ELESTAT
LOE ApproachingNDAOPHTHALMICSOLUTION/DROPS
Approved
Oct 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
2/8 — Basic
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELESTAT is an ophthalmic solution approved in 2003 for eye allergies, delivered as topical drops. The drug is a small-molecule mast cell stabilizer used to prevent allergic conjunctivitis symptoms. It represents a mature, established class in the ophthalmology market.
LOE Approaching
Product is nearing loss of exclusivity with moderate competitive pressure; expect declining team headcount and shift from growth-focused to maintenance-oriented roles.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS
Started Apr 2024
300 enrolled
Acute Respiratory Distress Syndrome
COVID-19 Study of Safety and Tolerability of Alvelestat
Started Jan 2021
15 enrolled
Covid19
Alvelestat (MPH966) for the Treatment of ALpha-1 ANTitrypsin Deficiency
Started Apr 2019
63 enrolled
Alpha-1 Antitrypsin Deficiency (AATD)Pi*ZZ, Pi*SZ, Pi*Null, Another Rare Phenotype/Genotype Known to be Associated With Either Low or Functionally Impaired AAT Including F or I MutationsEmphysema or COPD
A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.
Started Oct 2018
99 enrolled
Alpha 1-Antitrypsin DeficiencyEmphysemaCOPD
Safety and Efficacy of Relestat Ophthalmic Solution 0.05% for Allergic Conjunctivitis in Korea
Started Jan 2009
847 enrolled
Conjunctivitis, Allergic
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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.