Last reviewed 2026-04-20 · How we verify

Daurismo (glasdegib)

Daurismo works by blocking the Smoothened homolog, a protein involved in the Hedgehog signaling pathway, which is often dysregulated in cancer cells.

Daurismo (glasdegib) is a small molecule Hedgehog Pathway Inhibitor developed by Pfizer, targeting the Smoothened homolog. It was FDA-approved in 2018 for the treatment of acute myeloid leukemia. As a patented product, Daurismo is not yet available as a generic. Key safety considerations include its potential to cause gastrointestinal and hematologic adverse effects. Daurismo's commercial status remains under Pfizer's ownership.

At a glance

Mechanism of action

Glasdegib is an inhibitor of the Hedgehog pathway. Glasdegib binds to and inhibits Smoothened, transmembrane protein involved in hedgehog signal transduction.In 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 greater extent than glasdegib or low-dose cytarabine alone.

Approved indications

• Acute myeloid leukemia, disease

Boxed warnings

• WARNING: EMBRYO-FETAL TOXICITY DAURISMO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. DAURISMO is embryotoxic, fetotoxic, and teratogenic in animals [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) ] . Conduct pregnancy testing in females of reproductive potential prior to initiation of DAURISMO treatment. Advise females of reproductive potential to use effective contraception during treatment with DAURISMO and for at least 30 days after the last dose [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ] . Advise males of the potential risk of DAURISMO exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with DAURISMO and for at least 30 days after the last dose to avoid potential drug exposure [see Warnings and Precautions (5.1) , Use in Specific Populations (8.3) ] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. • DAURISMO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. DAURISMO is embryotoxic, fetotoxic, and teratogenic in animals. ( 5.1 , 8.1 ) • Conduct pregnancy testing in females of reproductive potential prior to initiation of DAURISMO treatment. Advise females of reproductive potential to use effective contraception during treatment with DAURISMO and for at least 30 days after the last dose. ( 5.1 , 8.1 , 8.3 ) • Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with DAURISMO and for at least 30 days after the last dose to avoid potential drug exposure. ( 5.1 , 8.3 )

Common side effects

• Anemia
• Hemorrhage
• Fatigue
• Edema
• Mucositis
• Pyrexia
• Musculoskeletal pain
• Thrombocytopenia
• Dyspnea
• Cough
• Decrease appetite
• Dysgeusia

Key clinical trials

• IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. (PHASE3)
• Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia (PHASE2)
• CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia (PHASE2)
• Molecular Profiling of Advanced Soft-tissue Sarcomas (PHASE3)
• A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies (PHASE1)
• Glasdegib for Chronic Graft-Versus-Host Disease (PHASE1,PHASE2)
• A Study Of PF-04449913 In Select Hematologic Malignancies (PHASE1)
• Glasdegib (PF-04449913) With Temozolomide Newly Diagnosed Glioblastoma (PHASE1,PHASE2)

Patents

Primary sources

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