Drugs / icovamenib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | type 2 diabetes mellitus | — | “As previously reported, dosing was interrupted by an interim clinical hold imposed by the U.S.” biomeafusion.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07254286 | Sep 2025 → Jan 2026 | — | Biomea Fusion Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05631574 | Jan 2023 → Jan 2025 | colorectal cancer, non-small cell lung carcinoma, pancreatic ductal adenocarcinoma | Biomea Fusion Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT05153330 | Jan 2022 → Feb 2025 | chronic lymphocytic leukemia/small lymphocytic lymphoma, diffuse large B-cell lymphoma, mixed phenotype acute leukemia, plasma cell myeloma | Biomea Fusion Inc. | Terminated | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05731544 | Aug 2022 → Nov 2024 | type 2 diabetes mellitus | Biomea Fusion Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07502508 | Apr 2026 → Jun 2027 expected | type 2 diabetes mellitus | Biomea Fusion Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07502495 | Mar 2026 → Jun 2027 expected | type 2 diabetes mellitus | Biomea Fusion Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT06152042 | Dec 2023 → May 2025 | type 1 diabetes mellitus | Biomea Fusion Inc. | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 47
| Date | Issuer | Release |
|---|---|---|
| 2026-06-05 | Biomea Fusion Inc. | Results Biomea Fusion Presents New Clinical and Translational Data for Icovamenib at the American Diabetes Association (“ADA”) 86th Scientific Sessions and Announces Expansion of Ongoing Phase I BMF-650 Study biomeafusion.com ↗
Clinical data presented at ADA from COVALENT-112 show improvements in HbA1c and C-peptide in type 1 diabetes patients treated with icovamenib, with no evidence of immune activation, and inflammatory markers stable or reduced |
| 2026-04-27 | Biomea Fusion Inc. | Results Biomea Fusion Announces Positive 52-Week Results from Phase 2 COVALENT-112 Trial in Type 1 Diabetes Showing C-Peptide Improvement and Durability Following 12-Weeks of Icovamenib Treatment biomeafusion.com ↗ |
| 2026-03-14 | Biomea Fusion Inc. | Results Biomea Fusion Presents Phase II COVALENT-111 Data in Type 2 Diabetes at the 19th International Conference on Advanced Technologies & Treatments for Diabetes 2026 biomeafusion.com ↗
“We are encouraged by the durability of icovamenib’s effect observed nine months post-dosing at Week 52,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. |
| 2025-12-09 | Biomea Fusion Inc. | Results Biomea Fusion Announces KOL Presentation and Interview on Menin and Icovamenib at WCIRDC 2025 biomeafusion.com ↗
He described icovamenib’s potential as a potentially disease modifying therapy for diabetes and reviewed long term follow up data from clinical studies. |
| 2025-12-05 | Biomea Fusion Inc. | Results Biomea Fusion Presents COVALENT-111 Study Results at the 23rd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) biomeafusion.com ↗
The data showed durable glycemic and c-peptide improvements with icovamenib, a menin inhibitor targeting beta-cell restoration in insulin deficient type 2 diabetes. |
| 2025-11-05 | Biomea Fusion Inc. | Results Biomea Fusion Showcases Preclinical Advances for BMF-650 and Icovamenib with Low Dose Semaglutide at ObesityWeek® 2025 biomeafusion.com ↗
In a rodent model of type 2 diabetes (“T2D”), icovamenib in combination with low dose semaglutide promoted enhanced glycemic control and body weight reduction with preservation of lean mass, outperforming the group given low dose semaglutide alone |
| 2025-10-06 | Biomea Fusion Inc. | Results Biomea Fusion Announces Positive 52-Week Results from Phase II COVALENT-111 Study in Type 2 Diabetes Demonstrating Non-Chronic Treatment with Icovamenib Benefits Two Distinct Patient Populations biomeafusion.com ↗ |
| 2025-09-16 | Biomea Fusion Inc. | Results Biomea Fusion Presents Data Demonstrating Enhanced Preclinical Activity of Icovamenib in Combination with Semaglutide in Type 2 Diabetes (T2D) Animal Model at the 61st EASD Annual Meeting and Provides Additional Corporate Update biomeafusion.com ↗
In a rodent model of T2D, icovamenib in combination with low-dose semaglutide promoted enhanced glycemic control and body weight reduction with preservation of lean mass, outperforming the group given semaglutide alone. |
| 2025-06-23 | Biomea Fusion Inc. | Results Biomea Fusion Presents New Preclinical and Clinical Data on Icovamenib at the 85th Scientific Sessions of the American Diabetes Association (ADA) biomeafusion.com ↗
In severely insulin-deficient patients from the Phase II COVALENT-111 trial, icovamenib achieved a 1.0% placebo-adjusted mean HbA1c reduction and a 55% increase in C-peptide at Week 26, three weeks after last dose |
| 2025-03-24 | Biomea Fusion Inc. | Results Icovamenib Treatment in Patients with Severe Insulin-Deficient Diabetes Led to a Significant Improvement in Pancreatic Beta-cell Function with a 53% Mean Increase in C-peptide Levels 3 Months After Last Dose biomeafusion.com ↗
Therapeutic effects were sustained off treatment, with persistent reduction in HbA1c and improvement in beta-cell function 3 months after last dose, suggesting disease-modifying potential of icovamenib |
| 2025-01-13 | Biomea Fusion Inc. | Results Biomea Fusion to Become a Diabetes & Obesity Medicines Company biomeafusion.com ↗
Icovamenib, a potential first-in-class menin inhibitor for the treatment of diabetes, demonstrated the strongest activity in patients with the lowest insulin production |
| 2025-01-07 | Biomea Fusion Inc. | Results Biomea Fusion Reports New Preclinical Data on Icovamenib-Semaglutide Combination Study biomeafusion.com ↗
New in vivo preclinical data announced today, demonstrate that icovamenib, in combination with semaglutide showed additional 11.5% body weight reduction and 43% increase in lean muscle mass compared to semaglutide alone |
| 2024-12-17 | Biomea Fusion Inc. | Results Biomea Fusion Announces Positive Topline Results from Ongoing Phase II COVALENT-111 Study in Patients with Type 2 Diabetes biomeafusion.com ↗ |
| 2024-12-12 | Biomea Fusion Inc. | Results Biomea Fusion Announces Oral and Poster Presentations of Icovamenib at the 22nd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) biomeafusion.com ↗
Overall results showed synergy of the combination therapy, which may allow lower doses of GLP-1-based therapies to achieve glycemic targets, potentially reducing side effects and improving tolerability of GLP-1 based therapies. |
| 2024-11-18 | Biomea Fusion Inc. | Results Late-Breaker Oral Presentation Showing New Analysis from the Escalation Portion of COVALENT-111 Presented at the 1st Annual Asian Conference on Innovative Therapies for Diabetes Management (ATTD-ASIA 2024) biomeafusion.com ↗
Icovamenib Achieves a Mean Reduction in HbA1c Greater than 1% at Week 26 Following 4 Weeks of Dosing in Type 2 Diabetes Patients Characterized by Insulin Deficiency |
| 2024-10-30 | Biomea Fusion Inc. | Results Biomea Fusion Presents Preclinical Data Showing Icovamenib (BMF-219) Enhanced Effectiveness of GLP-1-Based Therapies and Introduces BMF-650, a Next-Generation, Oral Small-Molecule GLP-1 Receptor Agonist Candidate biomeafusion.com ↗
Preclinical data from ex vivo human islet experiments showed that icovamenib (BMF-219) was able to enhance the activity of glucagon-like peptide-1 (GLP-1)-based therapies, potentially leading to increased insulin secretion and improved glycemic control in patients with diabetes |
| 2024-10-29 | Biomea Fusion Inc. | Regulatory Biomea Fusion Reports Third Quarter 2024 Financial Results and Corporate Highlights biomeafusion.com ↗ |
| 2024-09-26 | Biomea Fusion Inc. | Regulatory FDA Lifts Clinical Hold on BMF-219 in Type 2 and Type 1 Diabetes Trials biomeafusion.com ↗ |
