In April 2014 Entera received notification of approval from the FDA for Orphan Drug designation for Hypoparathyroidism.
In June 2015 Entera successfully completed a multi-center Phase II clinical trial in Israel with its oral PTH 1-34 for hypoparathyroidism. The trial’s end points were met with results that were comparable to a commercially available injection.
In May 2016 Entera received a positive opinion from the European Medicines Agency followed by an adoption note from the European Commission (EC) for recognition as an Orphan Medicinal Product for Hypoparathyroidism.
Entera is currently preparing for a larger multinational clinical trial including the United Kingdom, the United States.