| 2026-08-11 | Results | Results posted: Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2 | Trial register ClinicalTrials.gov |
| 2026-05-07 | Shortage | FDA shortage status to be discontinued: Icatibant Acetate, Injection, 10 mg/1 mL (NDC 63323-574-86) | Regulator FDA drug shortages |
| 2026-05-07 | Shortage | FDA shortage status to be discontinued: Icatibant Acetate, Injection, 10 mg/1 mL (NDC 63323-574-93) | Regulator FDA drug shortages |
| 2025-12-18 | Trial | New trial registered: A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema | Trial register ClinicalTrials.gov |
| 2025-07-07 | Label | FDA label revised: Firazyr (NDA022150) | Regulator FDA drug label register |
| 2025-07-01 | Label | FDA label revised: Icatibant (ANDA213773) | Regulator FDA drug label register |
| 2025-06-27 | Label | FDA label revised: Icatibant (ANDA213773) | Regulator FDA drug label register |
| 2025-06-06 | Trial | New trial registered: A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks | Trial register ClinicalTrials.gov |
| 2025-02-21 | Results | Results posted: FIRAZYR General Drug Use-Results Survey (Japan) | Trial register ClinicalTrials.gov |
| 2024-11-20 | Federal Register | Federal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability | Regulator Federal Register |
| 2024-09-04 | Trial | New trial registered: A Study to Explore Hereditary Angioedema (HAE) Symptoms and Treatment Patterns in Korean People | Trial register ClinicalTrials.gov |
| 2024-04-25 | Label | FDA label revised: Icatibant (ANDA211021) | Regulator FDA drug label register |
| 2024-04-04 | Trial | New trial registered: A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China | Trial register ClinicalTrials.gov |
| 2024-04-02 | Label | FDA label revised: Icatibant (ANDA213521) | Regulator FDA drug label register |
| 2024-02-16 | Label | FDA label revised: SAJAZIR (ANDA212446) | Regulator FDA drug label register |
| 2024-02-16 | Label | FDA label revised: ICATIBANT (ANDA212446) | Regulator FDA drug label register |
| 2024-02-15 | Label | FDA label revised: Icatibant (ANDA210118) | Regulator FDA drug label register |
| 2023-11-08 | Label | FDA label revised: Icatibant (ANDA208317) | Regulator FDA drug label register |
| 2023-04-28 | Trial | New trial registered: Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor | Trial register ClinicalTrials.gov |
| 2023-03-01 | Federal Register | Federal Register notice: Mylan Pharmaceuticals Inc., et.al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications | Regulator Federal Register |
| 2022-08-22 | Trial | New trial registered: A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema | Trial register ClinicalTrials.gov |
| 2022-08-05 | Trial | New trial registered: A Study in Adults With Hereditary Angioedema (HAE) Who Currently Receive Icatibant at Home | Trial register ClinicalTrials.gov |
| 2022-06-07 | Trial | New trial registered: Inhibition of Bradykinin in COVID-19 Infection With Icatibant | Trial register ClinicalTrials.gov |
| 2022-03-29 | Results | Results posted: A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema | Trial register ClinicalTrials.gov |
| 2021-08-18 | Trial | New trial registered: Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study). | Trial register ClinicalTrials.gov |
| 2021-07-27 | Trial | New trial registered: Investigating the Efficacy and Safety ICATIBANT For The Treatment of Patients With SARS-CoV-2 (COVID-19) Infection | Trial register ClinicalTrials.gov |
| 2020-12-04 | Trial | New trial registered: A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema | Trial register ClinicalTrials.gov |
| 2020-07-27 | Trial | New trial registered: I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients | Trial register ClinicalTrials.gov |
| 2019-10-29 | Results | Results posted: Mitochondria and Chronic Kidney Disease | Trial register ClinicalTrials.gov |
| 2019-10-02 | Trial | New trial registered: Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2 | Trial register ClinicalTrials.gov |
| 2019-08-13 | Trial | New trial registered: FIRAZYR General Drug Use-Results Survey (Japan) | Trial register ClinicalTrials.gov |
| 2019-08-08 | Results | Results posted: A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants | Trial register ClinicalTrials.gov |
| 2019-03-25 | Results | Results posted: A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema | Trial register ClinicalTrials.gov |
