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Drug

Concizumab

Approved medicine
ClassTissue factor pathway inhibitor inhibitorResearchOngoing clinical research

Also known as Alhemo.

RxNorm2708333ChEMBLCHEMBL4297730ATCB02BX10UNII68603V9EAF
3
Active clinical trials
Tissue factor pathway inhibitor
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Efficacy and Safety of Concizumab Prophylaxis in Patients With Haemophilia A or B With Inhibitors

Clinical trial2026-06-12Results posted · ClinicalTrials.gov

Efficacy and Safety of Concizumab Prophylaxis in Patients With Haemophilia A or B Without Inhibitors

Clinical trial2026-06-12Results posted · ClinicalTrials.gov

Open-label Study Investigating Efficacy, Safety and Pharmacokinetics of Concizumab Prophylaxis in Children Below 12 Years With Haemophilia A or B With or Without Inhibitors

Clinical trial2026-04-21Primary completion · ClinicalTrials.gov

Approval: Alhemo (EMA)

Regulatory2024-12-13EMA

A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

Clinical trial2021-11-16Results posted · ClinicalTrials.gov

A Multi-Centre, Randomised, Open-Label, Controlled Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors

Clinical trial2021-10-22Results posted · ClinicalTrials.gov

A Multi-centre, Randomised, Placebo Controlled, Double Blinded, Multiple Dose Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects (Explorer™3)

Clinical trial2016-10-14Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Concizumab
Aliases & brands
Alhemo
RxNorm CUI
2708333
ChEMBL ID
CHEMBL4297730
ATC codes
B02BX10
UNII
68603V9EAF
Primary mechanism
Tissue factor pathway inhibitor inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tissue factor pathway inhibitor
TFPI · P10646
INHIBITORTissue factor pathway inhibitor inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2024-12-13
Latest approval
2024-12-13
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2024-12-13Approval
Approval: Alhemo (EMA)
Indication: Alhemo is indicated for routine prophylaxis of bleeding in patients 12 years of age or more with: •    haemophilia A (congenital factor VIII deficiency) with… Show full indication

Alhemo is indicated for routine prophylaxis of bleeding in patients 12 years of age or more with: •    haemophilia A (congenital factor VIII deficiency) with FVIII inhibitors.•    severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without FVIII inhibitors.•    haemophilia B (congenital factor IX deficiency) with FIX inhibitors.•    moderate/severe haemophilia B (congenital factor IX deficiency, FIX ≤ 2%) without FIX inhibitors.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

6 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
6
registered trials across all phases
LATEST COMPLETION 2020
3
Active studies
3
Late-stage (III+)
3
Completed
PHASE DISTRIBUTIONn = 6
Phase 11Phase 22Phase 33

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Open-label Study Investigating Efficacy, Safety and Pharmacokinetics of Concizumab Prophylaxis in Children Below 12 Years With Haemophilia A or B With or Without Inhibitors

Active, not recruitingPH IIINovo Nordisk A/Sn=1532029

Efficacy and Safety of Concizumab Prophylaxis in Patients With Haemophilia A or B Without Inhibitors

Active, not recruitingPH IIINovo Nordisk A/Sn=1562028

Efficacy and Safety of Concizumab Prophylaxis in Patients With Haemophilia A or B With Inhibitors

Active, not recruitingPH IIINovo Nordisk A/Sn=1342027
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.