| 2024-06-06 | Biomea Fusion Inc. | Regulatory Biomea Fusion Announces BMF-219 in Diabetes Placed on Clinical Hold biomeafusion.com ↗
Biomea Fusion, Inc. (“Biomea” or the “Company”) (Nasdaq: BMEA), announced that the Company has received notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold has been placed on Biomea’s ongoing Phase I/II clinical trials of the Company’s investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112), respectively. |
| 2024-04-01 | Biomea Fusion Inc. | Results Biomea Fusion Highlights Initial Data from the First Two Type 1 Diabetes Patients Dosed with BMF-219 biomeafusion.com ↗
Both patients showed improvement in measures of beta-cell function after only 4 weeks of dosing with BMF-219. |
| 2024-03-06 | Biomea Fusion Inc. | Results Biomea Fusion Presents Patient Cohorts in COVALENT-111 Displaying a Durable Placebo-Adjusted Mean Reduction of up to 1.4% in HbA1c While Off Therapy at Week-26, after BMF-219’s 28-Day Treatment Cycle, Supporting Improved Pancreatic Function biomeafusion.com ↗
Patients in COVALENT-111 are displaying improved glycemic control while off therapy out to Week 26 following the 28-day treatment with BMF-219, supporting enhanced pancreatic islet function as the mechanism of action |
| 2023-12-11 | Biomea Fusion Inc. | Results Biomea Fusion Presents Achievement of Minimal Residual Disease Negativity (MRD-neg) in First Complete Responder from Ongoing Phase I Study (COVALENT-101) of BMF-219 in Patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) at the 2023 ASH biomeafusion.com ↗
BMF-219 demonstrated early signs of clinical activity and ability to achieve durable and sustained complete responses (CRs) with minimal residual disease negativity (MRD-neg) in acute myeloid leukemia (AML) patients |
| 2023-12-09 | Biomea Fusion Inc. | Results Biomea Fusion Announces Near Doubling the Percentage of Patients with Durable HbA1c Reduction in the 200 mg Dose Cohorts biomeafusion.com ↗
To date, the dose escalation portion has shown after only 4 weeks of dosing with BMF-219 that patients across all dosing cohorts have consistently experienced generally meaningful HbA1c reductions and no serious adverse events or study discontinuations. |
| 2023-12-08 | Biomea Fusion Inc. | Results Biomea Fusion Presents Long-Term Follow-Up Data Showing Improved Glycemic Control after 22 Weeks Off Treatment in Ongoing Phase II Study (COVALENT-111) of BMF-219 in Adults with Type 2 Diabetes in a Poster Presentation at the World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) biomeafusion.com ↗
Observed HbA1C reduction was supported by an increase from baseline in placebo adjusted mean HOMA-B (+270%) and in mean stimulated C-peptide AUC (+22%) at Week 26 in responders (defined as HbA1c reduction ≥0.5% at Week 26) |
| 2023-12-07 | Biomea Fusion Inc. | Results Biomea Fusion to Present Long-Term Follow-Up Data from Ongoing Phase II Study (COVALENT-111) of BMF-219 in Adults with Type 2 Diabetes and Results from Ex-Vivo Human Islet Experiments at the World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) biomeafusion.com ↗
BMF-219 was generally well tolerated; there were no dose reductions, dose discontinuations, or severe or serious adverse events |
| 2023-12-05 | Biomea Fusion Inc. | Regulatory Biomea Fusion Announces Health Canada Clearance of Clinical Trial Application (CTA) for BMF-219 in Type 1 Diabetes biomeafusion.com ↗
Health Canada has cleared Biomea's Clinical Trial Application (CTA) to study BMF-219 in adults living with type 1 diabetes. |
| 2023-10-05 | Biomea Fusion Inc. | Regulatory Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for BMF-219 in Type 1 Diabetes biomeafusion.com ↗ |
| 2023-09-28 | Biomea Fusion Inc. | Regulatory Biomea Fusion Announces FDA and Health Canada Clearance of the Expansion Cohorts of the Ongoing COVALENT-111 Phase II Study biomeafusion.com ↗
