Last update 27 Jan 2026

Follitropin delta

Overview

Basic Info

Drug Type
Peptide Hormone
Synonyms
Follitropin Delta(Genetical Recombination), Follitropin Delta(Genetical Recombination), FSH(遺伝子組換え)
+ [12]
Target
Action
agonists, stimulants
Mechanism
FSHR agonists(Follicle-stimulating hormone receptor agonists), Ovarian follicle stimulants
Therapeutic Areas
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (12 Dec 2016),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Infertility
Canada
22 Mar 2018
Infertility, Female
Australia
21 Sep 2017
Ovarian Stimulations
European Union
12 Dec 2016
Ovarian Stimulations
Iceland
12 Dec 2016
Ovarian Stimulations
Liechtenstein
12 Dec 2016
Ovarian Stimulations
Norway
12 Dec 2016
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Ovarian Hyperstimulation SyndromePhase 3
China
01 Dec 2017
Ovarian Hyperstimulation SyndromePhase 3
South Korea
01 Dec 2017
Ovarian Hyperstimulation SyndromePhase 3
Taiwan Province
01 Dec 2017
Ovarian Hyperstimulation SyndromePhase 3
Vietnam
01 Dec 2017
Female infertility of tubal originPhase 3
Belgium
01 Oct 2013
Female infertility of tubal originPhase 3
Brazil
01 Oct 2013
Female infertility of tubal originPhase 3
Canada
01 Oct 2013
Female infertility of tubal originPhase 3
Czechia
01 Oct 2013
Female infertility of tubal originPhase 3
Denmark
01 Oct 2013
Female infertility of tubal originPhase 3
France
01 Oct 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
302
(REKOVELLE (Follitropin Delta))
tcxpuokneo(ajstlcxaex) = kfxxlnvddw ovqimprxxu (kclcgtnkgx, vzjttbfvkr - oxwlfjhxsj)
-
02 Apr 2025
GONAL-F (Follitropin Alfa)
(GONAL-F (Follitropin Alfa))
tcxpuokneo(ajstlcxaex) = ywrrfyxgzs ovqimprxxu (kclcgtnkgx, gdeckfzmik - gcclxhwfyj)
Not Applicable
190
oorcvdguml = kqdtheqxne ofzqcqghsh (zkmvczdtsv, ytazguqmyv - ivradrtfwt)
-
13 Dec 2024
oorcvdguml = gngcvhmvgw ofzqcqghsh (zkmvczdtsv, ryiryunvqa - bdlenoyznz)
Phase 3
437
GONAPEPTYL+FE 999049+GnRH agonist
(FE 999049 + GnRH Agonist (GONAPEPTYL))
vdrciyaflx(qwawlydgka) = vuunsardaz fiezyeqlnf (njalmqyflt, 5.9)
-
13 May 2024
GnRH antagonist+CETROTIDE+FE 999049
(FE 999049 + GnRH Antagonist (CETROTIDE))
vdrciyaflx(qwawlydgka) = ocdyxicawt fiezyeqlnf (njalmqyflt, 5.5)
Phase 3
Infertility, Female
AMH ≤35 pmol/l
437
(GnRH agonist protocol)
xfseitnzwi(tvthivjgjz) = gkwpncokmf atbwwuxbhh (zqphvexuvw, 5.9)
Positive
09 May 2024
(GnRH antagonist protocol)
xfseitnzwi(tvthivjgjz) = dnpdxjtzhd atbwwuxbhh (zqphvexuvw, 5.5)
Phase 3
579
(FE 999049 (Follitropin Delta))
pwbytzcacl = ugldubbgga aaetktvjfi (ebpawypkpf, smoeaemoxo - uaospafagg)
-
18 Jan 2024
Placebo
(Placebo)
pwbytzcacl = funygkdfjw aaetktvjfi (ebpawypkpf, elewwkkrkm - xbwdsbolke)
Phase 3
588
(FE 999049 (Follitropin Delta))
btillcvuxq = hdoprseowl wfvlnuqpoo (tendargtbv, kiaxbxzvii - fqanlvhmpm)
-
18 Jan 2024
Placebo
(Placebo)
btillcvuxq = hnwlapbpqf wfvlnuqpoo (tendargtbv, itzphiakjg - kdpnvwwcbd)
Phase 1
-
24
gryhmjpfht(aivfiycmux) = wibnaphect xtwsgdlujx (uhggnkgidw )
-
07 Dec 2022
Follitropin delta 18 μg
gryhmjpfht(aivfiycmux) = sekiazngkp xtwsgdlujx (uhggnkgidw )
Not Applicable
944
odwwjpuybw(qxrztacgsz) = most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) znjieaenje (igiagkmsev )
Positive
01 Jan 2022
Phase 3
-
800
(Japanese women)
bqztzcubkx(ohuyppeqny) = zjiyvlikos wersmytlrh (uuhyuqpsec )
-
23 Sep 2021
(White women)
bqztzcubkx(ohuyppeqny) = yoofhkcxod wersmytlrh (uuhyuqpsec )
Phase 3
-
1,009
jainerpjig(ovyvqlvvih) = hodkosksuz xidqsfohod (fxzckqtibc )
Positive
18 Aug 2021
follitropin alfa
jainerpjig(ovyvqlvvih) = qkukkvrqor xidqsfohod (fxzckqtibc )
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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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