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Alpha-1 Antitrypsin Deficiency Treatments Compared

1 FDA-approved drug in 4 forms, plus 4 in development, side by side from the current prescribing labels. Newest label Dec 2025. Checked October 23, 2026.

The full Alpha-1 Antitrypsin Deficiency guide, with open trials and help paying →

Ready-to-use liquidsProlastin-C Liquid · Glassia
Powders mixed before each doseAralast NP · Zemaira

Four brands of the same treatment are FDA-approved for alpha-1 antitrypsin deficiency: Prolastin-C Liquid, Aralast NP, Zemaira and Glassia, all alpha1-proteinase inhibitor made from donated human plasma. Each is 60 mg/kg infused into a vein once a week, about 15 minutes at the label rates, and each is approved only for adults with emphysema caused by severe AATD. Their trials measured AAT levels in the blood, not breathing or lung damage, Zemaira's label says a benefit on emphysema progression has not been demonstrated in randomized controlled trials, and the other 3 say it has not been conclusively demonstrated. All 4 are ruled out for people with IgA deficiency who have antibodies against IgA, and Glassia is the only one whose label allows trained patients or caregivers to infuse at home. None is approved for AATD liver disease; fazirsiran for the liver, plus efdoralprin alfa, BEAM-302 and others for the lungs, are still in trials.

Side by side

4 approved alpha-1 antitrypsin deficiency 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.

Alpha-1 Antitrypsin Deficiency treatments compared: route, schedule, approved use and approval date
DrugHow it is givenHow oftenApproved forFirst approved
alpha1-proteinase inhibitor (human)
Grifols
Infusion into a vein once a week; ready-to-use liquidAbout 15 minutes per dose60 mg/kg once a week, infused at 0.08 mL/kg per minute as tolerated; stored in the refrigerator, or at room temperature for up to 1 monthAdults with emphysema caused by severe inherited alpha-1 antitrypsin deficiency, as long-term augmentation and maintenance therapyDecember 2, 1987
alpha1-proteinase inhibitor (human)
Takeda
Infusion into a vein once a week; powder mixed with sterile water before useAbout 15 minutes per dose60 mg/kg once a week, at no more than 0.2 mL/kg per minute; mixed with sterile water and given within 3 hours; stored at up to 25 C (77 F)Adults with clinically evident emphysema caused by severe inherited alpha-1 antitrypsin deficiency, as long-term augmentation therapyDecember 23, 2002
alpha1-proteinase inhibitor (human)
CSL Behring
Infusion into a vein once a week; powder mixed with sterile water before useAbout 15 minutes per dose60 mg/kg once a week, at about 0.08 mL/kg per minute as tolerated; mixed with sterile water, given within 3 hours through a 5 micron filter; stored at up to 25 C (77 F)Adults with alpha-1 antitrypsin deficiency and clinical evidence of emphysema, as long-term augmentation and maintenance therapyJuly 8, 2003
alpha1-proteinase inhibitor (human)
Takeda (brand licensed from Kamada)
Infusion into a vein once a week, by a healthcare professional or, after training, by the patient or a caregiver at home; ready-to-use liquidAbout 15 minutes per dose60 mg/kg once a week, at no more than 0.2 mL/kg per minute; ready-to-use liquid given through a 5 micron in-line filter within 3 hours of opening the vialsAdults with clinically evident emphysema caused by severe inherited alpha-1 antitrypsin deficiency, as long-term augmentation and maintenance therapyJuly 1, 2010
The calendar

A year on each alpha-1 antitrypsin deficiency treatment

Every dose in a year, drawn to the label schedule, so you can see at a glance how often each one is given.

Prolastin-C Liquid
Infusion
52 doses a year
Aralast NP
Infusion
52 doses a year
Zemaira
Infusion
52 doses a year
Glassia
Infusion
52 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 alpha-1 antitrypsin deficiency trials showed

