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Aralast NP
Aralast NP is a purified human alpha-1 protease inhibitor (AAT) that replaces deficient or dysfunctional alpha-1 antitrypsin to protect lung tissue from enzymatic degradation.
Aralast NP is a purified human alpha-1 protease inhibitor (AAT) that replaces deficient or dysfunctional alpha-1 antitrypsin to protect lung tissue from enzymatic degradation. Used for Alpha-1 antitrypsin deficiency with emphysema or chronic obstructive pulmonary disease (COPD).
At a glance
| Generic name | Aralast NP |
|---|---|
| Also known as | Alpha 1-Proteinase Inhibitor Human, Alpha,-antitrypsin, AAT, Alpha1-PI, TAK-883 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Drug class | Protease inhibitor (augmentation therapy) |
| Target | Alpha-1 protease inhibitor (AAT); neutrophil elastase inhibition |
| Modality | Small molecule |
| Therapeutic area | Pulmonology / Respiratory |
| Phase | FDA-approved |
Mechanism of action
Alpha-1 antitrypsin (AAT) is a serine protease inhibitor that protects lung tissue from neutrophil elastase and other proteases released during inflammation. In alpha-1 antitrypsin deficiency, insufficient AAT levels allow unopposed protease activity, leading to progressive lung damage. Aralast NP is an intravenous augmentation therapy that restores circulating AAT levels to therapeutic thresholds, thereby slowing the decline in lung function and reducing emphysema progression.
Approved indications
- Alpha-1 antitrypsin deficiency with emphysema or chronic obstructive pulmonary disease (COPD)
Common side effects
- Infusion-related reactions
- Headache
- Dizziness
- Fatigue
Key clinical trials
- Anti-inflammatory Therapy to Improve Outcomes After TPIAT (PHASE4)
- A Study of RYMPHYSIA for Alpha1-Proteinase Inhibitor (A1PI) Therapy in Adults With A1PI Deficiency and Chronic Obstructive Pulmonary Disease (COPD)-Emphysema (PHASE4)
- Aralast NP in Islet Transplant (PHASE1, PHASE2)
- Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency (PHASE3)
- Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 - Proteinase Inhibitor) (PHASE4)
- Aralast NP With Antiviral Treatment and Standard of Care Versus Antiviral Treatment With Standard of Care in Hospitalized Patients With Pneumonia and COVID-19 Infection (PHASE3)
- ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study (PHASE4)
- Pilot Study of alpha1-antitrypsin to Treat Neuromyelitis Optica Relapses (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Aralast NP CI brief — competitive landscape report
- Aralast NP updates RSS · CI watch RSS
- National Institute of Allergy and Infectious Diseases (NIAID) portfolio CI