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Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
No
New Molecular Entity
Yes
Highest Development Phases
Marketed
Bipolar depression; Schizophrenia
Phase III
Behavioural disorders; Major depressive disorder
Phase II
Sleep maintenance insomnia
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Intra-Cellular Therapies plans a phase III 'Study-505' trial for Major depressive disorders (Adjunctive therapy) in 2023
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