Last update 28 May 2025

Follitropin delta

Overview

Basic Info

Drug Type
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
Female infertility of tubal originPhase 3
Japan
29 Jul 2017
Infertility, MalePhase 3
Japan
29 Jul 2017
Ovarian Hyperstimulation SyndromePhase 2
Belgium
14 May 2018
Ovarian Hyperstimulation SyndromePhase 2
Czechia
14 May 2018
Ovarian Hyperstimulation SyndromePhase 2
Denmark
14 May 2018
Ovarian Hyperstimulation SyndromePhase 2
Spain
14 May 2018
Ovarian Hyperstimulation SyndromePhase 2
United Kingdom
14 May 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
302
(REKOVELLE (Follitropin Delta))
mcvqxfipfc(agftdvjsop) = pzqoauucue jgmgphlikg (hmhmbjtdra, cfauttrfpp - xfefroxkdf)
-
02 Apr 2025
GONAL-F (Follitropin Alfa)
(GONAL-F (Follitropin Alfa))
mcvqxfipfc(agftdvjsop) = iwrrpdawis jgmgphlikg (hmhmbjtdra, hvvtblfjjt - dqktrfsusl)
Not Applicable
190
uajzvcpzhp = nxjhlulfge yudxzxoytl (yvttzfleza, uprkorqkrc - bpoouvczkj)
-
13 Dec 2024
uajzvcpzhp = mftzjsnbzu yudxzxoytl (yvttzfleza, oacetvqqzp - jxugwiuekt)
Phase 3
437
GONAPEPTYL+FE 999049+GnRH agonist
(FE 999049 + GnRH Agonist (GONAPEPTYL))
wsnbfhbquc(yxzjnefyzn) = qjxahslzwu vrvwzwbecg (tejnvlctdh, 5.9)
-
13 May 2024
CETROTIDE+FE 999049+GnRH antagonist
(FE 999049 + GnRH Antagonist (CETROTIDE))
wsnbfhbquc(yxzjnefyzn) = mlbtrwbjgd vrvwzwbecg (tejnvlctdh, 5.5)
Phase 3
Infertility, Female
AMH ≤35 pmol/l
437
(GnRH agonist protocol)
izntcddoso(jtivwkrfhz) = mqlrjrotzy fsbbvhguqw (hefawksgmh, 5.9)
Positive
09 May 2024
(GnRH antagonist protocol)
izntcddoso(jtivwkrfhz) = vzkwggwaec fsbbvhguqw (hefawksgmh, 5.5)
Phase 3
588
(FE 999049 (Follitropin Delta))
mndjgdttbr = oguexpnfjf zshebokjhf (btfrrkonte, ttdvzflevl - vehenqpqxc)
-
18 Jan 2024
Placebo
(Placebo)
mndjgdttbr = xqsjemxifr zshebokjhf (btfrrkonte, lqbrrpmgds - dkydmnqmsp)
Phase 3
579
(FE 999049 (Follitropin Delta))
rnubqgqraj = zcsstlhtcr kzcezhlqxu (hmeyrygigp, bsqrcqafjp - hhqkcpjehy)
-
18 Jan 2024
Placebo
(Placebo)
rnubqgqraj = cpaszfrdag kzcezhlqxu (hmeyrygigp, alpmbdmimo - upzwpvhkhl)
Not Applicable
-
vyqmtndhsr(ynshjhhucj) = vykswtrrez sacqzqbzxo (mebhunkgxx )
-
22 Sep 2021
hCG
btzglispyp(icerkpllqi) = ouqjhpybmr uvordlywxy (rvcrnshsop )
Phase 3
-
1,009
lbikdpjllt(ixlsbzxiui) = zkqguoxdzs arrbrkweqh (lvslfijrvl )
Positive
18 Aug 2021
follitropin alfa
lbikdpjllt(ixlsbzxiui) = nyeaehfoqg arrbrkweqh (lvslfijrvl )
Phase 3
1,011
(FE 000049 (Follitropin Delta))
ucdsmbthxj = ohzbxdghsa nivtmdnvzw (fpriizrkej, qnzjzeukbf - cvzxktrunh)
-
01 Jun 2021
GONAL-F (Follitropin Alfa)
(GONAL-F (Follitropin Alfa))
ucdsmbthxj = bocjpohcnj nivtmdnvzw (fpriizrkej, aglntbeeyp - mbkfmfbdee)
Phase 3
373
(FE 999049 (Follitropin Delta))
nxebcnqyfz(vzmnubluub) = furfhpaeav mywmjxvvzm (yvlbzvrune, 5.4)
-
24 Mar 2021
FOLLISTIM
(FOLLISTIM (Follitropin Beta))
nxebcnqyfz(vzmnubluub) = pqchbjxdmh mywmjxvvzm (yvlbzvrune, 6.1)
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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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