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# Aeterna Zentaris Seeking FDA Approval for Macrilen
- URL: https://www.fdaweb.com/aeterna-zentaris-seeking-fda-approval-for-macrilen/
- Published: 2017-02-13T12:00:00.000Z
- Updated: 2026-09-14T22:06:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137964

Aeterna Zentaris says it is planning to seek FDA approval for Macrilen (macimorelin) for evaluating growth hormone deficiency in adults. A recent Phase 3 confirmatory study entitled Confirmatory validation of oral macimorelin as a growth hormone stimulation test for the diagnosis of adult growth hormone deficiency in comparison with the insulin tolerance test (ITT), was designed as a two-way crossover study with the ITT as the benchmark comparator and involved 26 sites in the U.S. and Europe. Based on the data, the company concluded that Macrilen stimulates the pituitary gland to produce growth hormone more effectively than the ITT; in about 80% of all patients, measured growth hormone levels following the administration of Macrilen were equal to or higher than the growth hormone levels produced by the ITT. It also found that data from a previous study (82% sensitivity, 92% specificity) could be reproduced.