.alpha.1-proteinase inhibitor human
As of the edition of 20 October 2026, .alpha.1-proteinase inhibitor human is a protein: marketed, first approved in 1987 (US); acts on ELANE; US protection ended in 1999.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Protein
- Brand name
- prolastin
- First approved
- 2 December 1987 (US)
- Approvals on record
- 18 in 3 regions
- Holder of the most recent approval
- Takeda; 4 holders in all
- Registered trials
- 52, 12 stopped early
- Disease areas
- Lungs and airways; Digestive system; Inherited and neonatal; Immune system; Hormones; Nutrition and metabolism
US protection
US protection ended in 1999.
US protection ended in 1999, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Grifols Therapeutics. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of .alpha.1-proteinase inhibitor human.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ELANE | Neutrophil elastase | P08246 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 0 |
| Phase 1 | 3 | 1 | 0 | 2 |
| Phase 2 | 25 | 19 | 2 | 3 |
| Phase 3 | 14 | 7 | 2 | 5 |
| Phase 4 | 8 | 5 | 1 | 2 |
| All trials | 52 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Grifols Therapeutics | Applicant and Lead sponsor of trials | 1996 to now |
| CSL Behring | Applicant and Lead sponsor of trials | 2006 to now |
| Takeda | Later holder and Lead sponsor of trials | 2006 to now |