At a glance
- Macimorelin was approved by the FDA (Macrilen, December 20, 2017), but the products are no longer marketed.
- PubMed lists 34 publications mentioning it, including 4 randomized controlled trials and 0 animal-only studies.
- ClinicalTrials.gov lists 6 registered studies testing it (0 active).
- FDA's adverse event system (FAERS) holds 5 reports mentioning it; 0 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA205598 | MACRILEN | Approved, discontinued | December 20, 2017 | AETERNA ZENTARIS |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Diagnostic accuracy of growth hormone stimulation tests for growth hormone deficiency following radiotherapy involving the hypothalamic-pituitary axis: protocol for a systematic review and planned meta-analysis.
- Neurophysin-I dynamics upon different pituitary provocation tests in healthy participants.
- Facts and news about growth hormone replacement therapy in adults.
- Real-world diagnostic performance of the macimorelin stimulation test in the diagnosis of adult growth hormone deficiency.
- Computational repurposing of approved drugs targeting KRAS G12D and EGFR for colorectal cancer therapy.
- Molecular recognition of two approved drugs Macimorelin and Anamorelin by the growth hormone secretagogue receptor.
- Consensus and controversies about diagnosing GH deficiency: a Delphi survey by the GH research society.
- Insights into the Effects of Ligand Binding on Leucyl-tRNA Synthetase Inhibitors for Tuberculosis: In Silico Analysis and Isothermal Titration Calorimetry Validation.
- Once upon a time: the glucagon stimulation test in diagnosing adult GH deficiency.
- New insights on diagnosis and treatment of AVP deficiency.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 6
- Active
- 0
- With posted results
- 3
Conditions studied
| Study | Status | Phase | Start |
|---|---|---|---|
| A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is | Completed | Phase 3 | November 16, 2021 |
| Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers | Completed | N/A | March 7, 2019 |
| Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency | Completed | Phase 3 | December 3, 2015 |
| Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia | Completed | Phase 2 | May 2012 |
| Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test. | Completed | Phase 3 | Jun 2007 |
| Oral Ghrelin Agonist in Healthy Subjects | Completed | Phase 1 | Nov 2005 |
All 6 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 5
- Serious
- 0
- With death outcome
- 0
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.