Daurismo (glasdegib)
An approved treatment for Acute Myeloid Leukemia.
The same compound appears under different names depending on the context. Here is how to identify Glasdegib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Glasdegib
- Brand name
- Daurismo
- Development code
- PF-04449913
- Drug class
- Hedgehog pathway inhibitor
- Manufacturer
- Pfizer
- How it's taken
- Oral tablet once daily, with low-dose cytarabine injections
A once-daily pill given with low-dose cytarabine injections for newly diagnosed AML in adults 75 or older or unfit for intensive chemotherapy. Approved November 21, 2018, the same day as Venclexta's AML approval; it is used much less often now that venetoclax combinations are standard.
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Where Glasdegib fits
An alternative low-intensity regimen for people who cannot have intensive chemotherapy. Venetoclax with azacitidine, which showed a larger survival gain in a larger trial, is used far more often, and the 2 have not been compared head to head.
How Glasdegib works
The Hedgehog signaling pathway helps leukemia stem cells survive chemotherapy. Glasdegib blocks Smoothened, a protein in that pathway, which the label describes as reducing the leukemia-initiating cell population; with low-dose cytarabine it produced more remissions and longer survival than cytarabine alone[1].
Mechanism: Oral Hedgehog pathway inhibitor that binds Smoothened and cuts a survival signal in leukemia stem cells
Side effects and safety
- Blood donation. No blood or blood product donation during treatment and for at least 30 days after.
- QTc prolongation. ECGs before starting, about weekly for the first month and monthly for the next 2 months; electrolytes kept normal.
- Musculoskeletal adverse reactions. Creatine phosphokinase and creatinine before starting and when muscle symptoms occur; dose interruption or reduction may be needed.
- Blood counts, electrolytes, kidney and liver function before starting and weekly for the first month, then electrolytes and kidney function monthly
- ECG schedule above
- Creatine phosphokinase before starting
Daurismo carries a boxed warning for embryo-fetal toxicity: it can cause fetal death or severe birth defects, so pregnancy testing, contraception for women for at least 30 days and for men (with condoms) for at least 30 days after the last dose, and no sperm donation apply[1]. Other warnings are no blood donation during treatment and for 30 days after, QTc prolongation (ECGs before starting, weekly for the first month, then monthly for 2 months) and muscle problems with creatine phosphokinase checks[1].
The most common side effects (20% or more) were anemia, fatigue, bleeding, febrile neutropenia, musculoskeletal pain, nausea, swelling, low platelets, shortness of breath, decreased appetite, altered taste, mouth sores, constipation and rash[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Glasdegib
The dose is 100 mg by mouth once a day on days 1 to 28 of each 28-day cycle, with cytarabine 20 mg injected under the skin twice a day on days 1 to 10 of each cycle, continued for at least 6 cycles if there is no unacceptable toxicity and then until the leukemia progresses[1]. Tablets are not split or crushed; a vomited dose is not replaced.
Availability and cost
Only available as the brand-name product.
Help paying for Daurismo
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Co-Pay Assistance for Pfizer oral oncology medicines: eligible commercially insured patients pay as little as $0 per month, up to $10,600 per product per year. Not for Medicare, Medicaid, TRICARE, VA or state programs.
For: private insurance · source - Free medicine program
Pfizer Patient Assistance Program provides Pfizer medicines free to eligible patients who have difficulty affording their Pfizer Oncology medicine.
For: no insurance, underinsured, Medicare · source - Insurance and case manager help
Pfizer Oncology Together Care Champions help with insurance, financial assistance options and day-to-day resources. Call 1-877-744-5675.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: The Pfizer Oncology Together page describes the oral co-pay tier without naming Daurismo.
Access and eligibility
Adults with newly diagnosed AML who are 75 or older or have comorbidities that preclude intensive induction, in combination with low-dose cytarabine only. It is not approved alone, with azacitidine, or in relapsed AML.
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
BRIGHT AML 1003 (NCT01546038) randomized 115 adults aged 55 or older with newly diagnosed AML who were 75 or older or had severe heart disease, a performance status of 2 or raised creatinine, 2 to 1 to glasdegib plus low-dose cytarabine or low-dose cytarabine alone. Median overall survival was 8.3 months against 4.3 months (hazard ratio 0.46, 95% CI 0.30 to 0.71, p=0.0002), and complete remission was 18.2% against 2.6%[1].
Development history
Explore Acute Myeloid Leukemia trials
Other Acute Myeloid Leukemia treatments
Common questions about Glasdegib
▸What is Glasdegib (Daurismo)?
A once-daily pill given with low-dose cytarabine injections for newly diagnosed AML in adults 75 or older or unfit for intensive chemotherapy. Approved November 21, 2018, the same day as Venclexta's AML approval; it is used much less often now that venetoclax combinations are standard.
▸How does Glasdegib work?
The Hedgehog signaling pathway helps leukemia stem cells survive chemotherapy. Glasdegib blocks Smoothened, a protein in that pathway, which the label describes as reducing the leukemia-initiating cell population; with low-dose cytarabine it produced more remissions and longer survival than cytarabine alone[1].
▸What are the side effects of Glasdegib?
Daurismo carries a boxed warning for embryo-fetal toxicity: it can cause fetal death or severe birth defects, so pregnancy testing, contraception for women for at least 30 days and for men (with condoms) for at least 30 days after the last dose, and no sperm donation apply[1]. Other warnings are no blood donation during treatment and for 30 days after, QTc prolongation (ECGs before starting, weekly for the first month, then monthly for 2 months) and muscle problems with creatine phosphokinase checks[1]. The most common side effects (20% or more) were anemia, fatigue, bleeding, febrile neutropenia, musculoskeletal pain, nausea, swelling, low platelets, shortness of breath, decreased appetite, altered taste, mouth sores, constipation and rash[1].
▸How is Glasdegib taken?
The dose is 100 mg by mouth once a day on days 1 to 28 of each 28-day cycle, with cytarabine 20 mg injected under the skin twice a day on days 1 to 10 of each cycle, continued for at least 6 cycles if there is no unacceptable toxicity and then until the leukemia progresses[1]. Tablets are not split or crushed; a vomited dose is not replaced.
▸Is Glasdegib FDA approved?
Yes, Glasdegib (Daurismo) is FDA approved (2018) for the treatment of Acute Myeloid Leukemia.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Pfizer via openFDA · 2025-12-12. Daurismo (glasdegib) tablets prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%22204a6f7e-c9a4-472b-abd2-9527bda64d17%22
- FDA. Daurismo approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210656
- Pfizer. Financial assistance. https://www.pfizeroncologytogether.com/patient/financial-assistance