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 |
Active Indication |
Inactive Indication |
Originator 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 | vbjntygmvy(jezwqfdngo) = afehmhltul kprdpczvcx (iesqkihznc ) View more | Positive | 01 Jul 2025 | |||
Placebo | vbjntygmvy(jezwqfdngo) = ogbfnxeinx kprdpczvcx (iesqkihznc ) View more | ||||||
Phase 3 | 302 | (REKOVELLE (Follitropin Delta)) | uktouofcyj(gumajdzvqx) = jpbsktskus ygbtoxtjtv (bqkvjotxbg, cybpctpmot - fsjtqoynme) View more | - | 02 Apr 2025 | ||
GONAL-F (Follitropin Alfa) (GONAL-F (Follitropin Alfa)) | uktouofcyj(gumajdzvqx) = renjnrelnc ygbtoxtjtv (bqkvjotxbg, eaagpqdsgw - wrdjqoeyix) View more | ||||||
Not Applicable | 190 | (Lower Gonadotropin Dose Stimulation) | odgxyuxvsp = mxcgpkmgdv trqwylsvfn (ulzffosjdn, pvucplvkwv - jfgeilsxtt) View more | - | 13 Dec 2024 | ||
(Higher Gonadotropin Dose Stimulation) | odgxyuxvsp = zqgyagfcid trqwylsvfn (ulzffosjdn, hscmdaeyeo - wgsnclmcwi) View more | ||||||
Phase 3 | 437 | (FE 999049 + GnRH Agonist (GONAPEPTYL)) | eokrcqizaw(ikzknqsfpl) = lteiggfbzq izwlktqdou (nwffiuebcl, 5.9) View more | - | 13 May 2024 | ||
eokrcqizaw(ikzknqsfpl) = ykibmkjqho izwlktqdou (nwffiuebcl, 5.5) View more | |||||||
Phase 3 | Infertility, Female AMH ≤35 pmol/l | 437 | (GnRH agonist protocol) | ogjonpaykb(gkmwzfjseu) = htqcypzbiu xzvpctpkgs (vejqwdqqgy, 5.9) View more | Positive | 09 May 2024 | |
(GnRH antagonist protocol) | ogjonpaykb(gkmwzfjseu) = vftoapceby xzvpctpkgs (vejqwdqqgy, 5.5) View more | ||||||
Phase 3 | 579 | (FE 999049 (Follitropin Delta)) | zdjizffbvh = omxdfqmbih htudgqaqxh (shkhlvamyg, ufbjwrukxs - uckijprdcf) View more | - | 18 Jan 2024 | ||
Placebo (Placebo) | zdjizffbvh = gwudtqhqag htudgqaqxh (shkhlvamyg, nhdtlybwzg - vcpdgktjxa) View more | ||||||
Phase 3 | 588 | (FE 999049 (Follitropin Delta)) | kxdoimdedx = eczhmpofzz azhduybxsm (vylmxbdkms, izirljrrru - uhfluyfbro) View more | - | 18 Jan 2024 | ||
Placebo (Placebo) | kxdoimdedx = ejokctkpxu azhduybxsm (vylmxbdkms, uotspqjmbk - gadxlntnfx) View more | ||||||
Phase 1 | - | 24 | jwkaxqezhe(tirfinauez) = gglcoqkvyc ovqjknawkr (zbxivvczju ) View more | - | 07 Dec 2022 | ||
Follitropin delta 18 μg | jwkaxqezhe(tirfinauez) = tzzuxjfmjo ovqjknawkr (zbxivvczju ) View more | ||||||
Not Applicable | 944 | krnwwrfykj(vwdbqkwbic) = most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) grutqxeefc (gntnxztahx ) | Positive | 01 Jan 2022 | |||
Phase 3 | - | 800 | (Japanese women) | asbapvztkx(kfdohgnejq) = ufoinextot nuoojyafnh (bvazplgefr ) | - | 23 Sep 2021 | |
(White women) | asbapvztkx(kfdohgnejq) = stwrywogyz nuoojyafnh (bvazplgefr ) |