lutropin alpha

Trade name: luveris

Recombinant proteinapproved

Approved

Aug 22, 1975

Luteinizing hormone is a hormone produced by gonadotropic cells in the anterior pituitary gland. The production of LH is regulated by gonadotropin-releasing hormone (GnRH) from the hypothalamus. In females, an acute rise of LH known as an LH surge, triggers ovulation and development of the corpus luteum. In males, where LH had also been called interstitial cell–stimulating hormone (ICSH), it stimulates Leydig cell production of testosterone. It acts synergistically with follicle-stimulating hormone (FSH). — Wikipedia

Clinical trial activity

60 trials · 61 clinical orgs · 4 marketing orgs

Phase 1
8
Phase 2
18
Phase 3
11
Phase 4
19

Earliest trial started Dec 1, 1999 (NCT01735422)

Timeline

1970s

  1. Aug 22, 1975

    Earliest FDA Approval

  2. Aug 22, 1975

    Serono — NDA Secondary Org

1990s

  1. Sep 1, 1994

    Organon — NDA Secondary Org

  2. Jan 30, 1997

    Ferring — NDA Secondary Org

  3. Jan 30, 1997

    Ferring — Marketing Organization

  4. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  2. Oct 8, 2004

    Serono — First NDA Organization

  3. Oct 8, 2004

    Merck Serono — NDA Secondary Org

  4. Oct 8, 2004

    Serono — NDA Organization

2010s

  1. Jan 1, 2012

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

Combination products

Approval history

  • approvedAug 22, 1975

Chemistry & pharmacology

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

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • atc g03 ga gonadotropins
  • follitropin alfa /lutropin alfa
  • icsh
  • insterstiial cell-stimulating hormone
  • leuveris
  • lh
  • lh
  • lh-b
  • lsh-b
  • lsh- beta
  • luteinising hormone
  • luteinising hormone
  • luteinising hormone
  • luteinising hormone
  • luteinizing hormone
  • luteinizing hormone
  • luteinizing hormone
  • luteinizing hormone beta subunit
  • lutrophin
  • lutropin
  • lutropina alfa
  • lutropin alfa
  • lutropin alfa
  • lutropin alfa
  • lutropin alfa
  • lutropin alfa
  • lutropin alfa
  • lutropin alfa for injection
  • lutropin alpha
  • lutropin alpha
  • lutropin beta chain precursor
  • luveris
  • luveris
  • luveris
  • luveris
  • pergoveris
  • recombinant human luteinizing hormone
  • r-hlh

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07213245N/ADec 1, 2025University of Gothenburg
NCT07269327Phase 1Nov 24, 2025Merck KGaA
NCT07178405N/ASep 29, 2025University of Gothenburg
NCT07121751Phase 4Sep 1, 2025Dunamenti REK Istenhegyi IVF Center, Szeged University
NCT06883890Phase 2Mar 17, 2025University of Modena and Reggio Emilia
NCT06571214Phase 4Sep 1, 2024Nanjing University
NCT06227949Phase 3Feb 29, 2024Merck Serono, University of Toronto
NCT05567731N/AOct 15, 2022Tanta University
NCT05405686Phase 4Sep 1, 2022Free University of Brussels, Merck KGaA
NCT05316935Phase 2/Phase 3 (Phase 3)Jul 13, 2022Fudan University
NCT04899193Phase 1May 8, 2021Merck KGaA
NCT04719000Phase 4Feb 4, 2021Fundación Santiago Dexeus Font, Merck, University Hospital Quirón Dexeus, Barcelona
NCT04189133Phase 2Mar 1, 2020University of Modena and Reggio Emilia
NCT04178135N/ANov 25, 2019Central South University
NCT04037605Early Phase 1 (Phase 1)Jul 24, 2019Los Angeles Biomedical Research Institute
NCT03882190N/AApr 1, 2019Wenzhou Medical University
NCT03741699Phase 3Feb 18, 2019Fundación IVI, Merck, Syntax for Science, University Alicante
NCT03400722Phase 4Dec 1, 2017Nova Clinic, Russia
NCT03142893Phase 1May 8, 2017Los Angeles Biomedical Research Institute
NCT02994550Early Phase 1 (Phase 1)Jan 1, 2017Osakidetza
Showing 20 of 60 trials
Page 1 / 3

Organizations

Research & Development (61)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Merck KGaAFor profit131241999
Merck SeronoFor profit12241999
MerckFor profit6032004
Hospitalsenhed MidtAcademic/Hospital3212003
Central South UniversityAcademic/Hospital2122009
Free University of BrusselsAcademic/Hospital2212005
Los Angeles Biomedical Research InstituteAcademic/Hospital2212017
Nanjing UniversityAcademic/Hospital2122009
University of GothenburgAcademic/Hospital2212025
University of Modena and Reggio EmiliaAcademic/Hospital2212020
University of ValenciaAcademic/Hospital2212005
Assuta Ashdod HospitalAcademic/Hospital1112010
BioromaAcademic/Hospital1112014
Cairo UniversityAcademic/Hospital1112013
Catholic University of Sacred Heart, RomeAcademic/Hospital1112012
Centro Riproduzione e AndrologiaAcademic/Hospital1112011
Chongqing Medical UniversityAcademic/Hospital1012009
Dunamenti REK Istenhegyi IVF CenterAcademic/Hospital1112025
Fudan UniversityAcademic/Hospital1112022
Fundación IVIAcademic/Hospital1012019
61 organizations
Page 1 / 4

Marketing (6)

OrganizationOrg typeRelationshipDate
FerringFor profitNDA2Jan 30, 1997
FerringFor profitMKTGJan 30, 1997
Merck SeronoFor profitNDA2Oct 8, 2004
OrganonFor profitNDA2Sep 1, 1994
SeronoFor profitNDA2Aug 22, 1975
SeronoFor profitNDAOct 8, 2004