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

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

  • Drugs Octreotide (Primary)
  • Indications Acromegaly
  • Focus Registrational; Therapeutic Use
  • Sponsors Chiasma

Most Recent Events

  • 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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