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

Alpha-1 Antitrypsin Deficiency pivotal trial results by drug
DrugPivotal trialPrimary result
alpha1-proteinase inhibitor (human)
Grifols
A 16-week crossover trial of 32 adults comparing it with Prolastin-C powder; the 1987 approval of the original Prolastin rested on a study of 23 people with the ZZ type
Trial record or paper		Blood levels, not lung outcomes: blood exposure matched Prolastin-C powder, with average lowest levels before the next dose of 17.7 micromolar against 16.9. The label says no adequately powered controlled trial has shown an effect on emphysema or flare-ups
alpha1-proteinase inhibitor (human)
Takeda
A trial of 28 adults with emphysema randomly assigned to the original Aralast or Prolastin for 10 weeks; Aralast NP was then matched to Aralast in a 25-person crossover study and tested in a 13-person lung fluid study
Trial record or paper		Blood levels, not lung outcomes: average lowest levels before the next dose were 15.3 micromolar on Aralast and 16.9 on Prolastin. In the Aralast NP lung fluid study, median blood AAT rose from 4.0 to 14.6 micromolar. The label says no adequately powered controlled trial has shown an effect on emphysema
alpha1-proteinase inhibitor (human)
CSL Behring
A 24-week trial of 44 adults randomly assigned to Zemaira or Prolastin for the first 10 weeks; the label also reports RAPID, a 2-year placebo-controlled trial of 180 adults, for safety
Trial record or paper		Blood levels, not lung outcomes: average lowest levels before the next dose were 17.7 micromolar on Zemaira and 19.1 on Prolastin, both above 11. The label reports RAPID only for safety and says controlled trials have not shown an effect on emphysema or flare-ups
alpha1-proteinase inhibitor (human)
Takeda (brand licensed from Kamada)
A 24-week trial of 50 adults randomly assigned to Glassia or Prolastin for the first 12 weeks, then all on Glassia
Trial record or paper		Blood levels, not lung outcomes: Glassia was non-inferior to Prolastin. Median lowest antigenic level before the next dose was 14.5 micromolar, but on the functional test 11 of 33 people (33%) averaged below 11. The label says controlled trials have not shown an effect on emphysema
Safety

Alpha-1 Antitrypsin Deficiency treatment side effects and warnings

None of these drugs carries a boxed warning. Each label's main precautions are listed. Side effect rates show how many people in each drug's trials reported each one, whether or not the drug caused it.

Alpha-1 Antitrypsin Deficiency treatments: most common side effects and key warnings from the FDA labels
DrugMost common side effectsKey warning
alpha1-proteinase inhibitor (human)
Grifols
diarrhea 6%, fatigue 6% and upper respiratory infection 16% in an earlier 38-person study of Prolastin-C powderNo boxed warning. Not for people with IgA deficiency who have antibodies against IgA, or anyone who has had anaphylaxis or another severe reaction to alpha1-proteinase inhibitor. Allergic reactions including anaphylaxis can occur. Made from human plasma, so it may carry a risk of passing on infectious agents such as viruses.
alpha1-proteinase inhibitor (human)
Takeda
headache, after 16% of infusions, muscle or joint discomfort, after 16% of infusions, bruising where the needle went in, after 8% of infusions, nausea, after 8% of infusions and runny nose, after 6% of infusionsNo boxed warning. Not for people with IgA deficiency who have antibodies against IgA. Allergic reactions including anaphylaxis can occur, so the label asks for continuous monitoring of vital signs during the infusion. Made from human plasma, so it may carry a risk of passing on infectious agents such as viruses.
alpha1-proteinase inhibitor (human)
CSL Behring
headache 20%, sinusitis 15%, upper respiratory infection 15%, bronchitis 8% and weakness 8%No boxed warning. Not for people with IgA deficiency who have antibodies against IgA, or anyone who has had anaphylaxis or a severe reaction to Zemaira or alpha1-proteinase inhibitor. Made from human plasma, so it may carry a risk of passing on infectious agents such as viruses. In RAPID, serious COPD flare-ups ran 0.15 a year on Zemaira against 0.12 on placebo, a difference that could be chance. In the open-label extension, people who stayed on Zemaira had 0.25 serious flare-ups a year, against 0.12 during RAPID itself.
alpha1-proteinase inhibitor (human)
Takeda (brand licensed from Kamada)
cough 9%, headache 9%, sinusitis 9%, upper respiratory infection 9% and chest discomfort, dizziness and raised liver enzymes, each 6%No boxed warning. Not for people with IgA deficiency who have antibodies against IgA, or anyone who has had anaphylaxis or a severe reaction to alpha1-proteinase inhibitor. Made from human plasma, so it may carry a risk of passing on infectious agents such as viruses. The serious reaction seen in its trials was a COPD flare-up.
Not yet approved

Alpha-1 antitrypsin deficiency treatments in clinical trials

Investigational drugs in Phase 1 to 3 trials shown separately because their results are not from an FDA label. Status as of the date in each row.

