CELESTONE
LOE ApproachingNDAORALSYRUP
Approved
Apr 1964
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
CELESTONE by Merck & Co. is clinical pharmacology glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Approved for dermatomyositis, polymyositis, systemic lupus erythematosus. First approved in 1964.
Drug data last refreshed 3h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CELESTONE (betamethasone) is a synthetic glucocorticoid oral syrup approved in 1964 for treatment of systemic inflammatory and autoimmune conditions. It treats dermatomyositis, polymyositis, and systemic lupus erythematosus by suppressing immune response and reducing inflammation through enhanced anti-inflammatory action via a 16β-methyl group modification. The drug is readily absorbed from the gastrointestinal tract and provides sustained anti-inflammatory effects with reduced mineralocorticoid activity compared to natural glucocorticoids.
LOE Approaching
This legacy product faces LOE pressures with minimal modern support; brand teams managing CELESTONE likely operate in maintenance mode with flat or declining headcount.
Mechanism of Action
CLINICAL PHARMACOLOGY Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement…
Indications (3)
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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.