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 22 · a red edge is where a trial was stopped
| 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 | ||||||
| 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 |
| 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 | No outcome recorded |
| Phase 2 | NCT01426386 | Sep 2011 → Apr 2012 | female infertility | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT03738618 | Oct 2018 → Dec 2020 | female infertility | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03740737 | Oct 2018 → Nov 2020 | infertility disorder | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03296527 | Dec 2017 → Jan 2020 | — | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03228680 | Jul 2017 → Jun 2019 | female infertility | Ferring Pharmaceuticals | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06154083 | Dec 2023 → Dec 2025 overdue | 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 |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06511791 Comparator | Jul 2024 → Oct 2025 | infertility disorder | Ferring Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT06466486 Comparator | Jun 2024 → Dec 2025 | infertility disorder | Ferring Pharmaceuticals | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03564509 Background | May 2018 → Oct 2019 | — | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07691073 Comparator | Sep 2026 → Feb 2029 expected | infertility disorder | Fundacion Dexeus | Not yet recruiting | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 28 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)” NCT07153367 ↗ “REKOVELLE (Follitropin Delta)” NCT03483545 ↗ |
| 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 ↗ |