Alpha-1 Antitrypsin Deficiency drugs not FDA-approved
DrugStatusHow it works and is givenPivotal trialResult so farWhat is next
Takeda, co-developed with Arrowhead Pharmaceuticals
Phase 3as of October 23, 2026RNA interference that shuts down the liver's production of misfolded Z-AAT; aimed at AATD liver disease, not the lungsUnder-the-skin injection on day 1, at week 4, then every 12 weeksREDWOOD (NCT05677971), Phase 3, about 160 adults with liver scarring (METAVIR F2 to F4) against placebo; a second Phase 3 (NCT06165341) enrolls about 50 with early scarring (F1)Primary endpoint: Improvement of at least 1 stage of liver scarring on biopsy at week 106, in people starting at F2 or F3
ClinicalTrials.gov		No Phase 3 results yet. In the Phase 2 SEQUOIA trial of 40 adults, blood Z-AAT fell 61%, 83% and 94% at 25, 100 and 200 mg by week 16. Median liver Z-AAT fell 93%, against a 26% rise on placebo (Gastroenterology, 2024)ClinicalTrials.gov lists REDWOOD primary completion in January 2029
SEQUOIA Phase 2 results, Gastroenterology, October 2024
Phase 2as of October 23, 2026Lab-made AAT joined to an antibody fragment (Fc) so it lasts longer in the body; not made from donated plasmaInfusion into a vein every 3 or 4 weeksElevAATe (NCT05856331), Phase 2, 97 adults with emphysema randomly assigned 2:2:1 to efdoralprin alfa every 3 or 4 weeks or weekly plasma-derived AAT (Zemaira)Primary endpoint: Change in functional AAT lowest levels at steady state through week 32
ClinicalTrials.gov		Met its primary endpoint: functional AAT trough rose 24.1 micromolar with dosing every 3 weeks and 16.8 every 4 weeks, against 7.6 on weekly plasma-derived AAT (p<0.0001). Sanofi says levels stayed in the normal range on 100% of days with every-3-week dosing against 40.8% on weekly therapy, and no one stopped for a side effectSanofi says it is talking with regulators about next steps; no Phase 3 trial was registered on ClinicalTrials.gov as of October 23, 2026
Sanofi press release, May 18, 2026
Beam Therapeutics
Phase 2as of October 23, 2026One-time base edit, delivered to the liver in a lipid nanoparticle, that corrects the Z mutation so the liver makes normal AATOne-time infusion into a veinPhase 1/2 trial (NCT06389877): 38 people dosed by August 17, 2026, plus a pivotal group of about 50 at 60 mg that began dosing in July 2026Primary endpoint: Safety and total blood AAT (registry timeframe 3 years)
ClinicalTrials.gov		At 60 mg, average steady-state total AAT was 14.4 micromolar in the lung group (from 5.0) and 13.5 in the liver group (from 4.7). Corrected normal AAT made up 93% of the total and Z-AAT fell 84%. Mild to moderate infusion reactions occurred in 41% of patients (Beam)Beam plans to seek U.S. accelerated approval based on AAT blood markers over 12 months, with 60 mg as the selected dose
Beam Therapeutics press release, September 8, 2026
Mereo BioPharma; U.S. option licensed to Sentynl Therapeutics
Phase 2as of October 23, 2026A pill that blocks neutrophil elastase, the enzyme that damages lung tissue, instead of replacing AATPill by mouth twice a dayASTRAEUS (NCT03636347, 98 adults) and ATALANTa (NCT03679598, 63 adults), Phase 2, 12 weeks against placeboPrimary endpoint: Blood markers of elastase activity and lung tissue breakdown
ClinicalTrials.gov		Both doses suppressed blood elastase, but only 240 mg twice daily lowered the disease markers A-alpha-Val360 and desmosine. Headache was the most common side effect. These trials measured markers, not lung function (European Respiratory Journal, 2025)Mereo says a Phase 3 trial could start in early 2027 if Sentynl exercises its option
Mereo BioPharma and Sentynl press release, August 11, 2026
Cost

Help paying for alpha-1 antitrypsin deficiency treatment

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

Assistance finderEvery program and fund for Alpha-1 Antitrypsin Deficiency, filtered by your insuranceGrifolsProlastin-C Liquid patient support programTakedaAralast NP patient support programCSL BehringZemaira patient support programTakeda (brand licensed from Kamada)Glassia patient support program
Insurance said no? Your Insurer Denied a Rare Disease Drug and Fewer Than 1 in 100 People Appeal, So Here Is the Playbook · 14 min read
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Questions

Alpha-1 Antitrypsin Deficiency treatment questions people ask

Prolastin-C vs Zemaira vs Aralast NP vs Glassia: what is the difference?

