Hydroxyprogesterone - AMAG Pharmaceuticals

Drug Profile

Hydroxyprogesterone - AMAG Pharmaceuticals

Alternative Names: 17 α-hydroxyprogesterone caproate; 17-AHPC; 17-OHPC; 17P; Gestiva; Hydroxyprogesterone caproate; Hydroxyprogesterone caproate injection; Hydroxyprogesterone long-acting; Makena

Latest Information Update: 08 Feb 2017

Price : $50

At a glance

  • Originator Cytyc Prenatal Products
  • Developer AMAG Pharmaceuticals
  • Class Pregnenediones; Progesterone congeners; Small molecules
  • Mechanism of Action Progesterone receptor agonists
  • Orphan Drug Status

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

    Yes - Preterm labour
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Preterm labour

Most Recent Events

  • 02 Feb 2017 Pharmacokinetics data from a phase I trial in Preterm labour released by AMAG Pharmaceuticals
  • 12 Oct 2016 Phase-I clinical trials in Preterm labour (In volunteers) in USA (SC)
  • 12 Oct 2016 AMAG Pharmaceuticals announces intention to submit orphan drug designation application to the US FDA for Makena SQ auto-injector
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