Overview
Icatibant (Firazyr) is a synthetic peptidomimetic drug consisting of ten amino acids, and acts as an effective and specific antagonist of bradykinin B2 receptors. It has been approved in the EU for use in hereditary angioedema, and is under investigation for a number of other conditions in which bradykinin is thought to play a significant role. Icatibant currently has orphan drug status in the United States and FDA approved on August 25, 2011.
Background
Icatibant (Firazyr) is a synthetic peptidomimetic drug consisting of ten amino acids, and acts as an effective and specific antagonist of bradykinin B2 receptors. It has been approved in the EU for use in hereditary angioedema, and is under investigation for a number of other conditions in which bradykinin is thought to play a significant role. Icatibant currently has orphan drug status in the United States and FDA approved on August 25, 2011.
Indication
Approved for use in acute attacks of hereditary angioedema (HAE). Investigated for use/treatment in angioedema, liver disease, and burns and burn infections.
Associated Conditions
- ACE Inhibitor-associated Angioedema
- Hereditary angioedema breakthrough attack
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/04/28 | Phase 3 | Recruiting | |||
2022/08/22 | N/A | Active, not recruiting | |||
2022/06/07 | Phase 2 | Completed | |||
2021/08/18 | Phase 2 | Completed | GCS Ramsay Santé pour l'Enseignement et la Recherche | ||
2021/07/27 | Phase 2 | Completed | |||
2020/12/04 | Phase 3 | Completed | |||
2020/07/27 | Phase 2 | Recruiting | |||
2019/10/02 | Phase 4 | Active, not recruiting | |||
2019/08/15 | N/A | Completed | |||
2019/03/25 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Takeda Pharmaceuticals America, Inc. | 54092-702 | SUBCUTANEOUS | 30.0 mg in 3 mL | 1/19/2024 | |
| Cycle Pharmaceuticals Ltd-Uk | 70709-013 | SUBCUTANEOUS | 30 mg in 3 mL | 5/31/2023 | |
| Fresenius Kabi USA, LLC | 63323-574 | SUBCUTANEOUS | 10 mg in 1 mL | 8/28/2019 | |
| Teva Pharmaceuticals USA, Inc. | 0093-3066 | SUBCUTANEOUS | 10 mg in 1 mL | 10/27/2022 | |
| Eugia US LLC | 55150-351 | SUBCUTANEOUS | 30 mg in 3 mL | 4/7/2023 | |
| Hikma Pharmaceuticals USA Inc. | 24201-207 | SUBCUTANEOUS | 30 mg in 3 mL | 11/30/2023 | |
| Apotex Corp. | 60505-6214 | SUBCUTANEOUS | 30 mg in 3 mL | 2/29/2024 | |
| Slayback Pharma LLC | 71225-114 | SUBCUTANEOUS | 30 mg in 3 mL | 1/28/2021 | |
| Cipla USA Inc. | 69097-664 | SUBCUTANEOUS | 30 mg in 3 mL | 5/31/2023 | |
| Bryant Ranch Prepack | 72162-2106 | SUBCUTANEOUS | 30 mg in 3 mL | 9/19/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/16/2021 | ||
Authorised | 7/16/2021 | ||
Authorised | 7/11/2008 | ||
Authorised | 7/11/2008 | ||
Authorised | 7/16/2021 | ||
Authorised | 7/16/2021 | ||
Authorised | 7/11/2008 | ||
Authorised | 7/11/2008 |
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 |
|---|---|---|---|---|---|
| Icatibant Acetate Injection | 国药准字HJ20210024 | 化学药品 | 注射剂 | 4/7/2021 | |
| Icatibant Acetate Injection | 国药准字H20233456 | 化学药品 | 注射剂 | 4/17/2023 | |
| Icatibant Acetate Injection | 国药准字H20223894 | 化学药品 | 注射剂 | 11/30/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||