Hereditary Angioedema
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CLINICAL_TRIALS trial_result · 2025-12-18Clinical Trial Update: A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema [Phase 4]
A Phase 4 clinical trial evaluating the safety and efficacy of icatibant in patients with bradykinin-mediated angioedema and hereditary angi…
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CLINICAL_TRIALS research · 2025-12-18Clinical Trial Update: HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE) [Phase 3]
Clinical trial update for NTLA-2002 in hereditary angioedema (HAE). It is a Phase 3 study sponsored by Intellia Therapeutics and is currentl…
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CLINICAL_TRIALS trial_result · 2025-12-17Clinical Trial Update: Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema [Phase 2]
Phase 2 dose-ranging study evaluating oral PHA-022121 for acute treatment of angioedema attacks in patients with hereditary angioedema. The …
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CLINICAL_TRIALS research · 2025-12-12Clinical Trial Update: A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE) [Phase 3]
This update concerns a Phase 3 study evaluating the long-term safety and efficacy of Donidalorsen for prophylaxis in hereditary angioedema; …
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FDA approval · 2025-12-11FDA Approved: ORLADEYO — Original Application (BioCryst Pharmaceuticals, Inc.)
FDA approves ORLADEYO (berotralstat hydrochloride) from BioCryst as an oral prophylaxis to prevent attacks of hereditary angioedema.
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CLINICAL_TRIALS trial_result · 2025-11-28Clinical Trial Update: Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002
This update reports long-term follow-up data for subjects treated with NTLA-2002 in hereditary angioedema, with ongoing enrollment by invita…
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CLINICAL_TRIALS trial_result · 2025-11-21Clinical Trial Update: Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema [Phase 3]
Phase 3 study of oral deucrictibant for on-demand treatment of hereditary angioedema attacks in adolescents and adults has completed.
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CLINICAL_TRIALS research · 2025-11-20Clinical Trial Update: A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)
This clinical trial update reports on lanadelumab being studied in teenagers and adults with hereditary angioedema; the study is currently a…
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CLINICAL_TRIALS trial_result · 2025-11-17Clinical Trial Update: 12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks [Phase 2, Phase 3]
BioCryst reports results from a 12-week safety and efficacy study of BCX4161 as an oral prophylaxis for hereditary angioedema (HAE) in a com…
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CLINICAL_TRIALS research · 2025-11-17Clinical Trial Update: A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema
Takeda-sponsored pediatric trial evaluating icatibant for hereditary angioedema has completed. The trial identifier is NCT05509569.
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CLINICAL_TRIALS research · 2025-11-05Clinical Trial Update: A Long-Term Study of Navenibart in Participants With Hereditary Angioedema [Phase 3]
A long-term Phase 3 study evaluating Navenibart in participants with hereditary angioedema is currently enrolling by invitation.
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EMA approval · 2025-10-08EMA Authorised: Ekterly (sebetralstat) — Kalvista Pharmaceuticals (Ireland) Limited
The EMA authorised Ekterly (sebetralstat) from Kalvista Pharmaceuticals for the treatment of hereditary angioedema, marking an approved ther…
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CLINICAL_TRIALS research · 2025-10-03Clinical Trial Update: Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks [Phase 3]
Phase 3 clinical trial evaluating IV human plasma-derived C1 esterase inhibitor concentrate for treatment and pre-procedure prevention of ac…
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EMA approval · 2025-10-02EMA Authorised: Takhzyro (lanadelumab) — Takeda Pharmaceuticals International AG Ireland Branch
The EMA authorised lanadelumab (Takhzyro) for hereditary angioedema, with orphan medicine designation and accelerated assessment.
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CLINICAL_TRIALS trial_result · 2025-09-08Clinical Trial Update: Post Study Access of CSL312 (Garadacimab) for Pediatric Participants With Hereditary Angioedema Who Have Completed the CSL312_3003 Study
Post-study access for pediatric participants who completed the CSL312_3003 trial evaluating garadacimab (CSL312) for hereditary angioedema.
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CLINICAL_TRIALS trial_result · 2025-09-02Clinical Trial Update: A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II
This document reports an update from a completed clinical trial evaluating lanadelumab in individuals with hereditary angioedema type I or I…
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FDA approval · 2025-08-21FDA Approved: DAWNZERA — Original Application (Ionis Pharmaceuticals Inc.)
The FDA approved Dawnzera (donidalorsen) from Ionis Pharmaceuticals as an original new drug for the prevention of hereditary angioedema atta…
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CLINICAL_TRIALS approval · 2025-08-06Clinical Trial Update: Treatment of Angioedema Attacks in Adolescent and Adult Patients 12 Years and Older With HAE Type I or II With Sebetralstat
Regulatory approval for sebetralstat to treat angioedema attacks in adolescents and adults aged 12 years and older with hereditary angioedem…
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CLINICAL_TRIALS trial_result · 2025-07-30Clinical Trial Update: Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II [Phase 2]
A Phase 2 dose-ranging study of oral PHA-022121 for prophylaxis against angioedema attacks in patients with hereditary angioedema (Types I a…
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CLINICAL_TRIALS research · 2025-07-23Clinical Trial Update: A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema [Phase 2]
Update on the Phase 2 long-term study of STAR-0215 in participants with hereditary angioedema.
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CLINICAL_TRIALS research · 2025-07-18Clinical Trial Update: PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial [Phase 3]
This document provides a clinical trial update on a pharmacokinetic subtrial in adolescent patients with hereditary angioedema types I or II…
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CLINICAL_TRIALS trial_result · 2025-07-11Clinical Trial Update: Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema
This update confirms an expanded access program for donidalorsen in patients with hereditary angioedema, allowing eligible patients to acces…
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FDA approval · 2025-07-03FDA Approved: EKTERLY — Original Application (KalVista Pharmaceuticals Ltd)
FDA approved EKTERLY (SEBETRALSTAT) from KalVista Pharmaceuticals Ltd through an original NDA for the treatment of hereditary angioedema.
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CLINICAL_TRIALS research · 2025-07-02Clinical Trial Update: Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients [Phase 1, Phase 2]
A Phase 1/2 clinical trial evaluating oral deucrictibant for prophylaxis and acute treatment in hereditary angioedema patients; recruitment …
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EMA approval · 2025-06-18EMA Authorised: Cinryze (C1 inhibitor (human)) — Takeda Manufacturing Austria AG
The European Medicines Agency authorised Cinryze for hereditary angioedema, with Takeda Manufacturing Austria AG as the marketing authorizat…