Drugs / Sutacimig
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07347249 | Mar → Jul 2026 overdue | congenital factor VII deficiency | Hemab ApS | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| 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 Phase 2 interim results demonstrate >50% reduction in treated bleeding events and prophylactic treatment potential in Glanzmann thrombasthenia |
| 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. |
All press releases naming this drug 6 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sutacimig | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07347249 ↗ |
| Modality | Monoclonal antibody | “bispecific antibody” NCT07347249 ↗ |
| Route | Subcutaneous | “subcutaneously administered” NCT07347249 ↗ |