| 2019-03-25 | Trial | New trial registered: A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants | Trial register ClinicalTrials.gov |
| 2017-06-06 | Trial | New trial registered: Mitochondria and Chronic Kidney Disease | Trial register ClinicalTrials.gov |
| 2017-02-17 | Results | Results posted: Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema | Trial register ClinicalTrials.gov |
| 2016-12-29 | Trial | New trial registered: Mechanism(s) Underlying Cardiovascular Effects of ARB/NEP Inhibition - Aim 2 | Trial register ClinicalTrials.gov |
| 2016-10-18 | Results | Results posted: Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE | Trial register ClinicalTrials.gov |
| 2016-10-10 | Results | Results posted: Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema | Trial register ClinicalTrials.gov |
| 2015-01-14 | Results | Results posted: Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volun | Trial register ClinicalTrials.gov |
| 2014-08-06 | Results | Results posted: A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3) | Trial register ClinicalTrials.gov |
| 2014-07-28 | Results | Results posted: EASSI - Evaluation of the Safety of Self-Administration With Icatibant | Trial register ClinicalTrials.gov |
| 2014-06-09 | Results | Results posted: Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE) | Trial register ClinicalTrials.gov |
| 2014-04-02 | Federal Register | Federal Register notice: Determination of Regulatory Review Period for Purposes of Patent Extension; FIRAZYR | Regulator Federal Register |
| 2014-01-24 | Trial | New trial registered: Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese | Trial register ClinicalTrials.gov |
| 2013-12-24 | Results | Results posted: Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema | Trial register ClinicalTrials.gov |
| 2013-10-11 | Results | Results posted: Bradykinin Receptor Antagonism During Cardiopulmonary Bypass | Trial register ClinicalTrials.gov |
| 2013-08-09 | Trial | New trial registered: Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema | Trial register ClinicalTrials.gov |
| 2012-04-10 | Trial | New trial registered: Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema | Trial register ClinicalTrials.gov |
| 2011-10-24 | Trial | New trial registered: Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE | Trial register ClinicalTrials.gov |
| 2011-07-01 | Trial | New trial registered: A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema | Trial register ClinicalTrials.gov |
| 2011-05-23 | Federal Register | Federal Register notice: Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting | Regulator Federal Register |
| 2010-06-30 | Trial | New trial registered: AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study | Trial register ClinicalTrials.gov |
| 2009-12-18 | Trial | New trial registered: Firazyr® Patient Registry (Icatibant Outcome Survey - IOS) | Trial register ClinicalTrials.gov |
| 2009-10-19 | Trial | New trial registered: EASSI - Evaluation of the Safety of Self-Administration With Icatibant | Trial register ClinicalTrials.gov |
| 2009-08-21 | Trial | New trial registered: The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway | Trial register ClinicalTrials.gov |
| 2009-08-19 | Trial | New trial registered: The Effect of Ischaemic-Reperfusion and Remote Ischaemic Preconditioning in Man - A Bradykinin Dependent Pathway | Trial register ClinicalTrials.gov |
| 2009-06-03 | Trial | New trial registered: A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3) | Trial register ClinicalTrials.gov |
| 2007-12-21 | Federal Register | Federal Register notice: Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting | Regulator Federal Register |
| 2007-08-15 | Trial | New trial registered: Bradykinin Receptor Blocker in ACE Inhibitor-associated Angioedema | Trial register ClinicalTrials.gov |
| 2007-07-13 | Trial | New trial registered: Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE) | Trial register ClinicalTrials.gov |
| 2006-03-15 | Trial | New trial registered: Efficacy and Safety Study of Intra-articular Multiple Doses of Icatibant in Patients With Painful Knee Osteoarthritis | Trial register ClinicalTrials.gov |
| 2005-09-19 | Trial | New trial registered: Bradykinin Receptor Antagonism During Cardiopulmonary Bypass | Trial register ClinicalTrials.gov |
| 2004-11-29 | Trial | New trial registered: Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema | Trial register ClinicalTrials.gov |