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TFDA approved a new investigational antidepressant BLI-1005 to proceed phase 2 clinical trial.
Phase 1 study of the new investigational antidepressant BLI-1005 has been proved high level of safety in single-dose administration in healthy subjects. Therefore, “A Phase II Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients with Major Depressive Disorder” protocol was submitted and the protocol was approved by TFDA in June this year (2014). The phase II clinical trial will commence after obtaining approvals from the IRBs of Taipei Veterans General Hospital, Linkou Chang Gung Memorial Hospital, and Taipei City Hospital, Songde Branch in Taiwan.