The FDA and Health Canada have cleared the initiation of the expansion portion of COVALENT-111, which will evaluate BMF-219 administered at 100 mg and 200 mg, with dosing durations up to 12 weeks in type 2 diabetes patients |
| 2023-07-24 | Biomea Fusion Inc. | Results BMF-219 Induces Complete Responses in Target Acute Myeloid Leukemia (AML) Patient Population biomeafusion.com ↗
Biomea Fusion, Inc. (“Biomea”) (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 preliminary topline data from its ongoing Phase I clinical trial, COVALENT-101, showcasing initial responses in relapsed/refractory AML patients with menin-dependent mutations. |
| 2023-06-23 | Biomea Fusion Inc. | Results Biomea Fusion Presents Positive Clinical Data from the Initial Cohorts of the Ongoing Phase II Study (COVALENT-111) of BMF-219 in Patients with Type 2 Diabetes Mellitus at the American Diabetes Association (ADA) 83rd Scientific Sessions; 100 mg Cohort 3 Demonstrated a 90% Response Rate and 70% Maintained or Improved Time in (Normal Glucose) Range, While Off-Treatment biomeafusion.com ↗
50% of Cohort 3 patients showed continued improvement in their HbA1c levels while being off treatment through Week 12 |
| 2023-04-13 | Biomea Fusion Inc. | Results Biomea Fusion To Present Two Preclinical Posters at the 114th AACR Annual Meeting biomeafusion.com ↗
BMF-219 showed greater potency and ability to achieve >98% growth inhibition in these CLL patient samples in comparison with reversible BTK inhibitor, pirtobrutinib, and irreversible BTK inhibitor, ibrutinib. |
| 2023-03-28 | Biomea Fusion Inc. | Results Biomea Fusion Announces Positive Data from Initial Cohorts of Ongoing Phase II Study (COVALENT-111) of BMF-219 in Patients with Type 2 Diabetes; 100 mg Cohort 3 Demonstrated an 89% Response Rate and 1% Median Reduction in HbA1c at Day 28 biomeafusion.com ↗ |
| 2022-12-14 | Biomea Fusion Inc. | Regulatory Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for Covalent Menin Inhibitor BMF-219 in Type 2 Diabetes biomeafusion.com ↗ |
| 2022-10-31 | Biomea Fusion Inc. | Results Biomea Fusion Announces Dosing of First Patient with Type 2 Diabetes and Completion of Phase I Healthy Volunteer Portion of Phase I/II (COVALENT-111) Study of BMF-219 biomeafusion.com ↗
The Phase I portion of COVALENT-111 in healthy volunteers is now completed and was designed to assess safety, tolerability, and pharmacokinetics; BMF-219 was well tolerated and showed a favorable PK and PD profile |
| 2022-10-14 | Biomea Fusion Inc. | Regulatory BMF-219 Enters the Clinic for KRAS Solid Tumors biomeafusion.com ↗ |
| 2022-09-22 | Biomea Fusion Inc. | Results Biomea Fusion Presents New Translational Data at the European Association for the Study of Diabetes (EASD) 2022 in Animal Models and Ex-vivo Human Donor Islets Further Supporting BMF-219’s Potential as an Oral, Long-Acting Treatment for Type 2 Diabetes biomeafusion.com ↗
The presentation highlighted BMF-219’s ability to improve pancreatic beta cell area and function in two preclinical rat models of diabetes. |
| 2022-09-20 | Biomea Fusion Inc. | Results Biomea Fusion Presents New Preclinical Data at the European Association for the Study of Diabetes (EASD) Annual Meeting Describing BMF-219’s Potential as a Novel, Oral, Long-Acting Treatment for Type 2 Diabetes biomeafusion.com ↗
BMF-219 significantly lowered HbA1c compared to active control, liraglutide, -3.5% vs -1.7%, respectively. |
| 2022-08-26 | Biomea Fusion Inc. | Results Biomea Fusion Presents Additional Preclinical Data Demonstrating Anti-Tumor Activity and Mechanistic Evidence for BMF-219 in Diffuse Large B-Cell Lymphoma and Multiple Myeloma Models at International Myeloma Society Annual Meeting biomeafusion.com ↗
Data demonstrated robust anti-tumor activity of BMF-219 and mechanistic evidence for novel inhibition of menin protein in preclinical models of Diffuse Large B-cell Lymphoma (DLBCL) and multiple myeloma (MM). |