They are the same protein, alpha1-proteinase inhibitor from donated human plasma, at the same dose of 60 mg/kg once a week, for the same adults with emphysema caused by severe AATD.

Form: Prolastin-C Liquid and Glassia are ready-to-use liquids. Aralast NP and Zemaira are powders mixed with sterile water and given within 3 hours.

Infusion time: About 15 minutes at the label rate for Prolastin-C Liquid, Zemaira and Glassia. Aralast NP's label gives a maximum rate that works out to about 15 minutes.

Home use: Glassia's label allows trained patients or caregivers to infuse at home. The other labels do not name a setting.

Trial results: In separate trials against Prolastin, the average lowest level before the next dose was 17.7 micromolar on Zemaira and 15.3 on the original Aralast, and the median was 14.5 on Glassia. The trials differed, so these numbers do not show that one brand works better.

More: augmentation therapy drug page

Source: Prolastin-C Liquid label, DailyMed, updated July 2022; Aralast NP label, DailyMed, updated November 2025; Zemaira label, DailyMed, updated September 2024; Glassia label, DailyMed, updated December 2025

Does alpha-1 augmentation therapy slow emphysema?

It has not been proven in the randomized trials the FDA labels describe. Zemaira's label says an effect on emphysema progression and flare-ups has not been demonstrated, and the other 3 labels say it has not been conclusively demonstrated.

What the label trials showed: Weekly infusions raised AAT in the blood above 11 micromolar and raised it in the fluid lining the lungs.

RAPID: In this 2-year trial of 180 adults, weekly Zemaira slowed the loss of lung density measured with the lungs full (p=0.03). The difference was not statistically significant on the combined measure (p=0.06) or at the end of a normal breath (p=0.18).

What is next: Grifols expects topline results by the end of 2026 from SPARTA, a 3-year placebo trial of Prolastin-C at 60 and 120 mg/kg in 345 adults.

More: augmentation therapy drug page

Source: Zemaira label, DailyMed, updated September 2024; RAPID trial, The Lancet, 2015; Grifols, August 10, 2026

Can people with IgA deficiency get alpha-1 augmentation therapy?

Not if they have antibodies against IgA. All 4 labels list this as a contraindication, because the products may contain trace amounts of IgA that can trigger a severe allergic reaction or anaphylaxis.

Other exclusions: Prolastin-C Liquid, Zemaira and Glassia also rule out anyone who has had anaphylaxis or another severe reaction to alpha1-proteinase inhibitor.

During infusions: The labels ask staff to watch vital signs, stop the infusion if allergy signs appear, and keep epinephrine on hand.

More: augmentation therapy drug page

Source: Prolastin-C Liquid label, DailyMed, updated July 2022; Aralast NP label, DailyMed, updated November 2025; Zemaira label, DailyMed, updated September 2024; Glassia label, DailyMed, updated December 2025

Can alpha-1 augmentation be given at home?

Glassia is the only one of the 4 whose label says the patient or a caregiver can give it after training, at home or another appropriate setting.

The other 3: The Prolastin-C Liquid, Aralast NP and Zemaira labels explain how to give the infusion but do not name a setting or mention self-infusion.

How long it takes: About 15 minutes for a 60 mg/kg dose at the label rate, plus time to set up.

Preparing for reactions: The Glassia label asks that people infusing outside a healthcare setting be trained to use epinephrine for severe allergic reactions and keep an infusion log.

More: augmentation therapy drug page

Source: Glassia label, DailyMed, updated December 2025; Prolastin-C Liquid label, DailyMed, updated July 2022; Aralast NP label, DailyMed, updated November 2025; Zemaira label, DailyMed, updated September 2024

What are the side effects of Prolastin-C, Aralast NP, Zemaira and Glassia?

The labels list mostly mild reactions from small trials that counted them in different ways, so the numbers do not rank the brands.

Prolastin-C Liquid: Diarrhea and fatigue, each in 6% of 32 people.

Aralast NP: Headache and muscle or joint discomfort, each after 16% of infusions in a 25-person trial.

Zemaira: Headache in 13 of 66 people (20%), and sinusitis and upper respiratory infection in 10 each (15%).

Glassia: Cough, headache, sinusitis and upper respiratory infection, each in 9% of 33 people.

Serious reactions: Allergic reactions, including anaphylaxis, can happen with all 4. Because they are made from human plasma, all 4 labels warn of a possible risk of passing on infectious agents such as viruses.

