Drugs / Follitropin beta
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Puregon | — | 1996-05-02 | europa.eu ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00702806 | Jul 2001 → Oct 2002 | infertility disorder | Organon and Co | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT00696800 | Jun 2006 → Nov 2007 | — | Organon and Co | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT04695483 | Feb 2022 → Jan 2024 | infertility disorder | IRCCS San Raffaele | Completed | No outcome recorded |
| Phase 4 | NCT02213627 | Oct 2014 → Sep 2015 | female reproductive system disorder, infertility disorder | IVI Madrid | Unknown | No outcome recorded |
| Phase 4 | NCT00823472 | Jan 2009 → Oct 2010 | female infertility | UMC Utrecht | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable1 trial | ||||||
| — | NCT01882166 | Oct 2013 → Jan 2015 | female infertility | St. Olavs Hospital | Terminated | No outcome recorded |
| Comparator or background therapy20 trials | ||||||
| Phase 1 | NCT05330130 Comparator | Jul 2023 → Mar 2024 | female infertility, ovarian dysfunction | ART Fertility Clinics LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT01319695 Comparator | Jan 2011 → Jul 2016 | female infertility | National and Kapodistrian University of Athens | Completed | Missed primary |
| Phase 2 | NCT02309671 Comparator | Dec 2014 → Nov 2015 | female infertility | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 2/3 | NCT01590173 Comparator | Jan 2012 → Jul 2016 | infertility disorder | National and Kapodistrian University of Athens | Completed | No outcome recorded |
| Phase 3 | NCT06134479 Comparator | Dec 2023 → Sep 2025 | infertility disorder | Fundacion Dexeus | Completed | No outcome recorded |
| Phase 3 | NCT03197077 Comparator | Nov 2017 → Dec 2022 | female infertility, polycystic ovary syndrome | University Hospital Brussels | Completed | No outcome recorded |
| Phase 3 | NCT03228680 Comparator | Jul 2017 → Jun 2019 | female infertility | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01146418 Comparator | Jun 2010 → Jul 2013 | infertility disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT01144416 Comparator | Jun 2010 → Jul 2011 | infertility disorder | Organon and Co | Completed | Met primary |
| Phase 3 | NCT01081639 Comparator | Nov 2003 → Sep 2004 | infertility disorder, ovarian disorder | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 4 | NCT06175832 Background | Jan 2025 → Dec 2027 expected | — | University Hospital, Ghent | Recruiting | No outcome recorded |
| Phase 4 | NCT04487925 Comparator | Jan 2022 → Sep 2024 | ovarian disorder | University Hospital, Ghent | Unknown | No outcome recorded |
| Phase 4 | NCT02471677 Comparator | Sep 2015 → Sep 2016 | infertility disorder | Eugonia | Unknown | No outcome recorded |
| Phase 4 | NCT02466204 Comparator | Jun 2015 → Aug 2016 | infertility disorder | Vietnam National University | Completed | No outcome recorded |
| Phase 4 | NCT00805935 Comparator | Jan 2009 → Jul 2010 | infertility disorder, polycystic ovary syndrome | Ferring Pharmaceuticals | Completed | Missed primary |
| Phase 4 | NCT00802360 Comparator | Dec 2008 → Nov 2009 | infertility disorder | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00750100 Comparator | Sep 2007 → Jan 2008 | infertility disorder | University Hospital Brussels | Completed | No outcome recorded |
| Phase 4 | NCT00225433 Comparator | Sep 2005 → Dec 2006 | infertility disorder | University of Pennsylvania | Completed | No outcome recorded |
| — | NCT03300518 Background | Nov 2017 → Jun 2021 | infertility disorder | Reproductive & Genetic Hospital of CITIC-Xiangya | Completed | Missed primary |
| — | NCT02635607 Background | Jan → Dec 2016 | female infertility | Chong Qing Reproducive and Genetic Institute | Unknown | No outcome recorded |
Evidence & citations 12 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 beta | “In this prospective case-control study, we compared 70 participants treated with 150 μg CFa combined with 150 IU of follitropin beta (study group) with 70 subfertile...” PMID 28508691 ↗ May 2017 |
| Known as | Fertavid | ChEMBL registry synonym — accepted as the source's own label CHEMBL5315126 ↗ |
| Known as | Folitropina beta | ChEMBL registry synonym — accepted as the source's own label CHEMBL5315126 ↗ |
| Known as | Follistim | “150 IU rFSH (Puregon/Follistim) until the day of triggering final oocyte maturation” PMID 15126522 ↗ May 2004 |
| Known as | Follitropine beta | ChEMBL registry synonym — accepted as the source's own label CHEMBL5315126 ↗ |
| Known as | Puregon | “for ovarian stimulation both recombinant FSH (Puregon; Organon, Oss, Netherlands or Gonal F; Serono, Rome, Italy) and human menopausal gonadotrophin” NCT01590173 ↗9“The control group received a standard treatment with rFSH (Puregon) plus a GnRH-antagonist, daily from Day 6 of stimulation.” PMID 19617207 ↗ Jul 2009 “stimulation of egg production by human urine derived FSH (Fostimon®) and recombinant FSH (Puregon®) will be compared.” NCT01882166 ↗ “Puregon 50 IU” NCT02213627 ↗ “Puregon” NCT00823472 ↗ |
| Known as | recFSH | “recFSH (follitropin beta)” NCT01146418 ↗1“RecFSH / follitropin beta” NCT01144416 ↗ |
| Known as | rFSH | “a daily SC dose of rFSH (Puregon®) 200IU/day up to the day of Triptorelin (Decapeptyl®) 0.2 mg administration” NCT06134479 ↗ |
| Action | Activate | “Follicle stimulating hormone receptor agonist” CHEMBL5315126 ↗ |
| Modality | Protein / enzyme biologic | “ovarian stimulation with recombinant follicle stimulating hormone (FSH)” NCT00225433 ↗ |
| Route | Subcutaneous | “Daily SC injections with 200 IU fixed dose recFSH” NCT00696800 ↗ |
| Target | FSHR | “Follicle stimulating hormone receptor agonist” CHEMBL5315126 ↗ |