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Lucinactant for

Phase 2

Respiratory Distress Syndrome | Small molecule | Other |Windtree Therapeutics, Inc.|Last Updated: Apr 21, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Lucinactant for · 1 trial · 1 indication

Phase 2 1
NCT02074059Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature NeonatesRespiratory Distress Syndrome
COMPLETED80 Analytics
PHASE2COMPLETED
Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
Respiratory Distress SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Peri-Dosing Events
Within 48 Hours after Initiation of Study Treatment

Pre-specified adverse events that occured during treatment administration; does not include nCPAP alone

All Cause Mortality
Within 36 Weeks PMA
Oxygen Saturation Levels
Within 3 Hours of Randomization

Oxygen saturation as determined by pulse oximetry

Serum Electrolytes
24 Hours Post Randomization

Secondary Endpoints

PCO2
Within 3 Hours of Randomization
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Aerosolized lucinactant (25 mg/kg)EXPERIMENTAL25 mg total phospholipids (TPL)/kg: Lucinactant for inhalation with nCPAP
Aerosolized lucinactant (50 mg/kg)EXPERIMENTAL50 mg TPL/kg: Lucinactant for inhalation with nCPAP
Aerosolized lucinactant (75 mg/kg)EXPERIMENTAL75 mg TPL/kg: Lucinactant for inhalation with nCPAP
Aerosolized lucinactant (100 mg/kg)EXPERIMENTAL100 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met.
Aerosolized lucinactant (150 mg/kg)EXPERIMENTAL150 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met.
nCPAP aloneACTIVE_COMPARATORnCPAP therapy alone

Interventions

NameTypeDescription
Lucinactant for InhalationDRUGLucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
nCPAP aloneDEVICEnCPAP therapy
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Eligibility Criteria

Age Range29 Weeks to 34 Weeks
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Informed consent from a legally authorized representative * Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA) * Successful implementation of controlled nCPAP within 90 minutes after birth * Spontaneous breathing * Chest radiograph consistent w...

Countries:United States
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Competitive Landscape -Acute Respiratory Distress Syndrome 15 trials (matched to "Respiratory Distress Syndrome")

Frequently asked questions about Lucinactant for

What is Lucinactant used for?

Lucinactant is an investigational drug being studied for Acute Hypoxemic Respiratory Failure, Respiratory Distress Syndrome, and COVID-19. It is developed by Windtree Therapeutics, Inc. (ticker: WINT). Lucinactant is currently in Phase 2 clinical development and is not yet approved by the FDA.

What does Lucinactant target?

Lucinactant is a small molecule being developed by Windtree Therapeutics, Inc. (ticker: WINT). It is being studied for conditions such as Acute Hypoxemic Respiratory Failure, Respiratory Distress Syndrome, and COVID-19. Lucinactant is currently in Phase 2 clinical trials.

Who makes Lucinactant?

Lucinactant is being developed by Windtree Therapeutics, Inc., a biopharmaceutical company traded under the ticker WINT. The drug is currently in Phase 2 clinical development for Acute Hypoxemic Respiratory Failure, Respiratory Distress Syndrome, and COVID-19.

What phase is Lucinactant in?

Lucinactant is in Phase 2 clinical development. It is being studied for Acute Hypoxemic Respiratory Failure, Respiratory Distress Syndrome, and COVID-19. Lucinactant is an investigational drug and has not been approved by the FDA. Windtree Therapeutics, Inc. (ticker: WINT) is the developer.

What clinical trials is Lucinactant in?

Lucinactant has completed three Phase 2 trials: NCT00578734 for Acute Hypoxemic Respiratory Failure in children, NCT02074059 for Respiratory Distress Syndrome in premature neonates, and NCT04389671 for COVID-19 and Acute Lung Injury/ARDS in adults. These trials were conducted by Windtree Therapeutics, Inc. (ticker: WINT).

Is Lucinactant the same as any other drug?

Lucinactant is also known by the brand name Surfaxin. It is being developed by Windtree Therapeutics, Inc. (ticker: WINT) for Acute Hypoxemic Respiratory Failure, Respiratory Distress Syndrome, and COVID-19. Lucinactant is currently in Phase 2 clinical trials.