Poractant alfa
As of the edition of 20 October 2026, Poractant alfa is a drug: marketed, first approved in 1992 (FR); US protection ended in 2011.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2000
- Kind
- Unknown
- Brand name
- Curosurf
- First approved
- 6 August 1992 (FR)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Chiesi Farmaceutici; 3 holders in all
- Registered trials
- 14, 3 stopped early
- Disease areas
- Lungs and airways; Inherited and neonatal; Pregnancy and women's health; Urinary and reproductive; Heart and blood vessels; Infections
US protection
US protection ended in 2011.
US protection ended in 2011, 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 Chiesi. 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 product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 0 |
| Phase 1 | 1 | 0 | 0 | 1 |
| Phase 2 | 3 | 0 | 0 | 1 |
| Phase 3 | 1 | 0 | 0 | 0 |
| Phase 4 | 6 | 2 | 2 | 1 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Cornerstone Pharmaceuticals | Earlier holder | 1999 to now |
| Chiesi Farmaceutici | Applicant and Lead sponsor of trials | 2000 to now |
| Chiesi | Acquired holder | 2014 to now |