Product Description
Glasdegib is a small-molecule inhibitor of a component of the hedgehog (HH) pathway, an upregulated pathway in leukemia and leukemia stem cells that is associated with relapse, drug resistance and poor survival. Preclinical studies suggested that glasdegib could sensitize AML cells to chemotherapy. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/31584572/)
Mechanisms of Action: Hh Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Austria | Belgium | Canada | Croatia | Cyprus | Czech | Denmark | Estonia | European Medicines Agency | Finland | Germany | Greece | Hungary | Iceland | Ireland | Israel | Italy | Latvia | Lithuania | Netherlands | Norway | Poland | Portugal | Romania | Slovakia | Slovenia | Spain | Sweden | United Kingdom | United States
Approved Indications: Acute Leukemia | Acute Myeloid Leukemia | Leukemia | Myeloid Leukemia
Known Adverse Events: Dysgeusia | Pain Unspecified | Mucositis | Anemia | Febrile Neutropenia | Thrombocytopenia | Neutropenia | Musculoskeletal Pain | Dyspnea | Constipation | Edema
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, Canada, Czech Republic, France, Hungary, Italy, Japan, Mexico, Poland, Spain, United Kingdom, United States
Active Clinical Trial Count: 6
Highest Development Phases
Phase 3: Acute Monocytic Leukemia|Acute Myeloid Leukemia|Acute Myelomonocytic Leukemia|Chronic Myeloid Leukemia|Chronic Myelomonocytic Leukemia|Juvenile Myelomonocytic Leukemia,|Myelodysplastic Syndrome|Preleukemia
Phase 2: Glioblastoma|Nose Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| AML1819 | P3 |
Active, not recruiting |
Acute Myeloid Leukemia |
2026-08-26 |
|
| UCI 18-105 | P2 |
Active, not recruiting |
Acute Myeloid Leukemia|Myelodysplastic Syndrome |
2025-06-30 |
|
| 2017-002822-19 | P3 |
Active, not recruiting |
Acute Myeloid Leukemia |
2025-03-30 |
|
| jRCT2080223841 | P3 |
Completed |
Acute Myeloid Leukemia |
2022-12-13 |