Follitropin alfa

Drug Profile

Follitropin alfa

Alternative Names: Follitropin-alpha; GONAL-f; GONAL-f RFF Redi-ject; Recombinant human follicle-stimulating hormone - Merck Serono; recombinant human follicle-stimulating hormone - Serono; rh-FSH; rhFSH - Merck Serono; rhFSH - Serono; SJ-0021

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Merck Serono
  • Developer EMD Serono; Merck Serono; Nippon Shinyaku
  • Class Follicle stimulating hormones; Infertility therapies; Peptide fragments; Pituitary gonadotropins; Recombinant proteins
  • Mechanism of Action Ovarian follicle stimulants
  • Orphan Drug Status

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

    Yes - Male infertility
  • 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 Yes

Highest Development Phases

  • Marketed Female infertility; Male infertility

Most Recent Events

  • 01 Jul 2015 Follitropin alfa licensed to Nippon Shinyaku in Japan for Male infertility and Female infertility
  • 16 Jan 2014 Phase-III clinical trials in Female infertility (combination therapy) in Finland, Germany, Hungary, Latvia and the United Kingdom (SC)
  • 01 Jan 2014 Phase-III clinical trials in Female infertility (Combination therapy) in Sweden, Poland, Spain, Denmark, Netherlands, Estonia, Belgium, Czech Republic (SC)
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