Drugs / Follitropin beta
Follitropin beta
also known as
Puregon · RecFSH · Follistim · Fertavid · Folitropin Beta · Folitropin β · Folitropina beta · follitropin β · +3 more
Protein / enzyme biologic targets FSHR via activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | FOLLISTIM | — | 1997-09-29 | fda.gov ↗ |
| Approved | EU (EMA) | Puregon | — | 1996-05-02 | europa.eu ↗ |
Trials 11 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT00697255 | May 2007 → Apr 2008 | female infertility | Organon and Co | Terminated | No outcome recorded |
| Phase 2 | NCT00702806 | Jul 2001 → Oct 2002 | infertility disorder | Organon and Co | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01599494 | Mar 2014 → May 2015 | infertility disorder | Organon and Co | Withdrawn | No outcome recorded |
| Phase 3 | NCT00696800 | Jun 2006 → Nov 2007 | — | Organon and Co | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT07523022 | Sep 2024 → Sep 2026 expected | male infertility | Szeged University | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT04695483 | Feb 2022 → Jan 2024 | infertility disorder | IRCCS San Raffaele | Completed | No outcome recorded |
| Phase 4 | NCT02430740 | Jan 2016 → Dec 2023 | infertility disorder | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Unknown | No outcome recorded |
| Phase 4 | NCT02213627 | Oct 2014 → Sep 2015 | female reproductive system disorder, infertility disorder | IVI Madrid | Unknown | No outcome recorded |
| Phase 4 | NCT02069808 | Apr 2014 → Feb 2017 | — | Michigan Reproductive Medicine | Completed | No outcome recorded |
| Phase 4 | NCT00823472 | Jan 2009 → Oct 2010 | female infertility | UMC Utrecht | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01882166 | Oct 2013 → Jan 2015 | female infertility | St. Olavs Hospital | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 24 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05330130 Comparator | Jul 2023 → Mar 2024 | female infertility, ovarian dysfunction | ART Fertility Clinics LLC | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01319695 Comparator | Jan 2011 → Jul 2016 | female infertility | National and Kapodistrian University of Athens | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02309671 Comparator | Dec 2014 → Nov 2015 | female infertility | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01590173 Comparator | Jan 2012 → Jul 2016 | infertility disorder | National and Kapodistrian University of Athens | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT00702845 Background | Dec 2006 → Jul 2007 | infertility disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT01081639 Comparator | Nov 2003 → Sep 2004 | infertility disorder, ovarian disorder | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 49 trials | ||||||
| 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 | NCT01577199 Comparator | Apr → Dec 2012 | female infertility | Weill Medical College of Cornell University | Withdrawn | No outcome recorded |
| Phase 4 | NCT00805935 Comparator | Jan 2009 → Jul 2010 | infertility disorder, polycystic ovary syndrome | Ferring Pharmaceuticals | Completed | No outcome recorded |
| 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 |
| Phase not applicable4 trials | ||||||
| — | NCT06193135 Comparator | Jul → Dec 2025 overdue | female infertility | Instituto Valenciano de Infertilidad, IVI VALENCIA | Recruiting | No outcome recorded |
| — | NCT03300518 Background | Nov 2017 → Jun 2021 | infertility disorder | Reproductive & Genetic Hospital of CITIC-Xiangya | Completed | No outcome recorded |
| — | NCT02635607 Background | Jan → Dec 2016 | female infertility | Chong Qing Reproducive and Genetic Institute | Unknown | No outcome recorded |
| — | NCT01286051 Comparator | Jan 2011 → Sep 2012 | — | Houston Fertility Institute | Completed | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 37 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 | Folitropin Beta | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06193135 ↗ |
| Known as | Folitropin β | “Patients will undergo controlled ovarian stimulation with Folitropin β (Puregon) + Progevera 10 mg.” NCT06193135 ↗ |
| 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 20043“225 international units of gonadotropins (eg Follistim , Menopur)” NCT01577199 ↗ |
| Known as | follitropin β | “daily dose of rFSH (follitropin β) as a control” NCT06193135 ↗ |
| 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” NCT01144416 ↗ |
| Known as | recombinant Follicle Stimulating Hormone (recFSH) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00697255 ↗ |
| 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 ↗ |