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ARRY-614, p38/Tie2 inhibitor · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| ARRY-614 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ARRY-614, p38/Tie2 inhibitor; oral | DRUG | Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule |
Key Inclusion Criteria (Part 1 and Part 2): * Diagnosis of MDS by bone marrow biopsy. * International Prognostic Scoring System (IPSS) score of low or intermediate-1 risk MDS. * May have received prior therapy for MDS. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2...
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ARRY-614 is an investigational oral small molecule being studied for the treatment of myelodysplastic syndromes, specifically in patients with low or intermediate-1 risk disease. It has been evaluated in Phase 1 clinical trials and is not approved for any indication.
ARRY-614 is a p38/Tie2 inhibitor. It targets both p38 mitogen-activated protein kinase and Tie2, a receptor tyrosine kinase. This dual mechanism is intended to affect signaling pathways relevant to myelodysplastic syndromes.
ARRY-614 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer is the company responsible for the clinical development of this oral small molecule.
ARRY-614 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. Two Phase 1 trials in myelodysplastic syndromes have been completed.
ARRY-614 has been studied in two completed Phase 1 trials: NCT01496495, which enrolled 71 patients with low or intermediate-1 risk myelodysplastic syndromes, and NCT00916227, which enrolled 45 patients with the same condition. Both trials were conducted in the United States.