Hereditary Angioedema
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-06-16FDA Approved: ANDEMBRY — Original Application (CSL)
The FDA approved ANDEMBRY (garadacimab) from CSL Behring under BLA761367, marking the first approval of this therapy. It is indicated for he…
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FDA approval · 2025-05-09FDA Approved: ICATIBANT — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for ICATIBANT submitted by Fresenius Kabi USA, LLC, finalizing changes to the product as described i…
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CLINICAL_TRIALS trial_result · 2025-04-29Clinical Trial Update: A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers [Phase 1]
Phase 1 study evaluating the safety, tolerability, pharmacokinetics and food effect of a single dose of KVD900 (Sebetralstat) in healthy vol…
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CLINICAL_TRIALS trial_result · 2025-04-11Clinical Trial Update: A Study of STAR-0215 in Participants With Hereditary Angioedema [Phase 1, Phase 2]
A Phase 1/2 clinical trial evaluating STAR-0215 in participants with hereditary angioedema has been completed.
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CLINICAL_TRIALS research · 2025-04-08Clinical Trial Update: C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks
This document reports the completion of a clinical trial registry evaluating C1 inhibitor use for treatment of hereditary angioedema attacks…
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CLINICAL_TRIALS research · 2025-04-08Clinical Trial Update: Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases
This entry describes the Armenian nationwide registry of systemic autoimmune and autoinflammatory diseases, which is currently recruiting pa…
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CLINICAL_TRIALS research · 2025-04-01Clinical Trial Update: HAE Burden and Crisis Management
Ongoing clinical trial update for NCT06806618 assessing the burden of hereditary angioedema and crisis management; the study is currently re…
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CLINICAL_TRIALS trial_result · 2025-03-24Clinical Trial Update: An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema [Phase 2]
Phase 2 extension study of Donidalorsen (IONIS-PKK-LRx) in participants with hereditary angioedema has completed.
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EMA approval · 2025-03-11EMA Authorised: Andembry (garadacimab) — CSL Behring GmbH
The EMA authorized Andembry (garadacimab) for hereditary angioedema. CSL Behring GmbH is the marketing authorization holder.
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CLINICAL_TRIALS trial_result · 2025-03-06Clinical Trial Update: OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE) [Phase 3]
Phase 3 trial results update for donidalorsen in hereditary angioedema (HAE) from the OASIS-HAE study, with results posted in March 2025.
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CLINICAL_TRIALS trial_result · 2025-02-21Clinical Trial Update: FIRAZYR General Drug Use-Results Survey (Japan)
A completed Japan-based survey evaluating real-world use of Firazyr (icatibant) for hereditary angioedema, with results posted in 2025.
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CLINICAL_TRIALS research · 2025-02-10Clinical Trial Update: Suicide Ideation in Hereditary Angioedema
A clinical trial update for a study examining suicidal ideation in hereditary angioedema. The trial is currently not recruiting.
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CLINICAL_TRIALS trial_result · 2025-02-10Clinical Trial Update: A Study to Explore Hereditary Angioedema (HAE) Symptoms and Treatment Patterns in Korean People
This completed clinical study conducted in Korean participants investigated hereditary angioedema symptoms and treatment patterns.
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FDA approval · 2025-01-03FDA Approved: ICATIBANT — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for icatibant (generic icatibant) under ANDA 211021.
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CLINICAL_TRIALS trial_result · 2024-12-13Clinical Trial Update: A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE) [Phase 3]
Phase 3 study of Lanadelumab (SHP643) in Chinese participants with hereditary angioedema has completed and results have been posted.
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CLINICAL_TRIALS trial_result · 2024-11-15Clinical Trial Update: Treatment of Hereditary Angioedema Prodrome with Recombinant C1-esterase Inhibitor (Ruconest) [Phase 4]
A Phase 4 trial evaluating the treatment of hereditary angioedema prodrome with recombinant C1-esterase inhibitor (Ruconest) has completed.
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CLINICAL_TRIALS trial_result · 2024-10-28Clinical Trial Update: Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)
This document reports the completed status of the Firazyr patient registry, the Icatibant Outcome Survey (IOS), tracking outcomes in heredit…
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FDA approval · 2024-10-22FDA Approved: ICATIBANT — Supplemental Application (Eugia US LLC)
The FDA approved a supplemental application for icatibant by Eugia US LLC under an Abbreviated New Drug Application (ANDA), marking regulato…
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FDA approval · 2024-10-21FDA Approved: ORLADEYO — Supplemental Application (BioCryst Pharmaceuticals, Inc.)
The FDA has approved a supplemental application for ORLADEYO (berotralstat hydrochloride) by BioCryst Pharmaceuticals, Inc. The approval add…
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FDA approval · 2024-09-03FDA Approved: ICATIBANT — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for icatibant from Teva Pharmaceuticals USA, Inc.
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CLINICAL_TRIALS trial_result · 2024-08-05Clinical Trial Update: A Study in Adults With Hereditary Angioedema (HAE) Who Currently Receive Icatibant at Home
This completed clinical trial evaluated adults with hereditary angioedema who are currently receiving icatibant at home.
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CLINICAL_TRIALS trial_result · 2024-07-30Clinical Trial Update: A Study to Review the Treatment and Outcomes of Teenagers and Adults With Non-histaminergic Angioedema With Normal C1 Inhibitor in Canada
This clinical trial update describes a completed study in Canada evaluating treatment approaches and outcomes for teenagers and adults with …
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CLINICAL_TRIALS trial_result · 2024-07-19Clinical Trial Update: A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE) [Phase 3]
Phase 3 crossover trial evaluating sebetralstat (KVD900) for on-demand treatment of hereditary angioedema attacks in adolescents and adults …
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FDA approval · 2024-07-18FDA Approved: ICATIBANT — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for ICATIBANT submitted by Teva Pharmaceuticals USA, Inc. This action relates to a supplemental …
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FDA approval · 2024-06-14FDA Approved: ICATIBANT — Original Application (Alembic Pharmaceuticals Limited)
FDA approved Alembic Pharmaceuticals Limited's generic icatibant (ANDA213773) for the treatment of acute attacks of hereditary angioedema.