Drugs / HMB-001
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT06211634 | Dec 2022 → Aug 2027 expected | Glanzmann thrombasthenia | Hemab ApS | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-07-14 | Hemab ApS | Results Hemab Therapeutics Presents Clinical and Preclinical Data from Sutacimig in Glanzmann Thrombasthenia and Factor VII Deficiency at the ISTH 2026 Congress hemab.com ↗
The data we’ve presented at ISTH 2026 show how we're closing that gap: sutacimig's Phase 2 LTE results demonstrate sustained bleed reduction alongside a manageable safety and tolerability profile that has enabled FDA alignment on a Phase 3 dose and regimen. |
| 2026-06-26 | Hemab ApS | Results Hemab Therapeutics to Present Clinical and Preclinical Data from Multiple Blood Coagulation Programs at the ISTH 2026 Congress hemab.com ↗ |
| 2026-03-05 | Hemab ApS | Regulatory Hemab Therapeutics Receives FDA Breakthrough Therapy Designation for Sutacimig in Glanzmann Thrombasthenia hemab.com ↗ |
| 2025-12-08 | Hemab ApS | Results Hemab Therapeutics Announces Positive Complete Phase 2 Data for Sutacimig in Glanzmann Thrombasthenia at ASH 2025; Plans to Advance to Pivotal Phase 3 Study hemab.com ↗
The data, presented today in an oral session at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, demonstrate clinically meaningful efficacy that was consistent across bleed locations, bleed types (spontaneous and traumatic), and dose cohorts evaluated. |
| 2025-06-24 | Hemab ApS | Results Hemab Therapeutics Presents Positive Clinical and Preclinical Data Across Bleeding Disorder Pipeline at ISTH 2025 Congress hemab.com ↗
Sutacimig shows promising safety and efficacy in Glanzmann thrombasthenia (GT). |
| 2025-06-10 | Hemab ApS | Regulatory Hemab Therapeutics to Present Clinical and Preclinical Data from Multiple Bleeding Disorder Programs at the ISTH 2025 Congress hemab.com ↗
Hemab also announced that the Non-Proprietary Name (INN) Expert Committee of the WHO has selected “sutacimig” for the nonproprietary name of the Company’s investigational drug for Glanzmann thrombasthenia (GT) and Factor VII Deficiency, previously known as HMB-001. |
| 2025-02-07 | Hemab ApS | Results Hemab Therapeutics Presents Interim Data from Ongoing Phase 2 Study of HMB-001 as First Ever Prophylactic Treatment in Glanzmann Thrombasthenia and Preclinical Data from HMB-002 in Von Willebrand Disease at the 2025 EAHAD Annual Congress hemab.com ↗
Interim efficacy data to date demonstrated >50% reduction in treated bleeds in all 3 tested dose cohorts. |
| 2024-02-09 | Hemab ApS | Results Hemab Therapeutics Presents Positive Phase 1 Results for HMB-001 in Glanzmann Thrombasthenia at 2024 EAHAD Annual Congress hemab.com ↗
HMB-001 was well tolerated with no drug-related adverse or thromboembolic events; dose-dependent improvements in blood-clotting activity support the potential of HMB-001 as a first-in-class prophylactic treatment for Glanzmann Thrombasthenia and other blood clotting disorders |
| 2023-06-24 | Hemab ApS | Results Hemab Therapeutics Presents New Preclinical Research Demonstrating Effects of Its Bispecific Antibody HMB-001 in Factor VII Deficiency hemab.com ↗
The new preclinical data presented today show HMB-001 successfully targeted and accumulated endogenous FVIIa to levels that would be expected to provide clinical benefit in FVII deficiency, supporting the potential for HMB-001 in an additional underserved bleeding disorder. |
| 2022-07-11 | Hemab ApS | Results Hemab Therapeutics Presents New Data on HMB-001 for the Treatment of Glanzmann Thrombasthenia and Other Bleeding Disorders at 2022 ISTH Congress hemab.com ↗
Data show HMB-001 potentiates endogenous factor Vlla (FVIIa)-dependent fibrin formation on platelets in GT and accumulates FVIIa to levels that are considered therapeutically effective. |
| 2022-04-02 | Hemab ApS | Results Hemab Therapeutics Announces First Drug Candidate: HMB-001, a Novel Bispecific Antibody with Potential for Treatment of Rare Bleeding Disorders hemab.com ↗ |
All press releases naming this drug 14 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HMB-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06211634 ↗ |