ALHEMO (concizumab-mtci)
Alhemo (concizumab-mtci) is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis in adult and pediatric patients 12 years of age and older. It is used to prevent or reduce the frequency of bleeding episodes in individuals with hemophilia A or hemophilia B. The treatment is applicable to patients regardless of whether they have developed inhibitory antibodies to factor VIII or factor IX.
How ALHEMO Works
Concizumab-mtci is a monoclonal antibody that acts as an antagonist to endogenous tissue factor pathway inhibitor (TFPI). By inhibiting TFPI, the drug enhances the production of factor Xa during the initiation phase of the coagulation process. This increase in factor Xa leads to improved thrombin generation and clot formation to achieve hemostasis. Because the drug has no structural relationship to factor VIII or factor IX, its effect is not influenced by the presence of inhibitors to those factors.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-12-20
- Routes
- Subcutaneous, INJECTION
- Dosage Forms
- Injectable, SOLUTION
ALHEMO Approval History
What ALHEMO Treats
2 indicationsALHEMO is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hemophilia A
- Hemophilia B
ALHEMO Target & Pathway
ProTarget
The central enzyme in blood coagulation that converts fibrinogen to fibrin, forming blood clots. Direct thrombin inhibitors prevent clot formation and are used to prevent stroke and treat blood clots.
ALHEMO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04082429 explorer8 results posted | NN7415-4307 U1111-1225-9722, 2018-004891-36 | Ph 3 | active not recruiting | Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors |
| NCT04083781 explorer7 results posted | NN7415-4311 U1111-1225-9670, 2018-004889-34 | Ph 3 | active not recruiting | Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors |
| NCT05135559 Explorer10 | NN7415-4616 U1111-1247-7330, 2020-000504-11 | Ph 3 | active not recruiting | A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors |
| NCT03196297 explorer™5 results posted | NN7415-4255 U1111-1179-3872, 2016-000614-29 | Ph 2 | completed | A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors |
| NCT03196284 explorer™4 results posted | NN7415-4310 U1111-1179-2925, 2016-000510-30 | Ph 2 | completed | A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors |
| NCT02490787 | NN7415-4159 2014-003793-16, U1111-1161-1501 | Ph 1 | completed | Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ALHEMO FDA Label Details
Indications & Usage
FDA Label (PDF)ALHEMO is indicated for the treatment of Hemophilia A; Hemophilia B.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment