NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Apr 2019
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
Priority Review
ELCYS (cysteine hydrochloride) by Baxter is enzyme, cystathionase, via the trans-sulfuration pathway, and serves as a precursor substrate for both glutathione and taurine. First approved in 2019.
Drug data last refreshed 9h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELCYS (cysteine hydrochloride) is an intravenous amino acid supplement for parenteral nutrition (PN) that restores systemic cysteine in patients with insufficient cystathionase activity. It acts as a substrate precursor for glutathione and taurine synthesis via the trans-sulfuration pathway. The drug addresses a critical metabolic gap in patients unable to synthesize adequate cysteine endogenously.
Peak12.6 years to LOE
Peak-stage orphan/specialty product with zero direct competitors and long patent protection suggests stable, specialized team focused on hospital/PN channel management rather than mass-market scaling.
Mechanism of Action
enzyme, cystathionase, via the trans-sulfuration pathway, and serves as a precursor substrate for both glutathione and taurine. ELCYS provides cysteine to the systemic circulation of patients who require PN and cannot synthesize adequate quantities of cysteine due to insufficient or deficient…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on ELCYS offers stability in a niche, uncontested market with long patent protection, but limited growth ceiling and zero linked job openings suggest a small, specialized team. This role suits professionals focused on deep clinical knowledge and relationship-based selling in hospital/nutrition support channels rather than high-growth, high-volume commercial dynamics.
Hospital Account Manager
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.