Macimorelin Test Register Entry
Ghryvelin is approved across the EU as an oral test for low growth hormone in adults (EMA; read 24 Aug 2026). Macimorelin is its active drug. The phase 3 test found 87% of true cases (PMID 29860473). It ruled out 96% of true non-cases. The drug is used as a test. It does not treat low growth hormone.
Which names and codes belong to Macimorelin?
GSRS says MACIMORELIN is the INN and USAN (GSRS; read 24 Aug 2026). It gives UNII 8680B21W73 and CAS 381231-18-1.
| GSRS development codes |
|---|
AEZS-130 · ARD-07 · ARD07 · D-87575 · EP-01572 · EP-1572 · EP1572 · JMV-1843 |
EMA says the active drug in Ghryvelin is macimorelin acetate.
What did the phase 3 test find?
NCT02558829 enrolled 157 people (read 24 Aug 2026). The order of the two tests was random. Each person had the oral and insulin tests. The paper's main group had 139 people (PMID 29860473).
| Result | Macimorelin finding |
|---|---|
| Tests evaluable after first test | 99% |
| Negative agreement with insulin test | 95.38% (95% CI 87%–99%) |
| Positive agreement with insulin test | 74.32% (95% CI 63%–84%) |
| Sensitivity | 87% |
| Specificity | 96% |
| Repeat result agreed | 97% of 33 people |
The paper reported no serious event from the oral drug. The insulin test could be read after the first test in 82% of cases.
Aeterna Zentaris paid for the study (full paper; checked 24 Aug 2026). All authors got research support from Aeterna. Two authors worked there.
What adverse reactions and QT findings were recorded?
EMA's product sheet gives side effects from the 154-person Study 052 safety set (EMA product information; read 24 Aug 2026).
| Frequency | Reactions |
|---|---|
| 5% | Bitter or metallic taste |
| 3% each | Headache, fatigue, nausea |
| 2% | Dizziness |
| 1% each | Abdominal pain, diarrhoea, feeling hot, feeling cold, hunger, palpitations, sinus bradycardia, sleepiness, thirst, tremor, vertigo |
Most effects were mild and brief. No special care was needed.
During drug development, one person had two brief ECG changes. They were reported as serious possible side effects. The changes were a T-wave change and a longer QT interval.
EMA says corrected QT rose by about 11 ms. The cause is not known. The phase 3 paper itself reported no serious event from the drug.
What exactly is authorized in the EU?
Ghryvelin got an EU-wide marketing approval on 11 January 2019 (EMA; read 24 Aug 2026). Its approval number is EU/1/18/1337/001.
The approved job is to test adults for low growth hormone. The active drug is macimorelin acetate. Atnahs Pharma Netherlands B.V. now holds the approval.
How can EU approval and the German list entry both be true?
Germany's current DmMV list names Macimorelin with GHS drugs and their mimetics (DmMV Anlage; read 24 Aug 2026).
The EU approval and the German list entry are two facts. Neither cancels the other.
What does evidence tier A mean here?
Ghryvelin has an approved use as a test and phase 3 data in people. Tier A still fits (read 24 Aug 2026).
The tier describes proof for the named test drug. It does not show what is in a vial.
Why is the first-observed field null?
The field tracks dated grey-market trade or use. It does not track approved medical supply. This review found no dated grey-market purchase, vial test, or self-use record (read 24 Aug 2026).
The field stays null. The 2019 EU approval date is not used as a grey-market date.
How is Macimorelin different from Lenomorelin?
Lenomorelin is human acyl-ghrelin. Macimorelin is a lab-made oral drug that acts at the same receptor.
A finding for either one does not apply to the other. This test result also does not apply to any other mimetic.
What does this register entry cover?
This entry covers Macimorelin and the approved Ghryvelin test. It does not call the drug a treatment or identify a grey-market vial.
→ Lenomorelin, the endogenous hormone → What can be in a vial → All register entries