NDAORALFOR SOLUTION
Approved
Dec 2017
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Data completeness
3/8 — Basic
MACRILEN (macimorelin acetate) by Azenta Life Sciences is growth hormone secretagogue receptor agonists [moa]. First approved in 2017.
Drug data last refreshed 15h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MACRILEN (macimorelin acetate) is an oral growth hormone secretagogue receptor agonist approved in 2017 for diagnostic use in assessing growth hormone deficiency. It stimulates endogenous GH secretion by activating GHS-R1a receptors, enabling clinicians to distinguish true GH deficiency from other causes of growth disorders. The product represents a non-invasive alternative to traditional stimulation testing.
LOE Approaching1.7 years to LOE
With LOE approaching in ~1.7 years and minimal linked job activity, the brand team is likely lean and focused on maximizing remaining exclusivity before generic entry.
Mechanism of Action
Growth Hormone Secretagogue Receptor Agonists
Pharmacologic Class:
Growth Hormone Secretagogue Receptor Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
Patent cliff in ~2 years — expect lifecycle management and generic defense hiring
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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.