","name":"Molecular Profiling of Advanced Soft-tissue Sarcomas","route":"/trials/nct03784014/"}]}}