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Hereditary Angioedema Treatments Compared

Name: Hereditary Angioedema Treatments Compared
Creator: Jason Hunter
Published: 2026-10-01

5 FDA-approved drugs, side by side from the current prescribing labels. Newest label Aug 2026. Checked October 1, 2026.

Prevention, injectionsTakhzyro · Andembry · Dawnzera

Prevention, daily pillOrladeyo

On-demand treatmentEkterly

Five newer drugs are FDA-approved for hereditary angioedema, and 4 of them prevent attacks while 1 treats an attack once it starts. The preventives are Takhzyro, an injection every 2 weeks; Orladeyo, a daily capsule; Andembry, a monthly injection; and Dawnzera, an injection every 4 or 8 weeks, all taken at home. In their placebo-controlled trials they cut attack rates by 44% for Orladeyo and 81% to 89% for the 3 injections. Ekterly, approved July 2025, is the first oral on-demand treatment: 2 tablets at the first sign of an attack, with symptom relief in a median of 2 hours. People on a preventive still carry an on-demand medicine for breakthrough attacks.

Side by side

5 approved hereditary angioedema treatments at a glance

How each drug is given, how often, who it is approved for and when it was first approved, from the current FDA label.

Hereditary Angioedema treatments compared: route, schedule, approved use and approval date
Drug	How it is given	How often	Approved for	First approved
Takhzyro lanadelumab-flyo Takeda	Under-the-skin injection every 2 weeks (every 4 weeks if attack-free for 6 months), self-given from age 12	300 mg under the skin every 2 weeks from age 12; 300 mg every 4 weeks may be considered if attack-free for more than 6 months. Ages 6 to 11: 150 mg every 2 weeks; ages 2 to 5: 150 mg every 4 weeks	Prevention of HAE attacks in adults and children 2 and older	August 23, 2018
Orladeyo berotralstat BioCryst	One capsule a day by mouth with food (oral pellets for ages 2 to 11)	150 mg capsule once daily with food from age 12; weight-based oral pellets (72 to 132 mg) once daily for ages 2 to 11; 110 mg if moderate or severe liver impairment	Prevention of HAE attacks in adults and children 2 and older; not for treating an attack	December 3, 2020
Andembry garadacimab-gxii CSL Behring	Under-the-skin injection once a month with a prefilled pen, self-given	400 mg loading dose (2 injections) on day 1, then 200 mg under the skin once a month	Prevention of HAE attacks in adults and children 12 and older	June 16, 2025
Ekterly sebetralstat KalVista Pharmaceuticals	2 tablets by mouth at the first sign of an attack; a second dose 3 hours later if needed	600 mg (2 tablets) at the earliest sign of an attack; may repeat 600 mg after at least 3 hours; maximum 1,200 mg in 24 hours. Dose reduced with moderate CYP3A4 inhibitors or moderate liver impairment	On-demand treatment of acute HAE attacks in adults and children 12 and older; not a preventive	July 3, 2025
Dawnzera donidalorsen Ionis Pharmaceuticals	Under-the-skin injection every 4 weeks (every 8 weeks is an option) with an autoinjector, self-given	80 mg under the skin every 4 weeks; 80 mg every 8 weeks may be considered	Prevention of HAE attacks in adults and children 12 and older	August 21, 2025

The calendar

A year on each hereditary angioedema treatment

Every dose in a year, drawn to the label schedule, so the difference between a daily pill and a twice-yearly infusion is the picture.

Takhzyro

Injection, at home

26 doses a year

Orladeyo

By mouth, at home

365 doses a year

Andembry

Injection, at home

12 doses a year

Ekterly

By mouth, at home

600 mg (2 tablets) at the earliest sign of an attack (no fixed yearly count)

Dawnzera

Injection, at home

13 doses a year

Counts follow the label schedule for a full year on the maintenance dose. Drugs given in cycles or adjusted to blood tests have no fixed count, so their schedule is written out instead.

The evidence

What the pivotal hereditary angioedema trials showed

The primary result from the trial each FDA approval rests on, as reported on the label.

Hereditary Angioedema pivotal trial results by drug
Drug	Pivotal trial	Primary result
Takhzyro lanadelumab-flyo Takeda	HELP (Trial 1), 125 people aged 12 and older Trial record or paper	0.26 attacks per month on 300 mg every 2 weeks vs 1.97 on placebo over 26 weeks, an 87% reduction (n=27 vs 41)
Orladeyo berotralstat BioCryst	APeX-2 (Trial 1, Part 1), 120 people aged 12 and older Trial record or paper	1.31 attacks per month on 150 mg vs 2.35 on placebo over 24 weeks, a 44% reduction (n=40 vs 40)
Andembry garadacimab-gxii CSL Behring	VANGUARD, 64 people aged 12 and older Trial record or paper	0.22 attacks per month vs 2.07 on placebo over 6 months, an 89% reduction (n=39 vs 25); 62% were attack-free vs 0%
Ekterly sebetralstat KalVista Pharmaceuticals	KONFIDENT, 110 people aged 12 and older treating 264 attacks (crossover) Trial record or paper	Symptom relief began in a median 2.0 hours; 76% of patients on 600 mg reached relief within 12 hours vs 49% on placebo (n=93 vs 84)
Dawnzera donidalorsen Ionis Pharmaceuticals	OASIS-HAE, 90 people aged 12 and older Trial record or paper	0.44 attacks per 4 weeks on the every-4-weeks dose vs 2.26 on placebo over 24 weeks, an 81% reduction (n=45 vs 22); every 8 weeks: 55% reduction (n=23)

