TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ELCYS

CYSTEINE HYDROCHLORIDE
Gastroenterology Approved 2019-04-16
1
Indication
--
Phase 3 Trials
1
Priority Reviews
6
Years on Market

Details

Status
Prescription
First Approved
2019-04-16
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: CYSTEINE HYDROCHLORIDE

ELCYS Approval History

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What ELCYS Treats

1 indications

ELCYS is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Liver Disease
Source: FDA Label

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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

Pro

Indications & Usage

FDA Label (PDF)

ELCYS ® is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN. It can also be added to amino acid solutions to provide a more complete profile of amino acids for protein synthesis. ELCYS ® is a sulfur-containing amino acid indicated to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with ...

ELCYS Patents & Exclusivity

Latest Patent: Jan 2039

Patents (32 active)

US11510942 Expires Jan 15, 2039
US11969439 Expires Jan 15, 2039
US10478453 Expires Jan 15, 2039
US10583155 Expires Jan 15, 2039
US10653719 Expires Jan 15, 2039
US10918662 Expires Jan 15, 2039
US10905713 Expires Jan 15, 2039
US10905714 Expires Jan 15, 2039
US11684636 Expires Jan 15, 2039
US10933089 Expires Jan 15, 2039
+ 22 more patents
Source: FDA Orange Book

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.