Last reviewed · How we verify
Prolastin-C
Prolastin-C is a purified human alpha-1 protease inhibitor (AAT) that replaces deficient or dysfunctional alpha-1 antitrypsin to protect lung tissue from enzymatic degradation.
Prolastin-C 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 | Prolastin-C |
|---|---|
| Also known as | AAT |
| Sponsor | Grifols Therapeutics LLC |
| Drug class | Alpha-1 protease inhibitor (augmentation therapy) |
| Target | Alpha-1 antitrypsin (AAT); serine protease inhibitor |
| Modality | Biologic |
| 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 destruction. Prolastin-C is an intravenous augmentation therapy derived from human plasma that restores 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 (fever, chills, malaise)
- Headache
- Dizziness
- Nausea
- Injection site reactions
Key clinical trials
- Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD) (PHASE3)
- Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency (PHASE3)
- A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin Deficiency (PHASE1, PHASE2)
- DREAM: Double Lung Transplant REgistry Aimed for Lung-limited Malignancies
- Measuring the Density of Iodine in Lipiodol Depositions: Detecting an Invisible Residual Tumor After Conventional Transarterial Chemoembolization for Hepatocellular Carcinoma (NA)
- Bronchiectasis Alpha-1 Augmentation Trial- Modulating Airway Neutrophil Function (PHASE4)
- Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis (PHASE1, PHASE2)
- Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE) (PHASE1, PHASE2)
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:
- Prolastin-C CI brief — competitive landscape report
- Prolastin-C updates RSS · CI watch RSS
- Grifols Therapeutics LLC portfolio CI