NDAORALTABLETPriority Review
Approved
Nov 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
14
Data completeness
6/8 — Strong
Priority Review
DAURISMO (glasdegib) by Pfizer is smoothened receptor antagonists [moa]. First approved in 2018.
Drug data last refreshed 5h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DAURISMO (glasdegib) is an oral small-molecule Hedgehog pathway inhibitor approved in November 2018 for treating acute myeloid leukemia (AML) in combination with low-dose cytarabine in elderly patients ineligible for intensive chemotherapy. It works by antagonizing the smoothened receptor, disrupting the oncogenic Hedgehog signaling pathway that drives leukemic cell survival and self-renewal.
$0.003BPart D
Peak9.8 years to LOEProduct is in peak commercial phase with modest Part D uptake (129 claims, $3M in 2023), suggesting stable but limited market penetration in a narrow elderly AML population.
Mechanism of Action
Smoothened Receptor Antagonists
Pharmacologic Class:
Hedgehog Pathway Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
Started May 2021
14 enrolled
Acute Myeloid LeukemiaMyelodysplastic SyndromeChronic Myelomonocytic Leukemia
Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia)
Started Apr 2021
28 enrolled
Acute Myeloid Leukemia
CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia
Started Feb 2020
30 enrolled
Acute Myelogenous Leukemia (AML) Due to TherapyAcute Myeloid Leukemia With Myelodysplasia-Related Changes
GLAD-AML - Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia
Started Dec 2019
1 enrolled
ACUTE MYELOID LEUKEMIA
Glasdegib for Chronic Graft-Versus-Host Disease
Started Dec 2019
15 enrolled
Chronic Graft Versus Host DiseaseFasciitis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.