Drugs / Gonal-f
Gonal-f
also known as
Follitropin alfa · follitropin alpha · r-FSH · Primapur · AFOLIA-150 · Domestic Recombinant Human Follitropin · FOLITIME · Follitropin alfa (r-hFSH) · +7 more
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | FOLLISTIM AQ | — | 2010-06-28 – 2011-08-22 | fda.gov ↗ |
| Label expansion | US (FDA) | GONAL-F | — | 2000-05-24 | fda.gov ↗ |
| Approved | US (FDA) | FOLLISTIM | — | 1997-09-29 | fda.gov ↗ |
| Approved | EU (EMA) | GONAL-f | — | 1995-10-20 | europa.eu ↗ |
Trials 34
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 1 met primary | ||||||
| Phase 1 | NCT07269327 | Nov 2025 → Mar 2026 | infertility disorder | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT06864793 | Apr 2025 → Feb 2026 overdue | female infertility | Qilu Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03535103 | Jun 2018 → Dec 2019 | female infertility | Alphamab Jilin Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT03857230 | Oct 2015 → May 2016 | — | IVFarma LLC | Completed | No outcome recorded |
| Phase 1 | NCT02592031 | Feb → May 2009 | — | Merckle GmbH | Completed | Met primary |
| Phase 22 trials | ||||||
| Phase 2 | NCT00553514 | Dec 2007 → Mar 2009 | female infertility | Merck KGaA, Darmstadt, Germany | Terminated | No outcome recorded |
| Phase 2 | NCT00505752 | Jan 2007 → Sep 2008 | infertility disorder | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02349945 | Jan 2011 → Dec 2014 | male infertility | Azienda USL Modena | Completed | No outcome recorded |
| Phase 310 trials · 2 met primary | ||||||
| Phase 3 | NCT07340827 | Feb 2026 → Jul 2028 expected | infertility disorder | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Recruiting | 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 | NCT02454556 | Apr 2015 → Dec 2016 | infertility disorder | Gema Biotech S.A. | Completed | No outcome recorded |
| Phase 3 | NCT01121666 | Jun 2010 → Dec 2011 | infertility disorder | Finox AG | Completed | Met primary |
| Phase 3 | NCT02335879 | May 2008 → Aug 2009 | anovulation | Changchun GeneScience Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01185782 | Feb → Dec 2007 | female infertility | Merck KGaA, Darmstadt, Germany | Completed | Met primary |
| Phase 3 | NCT00378001 | Mar 2005 → May 2006 | female infertility | IBSA Institut Biochimique SA | Completed | No outcome recorded |
| Phase 3 | NCT01183143 | May 2004 → Mar 2006 | infertility disorder, ovarian disorder | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 3 | NCT01081639 | Nov 2003 → Sep 2004 | infertility disorder, ovarian disorder | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 413 trials · 1 missed | ||||||
| Phase 4 | NCT06571214 | Sep 2024 → Dec 2026 expected | infertility disorder | Nanjing University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04983173 | Nov 2021 → Mar 2026 | infertility disorder | Fundacion Dexeus | Completed | No outcome recorded |
| Phase 4 | NCT03057574 | Feb → Dec 2017 | female infertility | MinaPharm Pharmaceuticals | Unknown | No outcome recorded |
| Phase 4 | NCT02719093 | Jul 2016 → Jul 2017 | male infertility, varicocele | U.O. Chirurgia Andrologica | Unknown | No outcome recorded |
| Phase 4 | NCT02834117 | May 2015 → Feb 2018 | infertility disorder | Dr Massin Nathalie | Completed | No outcome recorded |
| Phase 4 | NCT01948804 | Jan → Mar 2014 | — | Pınar Özcan Cenksoy | Unknown | No outcome recorded |
| Phase 4 | NCT01871532 | Jul 2013 → Mar 2014 | infertility disorder | Merck KGaA, Darmstadt, Germany | Terminated | No outcome recorded |
| Phase 4 | NCT01081626 | Mar 2009 → Mar 2011 | female infertility | Merck KGaA, Darmstadt, Germany | Completed | Missed primary |
| Phase 4 | NCT01210144 | Aug 2008 → Aug 2010 | — | Merck KGaA, Darmstadt, Germany | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00575302 | Dec 2007 → Dec 2009 | infertility disorder | Centre Hospitalier Chretien | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00439829 | Feb 2007 → May 2010 | female infertility | University of Saskatchewan | Completed | No outcome recorded |