Safety

Hereditary Angioedema treatment side effects and warnings

None of these drugs carries a boxed warning. Each label's main precautions are listed.

Hereditary Angioedema treatments: most common side effects and key warnings from the FDA labels
Drug	Most common side effects	Key warning
Takhzyro lanadelumab-flyo Takeda	injection site reactions 52%, upper respiratory infection 29% and headache 21%	No boxed warning. Hypersensitivity reactions.
Orladeyo berotralstat BioCryst	abdominal pain 23%, vomiting 15% and diarrhea 15%	No boxed warning. QTc prolongation (heart rhythm) at doses above the recommended dose; never take extra doses or use it for an acute attack.
Andembry garadacimab-gxii CSL Behring	nasopharyngitis (colds) 21%, injection site reactions 14% and abdominal pain 8%	No boxed warning and no Warnings and Precautions listed on the label. Prolonged clotting tests (aPTT, PT) seen in some patients without bleeding.
Ekterly sebetralstat KalVista Pharmaceuticals	headache 3.2%	No boxed warning and no Warnings and Precautions section. Avoid with strong CYP3A4 inhibitors, moderate or strong CYP3A4 inducers, and severe liver impairment.
Dawnzera donidalorsen Ionis Pharmaceuticals	injection site reactions 24%, upper respiratory tract infection 9% and urinary tract infection 9%	No boxed warning. Hypersensitivity reactions including anaphylaxis; platelet count decreases.

Cost

Help paying for hereditary angioedema treatment

Drugmaker copay and free-drug programs, plus charity funds for the condition, checked every week.

Questions

Hereditary Angioedema treatment questions people ask

What is the best preventive treatment for hereditary angioedema?

No trial has compared the 4 preventives. Against placebo, Andembry cut monthly attacks by 89%, Takhzyro by 87%, Dawnzera by 81% and Orladeyo by 44%, in separate trials with different designs. The practical choices are a daily capsule (Orladeyo) against an injection every 2 weeks (Takhzyro), 4 weeks (Andembry and Dawnzera) or 8 weeks (Dawnzera, in some patients), and which ages each covers.

Is there a pill to prevent hereditary angioedema attacks?

Yes. Orladeyo (berotralstat) is 1 capsule a day with food from age 12, with oral pellets for ages 2 to 11. In its trial it reduced attacks by 44% against placebo, less than the injected preventives, which were 81% to 89% in their own trials.

What is Ekterly used for?

Ekterly (sebetralstat) is taken when an attack starts: 2 tablets at the first sign, with a second dose 3 hours later if needed, for people 12 and older. In its trial, 76% reached symptom relief within 12 hours against 49% on placebo, with a median time to relief of 2 hours. It is the first oral on-demand HAE treatment and is not for prevention.

Which HAE preventive is given least often?

Dawnzera (donidalorsen), which is injected every 4 weeks and can be moved to every 8 weeks in patients who do well; Andembry is monthly. Takhzyro starts at every 2 weeks and can move to every 4 weeks after 6 attack-free months. Orladeyo is daily.

Go deeper

More on Hereditary Angioedema at Trial Friend

Sources

Where every number on this page comes from

Approved-drug facts are from the current FDA prescribing information on DailyMed, with the label's effective date. Investigational-drug facts are from ClinicalTrials.gov and the sources named in each row.

Takhzyro (lanadelumab-flyo) prescribing information, Takeda, label dated Aug 2026. DailyMed. Pivotal trial: ClinicalTrials.gov
Orladeyo (berotralstat) prescribing information, BioCryst, label dated Aug 2026. DailyMed. Pivotal trial: ClinicalTrials.gov
Andembry (garadacimab-gxii) prescribing information, CSL Behring, label dated Jun 2025. DailyMed. Pivotal trial: ClinicalTrials.gov
Ekterly (sebetralstat) prescribing information, KalVista Pharmaceuticals, label dated Apr 2026. DailyMed. Pivotal trial: ClinicalTrials.gov
Dawnzera (donidalorsen) prescribing information, Ionis Pharmaceuticals, label dated Sep 2025. DailyMed. Pivotal trial: ClinicalTrials.gov

This page compares what the FDA labels and pivotal trials report. It is not medical advice, and no trial on this page compared these drugs with each other. Written and checked by Jason Hunter; the method is on the editorial standards page.