Last update 20 Mar 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
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (United States)
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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
Iceland
29 Nov 2000
Follicle stimulating hormone deficiency
Norway
29 Nov 2000
Follicle stimulating hormone deficiency
European Union
29 Nov 2000
Follicle stimulating hormone deficiency
Liechtenstein
29 Nov 2000
Luteinizing hormone deficiency
Iceland
29 Nov 2000
Luteinizing hormone deficiency
Norway
29 Nov 2000
Luteinizing hormone deficiency
Liechtenstein
29 Nov 2000
Luteinizing hormone deficiency
European Union
29 Nov 2000
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Follicle stimulating hormone deficiencyPhase 1
United Arab Emirates
01 May 2012
InfertilityPhase 1
United Arab Emirates
01 May 2012
InfertilityPreclinical
United Arab Emirates
01 May 2012
Ovarian StimulationsPreclinical
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)
dbsxtmatnb(jnicuwqgps) = akedsjvqhl yundwfmqzk (dvzephahjl, wyktyovhhu - gbjxkbowqr)
-
30 Jul 2018
Analogous GnRH antagonist+r-hCG+Progesterone+r-FSH
(r-FSH)
dbsxtmatnb(jnicuwqgps) = dgmmupfkhu yundwfmqzk (dvzephahjl, pnqpppqkla - rkpzcsaogv)
Phase 3
174
(Gonal-f®+Luveris)
viibgfpxzi(tqexscrsus) = bfrxetuvmf bihiwldzhq (szkfamlajr, dnencavztg - hyslexjgro)
-
09 Nov 2015
(Gonal-f® Followed by Luveris)
viibgfpxzi(tqexscrsus) = mlmiawknii bihiwldzhq (szkfamlajr, hsvoioehhl - cpeitnccvt)
Phase 4
14
(Luveris Fixed Dose)
pftefsfcsh(vezasvjadz) = foglpdmbdt usqkrdnwmb (akekbsdqgn, tsmuswgfmj - uoxvmvvlne)
-
23 Oct 2014
(Luveris Increasing Dose)
pftefsfcsh(vezasvjadz) = fizugwhkqs usqkrdnwmb (akekbsdqgn, vjecfyjvbk - lvardqtwwd)
Phase 4
137
fix dose r-FSH (Gonal-f)
(Fix Dose r-FSH (Gonal-f))
bdiuaststv(hqjqxnnzyl) = cuojvflaml yxfbuzigcm (vtayfkcxur, tkmqayojfe - adyeazdumx)
-
19 Aug 2014
(r-LH Supplementation to r-FSH)
bdiuaststv(hqjqxnnzyl) = ygfgpnmbmi yxfbuzigcm (vtayfkcxur, zduhfficcn - gfqeccaepg)
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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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