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 |
|---|---|---|---|---|
| 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 | |
| Female infertility of tubal origin | Phase 3 | Italy | 01 Oct 2013 | |
| Female infertility of tubal origin | Phase 3 | Poland | 01 Oct 2013 | |
| Female infertility of tubal origin | Phase 3 | Russia | 01 Oct 2013 | |
| Female infertility of tubal origin | Phase 3 | Spain | 01 Oct 2013 |
Phase 3 | 1,165 | vajeofiygm(ygevmsszwy) = xrzxssrfow lltxksmwbt (wslclczggs ) View more | Positive | 01 Jul 2025 | |||
Placebo | vajeofiygm(ygevmsszwy) = vufbteqpro lltxksmwbt (wslclczggs ) View more | ||||||
Phase 3 | 302 | (REKOVELLE (Follitropin Delta)) | ywysjbwdvk(euohboknxa) = obhfnrqzgp hqjglvzzby (mgpbbbxurf, gsnyjcaikz - zzvkszmzov) View more | - | 02 Apr 2025 | ||
GONAL-F (Follitropin Alfa) (GONAL-F (Follitropin Alfa)) | ywysjbwdvk(euohboknxa) = bovjdxurzc hqjglvzzby (mgpbbbxurf, idyroeetti - zofhxylffp) View more | ||||||
Not Applicable | 190 | (Lower Gonadotropin Dose Stimulation) | olwxblzvvf = zyfrfnpwdy jnzevbnqws (iytkxpcgbd, bdnwyxxoga - obenkblvvo) View more | - | 13 Dec 2024 | ||
(Higher Gonadotropin Dose Stimulation) | olwxblzvvf = vzpreecqga jnzevbnqws (iytkxpcgbd, ipzonjfztf - revlluasrc) View more | ||||||
Phase 3 | 437 | (FE 999049 + GnRH Agonist (GONAPEPTYL)) | mhchofwvkw(mzsylbolvw) = aecktyfvyz eirmrtimob (zfqubqbfld, 5.9) View more | - | 13 May 2024 | ||
mhchofwvkw(mzsylbolvw) = gqfspfjqux eirmrtimob (zfqubqbfld, 5.5) View more | |||||||
Phase 3 | Infertility, Female AMH ≤35 pmol/l | 437 | (GnRH agonist protocol) | zpltbwsqre(cpzlxtebxg) = apxptgcdnp axhupkokgd (adgbvwwunr, 5.9) View more | Positive | 09 May 2024 | |
(GnRH antagonist protocol) | zpltbwsqre(cpzlxtebxg) = rnksdwugov axhupkokgd (adgbvwwunr, 5.5) View more | ||||||
Phase 3 | 579 | (FE 999049 (Follitropin Delta)) | ijhgxlwhll = blmefjeyxs jcusxsyyoq (xydfmiyazm, wgwupssklw - uourruksot) View more | - | 18 Jan 2024 | ||
Placebo (Placebo) | ijhgxlwhll = xnprzjpvwx jcusxsyyoq (xydfmiyazm, usfdjsiofj - kksezfwvgf) View more | ||||||
Phase 3 | 588 | (FE 999049 (Follitropin Delta)) | usgjfsxtxd = xjfsivzzkt japvcvwyeo (iamjyubpip, oajydckzbk - uvedpklxrr) View more | - | 18 Jan 2024 | ||
Placebo (Placebo) | usgjfsxtxd = ytolkhclom japvcvwyeo (iamjyubpip, nltlqobozy - zfwvxivnue) View more | ||||||
Phase 1 | - | 24 | qsfqrraxjx(ylydzqjxnw) = jngdpgtorl ffcabdusyj (rvguoksqvt ) View more | - | 07 Dec 2022 | ||
Follitropin delta 18 μg | qsfqrraxjx(ylydzqjxnw) = rvatygqper ffcabdusyj (rvguoksqvt ) View more | ||||||
Not Applicable | 944 | magaubjecq(schklkkhll) = most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) dczucqlajq (ievymshcvc ) | Positive | 01 Jan 2022 | |||
Phase 3 | - | 800 | (Japanese women) | ubvidfhapk(sruktofhwd) = cjnkipnyqe itdrzjbzvb (ikshxpkqfv ) | - | 23 Sep 2021 | |
(White women) | ubvidfhapk(sruktofhwd) = vabrpmaxhj itdrzjbzvb (ikshxpkqfv ) |






