NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Apr 2019
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
Priority Review
ELCYS (cysteine hydrochloride) by Baxter International 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 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELCYS (cysteine hydrochloride) is an intravenous amino acid supplement approved in 2019 for parenteral nutrition (PN) patients who cannot synthesize adequate cysteine due to cystathionase deficiency. It works by providing exogenous cysteine to systemic circulation, serving as a precursor for glutathione and taurine synthesis via the trans-sulfuration pathway. This is a specialized metabolic support therapy for critically ill and nutritionally dependent populations.
Peak12.3 years to LOE
Product is at peak commercial maturity with 5 years post-launch performance; team size likely stable with focus on market penetration in specialized PN settings.
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 career stability in a specialized, non-commoditized market niche with minimal competitive pressure and strong patent protection through 2039. This product suits professionals seeking depth in hospital/critical care channels and rare metabolic disease rather than high-volume commercial growth.
Brand Manager
Worked on ELCYS at Baxter International? Share your interview experience or compensation data (+7 days Pro)
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.