lucinactant
Trade name: surfaxin
Approved
Mar 6, 2012
Lucinactant is a liquid medication used to treat infant respiratory distress syndrome. It is a pulmonary surfactant for infants who lack enough natural surfactant in their lungs. Whereas earlier medicines of the class, such as beractant, calfactant (Infasurf), and poractant (Curosurf), are derived from animals, lucinactant is synthetic. It was approved for use in the United States by the U.S. Food and Drug Administration (FDA) on March 6, 2012. — Wikipedia
Clinical trial activity
4 trials · 5 clinical orgs · 1 marketing orgs
Earliest trial started Feb 1, 2014 (NCT02074059)
Timeline
2010s
- Mar 6, 2012
Windtree Therapeutics — Earliest FDA Approval
- Mar 6, 2012
Windtree Therapeutics — NDA Secondary Org
- Mar 6, 2012
Windtree Therapeutics — NDA Organization
- Jan 1, 2014
Windtree Therapeutics — Earliest Phase 2 Sponsor(trial)
2020s
- Jan 1, 2020
Windtree Therapeutics — Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Mechanism of action
SFTPD agonist
Approval history
- approvedFast trackMar 6, 2012
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Discontinued
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaLucinactant ↗
- ChEMBLCHEMBL1963685 ↗
Also known as
- aerosurf
- ati 02
- ati-02
- kl-surfactant
- lucinactant
- lucinactant
- lucinactant
- lucinactant
- lucinactant
- lucinactant
- lucinactant
- lucinactant
- lucinactant
- lucinactant
- surfaxin
- surfaxin
- surfaxin
- surfaxino
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04389671 | Phase 1/Phase 2 (Phase 2) | Jun 1, 2020 | Duke University, Harvard University, Windtree Therapeutics |
| NCT04264156 | Phase 2 | Mar 1, 2020 | Windtree Therapeutics |
| NCT03585296 | Phase 2 | Jul 10, 2018 | Aclaris Therapeutics, Inc. |
| NCT02074059 | Phase 2 | Feb 1, 2014 | National Heart, Lung, and Blood Institute (NHLBI), Windtree Therapeutics |
Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Windtree Therapeutics | For profit | 3 | 3 | 1 | 2014 |
| Aclaris Therapeutics, Inc. | For profit | 1 | 1 | 1 | 2018 |
| Duke University | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Harvard University | Academic/Hospital | 1 | 0 | 1 | 2020 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 1 | 0 | 1 | 2014 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Windtree Therapeutics | For profit | NDA2 | Mar 6, 2012 |
| Windtree Therapeutics | For profit | NDA | Mar 6, 2012 |