Prescription medicine
Glasdegib Brand names: Daurismo
Glasdegib (Daurismo) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the glasdegib FDA label on DailyMed (effective December 12, 2025, Pfizer Laboratories Div Pfizer Inc); the NDA 210656 record on Drugs@FDA; every glasdegib label on DailyMed.
Highlights of the record
FDA label of December 12, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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. […]
Used for
From the label: indications and usageDAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
Forms and strengths
- 25 mg
- 100 mg
Film-coated tablet.
On the market
- Earliest approval on file
- November 21, 2018 Daurismo, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 13, 2036 Daurismo tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 468 through July 30, 2026
What is glasdegib used for?
From the label: indications and usageDAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. DAURISMO is a hedgehog pathway inhibitor indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
Conditions named in the indications of glasdegib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hedgehog Pathway Inhibitor.
Source: FDA drug label (Daurismo), Pfizer Laboratories Div Pfizer Inc, effective December 12, 2025 (SPL set 204a6f7e-c9a4-472b-abd2-9527bda64d17), via openFDA; the full label on DailyMed
What does the patient leaflet for glasdegib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about DAURISMO?DAURISMO can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects. For females who can become pregnant: • You should talk to your healthcare provider about the risks of DAURISMO to your unborn child. • Your healthcare provider will do a pregnancy test within 7 days before you start taking DAURISMO. • You should not use DAURISMO during pregnancy. • You should use effective birth control during treatment and for at least 30 days after your last dose of DAURISMO. Talk with your healthcare provider about what birth control method is right for you during this time. • Talk to your healthcare provider right away if you have unprotected sex or if you think that your birth control has failed. • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant. For males: • It is not known if DAURISMO is present in semen. Do not donate semen during treatment with DAURISMO and for at least 30 days after your last dose. • You should always use effective birth control, including a condom, even if you have had a vasectomy, during sex with female partners who are pregnant or who are able to become pregnant, during treatment with DAURISMO and for at least 30 days after your last dose to protect your female partner from being exposed to DAURISMO. • Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking DAURISMO. Exposure to DAURISMO during pregnancy: If you think that you or your female partner may have been exposed to DAURISMO during pregnancy, talk to your healthcare provider right away. If you become pregnant during treatment with DAURISMO, you or your healthcare provider should report your pregnancy to Pfizer at 1-800-438-1985.
From the patient leaflet: What should I avoid while taking DAURISMO?Do not donate blood or blood products during treatment with DAURISMO and for at least 30 days after the last dose. • Do not donate semen during treatment with DAURISMO and for at least 30 days after the last dose.
From the patient leaflet: How should I store DAURISMO?Store DAURISMO at room temperature between 68°F to 77°F (20°C to 25°C). Keep DAURISMO and all medicines out of the reach of children.
Source: FDA drug label (Daurismo), Pfizer Laboratories Div Pfizer Inc, effective December 12, 2025 (SPL set 204a6f7e-c9a4-472b-abd2-9527bda64d17), via openFDA; the full label on DailyMed
Is there a generic for glasdegib (Daurismo)?
No generic glasdegib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Daurismo tablets: the compound patent runs to April 13, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the glasdegib label say about other medicines?
The glasdegib label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 2 other medicines name glasdegib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cytarabine | warnings and precautions | Of the 98 evaluable patients treated with DAURISMO 100 mg in combination with low-dose cytarabine in the clinical trial, 5% were found to have a QTc interval greater than 500 ms and 4% of patients had an increase from baseline QTc greater than 60 ms. |
Other labels that name glasdegib
Source: FDA drug label (Daurismo), Pfizer Laboratories Div Pfizer Inc, effective December 12, 2025 (SPL set 204a6f7e-c9a4-472b-abd2-9527bda64d17), via openFDA; the full label on DailyMed
What do FAERS reports show for glasdegib?
The FDA Adverse Event Reporting System holds 468 reports that list glasdegib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 190 are coded as a death and 224 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as glasdegib?
37 other medicines are given the same way (oral) and in the same FDA class as glasdegib or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lenalidomide | Leukemia, lymphoma and myeloma | 18 labelers | n/a | No current entry |
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Pomalidomide | Leukemia, lymphoma and myeloma | 11 labelers | n/a | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Hydroxyurea | Leukemia, lymphoma and myeloma | 10 labelers | $0.184 per capsule 500 mg capsule | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 4 labelers | $1.67 per capsule 50 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other hedgehog pathway inhibitors
- the pharmacologic class, with prices and generics
- Glasdegib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other