Drugs / Corifollitropin alfa
Corifollitropin alfa
also known as
Org 36286 · CFA · Elonva · Corifollitropin alpha · corifollitropin α · MK-8962 · SCH 900962 · CFα · +2 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Elonva | — | 2010-01-25 | europa.eu ↗ |
Trials 40 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02448459 | May 2015 → Mar 2016 | infertility disorder | University of Sao Paulo | Completed | No outcome recorded |
| Phase 1 | NCT00647933 | Jun → Dec 2000 | infertility disorder | Organon and Co | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01319695 | Jan 2011 → Jul 2016 | female infertility | National and Kapodistrian University of Athens | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT01732068 | Jul 2012 → May 2013 | infertility disorder, ovarian dysfunction | University Hospital Brussels | Completed | No outcome recorded |
| Phase 2 | NCT01732094 | Jul 2012 → May 2013 | infertility disorder, ovarian dysfunction | University Hospital Brussels | Completed | No outcome recorded |
| Phase 2 | NCT00697255 | May 2007 → Apr 2008 | female infertility | Organon and Co | Terminated | No outcome recorded |
| Phase 2 | NCT00702351 | Dec 2005 → Mar 2007 | — | Organon and Co | Completed | No outcome recorded |
| Phase 2 | NCT00598208 | May 2003 → Mar 2004 | — | Organon and Co | Completed | No outcome recorded |
| Phase 2 | NCT00702585 | Aug 2001 → Oct 2002 | female infertility | Organon and Co | Completed | No outcome recorded |
| Phase 2 | NCT00702806 | Jul 2001 → Oct 2002 | infertility disorder | Organon and Co | Completed | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT06134479 | Dec 2023 → Sep 2025 | infertility disorder | Fundacion Dexeus | Completed | No outcome recorded |
| Phase 3 | NCT03197077 | Nov 2017 → Dec 2022 | female infertility, polycystic ovary syndrome | University Hospital Brussels | Completed | No outcome recorded |
| Phase 3 | NCT03019575 | Feb 2017 → May 2020 | hypogonadotropic hypogonadism | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT02414737 | Feb 2016 → Jun 2017 | infertility disorder | Flinders Fertility | Completed | No outcome recorded |
| Phase 3 | NCT01599494 | Mar 2014 → May 2015 | infertility disorder | Organon and Co | Withdrawn | No outcome recorded |
| Phase 3 | NCT01816321 | Mar 2013 → May 2016 | infertility disorder, ovarian dysfunction | University Hospital Brussels | Completed | No outcome recorded |
| Phase 3 | NCT01709331 | Feb 2013 → Apr 2015 | hypogonadotropic hypogonadism | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT01146418 | Jun 2010 → Jul 2013 | infertility disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT01144416 | Jun 2010 → Jul 2011 | infertility disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00702845 | Dec 2006 → Jul 2007 | infertility disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00696878 | Sep 2006 → Feb 2009 | — | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00696800 | Jun 2006 → Nov 2007 | — | Organon and Co | Completed | No outcome recorded |
| Phase 415 trials | ||||||
| Phase 4 | NCT06175832 | Jan 2025 → Dec 2027 expected | — | University Hospital, Ghent | Recruiting | No outcome recorded |
| Phase 4 | NCT05815719 | Nov 2022 → Apr 2023 | infertility disorder | Instituto Bernabeu | Completed | No outcome recorded |
| Phase 4 | NCT04695483 | Feb 2022 → Jan 2024 | infertility disorder | IRCCS San Raffaele | Completed | No outcome recorded |
| Phase 4 | NCT04487925 | Jan 2022 → Sep 2024 | ovarian disorder | University Hospital, Ghent | Unknown | No outcome recorded |
| Phase 4 | NCT04446845 | Oct 2020 → Jan 2023 | infertility disorder | Fundacion Dexeus | Completed | No outcome recorded |
| Phase 4 | NCT03939390 | Jan 2020 → Apr 2022 | — | Instituto Bernabeu | Completed | No outcome recorded |
| Phase 4 | NCT03939403 | Nov 2019 → May 2021 | ovarian hyperstimulation syndrome | Instituto Bernabeu | Completed | No outcome recorded |
| Phase 4 | NCT02606500 | Mar 2016 → Jan 2017 | obesity disorder | University Medical Centre Ljubljana | Completed | No outcome recorded |
| Phase 4 | NCT02471677 | Sep 2015 → Sep 2016 | infertility disorder | Eugonia | Unknown | No outcome recorded |
| Phase 4 | NCT02490150 | Feb 2015 → Jun 2016 | — | Fundacion Dexeus | 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 | NCT02254928 | Sep 2014 → Jul 2015 | female infertility | Vida Recoletas Sevilla | Terminated | No outcome recorded |
| Phase 4 | NCT02215135 | Jan 2014 → Jun 2015 | — | Shin Kong Wu Ho-Su Memorial Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02070198 | Dec 2013 → Nov 2014 | female infertility | Bioroma | Unknown | No outcome recorded |
| Phase 4 | NCT02046655 | Jan 2011 → Mar 2014 | infertility disorder | Aristotle University Of Thessaloniki | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06193135 | Jul → Dec 2025 overdue | female infertility | Instituto Valenciano de Infertilidad, IVI VALENCIA | Recruiting | No outcome recorded |
