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follitropin alfa

Trade name: Gonal-F

Recombinant proteinapproved

Approved

Sep 29, 1997

Gonadotropin preparations are drugs that mimic the physiological effects of gonadotropins, used therapeutically mainly as fertility medication for ovarian hyperstimulation and ovulation induction. For example, the so-called menotropins consist of LH and FSH extracted from human urine from menopausal women. There are also recombinant variants. — Wikipedia

Clinical trial activity

202 trials · 187 clinical orgs · 3 marketing orgs

Phase 1
23
Phase 2
75
Phase 3
56
Phase 4
75

Earliest trial started Dec 1, 1999 (NCT01735422)

Timeline

1990s

  1. Sep 29, 1997

    Earliest FDA Approval

  2. Sep 29, 1997

    Merck Serono — NDA Secondary Org

  3. Sep 29, 1997

    Organon — NDA Secondary Org

  4. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedSep 29, 1997

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Discontinued
Multi-specific
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • afolia
  • bemfola
  • da-3801
  • fe 999049
  • follicle stimulating hormone
  • follicle stimulating hormone
  • follicle stimulating hormone
  • follicle-stimulating hormone
  • follicle-stimulating hormone
  • follitrophin alfa
  • follitrophin alpha
  • follitropin
  • follitropin
  • follitropin
  • follitropin alfa
  • follitropin alfa
  • follitropin alfa
  • follitropin alfa
  • follitropin alfa
  • follitropin alfa
  • follitropin alfa
  • follitropin-alfa
  • follitropin alfa/beta
  • follitropin alfa/beta
  • follitropin alfa/beta
  • follitropin alfa/beta
  • follitropin alfa /lutropin alfa
  • follitropin alpha
  • follitropin alpha
  • follitropin gamma
  • follotropin
  • follotropin recombinant
  • fsh
  • fsh
  • fsh
  • fsh
  • fsh
  • fsh-a
  • fsh alpha
  • gonal
  • gonal
  • gonal f
  • gonal-f
  • gonal-f
  • gonal-f
  • gonal-f
  • gonalpalium
  • hmg
  • hmg
  • human follicle stimulating hormone
  • human follicle stimulating hormone
  • human follicle stimulating hormone
  • human fsh
  • humegon
  • normegon
  • org 32489
  • org-32489
  • ovaleap
  • ovaleap
  • pergonal
  • pergonal low lh
  • pergoveris
  • recfsh
  • recombinant follicle stimulating hormone
  • recombinant fsh
  • recombinant human follicle-stimulating hormone (r-hfsh)
  • rfsh-alpha

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07269327Phase 1Nov 24, 2025Merck KGaA
NCT07121751Phase 4Sep 1, 2025Dunamenti REK Istenhegyi IVF Center, Szeged University
NCT07097259Phase 1Jul 21, 2025Merck KGaA, Merck Serono
NCT06864793Phase 1May 31, 2025Qilu Pharmaceutical Co., Ltd.
NCT06921395Phase 4Feb 15, 2025LG
NCT06571214Phase 4Sep 1, 2024Nanjing University
NCT06414096Phase 1Jun 30, 2024University of Colorado, University of Colorado, Denver
NCT06481696N/AJun 1, 2024Andros Day Surgery Clinic
NCT06173869Phase 3Apr 1, 2024Ferring
NCT07128394N/AFeb 1, 2024Nanjing University
NCT06175832Phase 4Jan 1, 2024Ghent University
NCT06134479Phase 3Dec 12, 2023Fundación Santiago Dexeus Font, Organon
NCT06091436Phase 3Mar 24, 2023GeneScience Pharmaceuticals Co., Ltd., Sun Yat-Sen University
NCT05670795N/AJan 1, 2023Bezmialem University
NCT05521828N/ADec 1, 2022Free University of Brussels
NCT05815719Phase 4Nov 17, 2022Instituto Bernabeu
NCT05405686Phase 4Sep 1, 2022Free University of Brussels, Merck KGaA
NCT05403476Phase 2Aug 16, 2022Ferring
NCT05266924Phase 3Jul 23, 2022Bharat Serums and Vaccines Limited
NCT05263388Phase 3Jul 14, 2022Ferring
Showing 20 of 202 trials
Page 1 / 11

Organizations

Research & Development (187)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Merck KGaAFor profit282641999
Merck SeronoFor profit24351999
FerringFor profit201732005
MerckFor profit11432004
University of ValenciaAcademic/Hospital8632005
Cairo UniversityAcademic/Hospital6642013
Free University of BrusselsAcademic/Hospital5432013
IBSA Institut Biochimique SAFor profit5522001
University of CopenhagenAcademic/Hospital5412003
Damascus UniversityAcademic/Hospital4412019
Fundación Santiago Dexeus FontAcademic/Hospital4422021
Mansoura UniversityAcademic/Hospital4422008
University of California, San DiegoAcademic/Hospital4422009
Assiut UniversityAcademic/Hospital3322015
Glycotope GmbHFor profit3322011
IVI MadridAcademic/Hospital3312009
National Institutes of Health (NIH)Government3232000
Peking UniversityAcademic/Hospital3212008
Shahid Sadoughi University of Medical ScienceAcademic/Hospital3322008
University Hospital Quirón Dexeus, BarcelonaAcademic/Hospital3012021
187 organizations
Page 1 / 10

Marketing (3)

OrganizationOrg typeRelationshipDate
Merck SeronoFor profitNDA2Sep 29, 1997
OrganonFor profitNDA2Sep 29, 1997
SeronoFor profitNDA—