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ClinicalTrials.gov 2 recruiting now official registry

Hereditary Angioedema clinical trials

Every US clinical trial registered for Hereditary Angioedema — phase mix, recruiting status, and the sponsors running them, straight from the NIH ClinicalTrials.gov registry.

15 US clinical trials · 2 currently recruiting

The research picture

Hereditary Angioedema has 15 registered US clinical trials, 2 of them open to new participants right now — about 13% of the total.

2
recruiting participants now
13%
of trials open to enrollment
9
in Phase 3–4 (later-stage)
4
top sponsor: Shire

Counts reflect the public ClinicalTrials.gov registry as last mirrored by PlainTrial. Status and phase are reported by each study's sponsor. This is reference information, not medical advice.

Active & Recent Trials

RECRUITING Phase 3 90 participants

STOP-HAE: A Phase 3 Study of ADX-324 in HAE

ADARx Pharmaceuticals

NCT06960213

RECRUITING Phase 4 30 participants

Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab

CSL Behring

NCT06806657

ACTIVE NOT RECRUITING Phase 3 154 participants

A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)

Ionis Pharmaceuticals

NCT05392114

ACTIVE NOT RECRUITING Phase 3 145 participants

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)

KalVista Pharmaceuticals

NCT05505916

ACTIVE NOT RECRUITING Phase 3 60 participants

HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)

Intellia Therapeutics

NCT06634420

ACTIVE NOT RECRUITING Phase 2 56 participants

A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema

Astria Therapeutics

NCT06007677

ACTIVE NOT RECRUITING Phase 1 44 participants

A Gene Therapy Study of BMN 331 in Subjects With Hereditary Angioedema

BioMarin Pharmaceutical

NCT05121376

ACTIVE NOT RECRUITING Phase 3 11 participants

PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial

KalVista Pharmaceuticals

NCT05511922

COMPLETED Phase 3 146 participants

Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks

Shire

NCT00462709

COMPLETED Phase 3 91 participants

OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)

Ionis Pharmaceuticals

NCT05139810

COMPLETED Phase 2 84 participants

A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II

KalVista Pharmaceuticals

NCT04208412

COMPLETED Phase 3 83 participants

C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks

Shire

NCT00289211

COMPLETED Phase 1 29 participants

A Study of STAR-0215 in Participants With Hereditary Angioedema

Astria Therapeutics

NCT05695248

COMPLETED Phase 2 26 participants

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration

Shire

NCT01095497

COMPLETED Phase 2 12 participants

A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase

Shire

NCT01426763

Phase Distribution

PhaseTrial count
Phase 1 2
Phase 2 4
Phase 3 8
Phase 4 1

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Hereditary Angioedema Trial Landscape

ClinicalTrials.gov lists 15 US studies indexed under Hereditary Angioedema, and 2 of those are currently open to recruitment — roughly 13% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

The phase distribution for Hereditary Angioedema shows 9 late-stage studies (Phase 3 and Phase 4 combined) alongside 6 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

Top sponsor activity for Hereditary Angioedema is led by Shire with 4 indexed trials, alongside 7 other organizations in the top contributor list. The list on this page surfaces up to 15 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Hereditary Angioedema?

PlainTrial tracks 15 US clinical trials for Hereditary Angioedema, of which 2 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Hereditary Angioedema?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Related

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

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