Overview
Human alpha-1 proteinase inhibitor or alpha-1-antitrypsin, prepared from human plasma via Cohn alcohol fractionation followed by PEG and zinc chloride fractionation.
Indication
For chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor (A1-PI) deficiency and clinical evidence of emphysema.
Associated Conditions
- Emphysema
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/15 | Phase 2 | Recruiting | Medizinische Universitaet Innsbruck | ||
2024/04/24 | Phase 2 | Recruiting | |||
2020/12/19 | Phase 3 | Withdrawn | |||
2019/12/18 | Phase 3 | Recruiting | |||
2018/03/08 | Phase 2 | Completed | John Levine | ||
2017/12/28 | Phase 2 | Withdrawn | |||
2017/06/01 | N/A | NO_LONGER_AVAILABLE | Impatients N.V. trading as myTomorrows | ||
2016/10/27 | Phase 1 | Completed | |||
2016/03/21 | Phase 4 | Completed | |||
2015/11/25 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CSL US ZEMAIRA human alpha1-proteinase inhibitor 1000 mg powder for injection vial with diluent vial | 356861 | Medicine | A | 3/16/2021 | |
| PROLASTIN C LIQUID alpha-1-proteinase inhibitor (human) 4000 mg solution for injection for intravenous infusion vial | 371339 | Medicine | A | 5/27/2022 | |
| PROLASTIN C LIQUID alpha-1-proteinase inhibitor (human) 1000 mg solution for injection for intravenous infusion vial | 305253 | Medicine | A | 7/1/2019 | |
| ZEMAIRA human alpha1-proteinase inhibitor 5 g powder for injection vial with diluent vial | 315073 | Medicine | A | 5/14/2020 | |
| ZEMAIRA human alpha1-proteinase inhibitor 1000 mg powder for injection vial with diluent vial | 273182 | Medicine | A | 2/13/2017 | |
| ZEMAIRA human alpha1-proteinase inhibitor 4 g powder for injection vial with diluent vial | 315059 | Medicine | A | 5/14/2020 | |
| PROLASTIN C LIQUID alpha-1-proteinase inhibitor (human) 500 mg solution for injection for intravenous infusion vial | 371334 | Medicine | A | 5/27/2022 |
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