Drugs / Follitropin delta
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Rekovelle | — | 2016-12-12 | europa.eu ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04150861 | Jun → Nov 2019 | infertility disorder | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 27 trials · 2 met primary | ||||||
| Phase 2 | NCT07153367 | Dec 2025 → Dec 2027 expected | female infertility | Centre Hospitalier Intercommunal Creteil | Recruiting | No outcome recorded |
| Phase 2 | NCT06997900 | Jul 2025 → Aug 2026 overdue | infertility disorder | Clinique Ovo | Recruiting | No outcome recorded |
| Phase 2 | NCT05403476 | Aug 2022 → Oct 2024 | male infertility | Ferring Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04778358 | Sep 2021 → Jun 2022 | — | IVI Madrid | Completed | No outcome recorded |
| Phase 2 | NCT03830723 | Jan 2020 → Jan 2021 | infertility disorder | Clinique Ovo | Completed | No outcome recorded |
| Phase 2 | NCT02309671 | Dec 2014 → Nov 2015 | female infertility | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT01426386 | Sep 2011 → Apr 2012 | female infertility | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 311 trials · 6 met primary | ||||||
| Phase 3 | NCT07816562 | Sep 2024 → Jul 2027 expected | ovarian dysfunction | Fundación para la Investigación del Hospital Clínico de Valencia | Recruiting | No outcome recorded |
| Phase 3 | NCT06173869 | Mar 2024 → May 2025 | female infertility | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT05263388 | Jul 2022 → Apr 2024 | infertility disorder | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT04773353 | Dec 2021 → Dec 2023 | female infertility | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03809429 | Apr 2019 → Feb 2022 | female infertility | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03738618 | Oct 2018 → Dec 2020 | female infertility | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03740737 | Oct 2018 → Nov 2020 | infertility disorder | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03296527 | Dec 2017 → Jan 2020 | — | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03228680 | Jul 2017 → Jun 2019 | female infertility | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01956123 | Mar 2014 → May 2015 | infertility disorder | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01956110 | Oct 2013 → May 2015 | infertility disorder | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06154083 | Dec 2023 → Dec 2026 expected | infertility disorder | Fundacion Dexeus | Recruiting | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT05521828 | Apr 2023 → Sep 2024 | — | CRG UZ Brussel | Unknown | No outcome recorded |
| — | NCT05103228 | Dec 2021 → Jul 2023 | infertility disorder, ovarian dysfunction | Peter Kovacs MD | Completed | No outcome recorded |
| — | NCT03483545 | Jul 2018 → Jul 2019 | infertility disorder | Dr François Bissonnette | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT06511791 Comparator | Jul 2024 → Oct 2025 | infertility disorder | Ferring Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT06466486 Comparator | Jun 2024 → Dec 2025 | infertility disorder | Ferring Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03564509 Background | May 2018 → Oct 2019 | — | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT07691073 Comparator | Sep 2026 → Feb 2029 expected | infertility disorder | Fundacion Dexeus | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-05-03 | Ferring Pharmaceuticals | Results Ferring Pharmaceuticals announces results of the IRIS Study: A comparative analysis of individualised vs.conventional recombinant follicular stimulating hormone dosing in Indian infertile patients ferring.com ↗
The study shows comparable efficacy and safety of individualized dosing of follitropin delta versus conventional dosing of follitropin alfa on ovarian stimulation, with reported rates of ongoing pregnancy rate and live birth rate in follitropin delta numerically higher. |
| 2024-05-17 | Ferring Pharmaceuticals | Results Ferring announces results demonstrating the efficacy and safety of follitropin delta for women undergoing in vitro fertilisation using an agonist protocol ferring.com ↗
Results from this randomised, controlled, open-label, multicentre trial showed that a statistically significant mean difference of 1.3 extra oocytes (95% CI: 0.22; 2.40, p=0.0185) were retrieved for women using the GnRH agonist protocol versus women using antagonist protocol. |
| 2023-03-13 | Ferring Pharmaceuticals | Results Ferring announces abstract of the first prospective, multi-national, real-world study of Rekovelle® (follitropin delta) at the congress of the Pacific Society for Reproductive Medicine ferring.com ↗
The large, prospective, multi-national study confirms the effectiveness and safety of Rekovelle in routine clinical practice, with ongoing pregnancy rates similar to Phase 3 RCTs. |
| 2021-06-29 | Ferring Pharmaceuticals | Results Ferring presents new data at ESHRE 2021 supporting the use of Rekovelle® (follitropin delta) for individualized fertility treatment ferring.com ↗
New study demonstrates that individualised dosing with Rekovelle® (follitropin delta) was comparable to conventional dosing with follitropin alfa in terms of ongoing pregnancy rate in a broad Asian population. |
All press releases naming this drug 4 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Follitropin Delta | “REKOVELLE (Follitropin Delta)” NCT05263388 ↗ |
| Known as | FE 999049 | “Follitropin Delta (FE 999049)” NCT01956110 ↗6“Follitropin Delta (FE 999049)” NCT01956123 ↗ |
| Known as | FE-999049 (R-HFSH) | ChEMBL registry synonym — accepted as the source's own label CHEMBL5315064 ↗ |
| Known as | FE-999049 (RECOMBINANT FSH) | ChEMBL registry synonym — accepted as the source's own label CHEMBL5315064 ↗ |
| Known as | Rekovelle | “Among gonadotropins, follitropin delta (REKOVELLE) is a recombinant FSH with allowing for individualized dosing based on anti-Müllerian hormone (AMH) levels and body weight.” NCT06997900 ↗5“Administration of a higher dose of Rekovelle (follitropin delta) to increase the ovarian response to 17 oocytes” NCT04778358 ↗ “Follitropin delta (Rekovelle) 12 mcg/daily” NCT05521828 ↗ “REKOVELLE (Follitropin Delta)” NCT03483545 ↗ “REKOVELLE (Follitropin Delta)” NCT07153367 ↗ |
| Action | Activate | “Follicle stimulating hormone receptor agonist” CHEMBL5315064 ↗ |
| Modality | Protein / enzyme biologic | “a novel recombinant human FSH (rhFSH; FE 999049)” PMID 25256937 ↗ Sep 2014 |
| Route | Subcutaneous | “Single daily subcutaneous administration through pre-filled injection pen” NCT03228680 ↗ |
| Target | FSHR | “Follicle stimulating hormone receptor agonist” CHEMBL5315064 ↗ |