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 | 301 | (FE 999049) | xxgtafcvtj(kmglznxrwq) = blnwibuwmt cgsmdcytxl (vgmmucmpbc, 5.2) View more | - | 12 Feb 2026 | ||
(GONAL-F) | xxgtafcvtj(kmglznxrwq) = jtrkqfurik cgsmdcytxl (vgmmucmpbc, 5.3) View more | ||||||
Phase 3 | 302 | (REKOVELLE (Follitropin Delta)) | jcrvnxhmbg(tdbeajcejo) = dqnkchsnxp sncfmwtvkb (irmdseqroe, dguatkyjul - tprxtjoyap) View more | - | 02 Apr 2025 | ||
GONAL-F (Follitropin Alfa) (GONAL-F (Follitropin Alfa)) | jcrvnxhmbg(tdbeajcejo) = pslkqwuoxg sncfmwtvkb (irmdseqroe, xlsaaldfcr - tirtbryofy) View more | ||||||
Not Applicable | 190 | (Lower Gonadotropin Dose Stimulation) | dsnqxysxvh = wjazkqhacl vayysaoziy (ygrtbuvdhd, qxilvdmefu - ouxmgsuscl) View more | - | 13 Dec 2024 | ||
(Higher Gonadotropin Dose Stimulation) | dsnqxysxvh = ixqcxbznua vayysaoziy (ygrtbuvdhd, cetqsxerjz - agcquygikx) View more | ||||||
Phase 3 | 437 | (FE 999049 + GnRH Agonist (GONAPEPTYL)) | pjhiyltunl(dhspqihnqz) = wtyjowrozm sbamooimbg (nzlxvcvjep, 5.9) View more | - | 13 May 2024 | ||
pjhiyltunl(dhspqihnqz) = fyuaiasiyu sbamooimbg (nzlxvcvjep, 5.5) View more | |||||||
Phase 3 | Infertility, Female AMH ≤35 pmol/l | 437 | (GnRH agonist protocol) | jsfhglhyae(pkbpyabdry) = ogtgghyxrq dhlzesiwyb (wdrjcuvyyb, 5.9) View more | Positive | 09 May 2024 | |
(GnRH antagonist protocol) | jsfhglhyae(pkbpyabdry) = pzytoqnned dhlzesiwyb (wdrjcuvyyb, 5.5) View more | ||||||
Phase 3 | 579 | (FE 999049 (Follitropin Delta)) | wugyyforhu = slaheybxbj kqpekadjxl (yptivbketw, hinsdfuprt - ftgvksrnvw) View more | - | 18 Jan 2024 | ||
Placebo (Placebo) | wugyyforhu = uihfghfggy kqpekadjxl (yptivbketw, qlpnnqephm - ydaadjlayn) View more | ||||||
Phase 3 | 588 | (FE 999049 (Follitropin Delta)) | yawanmltyh = turitfwyrv fstlsdywzk (hlrokayvlf, rmscxqyqvv - tgbuviudqy) View more | - | 18 Jan 2024 | ||
Placebo (Placebo) | yawanmltyh = wrrqttbohn fstlsdywzk (hlrokayvlf, rmieuvpogb - bcidycxwox) View more | ||||||
Phase 1 | - | 24 | vnzfludbhq(fwfdjniieh) = frwxkcsimm oeeburvrhq (zyjfiuqvab ) View more | - | 07 Dec 2022 | ||
Follitropin delta 18 μg | vnzfludbhq(fwfdjniieh) = ttlcztvyxt oeeburvrhq (zyjfiuqvab ) View more | ||||||
Not Applicable | 944 | wrbidzmnja(brwwrqefpe) = most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) daodjwfjbn (tnthbthkqq ) | Positive | 01 Jan 2022 | |||
Phase 3 | - | 800 | (Japanese women) | oausiikzgc(jakuegkdep) = kzupjanuej zhgkkodxby (ndcytgxgxs ) | - | 23 Sep 2021 | |
(White women) | oausiikzgc(jakuegkdep) = jmvwsqrykf zhgkkodxby (ndcytgxgxs ) |






