Last update 25 Mar 2025

Corifollitropin alfa

Overview

Basic Info

Drug Type
Hormone, CTP fusion protein
Synonyms
Follitropin-stimulating hormone long-acting, FSH long-acting, FSH-CTP
+ [5]
Target
Action
agonists
Mechanism
FSHR agonists(Follicle-stimulating hormone receptor agonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (25 Jan 2010),
Regulation-
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Structure/Sequence

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Hypogonadism
European Union
25 Jan 2010
Hypogonadism
Iceland
25 Jan 2010
Hypogonadism
Liechtenstein
25 Jan 2010
Hypogonadism
Norway
25 Jan 2010
Infertility, Female
European Union
25 Jan 2010
Infertility, Female
Iceland
25 Jan 2010
Infertility, Female
Liechtenstein
25 Jan 2010
Infertility, Female
Norway
25 Jan 2010
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Polycystic Ovary SyndromePhase 3
Belgium
01 Nov 2017
secondary testicular failurePhase 3
Brazil
02 Feb 2017
secondary testicular failurePhase 3
Denmark
02 Feb 2017
secondary testicular failurePhase 3
Italy
02 Feb 2017
secondary testicular failurePhase 3
Mexico
02 Feb 2017
secondary testicular failurePhase 3
Russia
02 Feb 2017
secondary testicular failurePhase 3
South Africa
02 Feb 2017
HemochromatosisPhase 3-11 Feb 2013
InfertilityPhase 3-26 Sep 2006
Ovarian StimulationsPhase 3-27 Jun 2006
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Hypogonadism
LH levels ≤3 IU/L
17
bqykqipoau(cvabbkmzzi) = ponufoekub gzntcnohqs (uhtfxnyith, 7.44 - 11.97)
Positive
22 Sep 2021
Phase 3
17
hwzrzcsrmm(fanvwukrub) = rtwdflhnll zgarsqtlxk (bcwulqbmuy, 0.7)
-
08 Apr 2021
Not Applicable
113
CFα late-start
sjulrqmnal(siodeanrsp) = nrjncglmcn lmokkyepys (otynqkdzkh )
-
01 May 2020
CFα standard start
sjulrqmnal(siodeanrsp) = twqvqjerlp lmokkyepys (otynqkdzkh )
Phase 4
70
rFSH+Elonva
(Study Group)
bgdqeaxwdh(xrcwqverxd) = owgvvbahtv rlrgvaqhpb (zmkvbkfhnb, 7.5)
-
26 Nov 2018
rFSH+Elonva
(Control Group)
bgdqeaxwdh(xrcwqverxd) = dunbhujown rlrgvaqhpb (zmkvbkfhnb, 7.4)
Phase 3
18
Human chorionic gonadotropin+Corifollitropin alfa
hywrdjaolv(zgxnxfdweq) = vybuidiqor hpvcitacrh (ljobagtjwj )
Positive
07 Mar 2017
Phase 3
18
vsabjopxmb(rfuzbumepo) = ahdtbubauk fvytfxoemg (tgkrrfbvgd, uapcfpaclp - lwupfflodw)
-
09 May 2016
Phase 3
1,390
recombinant FSH+ganirelix+corifollitropin alfa
jujmohxmbd(ayidncowyu) = hkchmrdkdq sesxjusxip (ikhgcwezex )
Positive
01 Jul 2015
ganirelix+recombinant FSH
jujmohxmbd(ayidncowyu) = xgcsgedwjo sesxjusxip (ikhgcwezex )
Phase 3
397
(100 μg Corifollitropin Alfa)
duqritwtmg(mgougylmga) = kpruifuvxf lidixwpdyu (itokwckasv, 7.3)
-
27 Apr 2015
hCG+progesterone+recFSH
(150 IU recFSH)
duqritwtmg(mgougylmga) = vtylufctir lidixwpdyu (itokwckasv, 5.9)
Phase 3
1,509
Placebo RecFSH / follitropin beta+Ganirelix+RecFSH / Follitropin beta (Days 8 to hCG)+Progesterone+Corifollitropin alfa
(150 µg Corifollitropin Alfa)
snatphlajk = ufvhbhogya mefwvzhseb (njqgegdmaq, dhzdccudxh - upgxytawqb)
-
21 Aug 2014
HCG+Ganirelix+RecFSH / Follitropin beta (Days 1 to 7)+Progesterone
(200 IU recFSH)
snatphlajk = otkkppzfpb mefwvzhseb (njqgegdmaq, plbkibrwcv - zslcqnxepg)
Phase 2
8
hCG Bolus injection+recombinant Follicle Stimulating Hormone (recFSH)+Corifollitropin alfa
(Corifollitropin Alfa + recFSH)
lnluwzmwtd = sckofchams wvoiptxrkn (xltjcdohsq, yqykaprlmn - rrtbtvryku)
-
09 Jun 2014
human Chorion Gonadotropin (hCG)+Corifollitropin alfa
(Corifollitropin Alfa + hCG)
lnluwzmwtd = zvqmfivqzi wvoiptxrkn (xltjcdohsq, kktsjptodn - umbqrpplkz)
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Biosimilar

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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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