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glasdegib

Generic: GLASDEGIB MALEATE·Brand: DAURISMO, Daurismo

glasdegib: developed by 1 company · 1 clinical trial tracked · 1 FDA decision.

glasdegib evidence translation

What we can confirm

1 FDA record · 1 tracked trial

What it means

Source-backed records connect glasdegib to PFE; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could glasdegib → PFE affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

Development Pipeline (1)
CompanyPhase
PFIZER INC (PFE)Approved
Clinical Trials (1)

Phase II Study of the Combination of CPX-351 and Glasdegib in Previously Untreated Patients With Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia

NCT04231851·Phase 2
Active, not recruiting

Primary endpoint: Percentage of Participants With Event-Free Survival at 6 Months

Interventionalopen30 enrolledStarted 2020-02Completion 2027-064 sites · United StatesUniversity of California, Irvine
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE DAURISMO 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 (PFE)FDA ↗
NDA210656Type 1 - New Molecular EntityOrphan DrugPriorityOralTablet

Frequently asked questions

Who is developing glasdegib?

glasdegib is being developed by PFIZER INC.

How many clinical trials involve glasdegib?

BioSniper tracks 1 clinical trial involving glasdegib.

What is glasdegib's latest FDA decision?

The most recent tracked FDA decision for glasdegib is Approval for 1 INDICATIONS AND USAGE DAURISMO 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 , dated November 21, 2018.