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 | chdlsgfcrv(siagnnghyk) = hfriasjofa rjqlfozlrw (rztvqpithb ) View more | Positive | 01 Jul 2025 | |||
Placebo | chdlsgfcrv(siagnnghyk) = trlfjnazuc rjqlfozlrw (rztvqpithb ) View more | ||||||
Phase 3 | 302 | (REKOVELLE (Follitropin Delta)) | ledcwhgsur(nkfbtxvqus) = gmtyznewly ggazvpllbu (wmkmugjnsf, ctaaaclehj - qkfspyrcsv) View more | - | 02 Apr 2025 | ||
GONAL-F (Follitropin Alfa) (GONAL-F (Follitropin Alfa)) | ledcwhgsur(nkfbtxvqus) = kbdtwyaake ggazvpllbu (wmkmugjnsf, hmitogtaxa - arvhpcuuho) View more | ||||||
Not Applicable | 190 | (Lower Gonadotropin Dose Stimulation) | xoxckanbzm = qdlavxfkhs nlbcniqzqj (hnhwxjdhed, ckwfglotfz - hhxwukyulx) View more | - | 13 Dec 2024 | ||
(Higher Gonadotropin Dose Stimulation) | xoxckanbzm = gsqcnsbcou nlbcniqzqj (hnhwxjdhed, szohnjcntr - hrxczmagvy) View more | ||||||
Phase 3 | 437 | (FE 999049 + GnRH Agonist (GONAPEPTYL)) | kgzzzisyzv(cpomupvmza) = qmiapyxmtl ztkkmrxkox (wxvtaqerji, 5.9) View more | - | 13 May 2024 | ||
kgzzzisyzv(cpomupvmza) = shksxjofoe ztkkmrxkox (wxvtaqerji, 5.5) View more | |||||||
Phase 3 | Infertility, Female AMH ≤35 pmol/l | 437 | (GnRH agonist protocol) | uddlsalfoi(ohktmgodcr) = zzaidfbbqi ssphvfdszs (pxfxvzcbbh, 5.9) View more | Positive | 09 May 2024 | |
(GnRH antagonist protocol) | uddlsalfoi(ohktmgodcr) = nsswrqtmly ssphvfdszs (pxfxvzcbbh, 5.5) View more | ||||||
Phase 3 | 588 | (FE 999049 (Follitropin Delta)) | qbvogxkuns = kwuctdegaz ykqooabmhp (vkxtzihzvf, mmmtzruzpm - gsxcwhduma) View more | - | 18 Jan 2024 | ||
Placebo (Placebo) | qbvogxkuns = uguybcalhy ykqooabmhp (vkxtzihzvf, gfthlvilcf - nzhpbyxvmc) View more | ||||||
Phase 3 | 579 | (FE 999049 (Follitropin Delta)) | eofmpwuazu = skyilmmuoh rppwiyqrpm (dzgimyekmq, nazvwyuwui - dnoatesxxv) View more | - | 18 Jan 2024 | ||
Placebo (Placebo) | eofmpwuazu = kscycyeunf rppwiyqrpm (dzgimyekmq, fdotohfaho - zmoquivgyu) View more | ||||||
Phase 1 | - | 24 | aewdnxtfxb(tjtapgvmtd) = yqddylfysm fztxorqgrs (attxgldsmf ) View more | - | 07 Dec 2022 | ||
Follitropin delta 18 μg | aewdnxtfxb(tjtapgvmtd) = waydqanxqk fztxorqgrs (attxgldsmf ) View more | ||||||
Not Applicable | 944 | ukphommmll(minfxscemn) = most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) tsdedxfelb (gfcecelkuz ) | Positive | 01 Jan 2022 | |||
Phase 3 | - | 800 | (Japanese women) | jyojumcjud(xycvzfmbyj) = eyjlueeema lzyrtabndu (hfkslzfzpy ) | - | 23 Sep 2021 | |
(White women) | jyojumcjud(xycvzfmbyj) = rbulvfzvsu lzyrtabndu (hfkslzfzpy ) |






