Simple Oral Administration, High Accuracy and the Only Approved Diagnostic for Adult Growth Hormone Deficiency
Macimorelin for the Diagnosis of Adult Growth Hormone Deficiency (AGHD)
U.S. FDA Approved
European Commission Approved
Macimorelin, a ghrelin agonist, is an orally active peptidomimetic small molecule that stimulates the secretion of growth hormone (GH) from the pituitary gland. Stimulated growth hormone levels are measured in blood samples after oral administration of macimorelin for the assessment of GHD.
Macimorelin, is the only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Aeterna regained commercial rights to macimorelin in the United States and Canada in May 2023 and is engaged in robust business development efforts to identify and secure a new development and commercialization partner in these territories.
American Association of Clinical Endocrinologists 2019 Guidelines
“Because the macimorelin test is simple, well tolerated with minimal side effects, and of shorter duration with only 3 to 4 blood draws compared to other GH–stimulation tests, it is anticipated that its use will increase over time.”*
“Very promising test that is easy to conduct with high reproducibility, safety, and diagnostic accuracy comparable to the ITT and GHRH plus ARG test.”*
*AACE 2019 Guidelines: American Association Of Clinical Endocrinologists And American College Of Endocrinology Guidelines For Management Of Growth Hormone Deficiency In Adults And Patients Transitioning From Pediatric To Adult Care, 2019
Macimorelin for the Diagnosis of Childhood-Onset Growth Hormone Deficiency (CGHD)
We are also leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need
Growth Hormone is Critical to Lifelong Health
Reduction in auxological parameters:
• Short stature
• Low growth velocity (speed) for age
• Increased fat around the waist
• Delayed tooth development
Maintains normal body stature and regulates metabolism
No clear signs or symptoms, but recognized by:
• Metabolic syndrome
• Muscle wasting
• Low physical/mental energy
• Impaired quality of life
Increased risk of:
Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally balanced health status. AGHD most commonly results from damage to the pituitary gland. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life as well as an increase of cardiovascular risks.
AGHD may occur in an adult subject who has a history of childhood-onset growth hormone deficiency (CGHD) or may occur during adulthood as an acquired condition.
Once accurately diagnosed growth hormone deficiency can be treated with growth hormone replacement therapy.
Potential Tests Annually
*Navigant study 2009, TVG study 2017, Huron Consulting study 2018
1. Sales of Macrilen® (macimorelin) are temporarily discontinued in the United States commercial market for the diagnosis of adult growth hormone deficiency ("AGHD"), until anticipated re-launch with an alternate commercialization partner. Aeterna has an ongoing effort to identify strategic development and commercialization partner.