NDAORALELIXIR
Approved
Dec 1960
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
HEXADROL (dexamethasone) by Aspen Surgical is clinical pharmacology naturally occurring glucocorticoids, (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. First approved in 1960.
Drug data last refreshed 16h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HEXADROL (dexamethasone) is a synthetic glucocorticoid that exerts potent anti-inflammatory and immunomodulatory effects across multiple organ systems. It works by modifying the body's immune response to diverse stimuli and causing profound metabolic effects. Unlike natural glucocorticoids, dexamethasone lacks significant sodium-retaining properties, making it suitable for long-term use in inflammatory and autoimmune conditions.
LOE Approaching
As a 1960 approval approaching loss of exclusivity with moderate competitive pressure (30/100), commercial teams are likely focused on cost containment and niche indication penetration rather than expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids, (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs, including dexamethasone, are primarily used for their potent…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of NXC-201 Compared With Daratumumab With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) in Newly Diagnosed Systemic AL Amyloidosis
Started Jan 2027
260 enrolled
Light Chain (AL) Amyloidosis
A Study of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Multiple Myeloma and Moderate Hepatic Impairment
Started Oct 2026
20 enrolled
Multiple Myeloma
A Study of LP-118 In Combination With Ponatinib, Dexamethasone And Blinatumomab For Adults With Newly-Diagnosed, BCR::ABL1-Positive Acute Lymphoblastic Leukemia (ALL)
Started Oct 2026
26 enrolled
Philadelphia Positive Acute Lymphoblastic Leukemia
HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
Started Oct 2026
42 enrolled
Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) RecurrentLymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory+2 more
Steroid Avoidance, Dexamethasone, and RAGE Inhibition for Perioperative Cerebral Edema Management in High-Grade Gliomas
Started Oct 2026
80 enrolled
High-grade Gliomas (HGG)
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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.