| 2022-07-01 | Biomea Fusion Inc. | Results Biomea Fusion Selected for Two Oral Presentations at the European Association for the Study of Diabetes Annual Meeting Describing BMF-219’s Potential as a Novel, Oral, Long-Acting, Acute Treatment for Type 2 Diabetes biomeafusion.com ↗
Biomea to present two oral abstracts across multiple animal models highlighting the ability of BMF-219, a covalent menin inhibitor, to significantly lower HbA1C (approximately two-fold greater reduction than active control, liraglutide) and to increase beta cell function. |
| 2022-06-04 | Biomea Fusion Inc. | Results Biomea Fusion Presents Novel Preclinical Data at ADA 2022 Suggesting BMF-219’s Potential as an Oral, Long-Acting Treatment for Type 2 Diabetes biomeafusion.com ↗
Biomea Fusion, Inc. (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, presented new data at the American Diabetes Association (ADA) Scientific Sessions demonstrating BMF-219’s strong, prolonged glycemic control, insulin sensitization, and HbA1c reduction in two preclinical rat models of diabetes. |
| 2022-06-01 | Biomea Fusion Inc. | Results Biomea Fusion to Present New Preclinical Data on BMF-219 in Two Diabetic Animal Models at ADA 2022 biomeafusion.com ↗
Collectively, the pre-clinical data presented in the abstracts supports the mechanism of action of BMF-219, reestablishing a pool of functional beta cells via the covalent inhibition of menin and maintaining durable glycemic control. |
| 2022-05-26 | Biomea Fusion Inc. | Results Biomea Fusion to Present New Preclinical Data Showing BMF-219’s Strong Activity in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Tumor Models at ASCO 2022 biomeafusion.com ↗
BMF-219, a covalent menin inhibitor, demonstrated potency across ex vivo CLL tumor models with varying cytogenetic risk profiles and Rai stages, indicating broad activity with over 98% cell lethality in these models |
| 2022-04-08 | Biomea Fusion Inc. | Results Biomea Fusion Reports Preclinical Data on BMF-219 and Trial in Progress Presentations at AACR 2022 Annual Meeting biomeafusion.com ↗
today presented new data at the American Association of Cancer Research (AACR) Annual Meeting demonstrating BMF-219’s potent and highly effective activity in multiple preclinical models of DLBCL, MM, and KRAS human ex vivo tumor models and cell lines in poster presentations. |
| 2022-04-06 | Biomea Fusion Inc. | Regulatory Biomea Fusion Announces Acceptance of Late Breaking Presentation of Lead Menin Inhibitor BMF-219 in Diabetes at ADA 82nd Scientific Sessions 2022 biomeafusion.com ↗
today announced that a late breaking abstract has been accepted at the upcoming American Diabetes Association (ADA) 82 nd Scientific Sessions. |
| 2022-01-06 | Biomea Fusion Inc. | Results Biomea Fusion Releases Pre-Clinical Data with BMF-219 in Diabetes biomeafusion.com ↗ |
| 2021-11-04 | Biomea Fusion Inc. | Results Biomea Fusion Publishes Abstract on BMF-219 at ASH Annual Meeting biomeafusion.com ↗
BMF-219 demonstrated potent preclinical efficacy in diffuse large B cell lymphoma (DLBCL) cell lines as a single agent |
| 2021-09-16 | Biomea Fusion Inc. | Regulatory Biomea Fusion Announces FDA Clearance of Investigational New Drug Application for Irreversible Menin Inhibitor BMF-219 biomeafusion.com ↗ |
All press releases naming this drug 68 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | icovamenib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07502508 ↗ |
| Known as | BMF-219 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05731544 ↗ |
| Action | Inhibit | “oral covalent menin inhibitor” NCT05153330 ↗ |
| Modality | Small molecule | “covalent small-molecule menin inhibitor” NCT05631574 ↗ |
| Route | Oral | “BMF-219 is orally administered in continuous 28 day cycles.” NCT05153330 ↗ |