Trial Profile

Efficacy and Safety of Oral Octreolin in Patients With Acromegaly Who Are Currently Receiving Parenteral Somatostatin Analogs

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 07 Jan 2022

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At a glance

31 Aug 2015 According to a Chiasma media release, the agency has set a target review date under the Prescription Drug User Fee Act (PDUFA) of April 15, 2016.
17 Aug 2015 According to a Chiasma media release, the U.S. FDA has accepted for filing the company's NDA for octreotide capsules for the maintenance therapy of adult patients with acromegaly.
16 Jun 2015 According to a Chiasma media release, the company has submitted a New Drug Application for the Octreotide capsules to the US FDA as the maintenance treatment of adults with acromegaly, based on the results of this trial in June 2015.

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