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 |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date European Union (12 Dec 2016), |
Regulation- |


| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Ovarian Hyperstimulation Syndrome | Phase 3 | China | 01 Dec 2017 | |
| Ovarian Hyperstimulation Syndrome | Phase 3 | South Korea | 01 Dec 2017 | |
| Ovarian Hyperstimulation Syndrome | Phase 3 | Taiwan Province | 01 Dec 2017 | |
| Ovarian Hyperstimulation Syndrome | Phase 3 | Vietnam | 01 Dec 2017 | |
| Female infertility of tubal origin | Phase 3 | Belgium | 01 Oct 2013 | |
| Female infertility of tubal origin | Phase 3 | Brazil | 01 Oct 2013 | |
| Female infertility of tubal origin | Phase 3 | Canada | 01 Oct 2013 | |
| Female infertility of tubal origin | Phase 3 | Czechia | 01 Oct 2013 | |
| Female infertility of tubal origin | Phase 3 | Denmark | 01 Oct 2013 | |
| Female infertility of tubal origin | Phase 3 | France | 01 Oct 2013 |
Phase 3 | 302 | (REKOVELLE (Follitropin Delta)) | tcxpuokneo(ajstlcxaex) = kfxxlnvddw ovqimprxxu (kclcgtnkgx, vzjttbfvkr - oxwlfjhxsj) View more | - | 02 Apr 2025 | ||
GONAL-F (Follitropin Alfa) (GONAL-F (Follitropin Alfa)) | tcxpuokneo(ajstlcxaex) = ywrrfyxgzs ovqimprxxu (kclcgtnkgx, gdeckfzmik - gcclxhwfyj) View more | ||||||
Not Applicable | 190 | (Lower Gonadotropin Dose Stimulation) | oorcvdguml = kqdtheqxne ofzqcqghsh (zkmvczdtsv, ytazguqmyv - ivradrtfwt) View more | - | 13 Dec 2024 | ||
(Higher Gonadotropin Dose Stimulation) | oorcvdguml = gngcvhmvgw ofzqcqghsh (zkmvczdtsv, ryiryunvqa - bdlenoyznz) View more | ||||||
Phase 3 | 437 | (FE 999049 + GnRH Agonist (GONAPEPTYL)) | vdrciyaflx(qwawlydgka) = vuunsardaz fiezyeqlnf (njalmqyflt, 5.9) View more | - | 13 May 2024 | ||
vdrciyaflx(qwawlydgka) = ocdyxicawt fiezyeqlnf (njalmqyflt, 5.5) View more | |||||||
Phase 3 | Infertility, Female AMH ≤35 pmol/l | 437 | (GnRH agonist protocol) | xfseitnzwi(tvthivjgjz) = gkwpncokmf atbwwuxbhh (zqphvexuvw, 5.9) View more | Positive | 09 May 2024 | |
(GnRH antagonist protocol) | xfseitnzwi(tvthivjgjz) = dnpdxjtzhd atbwwuxbhh (zqphvexuvw, 5.5) View more | ||||||
Phase 3 | 579 | (FE 999049 (Follitropin Delta)) | pwbytzcacl = ugldubbgga aaetktvjfi (ebpawypkpf, smoeaemoxo - uaospafagg) View more | - | 18 Jan 2024 | ||
Placebo (Placebo) | pwbytzcacl = funygkdfjw aaetktvjfi (ebpawypkpf, elewwkkrkm - xbwdsbolke) View more | ||||||
Phase 3 | 588 | (FE 999049 (Follitropin Delta)) | btillcvuxq = hdoprseowl wfvlnuqpoo (tendargtbv, kiaxbxzvii - fqanlvhmpm) View more | - | 18 Jan 2024 | ||
Placebo (Placebo) | btillcvuxq = hnwlapbpqf wfvlnuqpoo (tendargtbv, itzphiakjg - kdpnvwwcbd) View more | ||||||
Phase 1 | - | 24 | gryhmjpfht(aivfiycmux) = wibnaphect xtwsgdlujx (uhggnkgidw ) View more | - | 07 Dec 2022 | ||
Follitropin delta 18 μg | gryhmjpfht(aivfiycmux) = sekiazngkp xtwsgdlujx (uhggnkgidw ) View more | ||||||
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 ) View more | Positive | 18 Aug 2021 | ||
follitropin alfa | jainerpjig(ovyvqlvvih) = qkukkvrqor xidqsfohod (fxzckqtibc ) View more |






