Macimorelin acetate

(Macrilen®)

Macimorelin acetate

Drug updated on 5/17/2024

Dosage FormSuspension (oral: 60 mg)
Drug ClassGrowth hormone secretagogue receptor agonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the diagnosis of adult growth hormone deficiency.

Summary
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  • Macimorelin acetate (Macrilen) is indicated for the diagnosis of adult growth hormone deficiency. It has been evaluated in a study involving subjects with varying likelihoods of this condition, including high, intermediate, and low probability groups as well as healthy controls.
  • A randomized controlled trial was reviewed, providing comprehensive information on the effectiveness and safety of macimorelin acetate compared to insulin tolerance tests.
  • The study showed that 99% of Macrilen tests were evaluable after the first test compared to 82% for insulin tolerance tests. This suggests that Macrilen may provide more consistently interpretable results than its comparator.
  • In terms of diagnostic accuracy using different growth hormone cut-off levels, Macrilen demonstrated strong performance metrics such as negative agreement at 94%, positive agreement at 82%, sensitivity at 92%, and specificity at 96%. These figures indicate an excellent balance between sensitivity and specificity when diagnosing adult growth hormone deficiency.
  • No serious adverse events were reported with the use of macimorelin acetate during the trial. Furthermore, unlike insulin tolerance testing, which can cause severe hypoglycemia among other issues, no such problems are associated with Macrilen, making it a potentially safer alternative for individuals undergoing diagnostic procedures.
  • Compared to the Insulin Tolerance Test (ITT), macimorelin offers a simpler diagnostic approach through oral administration while maintaining comparable accuracy rates when appropriate growth hormone cut-off levels are employed. This makes it not only easier but also less risky than ITT, thus presenting itself as an effective tool in diverse populations suspected of having Adult Growth Hormone Deficiency (AGHD).

Product Monograph / Prescribing Information

Document TitleYearSource
Macrilen (macimorelin acetate) Prescribing Information.2021Novo Nordisk Inc., Plainsboro, NJ

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Macimorelin as a diagnostic test for adult GH deficiency.
157Subjects
F: 41%
M: 59%
2018The Journal of Clinical Endocrinology & Metabolism

Sex Distribution:

F:41%
M:59%
157Subjects

Year:

2018

Source:The Journal of Clinical Endocrinology & Metabolism

Clinical Practice Guidelines