ELCYS (cysteine hydrochloride)
ELCYS is a sulfur-containing amino acid used as an additive to nutritional solutions for patients receiving total parenteral nutrition. It helps newborn infants and individuals with severe liver disease meet their specific nutritional requirements, especially when impaired enzymatic processes prevent them from producing enough cysteine naturally. Adding this drug to amino acid mixtures provides a more complete profile of nutrients necessary for protein synthesis.
How ELCYS Works
This medication works by providing cysteine directly to the systemic circulation for patients who cannot synthesize enough of it naturally due to low cystathionase activity. As a precursor substrate, the cysteine provided helps the body produce glutathione and taurine while supporting the trans-sulfuration pathway.
Details
- Status
- Prescription
- First Approved
- 2019-04-16
- Patent Cliff
- 2039
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
ELCYS Approval History
What ELCYS Treats
1 indicationsELCYS is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Liver Disease
ELCYS 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.
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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.
ELCYS FDA Label Details
Indications & Usage
FDA Label (PDF)ELCYS is indicated for the treatment of Liver Disease.
ELCYS Patents & Exclusivity
Patents (16 active)
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 32 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.