64 completed, 7 active not recruiting, 4 terminated, 3 approved for marketing. 35 Phase 3, 23 Phase 2, 16 Phase 1, 7 Phase 4.
Follow Hereditary Angioedema: new trials by email Literature Review of Hereditary Angioedema trials Research Report on Hereditary Angioedema
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL) KVD900 600 mg - Hereditary Angioedema | Phase 4 | Recruiting | KalVista Pharmaceuticals, Ltd. | 100 | 2026-08-17 | 2026-09-17 |
| STOP-HAE: A Phase 3 Study of ADX-324 in HAE ADX-324, Placebo - Hereditary Angioedema, HAE | Phase 3 | Recruiting | ADARx Pharmaceuticals, Inc. | 90 | 2025-08-28 | 2026-09-10 |
| Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab Garadacimab - Hereditary Angioedema | Phase 4 | Completed | CSL Behring | 18 | 2025-04-28 | 2026-07-23 |
| A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks Inapplicable - Hereditary Angioedema | Completed | KalVista Pharmaceuticals, Ltd. | 88 | 2025-04-21 | 2026-01-13 | |
| HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE) NTLA-2002, Normal Saline IV Administration - Hereditary Angioedema | Phase 3 | Active not recruiting | Intellia Therapeutics | 80 | 2025-01-15 | 2026-10-08 |
| Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II KVD900 150 mg, KVD900 300 mg, KVD900 600 mg - Hereditary Angioedema | Phase 3 | Completed | KalVista Pharmaceuticals, Ltd. | 36 | 2024-08-01 | 2026-08-05 |
| Institutional Registry of Rare Diseases Rare Diseases, Amyloidosis | Recruiting | Hospital Italiano de Buenos Aires | 380 | 2024-07-01 | 2026-01-14 | |
| Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002 Hereditary Angioedema | Enrolling by invitation | Intellia Therapeutics | 100 | 2024-04-12 | 2025-11-28 | |
| Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema Deucrictibant, Placebo - Hereditary Angioedema, Hereditary Angioedema Type I | Phase 3 | Completed | Pharvaris Netherlands B.V. | 134 | 2024-02-26 | 2025-11-21 |
| A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema STAR-0215 - Hereditary Angioedema | Phase 2 | Active not recruiting | Astria Therapeutics, Inc. | 56 | 2023-09-26 | 2025-07-23 |
| Autonomic Nervous System Profile in Hereditary Angioedema Hereditary Angioedema | Completed | Istituti Clinici Scientifici Maugeri SpA | 60 | 2023-07-12 | 2024-05-10 | |
| Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients Hereditary Angioedema | Completed | Istituti Clinici Scientifici Maugeri SpA | 40 | 2023-05-15 | 2024-05-16 | |
| A Study of Navenibart (STAR-0215) in Participants With Hereditary Angioedema Navenibart - Hereditary Angioedema | Phase 1 / Phase 2 | Completed | Astria Therapeutics, Inc. | 29 | 2023-02-21 | 2026-05-08 |
| Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema deucrictibant - Hereditary Angioedema, Hereditary Angioedema Type I | Phase 2 / Phase 3 | Enrolling by invitation | Pharvaris Netherlands B.V. | 150 | 2022-12-28 | 2026-07-21 |
| Safety, Tolerability, PK, PD of ADX-324 in Healthy Volunteers and Hereditary Angioedema Patients ADX-324, Placebo - Hereditary Angioedema | Phase 1 / Phase 2 | Active not recruiting | ADARx Pharmaceuticals, Inc. | 53 | 2022-12-14 | 2026-06-16 |
| Berotralstat Treatment in Children With Hereditary Angioedema Berotralstat - Hereditary Angioedema, Pediatric | Phase 3 | Active not recruiting | BioCryst Pharmaceuticals | 29 | 2022-10-25 | 2026-02-25 |
| 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) KVD900 600 mg, KVD900 300 mg - Hereditary Angioedema | Phase 3 | Completed | KalVista Pharmaceuticals, Ltd. | 145 | 2022-10-24 | 2026-06-05 |
| PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial KVD900 600 mg, Drug: KVD900 300 mg - Hereditary Angioedema | Phase 3 | Completed | KalVista Pharmaceuticals, Ltd. | 11 | 2022-10-24 | 2026-06-08 |
| A Study of STAR-0215 in Healthy Adult Participants STAR-0215 (SC), Placebo (SC), STAR-0215 (IV) - Hereditary Angioedema | Phase 1 | Completed | Astria Therapeutics, Inc. | 41 | 2022-07-27 | 2024-01-11 |
| A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE) Donidalorsen - Hereditary Angioedema | Phase 3 | Active not recruiting | Ionis Pharmaceuticals, Inc. | 154 | 2022-07-13 | 2025-12-12 |
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Angioedemas, Hereditary (89) · Angioedema (13) · Hereditary Angioedema Types I and II (6) · Genetic Diseases, Inborn (5) · Rare Diseases (4) · Hereditary Angioedema Type III (3) · Hypersensitivity (2) · Immune System Diseases (2) · Adrenal Hyperplasia, Congenital (1) · Amyloidosis (1) · Anxiety Disorders (1) · Cardiomyopathy, Hypertrophic (1) · Cardiovascular Diseases (1) · Cushing Syndrome (1) · Demyelinating Diseases (1)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities (89) · Hereditary Complement Deficiency Diseases (89) · Immunologic Deficiency Syndromes (89) · Primary Immunodeficiency Diseases (89) · Skin and Connective Tissue Diseases (89) · Cardiovascular Diseases (88) · Hypersensitivity, Immediate (88) · Skin Diseases (88) · Skin Diseases, Vascular (88) · Urticaria (88) · Vascular Diseases (88) · Hypersensitivity (87) · Immune System Diseases (87) · Genetic Diseases, Inborn (84) · Angioedema (76)
Complement C1 Inhibitor Protein (15) · berotralstat (9) · sebetralstat (9) · Sodium Chloride (8) · conestat alfa (8) · avoralstat (5) · donidalorsen (5) · icatibant (5) · IONIS-PKK-LRx (4) · SERPING1 protein, human (3) · RNA, Small Interfering (2) · lanadelumab (2) · Blood Specimen Collection (1) · Complement C1 (1) · Cyclosporine (1)
BioCryst Pharmaceuticals (14) · KalVista Pharmaceuticals, Ltd. (12) · Shire (12) · Pharming Technologies B.V. (8) · CSL Behring (6) · Ionis Pharmaceuticals, Inc. (5) · Pharvaris Netherlands B.V. (5) · Astria Therapeutics, Inc. (3) · Intellia Therapeutics (3) · Takeda (3) · ADARx Pharmaceuticals, Inc. (2) · AO GENERIUM (2) · CENTOGENE GmbH Rostock (2) · Istituti Clinici Scientifici Maugeri SpA (2) · University Hospital, Grenoble (2)
United States (48) · Germany (34) · United Kingdom (33) · Canada (29) · France (24) · Italy (23) · Israel (20) · Poland (20) · Hungary (19) · Netherlands (19) · Spain (19) · Australia (16) · Bulgaria (16) · Czechia (15) · Romania (15)
Anurag Relan, MD (4) · Joanne Collier, MBChB, FFPM, Dip Stats (OU) (2) · Lauge Farnaes, MD (2) · Oksana A. Markova, MD (2) · Peter Bauer, MD (2) · Adrian Gadano, MD (1) · Aleena Banerji, M.D. (1) · Anne Pagnier (1) · Bruce Zuraw, MD (1) · Bruno Giannetti, MD (1) · Eduardo Jorge Premoli, MD (1) · Firas Almazedi, MBChB, Msc, CPI (1)
PMID 36326435, PMID 20818886, PMID 23312695, PMID 42159953, PMID 42268494, PMID 20920772, PMID 22856635, PMID 23484892, PMID 23987198, PMID 28284978, PMID 36408587, PMID 36774155, PMID 40380356, PMID 40886933, PMID 42318595, PMID 17073887, PMID 19767078, PMID 20674826, PMID 20818888, PMID 21195947, PMID 21884533, PMID 22123383, PMID 22192966, PMID 22856636, PMID 22909164, PMID 23167682, PMID 23535096, PMID 24111645, PMID 24266596, PMID 24438203, PMID 25198193, PMID 25295804, PMID 26556097, PMID 27140403, PMID 28754491, PMID 29503044, PMID 30993784, PMID 31109849, PMID 33098856, PMID 33866032, PMID 34161665, PMID 35086692, PMID 35219377, PMID 35294812, PMID 35820771, PMID 36868261, PMID 37730089, PMID 38006972, PMID 38009241, PMID 38020288
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