IBUPROFEN LYSINE · XGEN PHARMS
Ibuprofen Lysine is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g who are 32 weeks gestational age or less. It is intended for use when usual medical management (e.g., fluid restriction, diuretics, and respiratory support) has proven ineffective. Because long-term consequences beyond 8 weeks post-treatment have not been evaluated, treatment should be reserved for infants with clear evidence of a clinically significant PDA.
How IBUPROFEN LYSINE Works
The specific mechanism by which ibuprofen induces closure of a patent ductus arteriosus (PDA) in neonates is not fully known. In adults, ibuprofen is an inhibitor of prostaglandin synthesis. This inhibition of prostaglandins is the mechanism generally associated with the drug’s therapeutic effect in closing the ductus.
Details
- Status
- Prescription
- First Approved
- 2006-04-13
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
IBUPROFEN LYSINE Approval History
What IBUPROFEN LYSINE Treats
1 indicationsIBUPROFEN LYSINE is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Patent Ductus Arteriosus
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03497715 | NL1401 | Ph 1 | terminated | Gamma Scintigraphy Study to Investigate Tablet Disintegration in Healthy Volunteers. |
| NCT02974361 | OAT-01 | Ph 1 | completed | Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen |
| NCT02452450 | NL1307 | Ph 1 | completed | Ibuprofen and Paracetamol Pharmacokinetic Study |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IBUPROFEN LYSINE FDA Label Details
Indications & Usage
FDA Label (PDF)Ibuprofen Lysine Injection is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA. Ibuprofen Lysine Injectio...
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Full clinical data, patents, trials, and competitive landscape for ibuprofen lysine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.