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Follitropin alfa - Merck Serono

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Drug Profile

Follitropin alfa - Merck Serono

Alternative Names: follitropin alfa injection - EMD; Follitropin-alpha; GONAL-f; GONAL-f RFF Redi-ject; Gonalef; 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: 03 Mar 2026

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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 Chorionic gonadotropin stimulants; 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
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Female infertility; Male infertility

Most Recent Events

  • 23 Dec 2025 EMD Serono completes a phase I bioequivalence trial in Healthy volunteers in USA (Parenteral, Injection) (NCT07097259)
  • 21 Jul 2025 EMD Serono initiates a phase I trial in healthy downregulated male participants (In volunteers) in USA (Parenteral, Injection) (NCT07097259)
  • 21 Jul 2025 EMD Serono plans a phase I trial in healthy downregulated male participants (In Volunteers) in USA (Parenteral, Injection) in July 2025 (NCT07097259)

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