The Only Approved Oral Diagnostic for Adult Growth Hormone Deficiency
Positive results in dose finding studies
announced April 2020
Planned safety and efficacy study
to commence Q1 2021
Our lead product, macimorelin, is the only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Macimorelin is currently marketed in the United States under the tradename Macrilen™, through a license agreement with Novo Nordisk. Through a license agreement with Consilient Health Ltd, macimorelin will be commercialized in Europe and the United Kingdom upon receipt of pricing and reimbursement approvals in the particular country. Additionally, we have entered into a distribution agreement with MegaPharm Ltd. under which MegaPharm will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority.
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, in collaboration with Novo Nordisk.
Macimorelin, a ghrelin agonist, is an orally active 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.
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