MetabolicApprovedEvidence tier: Human RCT

Macimorelin

Last updated October 21, 2026. Approval line checked October 21, 2026. No compounding source date is assigned.

FDA status

Approved

Approved. Macimorelin is the active ingredient in Macrilen, FDA-approved for the diagnosis of adult growth hormone deficiency. Approval is specific to that product and indication.

Drugs@FDA: Macrilen (NDA 205598)

Evidence tier

Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 5/5. 44 PubMed citations indexed.

Macimorelin in the literature

Macimorelin (Macrilen) is an oral ghrelin receptor agonist (growth hormone secretagogue receptor/GHSR-1a agonist) that stimulates pulsatile GH release from the anterior pituitary by activating GHSR-1a

What the literature studies

Metabolic Research

Evidence tier

Human RCT

Compounding record

Status not verified

Confidence
5/5

Regulatory record

Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.

Regulatory source not verified; no checked date is assigned.

Macimorelin prolongs the QTc interval; contraindicated with drugs that prolong QT (sotalol, azithromycin, etc.) and should not be used in patients with known QT prolongation or rel

Questions

Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.