| — | NCT04416607 | Jun 2018 → Jan 2019 | female infertility | Hospital de Clinicas de Porto Alegre | Completed | No outcome recorded |
| — | NCT03816670 | Apr 2017 → Apr 2018 | infertility disorder | University of Turin, Italy | Completed | No outcome recorded |
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 45 trials | ||||||
| Phase 4 | NCT03177538 Comparator | Sep 2017 → Nov 2018 | female infertility | D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology | Completed | No outcome recorded |
| Phase 4 | NCT02466204 Comparator | Jun 2015 → Aug 2016 | infertility disorder | Vietnam National University | Completed | No outcome recorded |
| Phase 4 | NCT02402192 Comparator | Apr → Sep 2015 | female infertility | IVI Madrid | Terminated | No outcome recorded |
| Phase 4 | NCT03208972 Background | Oct 2014 → Nov 2015 | infertility disorder | AZ Jan Palfijn Gent | Completed | No outcome recorded |
| Phase 4 | NCT01633580 Comparator | Dec 2011 → Mar 2013 | infertility disorder | University Hospital Brussels | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06635538 Background | Oct 2024 → Apr 2025 overdue | female infertility | Fundacion Dexeus | Recruiting | No outcome recorded |
| — | NCT03555942 Comparator | May 2018 → Nov 2021 | infertility disorder | Fundacion Dexeus | Completed | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 52 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | corifollitropin alfa | “Woman in long acting FSH and GnRH antagonist arm receive an initial dose of 150 mcg Corifollitropin alfa on second day of the menstrual cycle followed by a fixed daily dose of...” NCT02070198 ↗39“The aim of the present study is to determine, whether clinical efficacy of 150 mcg of Corifollitropin alfa is the same in normal weighing and obese women.” NCT02606500 ↗ “recombinant long-acting FSH [FSH-carboxy terminal peptide (CTP), ORG 36286, corifollitropin alfa; NV Organon, The Netherlands]” PMID 15579793 ↗ Dec 2004 “a first subcutaneous (SC) injection of corifollitropin alfa (CFA) (Elonva®) 150μg will be administered” NCT06134479 ↗ “Corifollitropin alfa for ovarian stimulation in IVF: a randomized trial in lower-body-weight women.” PMID 20483664 ↗ Mar 2010 “Corifollitropin Alfa: 100 mcg on the 3rd day of the controlled ovarian stimulation.” NCT02448459 ↗ “corifollitropin alfa (Elonva” NCT04446845 ↗ |
| Known as | CFA | “Recombinant DNA technologies have produced Corifollitropin alfa (CFa) used during IVF/ICSI in order to keep the circulating FSH levels above the threshold necessary to support...” PMID 28508691 ↗ May 20173“a first subcutaneous (SC) injection of corifollitropin alfa (CFA) (Elonva®) 150μg will be administered” NCT06134479 ↗ “A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation” NCT04487925 ↗ “Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1” NCT06635538 ↗ |
| Known as | CFα | “corifollitropin-α (CFα) late-start administration” PMID 32185595 ↗ Mar 2020 |
| Known as | corifollitrophin alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02414737 ↗ |
| Known as | Corifollitropin alpha | “Ovarian stimulation protocol will be performed with a single dose of 100 μg (<60 kg) or 150 μg (≥60 kg) of corifollitropin alpha (Elonva, Schering-Plough, Brazil) in group 1” NCT04416607 ↗1“Under current practice, 67 participants will be stimulated with a single injection of 100 mg, sc of Corifollitropin alpha (Elonva®).” NCT02402192 ↗ |
| Known as | corifollitropin α | “This study aimed to evaluate the degree of satisfaction in oocyte donors undergoing treatment with corifollitropin α, a synthetic recombinant rFSH which replaces daily FSH...” PMID 23352098 ↗ Dec 20121“corifollitropin-α (CFα) late-start administration” PMID 32185595 ↗ Mar 2020 |
| Known as | Elonva | “a first subcutaneous (SC) injection of corifollitropin alfa (CFA) (Elonva®) 150μg will be administered” NCT06134479 ↗ |
| Known as | FSH-carboxy terminal peptide (CTP) | “recombinant long-acting FSH [FSH-carboxy terminal peptide (CTP), ORG 36286, corifollitropin alfa; NV Organon, The Netherlands]” PMID 15579793 ↗ Dec 2004 |
| Known as | MK-8962 | “MK-8962 (Corifollitropin Alfa)” NCT01709331 ↗ |
| Known as | Org 36286 | “recombinant long-acting FSH [FSH-carboxy terminal peptide (CTP), ORG 36286, corifollitropin alfa; NV Organon, The Netherlands]” PMID 15579793 ↗ Dec 20045“SCH 900962 / Corifollitropin alfa / Org 36286” NCT01144416 ↗ |
| Known as | SCH 900962 | “a single injection of corifollitropin alfa (SCH 900962)” NCT01146418 ↗1“SCH 900962 / Corifollitropin alfa / Org 36286” NCT01144416 ↗ |
| Modality | Protein / enzyme biologic | “Corifollitropin alfa, a fusion protein lacking LH activity” PMID 19684043 ↗ Aug 2009 |
| Route | Subcutaneous | “single subcutaneous dose of Org 36286 15 μg” NCT00647933 ↗ |