Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Glasdegib single dose · 1 trial · 1 indication
PK parameter of glasdegib to be calculated from the plasma concentration-time data
PK parameter of glasdegib to be calculated from the plasma concentration-time data
| Arm | Type | Description |
|---|---|---|
| Moderate Hepatic Impairment Group | EXPERIMENTAL | Subjects with Child-Pugh Classification B (score 7-9) |
| Severe Hepatic Impairment Group | EXPERIMENTAL | Subjects with Child-Pugh Classification C (score 10-15) |
| Normal Hepatic Function Group | EXPERIMENTAL | Healthy subjects with normal hepatic function |
| Name | Type | Description |
|---|---|---|
| Glasdegib 100 mg single oral dose | DRUG | A single dose of 100 mg glasdegib tablet will be administered after an overnight fast, followed by serial PK collection, discharge and follow-up. |
Inclusion Criteria: 1. Healthy or hepatically impaired female subjects of non-child bearing potential and/or male subjects who, at the time of Screening, are between the ages of 18 and 75 years, inclusive. 2. Female subjects of nonchildbearing potential must meet at least 1 of the following criteri...
Glasdegib is an investigational small molecule being studied for the treatment of Acute Myeloid Leukemia (AML). It has also been evaluated in clinical trials involving healthy volunteers and patients with hepatic impairment. The drug is being developed by Pfizer, Inc. and is currently in Phase 3 clinical development.
Glasdegib is a small molecule that targets the Hedgehog signaling pathway. It works by inhibiting the Smoothened receptor, which is a key component of this pathway. By blocking this receptor, Glasdegib aims to disrupt signaling that can promote cancer cell growth and survival in conditions like Acute Myeloid Leukemia.
Glasdegib is being developed by Pfizer, Inc., a multinational pharmaceutical company. Pfizer is listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the safety and efficacy of Glasdegib for the treatment of Acute Myeloid Leukemia and other conditions.
Glasdegib is currently in Phase 3 clinical development. It has completed two Phase 3 trials, including a study evaluating intensive chemotherapy with or without Glasdegib in patients with previously untreated Acute Myeloid Leukemia. The drug is investigational and has not yet been approved by regulatory authorities.
Glasdegib has been studied in several clinical trials, including NCT03416179, a Phase 3 study of intensive chemotherapy with or without Glasdegib in previously untreated Acute Myeloid Leukemia. Other trials include NCT02430545 and NCT03627754, which evaluated the drug's pharmacokinetics in healthy volunteers and patients with hepatic impairment, respectively.
Glasdegib is also known by the brand name Daurismo. This alternative name is used in some contexts to refer to the same drug. Both names refer to the investigational small molecule being developed by Pfizer for the treatment of Acute Myeloid Leukemia.