Overview
Interleukin 7 has been used in trials studying the treatment of Metastatic Breast Cancer.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Lucinactant (Surfaxin): A Comprehensive Monograph on a Synthetic Surfactant's Clinical Promise and Commercial Trajectory
Executive Summary
Lucinactant, marketed under the brand name Surfaxin, represents a significant milestone in the pharmacological management of neonatal respiratory distress syndrome (RDS). As a first-in-class synthetic pulmonary surfactant, its composition is distinguished by the inclusion of sinapultide, a biomimetic peptide engineered to replicate the function of human surfactant protein-B (SP-B). This design was intended to confer the efficacy of protein-containing, animal-derived surfactants while retaining the safety and manufacturing advantages of a fully synthetic product. The clinical development program for lucinactant yielded robust evidence supporting its use for the prevention of RDS in high-risk premature infants. Pivotal clinical trials, notably the SELECT and STAR studies, demonstrated that lucinactant significantly reduced RDS-related mortality compared to both older synthetic and contemporary animal-derived surfactants and established non-inferiority to the market-leading poractant alfa.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/26 | Phase 1 | Recruiting | |||
2021/06/15 | Phase 2 | Terminated | Revimmune | ||
2020/05/29 | Phase 2 | Terminated | Revimmune | ||
2020/05/07 | Phase 2 | Terminated | Revimmune | ||
2019/11/07 | Phase 2 | Terminated | Revimmune | ||
2019/05/08 | Phase 1 | Completed | |||
2016/06/13 | Phase 2 | Terminated | University Hospital, Limoges | ||
2015/12/29 | Phase 2 | Completed | Revimmune | ||
2011/06/07 | Phase 2 | Completed | |||
2011/04/20 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.