Drugs / Corifollitropin alfa
Corifollitropin alfa
also known as
Org 36286 · CFA · Elonva · Corifollitropin alpha · corifollitropin α · MK-8962 · SCH 900962 · CFα · +1 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed ovarian hyperstimulation syndrome 1 milestone | |||||
| Filed | US (FDA) | — | ovarian hyperstimulation syndrome | 2013-09-09 | “today announced that the New Drug Application (NDA) for its investigational fertility treatment, corifollitropin alfa, has been accepted for standard review by the U.S.” merck.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Elonva | — | 2010-01-25 | europa.eu ↗ |
Trials 39
| 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 · 1 missed | ||||||
| Phase 1/2 | NCT01319695 | Jan 2011 → Jul 2016 | female infertility | National and Kapodistrian University of Athens | Completed | Missed primary |
| Phase 27 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT01732094 | Jul 2012 → May 2013 | infertility disorder, ovarian dysfunction | University Hospital Brussels | Completed | No outcome recorded |
| Phase 2 | NCT01732068 | 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 | Met primary |
| Phase 2 | NCT00702585 | Aug 2001 → Oct 2002 | female infertility | Organon and Co | Completed | Missed primary |
| Phase 2 | NCT00702806 | Jul 2001 → Oct 2002 | infertility disorder | Organon and Co | Completed | No outcome recorded |
| Phase 311 trials · 4 met primary · 1 missed | ||||||
| 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 | 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 | Missed primary |
| Phase 3 | NCT01709331 | Feb 2013 → Apr 2015 | hypogonadotropic hypogonadism | Organon and Co | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00702845 | Dec 2006 → Jul 2007 | infertility disorder | Organon and Co | Completed | Met primary |
| 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 | Met primary |
| Phase 415 trials · 2 met primary · 1 missed | ||||||
| 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 | Met primary |
| Phase 4 | NCT03939390 | Jan 2020 → Apr 2022 | — | Instituto Bernabeu | Completed | Missed primary |
| 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 Stop: Business |
| 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 | Met primary |
| 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 |
| Comparator or background therapy7 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 |
| — | NCT06635538 Background | Oct 2024 → Nov 2025 | female infertility | Fundacion Dexeus | Completed | No outcome recorded |
| — | NCT03555942 Comparator | May 2018 → Nov 2021 | infertility disorder | Fundacion Dexeus | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2013-09-09 | Merck Sharp & Dohme LLC | Regulatory Merck Announces FDA Acceptance of New Drug Application for Investigational Fertility Treatment merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for its investigational fertility treatment, corifollitropin alfa, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). |
| 2012-10-23 | Merck Sharp & Dohme LLC | Results Merck Announces Results From New Phase III Study Amongst Women for Corifollitropin Alfa, an Investigational Fertility Treatment for Controlled Ovarian Stimulation merck.com ↗
The study met its primary endpoint of achieving vital pregnancy rates with data revealing that a single injection of 150 mcg of corifollitropin alfa was non-inferior to seven daily injections of 300 IU recombinant follicle stimulating hormone (rFSH). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-09-09 | Merck Sharp & Dohme LLC | Merck Announces FDA Acceptance of New Drug Application for Investigational Fertility Treatment merck.com ↗ |
| 2012-10-23 | Merck Sharp & Dohme LLC | Merck Announces Results From New Phase III Study Amongst Women for Corifollitropin Alfa, an Investigational Fertility Treatment for Controlled Ovarian Stimulation merck.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 51 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 | 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 ↗ |