CLINOLIPID 20% (olive oil)
CLINOLIPID 20% is indicated for the treatment of Eczema.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2013-10-03
- Patent Cliff
- 2027
- Routes
- INTRAVENOUS
- Dosage Forms
- EMULSION
CLINOLIPID 20% Approval History
What CLINOLIPID 20% Treats
1 indicationsCLINOLIPID 20% is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Eczema
CLINOLIPID 20% Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to CLINOLIPID 20%
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04417595 INFANTS | 200609 R01HD098719 | Ph 2 | active not recruiting | Omega-3 Fatty Acids for Smoking Cessation in Pregnancy |
| NCT04555044 results posted | 6344-001A | Ph 4 | completed | Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A) |
| NCT02476994 results posted | 6344-001 | Ph 4 | terminated | Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion |
| NCT02009865 EVOLVEII results posted | D5880C00001 OM-EPA-011 | Ph 3 | completed | Epanova® for Lowering Very High Triglycerides II (EVOLVE II) |
| NCT03544411 | BeZaproject | Ph 1 | completed | Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Type 2 DM |
| NCT01850979 | 1307/09 | Ph 4 | completed | Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops |
| NCT01102257 DREAM results posted | 05-1099 1R34EY017626 | Ph 2, Ph 3 | completed | Dry Eye Assessment and Management: Feasibility 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.
CLINOLIPID 20% FDA Label Details
Indications & Usage
FDA Label (PDF)CLINOLIPID 20% is indicated for the treatment of Eczema.
CLINOLIPID 20% Patents & Exclusivity
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment