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Daurismo (Glasdegib Maleate)

Pfizer · FDA-approved approved Small molecule Verified Quality 76/100

Glasdegib inhibits Smoothened, a transmembrane protein in the Hedgehog signaling pathway.

Glasdegib is a Hedgehog pathway inhibitor approved in combination with low-dose cytarabine for newly-diagnosed AML in elderly or comorbid patients. The drug demonstrates dose-proportional pharmacokinetics with a 17.4-hour half-life and is primarily metabolized by CYP3A4, requiring careful management of drug interactions. Key safety concerns include QTc interval prolongation and increased exposure with strong CYP3A4 inhibitors or renal impairment. Clinical efficacy and tolerability depend on appropriate patient selection and monitoring for drug interactions.

At a glance

Generic nameGlasdegib Maleate
SponsorPfizer
Drug classHedgehog pathway inhibitor
TargetSmoothened (transmembrane protein)
ModalitySmall molecule
Therapeutic areaOncology
PhaseFDA-approved
First approval2018
Annual revenue150

Mechanism of action

Glasdegib is an inhibitor of the Hedgehog pathway that binds to and inhibits Smoothened, a transmembrane protein involved in hedgehog signal transduction. In a murine xenotransplant model of human AML, glasdegib in combination with low-dose cytarabine inhibited increases in tumor size and reduced the percentage of CD45+/CD33+ blasts in the marrow to a greater extent than glasdegib or low-dose cytarabine alone.

Approved indications

Common side effects

Drug interactions

Patents

PatentExpiryType

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
FDA Orange BookPatents + exclusivity
SEC EDGARRevenue + earnings

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