Last reviewed 2026-04-20 · How we verify

GLASDEGIB

At a glance

Approved indications

No approved indications tracked.

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
• Fatigue
• Edema
• Thrombocytopenia
• Febrile neutropenia
• Hemorrhage
• Mucositis
• Pyrexia
• Nausea
• Dyspnea
• Decreased appetite
• Dysgeusia

Serious adverse events

• Febrile neutropenia
• Pneumonia
• Hemorrhage
• Anemia
• Sepsis
• Sudden death
• Myocardial infarction
• Renal insufficiency
• Nausea
• ECG QT prolonged

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)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• GLASDEGIB CI brief — competitive landscape report
• GLASDEGIB updates RSS · CI watch RSS