Drugs / ZE46-0134
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06366789 | May 2024 → Jan 2026 overdue | acute myeloid leukemia | Lomond Therapeutics Holdings, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06399315 | Jul 2023 → Jun 2025 | acute myeloid leukemia | Lomond Therapeutics Holdings, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03013998 | Nov 2016 → Dec 2032 expected | acute myeloid leukemia | Beat AML, LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-06-10 | Eilean Therapeutics | Regulatory Eilean Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Lomonitinib for the Treatment of Acute Myeloid Leukemia (AML) eileanther.com ↗
Eilean Therapeutics LLC, is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the IND for lomonitinib (ZE46-0134), allowing the company to proceed with a Phase 1 clinical trial in FLT3 mutated relapsed/refractory (R/R) AML. |
| 2024-04-04 | Eilean Therapeutics | Regulatory EILEAN THERAPEUTICS RECEIVES CLEARANCE TO INITIATE R/R AML TRIAL WITH LOMONITINIB, A SELECTIVE PAN-FLT3/IRAK4 INHIBITOR eileanther.com ↗ |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-06-10 | Eilean Therapeutics | Eilean Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Lomonitinib for the Treatment of Acute Myeloid Leukemia (AML) eileanther.com ↗ |
| 2024-04-04 | Eilean Therapeutics | EILEAN THERAPEUTICS RECEIVES CLEARANCE TO INITIATE R/R AML TRIAL WITH LOMONITINIB, A SELECTIVE PAN-FLT3/IRAK4 INHIBITOR eileanther.com ↗ |
| 2023-08-24 | Eilean Therapeutics | EILEAN THERAPEUTICS DOSES FIRST PATIENT WITH ZE46-0134, A SELECTIVE FLT3wt-SPARING, PAN FLT3mut INHIBITOR eileanther.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ZE46-0134 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06399315 ↗ |
| Route | Oral | “10 mg to 100 mg oral on Days 1-28” NCT03013998 ↗ |