Drugs / BMF-500
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05918692 | Jul 2023 → Apr 2026 overdue | acute myeloid leukemia | Biomea Fusion Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-06-13 | Biomea Fusion Inc. | Results Biomea Fusion Presents Updated Preliminary Clinical Data for Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia at EHA 2025 biomeafusion.com ↗
Biomea Fusion, Inc. (“Biomea” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced updated preliminary clinical data from the ongoing Phase I COVALENT-103 trial of BMF-500 in adults with relapsed or refractory (“R/R”) acute leukemia (“AL”). |
| 2025-05-14 | Biomea Fusion Inc. | Results Biomea Fusion’s BMF-500 Selected for Poster Presentation at EHA 2025 Highlighting Phase I Data in Relapsed/Refractory Acute Leukemia biomeafusion.com ↗
The majority of efficacy-evaluable pts showed reduced BM blasts, with 1 pt achieving CRi. |
| 2024-12-09 | Biomea Fusion Inc. | Results Biomea Fusion Announces Preliminary Data from Ongoing COVALENT-103 Study of Investigational Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia biomeafusion.com ↗
These early findings from the COVALENT-103 study announced today highlight the potential of BMF-500 to deliver meaningful clinical benefits for patients with acute leukemia harboring a FLT3 mutation. |
| 2023-05-01 | Biomea Fusion Inc. | Regulatory Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia biomeafusion.com ↗
Biomea Fusion, Inc. (“Biomea” or “the company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application to begin a Phase I trial (COVALENT-103) of BMF-500, an investigational covalent FLT3 inhibitor, in adult patients with relapsed or refractory acute leukemia. |
| 2023-04-13 | Biomea Fusion Inc. | Results Biomea Fusion To Present Two Preclinical Posters at the 114th AACR Annual Meeting biomeafusion.com ↗
Abstract 4939 demonstrates the potential utility of combining a covalent menin inhibitor, BMF-219, and a FLT3 covalent inhibitor, BMF-500, to achieve higher cell killing at lower concentrations in preclinical acute myeloid leukemia (AML) models. |
| 2022-12-12 | Biomea Fusion Inc. | Results Biomea Fusion Presents at the 2022 ASH Annual Meeting Preclinical Data on BMF-500 Supporting its Potential as the Most Potent and Selective FLT3 Inhibitor to Date biomeafusion.com ↗ |
| 2022-11-03 | Biomea Fusion Inc. | Results Biomea Fusion to Present Preclinical Data for BMF-500, an Investigational Oral Covalent FLT3 Inhibitor, at the 64th American Society of Hematology (ASH) Annual Meeting biomeafusion.com ↗
BMF-500, an investigational third generation covalent FLT3 inhibitor, has demonstrated preclinically that it may be the most potent and selective inhibitor of FLT3 evaluated to date: |
All press releases naming this drug 10 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BMF-500 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05918692 ↗ |
| Action | Inhibit | “oral covalent FLT3 inhibitor” NCT05918692 ↗ |
| Route | Oral | “BMF-500, an oral FLT3 inhibitor” NCT05918692 ↗ |
| Target | FLT3 | “oral covalent FLT3 inhibitor” NCT05918692 ↗ |