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Daurismo (Glasdegib Maleate)
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 name | Glasdegib Maleate |
|---|---|
| Sponsor | Pfizer |
| Drug class | Hedgehog pathway inhibitor |
| Target | Smoothened (transmembrane protein) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2018 |
| Annual revenue | 150 |
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
- Acute myeloid leukemia, disease
Common side effects
- Fatigue
- Alanine aminotransferase increased
- Blood bilirubin increased
- Anemia
- Anorexia
- Aspartate aminotransferase
- Constipation
- Diarrhea
- Infections and infestations - Other, specify
- Infusion related reaction
- Nausea
- Platelet count decreased
Drug interactions
- Strong CYP3A4 inhibitors
- Strong and moderate CYP3A4 inducers
- QTc prolonging drugs
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Daurismo CI brief — competitive landscape report
- Daurismo updates RSS · CI watch RSS
- Pfizer portfolio CI