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 19h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HEXADROL (dexamethasone) is a synthetic glucocorticoid oral elixir approved in 1960 that exerts potent anti-inflammatory effects across multiple organ systems. It works by modifying immune responses and metabolic processes while lacking the salt-retaining properties of hydrocortisone, making it suitable for long-term glucocorticoid replacement and anti-inflammatory therapy.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%); commercial team likely focused on cost management and generic transition planning rather than growth initiatives.
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
Linvoseltamab Versus Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-Vcd) in Adult Participants With Newly Diagnosed Systemic Light Chain Amyloidosis
Started Dec 2026
382 enrolled
Newly Diagnosed AmyloidosisAmyloidosis Stage I-IIIA
A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Started Dec 2026
1,000 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 Dec 2026
26 enrolled
Philadelphia Positive Acute Lymphoblastic Leukemia
Study to Evaluate Change in Disease Activity and Adverse Events of Subcutaneous Etentamig Compared With Daratumumab Plus Cyclophosphamide Plus Bortezomib Plus Dexamethasone (Dara-CyBorD) in Adults With Amyloid Light Chain (AL) Amyloidosis
Started Nov 2026
370 enrolled
Amyloid Light Chain (AL) Amyloidosis
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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.