Product Description
Gilteritinib is an oral, potent, selective FLT3 inhibitor with single-agent activity in relapsed or refractory FLT3-mutated AML. (Sourced from: https://www.nejm.org/doi/full/10.1056/NEJMoa1902688)
Mechanisms of Action: FLT3 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Colombia | Croatia | Czech | Denmark | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: Acute Leukemia | Acute Myeloid Leukemia | Leukemia | Myeloid Leukemia
Known Adverse Events: Hypotension | Headache Disorders | Dizziness | Headache | Mucositis | Arthralgia | Myalgia | Dyspnea | Constipation | Diarrhea | Edema
Company: Astellas Pharma
Company Location: NEW YORK NY 10005
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Bulgaria, Canada, China, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Korea, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Russia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States
Active Clinical Trial Count: 19
Highest Development Phases
Phase 3: Acute Myeloid Leukemia|Anemia, Refractory, with Excess of Blasts|Myelodysplastic Syndrome|Preleukemia
Phase 1: Kidney Diseases
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| HOVON 156 AML / AMLSG 28-18 | P3 |
Active, not recruiting |
Myelodysplastic Syndrome|Acute Myeloid Leukemia |
2032-08-01 |
|
| 2215-CL-0603 | P2 |
Unknown Status |
Acute Myeloid Leukemia |
2031-07-30 |
|
| 2215-CL-0203 | P2 |
Recruiting |
Acute Myeloid Leukemia |
2028-07-31 |
|
| NCI-2024-00669 | P2 |
Recruiting |
Acute Myeloid Leukemia |
2027-10-01 |