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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: 24 Aug 2017

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At a glance

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

    • 31 Aug 2018 Biomarkers information updated
    • 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.
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