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Macrilen (MACIMORELIN)
Macrilen works by binding to the growth hormone secretagogue receptor type 1, triggering a response that stimulates the release of growth hormone.
Macrilen (Macimorelin) is a small molecule growth hormone secretagogue receptor agonist developed by Aeterna Zentaris. It targets the growth hormone secretagogue receptor type 1 to stimulate the release of growth hormone. Macrilen is FDA-approved for diagnostic use in adults with a high risk of having a growth hormone deficiency. The drug has a half-life of 4.1 hours but its bioavailability is unknown. Macrilen is patented and has no generic manufacturers.
At a glance
| Generic name | MACIMORELIN |
|---|---|
| Sponsor | Aeterna Zentaris |
| Drug class | Growth Hormone Secretagogue Receptor Agonist |
| Target | Growth hormone secretagogue receptor type 1 |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2017 |
Mechanism of action
Macimorelin stimulates GH release by activating growth hormone secretagogue receptors present in the pituitary and hypothalamus.
Approved indications
Common side effects
- Dysgeusia
- Dizziness
- Headache
- Fatigue
- Nausea
- Hunger
- Diarrhea
- Upper respiratory tract infection
- Feeling hot
- Hyperhidrosis
- Nasopharyngitis
- Sinus bradycardia
Key clinical trials
- A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is (PHASE3)
- Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia (PHASE2)
- Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers (NA)
- Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test. (PHASE3)
- Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency (PHASE3)
- Oral Ghrelin Agonist in Healthy Subjects (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Macrilen CI brief — competitive landscape report
- Macrilen updates RSS · CI watch RSS
- Aeterna Zentaris portfolio CI