Calcitonin oral - Enteris BioPharma/Tarsa Therapeutics

Drug Profile

Calcitonin oral - Enteris BioPharma/Tarsa Therapeutics

Alternative Names: Calcitonin-salmon [rDNA origin] delayed release tablets; Oral recombinant salmon calcitonin - Tarsa Therapeutics; Ostora; rsCT; Salmon calcitonin oral - Tarsa Therapeutics; sCT oral; TBRIA

Latest Information Update: 29 Jun 2016

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At a glance

  • Originator Unigene Laboratories
  • Developer Enteris BioPharma; Tarsa Therapeutics
  • Class Antihypercalcaemics; Calcium regulators; Neuropeptides; Osteoporosis therapies; Peptide hormones
  • Mechanism of Action Calcitonin receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Postmenopausal osteoporosis
  • Preclinical Osteoarthritis

Most Recent Events

  • 19 Oct 2015 Planned Prescription Drug User Fee Act (PDUFA) date for Postmenopausal osteoporosis in USA (PO) is 2016-05-30
  • 19 Oct 2015 The US FDA accepts NDA for oral calcitonin for Postmenopausal osteoporosis for review
  • 12 Oct 2015 No recent reports on development identified - Phase-III for Postmenopausal osteoporosis in European Union and South Africa (PO)
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