FDA Approved Growth Hormone Axis

Macimorelin

also known as: Macrilen, Ghryvelin, AEZS-130, JMV 1843

An orally active ghrelin receptor agonist FDA-approved in 2017 as a diagnostic test for adult growth hormone deficiency — the only oral alternative to the insulin tolerance test.

A mimetic growth-hormone-secretagogue receptor agonist approved by the FDA as Macrilen for the diagnosis of adult GH deficiency, providing an oral alternative to the insulin tolerance test.

Mechanism of action

Orally active agonist at GHS-R1a. After a single 0.5 mg/kg oral dose, stimulates a robust GH pulse within 30–90 minutes that can be used to distinguish patients with adult GHD from healthy controls, providing a safer diagnostic than the insulin tolerance test (which requires induction of hypoglycemia).

Primary uses

Diagnosis of adult growth hormone deficiency

Typical dosing

0.5 mg/kg single diagnostic dose (oral)

Prescribing information specifies a specific fasting protocol and serial GH sampling at 30, 45, 60, and 90 minutes post-dose.

Regulatory status

FDA-approved December 2017 as Macrilen (Strongbridge Biopharma, later acquired by Novo Nordisk) for the diagnosis of adult growth hormone deficiency.

References

[fda-pi] Macrilen (macimorelin) Prescribing Information. Novo Nordisk.
[clinical-trial] Garcia JM, et al. "Macimorelin as a diagnostic test for adult growth hormone deficiency." J Clin Endocrinol Metab, 2018;103:3083-3093.

Related peptides

MK-677

An orally active non-peptide ghrelin receptor agonist — included here by convention because it is universally marketed alongside peptide GH secretagogues. FDA warns of heart failure risk.

Sermorelin

The N-terminal 29 amino acids of native GHRH — a former FDA-approved diagnostic and pediatric GH-deficiency therapy, now widely compounded for adult anti-aging protocols.

Tesamorelin

An FDA-approved GHRH analog for reducing excess visceral fat in HIV-associated lipodystrophy.

Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.