Concizumab

Overview

Concizumab has been used in trials studying the treatment of Haemophilia A and Congenital Bleeding Disorder.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo	2025/02/18	NCT06831734	N/A	Not yet recruiting	Novo Nordisk A/S
Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors	2024/02/29	NCT06285071	N/A	ENROLLING_BY_INVITATION	Novo Nordisk A/S
A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors	2021/11/26	NCT05135559	Phase 3	Recruiting	Novo Nordisk A/S
Compassionate Use of Concizumab if You Have Haemophilia	2021/06/10	NCT04921956	N/A	AVAILABLE	Novo Nordisk A/S
Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors	2019/09/10	NCT04083781	Phase 3	Active, not recruiting	Novo Nordisk A/S
Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors	2019/09/09	NCT04082429	Phase 3	Active, not recruiting	Novo Nordisk A/S
A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors	2017/06/22	NCT03196297	Phase 2	Completed	Novo Nordisk A/S
A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors	2017/06/22	NCT03196284	Phase 2	Completed	Novo Nordisk A/S
Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects	2015/07/07	NCT02490787	Phase 1	Completed	Novo Nordisk A/S

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Alhemo	Novo Nordisk	0169-2081	SUBCUTANEOUS	100 mg in 1 mL	12/10/2024
Alhemo	Novo Nordisk	0169-2080	SUBCUTANEOUS	100 mg in 1 mL	12/10/2024
Alhemo	Novo Nordisk	0169-2084	SUBCUTANEOUS	40 mg in 1 mL	12/10/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Alhemo	Novo Nordisk A/S,DK-2880 Bagsværd,Denmark	Authorised	12/13/2024

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ALHEMO concizumab 150mg / 1.5 mL solution for injection prefilled pen	394067	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	7/5/2023
ALHEMO concizumab 300 mg / 3 mL solution for injection prefilled pen	394066	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	7/5/2023
ALHEMO concizumab 15 mg / 1.5 mL solution for injection prefilled pen	394068	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	7/5/2023
ALHEMO concizumab 60 mg / 1.5 mL solution for injection prefilled pen	394065	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	7/5/2023

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ALHEMO	Novo Nordisk Canada Inc	02536110	Solution - Subcutaneous	300 MG / 3 ML	N/A
ALHEMO	Novo Nordisk Canada Inc	02536080	Solution - Subcutaneous	15 MG / 1.5 ML	N/A
ALHEMO	Novo Nordisk Canada Inc	02536099	Solution - Subcutaneous	60 MG / 1.5 ML	N/A
ALHEMO	Novo Nordisk Canada Inc	02536102	Solution - Subcutaneous	150 MG / 1.5 ML	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Novo Nordisk to Present Phase 3 Hemophilia Trial Data at ISTH 2025 Congress

2 months ago

Novo Nordisk will present new phase 3 trial data for two investigational hemophilia treatments, Mim8 (denecimig) and concizumab, at the International Society on Thrombosis and Haemostasis Congress from June 21-25, 2025.

Acquired Hemophilia A Pipeline Expands with 10+ Novel Therapies in Development

2 months ago

Global Acquired Hemophilia A pipeline comprises over 10 companies developing innovative therapies across various clinical stages, according to DelveInsight's 2025 report.

FDA Approves Alhemo for Hemophilia and alfapump System for Liver Cirrhosis

7 months ago

The FDA has approved Alhemo (concizumab-mtci) for routine prophylaxis to prevent bleeding episodes in hemophilia A and B patients with inhibitors.

FDA Approves New Therapies for Hemophilia, Colorectal Cancer, and Cystic Fibrosis

7 months ago

• The FDA approved Alhemo (concizumab) from Novo Nordisk for hemophilia A and B with inhibitors, offering a once-daily subcutaneous option. • Pfizer's Braftovi (encorafenib) received accelerated approval as a first-line treatment for BRAF V600E-mutated metastatic colorectal cancer in combination with other therapies. • Vertex Pharma's Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a new triplet therapy for cystic fibrosis, has been approved for patients aged six and older with responsive mutations. • Hikma Pharma gains FDA approval for the first generic version of Novo Nordisk's Victoza (liraglutide) for treating type 2 diabetes.

FDA Approves Novo Nordisk's Alhemo for Hemophilia A and B with Inhibitors

7 months ago

The FDA has approved Alhemo (concizumab-mtci) as a once-daily prophylactic treatment for hemophilia A and B with inhibitors in patients 12 years and older.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access

Overview

Indication

Associated Conditions

Clinical Trials

FDA Drug Approvals

EMA Drug Approvals

HSA Drug Approvals

NMPA Drug Approvals

PPB Drug Approvals

TGA Drug Approvals

Health Canada Drug Approvals

CIMA AEMPS Drug Approvals

Philippines FDA Drug Approvals

Saudi SFDA Drug Approvals

Malaysia NPRA Drug Approvals

UK EMC Drug Information

Related News

Novo Nordisk to Present Phase 3 Hemophilia Trial Data at ISTH 2025 Congress

Acquired Hemophilia A Pipeline Expands with 10+ Novel Therapies in Development

FDA Approves Alhemo for Hemophilia and alfapump System for Liver Cirrhosis

FDA Approves New Therapies for Hemophilia, Colorectal Cancer, and Cystic Fibrosis

FDA Approves Novo Nordisk's Alhemo for Hemophilia A and B with Inhibitors

Help Us Improve

MedPath

Product

Company

Legal