Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AEROSURF
Lucinactant delivered via investigational delivery device · 1 trial · 1 indication
Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure
| Arm | Type | Description |
|---|---|---|
| Aerosolized lucinactant (low dose) | EXPERIMENTAL | Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met. |
| Aerosolized lucinactant (high dose) | EXPERIMENTAL | Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met. |
| nasal CPAP | ACTIVE_COMPARATOR | nCPAP alone |
| Name | Type | Description |
|---|---|---|
| Lucinactant delivered via investigational delivery device | DRUG | Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product) |
| nCPAP | DRUG | Nasal CPAP |
Inclusion Criteria: 1. Signed informed consent form (ICF) from legally authorized representative 2. 26 0/7 to 32 6/7 completed weeks gestation PMA 3. Successful implementation of non-invasive support or ventilation within 90 minutes after birth 4. Spontaneous breathing 5. Chest radiograph consisten...
Top 2 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Akebia Therapeutics, Inc. | AKBA | 1 | PHASE2 | Vadadustat |
| Rigel Pharmaceuticals, Inc. | RIGL | 1 | PHASE2 | Fostamatinib |
Lucinactant is being developed for the treatment of respiratory distress syndrome in premature neonates. It is delivered via an investigational delivery device. Windtree Therapeutics is studying it in infants born between 26 and 32 weeks gestational age, a population at risk for respiratory distress syndrome because of immature lung function.
Windtree Therapeutics, Inc. is developing lucinactant delivered via an investigational delivery device. The company trades under the ticker WINT. Windtree is the sponsor of the clinical program evaluating this drug and delivery approach in premature neonates with respiratory distress syndrome.
Lucinactant delivered via an investigational delivery device is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The Phase 2 program studied the drug in premature neonates, and the completed trial enrolled 221 participants across multiple countries.
The Phase 2 trial NCT02636868 evaluated the safety and efficacy of lucinactant for inhalation in premature neonates 26 to 32 weeks gestational age. The trial was completed, enrolled 221 participants, and was randomized, double blind, and active controlled. It ran in the United States, Canada, Chile, Colombia, Hungary, Ireland, the Netherlands, and Poland.
The Phase 2 trial NCT02636868 was a randomized, double blind, active controlled study of lucinactant for inhalation in premature neonates 26 to 32 weeks gestational age. It enrolled 221 participants and has been completed. Participants were enrolled across sites in eight countries, including the United States, Canada, and several European and South American nations.
Lucinactant for inhalation was studied in premature neonates born between 26 and 32 weeks gestational age who were at risk for respiratory distress syndrome. The Phase 2 trial NCT02636868 enrolled 221 infants of all sexes, with a minimum age of 26 weeks. The study did not enroll healthy volunteers.