More: augmentation therapy drug page

Source: Prolastin-C Liquid label, DailyMed, updated July 2022; Aralast NP label, DailyMed, updated November 2025; Zemaira label, DailyMed, updated September 2024; Glassia label, DailyMed, updated December 2025

Is there a treatment for alpha-1 antitrypsin deficiency liver disease?

No drug is FDA-approved for AATD liver disease. The 4 augmentation products are approved only for adults with emphysema.

In trials: Fazirsiran, from Takeda and Arrowhead, is an injection every 12 weeks that cuts the liver's production of misfolded Z-AAT. In the Phase 2 SEQUOIA trial it lowered median liver Z-AAT by 93%. Its Phase 3 REDWOOD trial measures liver scarring on biopsy, with primary completion listed for January 2029.

Also being studied: The BEAM-302 gene editing trial includes a group of people with liver disease.

More: fazirsiran drug page and BEAM-302 drug page

Source: SEQUOIA trial, Gastroenterology, 2024; REDWOOD on ClinicalTrials.gov; Beam Therapeutics, September 8, 2026

What new alpha-1 antitrypsin deficiency treatments are coming?

No new AATD drug had been publicly reported as under FDA review as of October 23, 2026.

Closest to results: Grifols expects SPARTA results for Prolastin-C by the end of 2026, and is testing a weekly under-the-skin form, Alpha-1 15%, in the Phase 3 SWIFT-SC trial. Takeda's fazirsiran is in Phase 3 for liver disease.

Less frequent dosing: Sanofi's efdoralprin alfa, a lab-made AAT given every 3 or 4 weeks, beat weekly plasma-derived AAT on functional AAT levels in Phase 2. Sanofi says it is talking with regulators about next steps.

Gene and RNA editing: Beam Therapeutics began dosing a pivotal group for BEAM-302, a one-time infusion, in July 2026 and plans to seek accelerated approval based on blood AAT markers. Wave Life Sciences' WVE-006, an injection that edits RNA, is in a Phase 1b/2a trial.

A pill: Mereo BioPharma says a Phase 3 trial of alvelestat, which blocks the enzyme that damages lung tissue, could start in early 2027 if its partner Sentynl exercises its option.

More: efdoralprin alfa, BEAM-302, fazirsiran and alvelestat

Source: Grifols, August 10, 2026; Sanofi, May 18, 2026; Beam Therapeutics, September 8, 2026; Mereo BioPharma, August 11, 2026; WVE-006 trial on ClinicalTrials.gov

Go deeper

More on Alpha-1 Antitrypsin Deficiency at Trial Friend

Condition pageAlpha-1 Antitrypsin Deficiency: trials, approved drugs, medication conflict checker and communitiesTrials near meRecruiting Alpha-1 Antitrypsin Deficiency trials ranked by distance to youAnalysis, September 27, 2026Alpha-1 Antitrypsin Deficiency Treatment Has Meant a Weekly Infusion Since 1987, and a One-Time Gene Edit Is Now Testing That
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.

  1. Prolastin-C Liquid (alpha1-proteinase inhibitor (human)) prescribing information, Grifols, label dated Jul 2022. DailyMed. Pivotal trial: ClinicalTrials.gov
  2. Aralast NP (alpha1-proteinase inhibitor (human)) prescribing information, Takeda, label dated Nov 2025. DailyMed. Pivotal trial: ClinicalTrials.gov
  3. Zemaira (alpha1-proteinase inhibitor (human)) prescribing information, CSL Behring, label dated Sep 2024. DailyMed. Pivotal trial: ClinicalTrials.gov
  4. Glassia (alpha1-proteinase inhibitor (human)) prescribing information, Takeda (brand licensed from Kamada), label dated Dec 2025. DailyMed. Pivotal trial: ClinicalTrials.gov
  5. fazirsiran (TAK-999, formerly ARO-AAT), Takeda, co-developed with Arrowhead Pharmaceuticals: ClinicalTrials.gov record; SEQUOIA Phase 2 results, Gastroenterology, October 2024. Checked October 23, 2026.
  6. efdoralprin alfa (SAR447537, formerly INBRX-101), Sanofi: ClinicalTrials.gov record; Sanofi press release, May 18, 2026. Checked October 23, 2026.
  7. BEAM-302, Beam Therapeutics: ClinicalTrials.gov record; Beam Therapeutics press release, September 8, 2026. Checked October 23, 2026.
  8. alvelestat (MPH966), Mereo BioPharma; U.S. option licensed to Sentynl Therapeutics: ClinicalTrials.gov record; Mereo BioPharma and Sentynl press release, August 11, 2026. Checked October 23, 2026.

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.