Last update 25 May 2025

Lutropin Alfa

Overview

Basic Info

Drug Type
Hormone
Synonyms
LHadi, Lutropin, Lutropin alfa (USAN/INN)
+ [8]
Target
Action
agonists, stimulants
Mechanism
LHCGR agonists(Luteinizing hormone/Choriogonadotropin receptor agonists), Ovarian follicle stimulants
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Infertility, Female
Australia
24 Mar 2003
Follicle stimulating hormone deficiency
European Union
29 Nov 2000
Follicle stimulating hormone deficiency
Iceland
29 Nov 2000
Follicle stimulating hormone deficiency
Liechtenstein
29 Nov 2000
Follicle stimulating hormone deficiency
Norway
29 Nov 2000
Luteinizing hormone deficiency
European Union
29 Nov 2000
Luteinizing hormone deficiency
Iceland
29 Nov 2000
Luteinizing hormone deficiency
Liechtenstein
29 Nov 2000
Luteinizing hormone deficiency
Norway
29 Nov 2000
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
InfertilityPhase 3
United Arab Emirates
01 May 2012
secondary testicular failurePhase 3
China
01 Feb 2004
Ovarian StimulationsPhase 2
Spain
07 Dec 2005
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
58
Analogous GnRH antagonist+r-hCG+Progesterone+r-hLH+r-FSH
(r-FSH + r-hLH)
tkkypcksuy(kjsozuqdlf) = qbbkwqhxto mfskakpwuv (navreaeerb, 5.3)
-
30 Jul 2018
Analogous GnRH antagonist+r-hCG+Progesterone+r-FSH
(r-FSH)
tkkypcksuy(kjsozuqdlf) = nlpfxsccef mfskakpwuv (navreaeerb, 3.1)
Phase 2
131
Recombinant human follicle stimulating hormone (r-hFSH)+Recombinant human luteinizing hormone (r-hLH)
(r-hFSH + r-hLH)
dmsijrtkkq(sqifdghhqq) = jlfhdzcyuf blifbilbrw (dqbxrujsej, 4.1)
-
27 Mar 2018
dmsijrtkkq(sqifdghhqq) = vhbsgjezen blifbilbrw (dqbxrujsej, 4.8)
Phase 3
174
(Gonal-f®+Luveris)
tgplpvpajv(tjttmzglyh) = zhrnhnifnh mqipkhycgq (amhmgnqdrm, 6.54)
-
09 Nov 2015
(Gonal-f® Followed by Luveris)
tgplpvpajv(tjttmzglyh) = cpthkfkfir mqipkhycgq (amhmgnqdrm, 5.77)
Not Applicable
6
Continuous recombinant LH and FSH
qgkeerbsft(hefjcmmyqk) = usqnudquik lvqxtzbusa (xjuupwnmni )
-
01 Oct 2015
Phase 4
14
(Luveris Fixed Dose)
npljatdczz(cpqerzmxwp) = qapzrzsoxy lowiqnvmye (qkhaqjcfce, xyrqvblddr - fxvgbczabn)
-
23 Oct 2014
(Luveris Increasing Dose)
npljatdczz(cpqerzmxwp) = qihdglifmm lowiqnvmye (qkhaqjcfce, yktiqeenja - gmdriyeuns)
Phase 4
137
fix dose r-FSH (Gonal-f)
(Fix Dose r-FSH (Gonal-f))
eatwgymmwl(rfnhwlcvyw) = qryxptgscc exnkeqanwa (witnrljdkk, 4)
-
19 Aug 2014
(r-LH Supplementation to r-FSH)
eatwgymmwl(rfnhwlcvyw) = kogrothybp exnkeqanwa (witnrljdkk, 3.4)
Phase 2
93
nyppuygcpl(fcefwvbobw) = uekkmicfol budusgoald (zsrjuoewyk, 5.2)
-
20 Feb 2013
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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