ACTHAR
LOE ApproachingNDAINJECTIONINJECTABLEPriority Review
Approved
Jul 1950
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
5/8 — Partial
Priority Review
ACTHAR by Sanofi is unknown. Approved for exacerbations of multiple sclerosis in adults, acute exacerbations of multiple sclerosis in adults. First approved in 1950.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACTHAR is a repository corticotropin (ACTH) injection approved in 1950 for acute exacerbations of multiple sclerosis in adults. It stimulates the adrenal cortex to secrete cortisol and other corticosteroids, with additional binding to melanocortin receptors. The exact mechanism of therapeutic benefit in MS remains incompletely understood but appears mediated through cyclic AMP signaling.
$378MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Medicare spending ($378M in 2023); expect team consolidation and focus shift to generics defense or niche positioning.
Mechanism of Action
unknown. Acthar Gel and endogenous ACTH stimulate the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances. Prolonged administration of large doses of Acthar Gel induces hyperplasia and hypertrophy of the adrenal cortex and continuous high…
Indications (2)
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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.