Hydroxyprogesterone oral - Lipocine

Drug Profile

Hydroxyprogesterone oral - Lipocine

Alternative Names: Hydroxyprogesterone caproate - Lipocine; LPCN-1107; Oral hydroxyprogesterone caproate - Lipocine

Latest Information Update: 17 Mar 2017

Price : $50

At a glance

  • Originator Lipocine
  • Class Hormones; 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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase I/II Preterm labour

Most Recent Events

  • 06 Mar 2017 Lipocine plans to initiate a phase III trial for Preterm labour (Prevention) in H1 2017
  • 06 Mar 2017 Lipocine completed an End-of-phase-II meeting before March 2017 with US FDA to discuss protocol for planned phase III study in Preterm labour
  • 06 Mar 2017 Lipocine announces intention to submit protocol for phase III study to US FDA through Special Protocol Assessment (SPA) for Preterm labour (Prevention) in 1H 2017
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