Product Description
Macimorelin is used for the diagnosis of adult growth hormone deficiency (AGHD). (Sourced from: https://www.mayoclinic.org/drugs-supplements/macimorelin-oral-route/side-effects/drg-20406758?p=1)
Mechanisms of Action: GHR Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Austria | Belgium | Croatia | Czech | Estonia | European Medicines Agency | Finland | Hungary | Iceland | Ireland | Israel | Italy | Latvia | Lithuania | Poland | Portugal | Slovakia | Spain | Sweden | United Kingdom | United States
Approved Indications: Hypopituitarism
Known Adverse Events: Bradycardia | Dizziness | Dysgeusia | Headache | Hyperhidrosis | Nasopharyngitis | Pharyngitis | Respiratory Tract Infections | Diarrhea
Company: Aeterna Zentaris
Company Location:
Company CEO:
Additonal Commercial Interests: Novo Nordisk
Clinical Description
Countries in Clinic: Armenia, Georgia, Germany, Italy, Poland, Romania, Serbia, Slovakia, Slovenia, Turkey, United States
Active Clinical Trial Count: 2
Highest Development Phases
Phase 3: Deficiency Diseases|Dwarfism, Pituitary|Hypopituitarism|Pituitary Diseases
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| DETECT | P3 |
Completed |
Dwarfism, Pituitary|Deficiency Diseases|Pituitary Diseases|Hypopituitarism |
2024-06-13 |
|
| the DETECT Trial | P3 |
Active, not recruiting |
Hypopituitarism |
2023-09-19 |