Hereditary Angioedema
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CLINICAL_TRIALS research · 2026-03-27Clinical Trial Update: A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE)
The document reports a clinical trial evaluating garadacimab for hereditary angioedema. The study is currently recruiting.
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CLINICAL_TRIALS research · 2026-03-24Clinical Trial Update: NTLA-2002 in Adults With Hereditary Angioedema (HAE) [Phase 1, Phase 2]
An update on a Phase 1/2 clinical trial of NTLA-2002 for hereditary angioedema. The study is currently listed as active but not recruiting.
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CLINICAL_TRIALS trial_result · 2026-03-16Clinical Trial Update: Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema [Phase 2, Phase 3]
Extension study of oral PHA-022121 for acute treatment of angioedema attacks in hereditary angioedema. The trial is in Phase 2/Phase 3 and i…
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CLINICAL_TRIALS research · 2026-03-16Clinical Trial Update: Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE [Phase 3]
A long-term, open-label Phase 3 trial evaluating an oral extended-release deucrictibant tablet for prophylaxis of angioedema attacks in adol…
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CLINICAL_TRIALS research · 2026-03-13Clinical Trial Update: A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt
Takeda-sponsored clinical trial in Egypt focusing on the diagnosis and management of hereditary angioedema, with recruitment not yet started…
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CLINICAL_TRIALS trial_result · 2026-03-13Clinical Trial Update: A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
A clinical trial update shows a South Korea study of lanadelumab (Takhzyro) for hereditary angioedema in teenagers and adults is NOT_YET_REC…
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CLINICAL_TRIALS research · 2026-03-04Clinical Trial Update: Real-life Ecological Momentary Assessment of Lived Burden in Hereditary AngioEdema
A clinical trial update notes that a study assessing lived burden of hereditary angioedema using ecological momentary assessment is currentl…
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CLINICAL_TRIALS trial_result · 2026-03-02Clinical Trial Update: Safety, Tolerability, PK, PD of ADX-324 in Healthy Volunteers and Hereditary Angioedema Patients [Phase 1, Phase 2]
Clinical trial update reports on safety, tolerability, and pharmacokinetics/pharmacodynamics of ADX-324 in healthy volunteers and hereditary…
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CLINICAL_TRIALS research · 2026-03-02Clinical Trial Update: Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE) [Phase 3]
Phase 3 extension study update for ADX-324 in hereditary angioedema; the trial is not yet recruiting.
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CLINICAL_TRIALS trial_result · 2026-02-25Clinical Trial Update: Berotralstat Treatment in Children With Hereditary Angioedema [Phase 3]
Phase 3 trial update reporting results for berotralstat in pediatric hereditary angioedema; the study is active but not recruiting, with res…
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CLINICAL_TRIALS research · 2026-02-25Clinical Trial Update: A Study of Lanadelumab in Children With Hereditary Angioedema (HAE) in Multiple Countries
A study evaluating lanadelumab for hereditary angioedema in children across multiple countries is currently recruiting.
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EMA approval · 2026-02-20EMA Authorised: Dawnzera (donidalorsen) — Otsuka Pharmaceutical Netherlands B.V.
EMA authorised Dawnzera (donidalorsen) for hereditary angioedema. The product is developed by Otsuka Pharmaceutical Netherlands B.V.
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EMA approval · 2026-02-18EMA Authorised: Orladeyo (berotralstat dihydrochloride) — BioCryst Ireland Limited
The EMA authorised Orladeyo (berotralstat dihydrochloride) for hereditary angioedema, with BioCryst Ireland Limited as the marketing authori…
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CLINICAL_TRIALS trial_result · 2026-02-18Clinical Trial Update: An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE) [Phase 3]
Open-label extension study evaluating the long-term safety of KVD900 (Sebetralstat) for on-demand treatment of angioedema attacks in adolesc…
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CLINICAL_TRIALS trial_result · 2026-02-13Clinical Trial Update: Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE [Phase 3]
Phase 3 clinical trial update evaluating an extended-release oral deucrictibant tablet for prophylaxis of angioedema attacks in adolescents …
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CLINICAL_TRIALS trial_result · 2026-02-05Clinical Trial Update: Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema [NA]
A completed clinical trial conducted at University Hospital, Rouen, investigating the role of monocytic B1 and B2 receptors in inflammation …
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CLINICAL_TRIALS trial_result · 2026-02-04Clinical Trial Update: Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With HAE With Sebetralstat
This clinical trial update reports on the use of Sebetralstat for treating angioedema attacks in pediatric patients aged 2-11 with hereditar…
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CLINICAL_TRIALS trial_result · 2026-01-26Clinical Trial Update: Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks [Phase 3]
Phase 3 study evaluating long-term safety and efficacy of garadacimab (CSL312) as prophylaxis for hereditary angioedema completed.
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CLINICAL_TRIALS trial_result · 2026-01-26Clinical Trial Update: CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema [Phase 3]
A Phase 3 safety and pharmacokinetic study of CSL312_3003 in children aged 2 to 11 with hereditary angioedema has completed.
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CLINICAL_TRIALS trial_result · 2026-01-23Clinical Trial Update: Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II [Phase 3]
Open-label Phase 3 pediatric trial evaluating safety, pharmacokinetics, and efficacy of Sebetralstat (KVD900) in children aged 2-11 with her…
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CLINICAL_TRIALS trial_result · 2026-01-21Clinical Trial Update: A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China
This update indicates the completion of a clinical trial evaluating lanadelumab (Takhzyro) and icatibant (Firazyr) for hereditary angioedema…
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CLINICAL_TRIALS trial_result · 2026-01-13Clinical Trial Update: A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks
A completed observational study in the United States evaluating icatibant for treating attacks in patients with hereditary angioedema types …
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FDA approval · 2025-12-23FDA Approved: ORLADEYO — Supplemental Application (BioCryst Pharmaceuticals, Inc.)
FDA approval of a supplemental application for ORLADEYO (berotralstat hydrochloride) submitted by BioCryst Pharmaceuticals, Inc.
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CLINICAL_TRIALS trial_result · 2025-12-23Clinical Trial Update: Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies [Phase 3]
Open-label access for Berotralstat is being offered to hereditary angioedema patients who were previously enrolled in Berotralstat studies, …
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EMA approval · 2025-12-19EMA Authorised: Ruconest (recombinant human C1-inhibitor) — Pharming Group N.V.
The EMA authorised Ruconest (recombinant human C1-inhibitor) for hereditary angioedema, with marketing authorization granted to Pharming Gro…