Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Lucinactant for Inhalation, Sinapultide (KL4) Surfactant, SURFAXIN®, Surfactant
Lucinactant · 3 trials · 4 indications
Change from baseline in OI. OI is an index value, calculated as (Mean Airway Pressure \[Paw\]) x (Fraction of Inspired Oxygen \[FiO2\]) x (100) / (Partial Pressure of Oxygen \[PaO2\]) measured using mean and standard deviation. It is a calculation that measures the fraction of inspired oxygen and its usage within the body, and a lower value is better. Values can range from 0 to 1000; values under 25 are correspond with a good outcome.
Pre-specified adverse events that occured during treatment administration; does not include nCPAP alone
Oxygen saturation as determined by pulse oximetry
Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.
| Arm | Type | Description |
|---|---|---|
| Lyophilized Lucinactant | EXPERIMENTAL | Lyophilized Lucinactant reconstituted with sterile water for injection |
| Aerosolized lucinactant (25 mg/kg) | EXPERIMENTAL | 25 mg total phospholipids (TPL)/kg: Lucinactant for inhalation with nCPAP |
| Aerosolized lucinactant (50 mg/kg) | EXPERIMENTAL | 50 mg TPL/kg: Lucinactant for inhalation with nCPAP |
| Aerosolized lucinactant (75 mg/kg) | EXPERIMENTAL | 75 mg TPL/kg: Lucinactant for inhalation with nCPAP |
| Aerosolized lucinactant (100 mg/kg) | EXPERIMENTAL | 100 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met. |
| Aerosolized lucinactant (150 mg/kg) | EXPERIMENTAL | 150 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met. |
| nCPAP alone | ACTIVE_COMPARATOR | nCPAP therapy alone |
| Lucinactant | EXPERIMENTAL | SURFAXIN® (lucinactant) for intratracheal instillation |
| Sham Air | SHAM_COMPARATOR | Sham air (placebo) instillation |
| Name | Type | Description |
|---|---|---|
| Lucinactant | DRUG | Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered |
| Lucinactant for Inhalation | DRUG | Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) |
| nCPAP alone | DEVICE | nCPAP therapy |
| Sham Comparator | OTHER | Slow intra-tracheal instillation |
Inclusion Criteria: * Signed and dated informed consent form (ICF) by the subject or legally authorized representative; * Age 18-75 (inclusive); * Assay positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus, preferably by polymerase chain reaction (PCR); * Endotracheal int...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
Lucinactant is an investigational drug being studied for respiratory conditions including acute hypoxemic respiratory failure, respiratory distress syndrome, and COVID-19-related lung injury. It has been tested in adults, children, and premature neonates. It is not yet approved for any indication and remains in clinical development.
Lucinactant is being developed by Windtree Therapeutics, Inc., which trades on the Nasdaq under the ticker WINT. The company has sponsored Phase 2 clinical trials of the drug in respiratory distress syndrome, acute hypoxemic respiratory failure, and COVID-19.
Lucinactant is in Phase 2 clinical development. All three of its completed trials were Phase 2 studies, and no Phase 3 trials have been registered. It is an investigational product and has not received FDA approval for any indication.
Lucinactant has been evaluated in three completed Phase 2 trials: NCT04389671 in adults with COVID-19 and acute lung injury or ARDS, NCT02074059 in premature neonates with respiratory distress syndrome, and NCT00578734 in children up to two years old with acute hypoxemic respiratory failure.
Yes, Lucinactant for Inhalation is an alternative name for Lucinactant. Both refer to the same investigational drug developed by Windtree Therapeutics. The inhaled formulation has been studied in clinical trials for respiratory conditions such as respiratory distress syndrome and acute hypoxemic respiratory failure.