| Phase 4 | NCT00334425 | Apr 2006 → ? | infertility disorder | Central Jutland Regional Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00249834 | Sep 2004 → Jan 2006 | infertility disorder | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT05103228 | Dec 2021 → Jul 2023 | infertility disorder, ovarian dysfunction | Peter Kovacs MD | Completed | No outcome recorded |
| — | NCT04134130 | Sep → Dec 2019 | prostate cancer | Lund University | Completed | No outcome recorded |
| — | NCT03098199 | Oct 2015 → Dec 2017 | infertility disorder | Reproductive Specialists of New York | Completed | No outcome recorded |
| Comparator or background therapy41 trials | ||||||
| Phase 1 | NCT01604044 Comparator | May 2012 → Sep 2013 | female infertility | Catholic University of the Sacred Heart | Completed | No outcome recorded |
| Phase 1 | NCT01477073 Comparator | Oct 2011 → Apr 2012 | female infertility | Glycotope GmbH | Completed | No outcome recorded |
| Phase 1 | NCT01354886 Comparator | Apr → Oct 2011 | female infertility | Glycotope GmbH | Completed | No outcome recorded |
| Phase 1 | NCT01141270 Comparator | Jan → Aug 2009 | — | Polymun Scientific GmbH | Completed | No outcome recorded |
| Phase 1/2 | NCT00823004 Comparator | Jun 2008 → Feb 2009 | ovarian hyperstimulation syndrome | Yazd Research & Clinical Center for Infertility | Completed | No outcome recorded |
| Phase 2 | NCT01794208 Comparator | Jan → Jul 2013 | infertility disorder | Glycotope GmbH | Completed | Missed primary |
| Phase 2 | NCT01426386 Comparator | Sep 2011 → Apr 2012 | female infertility | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT01337531 Comparator | May → Nov 2011 | polycystic ovary syndrome | Genesis Center for Fertility & Human Pre-Implantation Genetics | Unknown | No outcome recorded |
| Phase 2 | NCT01204840 Comparator | Sep 2010 → May 2015 | infertility disorder, ovarian dysfunction | Ottawa Fertility Centre | Completed | No outcome recorded |
| Phase 2/3 | NCT01590173 Comparator | Jan 2012 → Jul 2016 | infertility disorder | National and Kapodistrian University of Athens | Completed | No outcome recorded |
| Phase 3 | NCT06173869 Comparator | Mar 2024 → May 2025 | female infertility | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT06091436 Comparator | Mar → Dec 2023 | infertility disorder | Changchun GeneScience Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05149924 Comparator | Oct 2018 → Oct 2019 | female infertility | Qilu Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03296527 Comparator | Dec 2017 → Jan 2020 | — | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03088137 Comparator | Feb 2017 → Aug 2018 | female infertility | IVFarma LLC | Completed | No outcome recorded |
| Phase 3 | NCT03506243 Comparator | Apr 2015 → Sep 2016 | female infertility | Hangzhou YuYuan Bioscience Technology Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01956123 Comparator | Mar 2014 → May 2015 | infertility disorder | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02047227 Comparator | Jan 2014 → Aug 2015 | infertility disorder | Merck KGaA, Darmstadt, Germany | Completed | Missed primary |
| Phase 3 | NCT01956110 Comparator | Oct 2013 → May 2015 | infertility disorder | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01653743 Background | Sep 2012 → Nov 2014 | anovulation, hypothalamic dysfunction, polycystic ovary syndrome | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 3 | NCT01497197 Background | May 2012 → Jan 2014 | infertility disorder, pituitary deficiency | Merck KGaA, Darmstadt, Germany | Terminated | No outcome recorded |
| Phase 3 | NCT01297465 Comparator | May 2011 → Oct 2012 | — | Merck KGaA, Darmstadt, Germany | Completed | Missed primary |
| Phase 3 | NCT01820728 Comparator | Jan 2007 → Oct 2012 | anovulation, infertility disorder | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00335725 Comparator | Mar 2003 → Dec 2005 | infertility disorder | IBSA Institut Biochimique SA | Completed | No outcome recorded |
| Phase 4 | NCT05405686 Background | May → Aug 2023 | female infertility due to oocyte meiotic arrest | CRG UZ Brussel | Withdrawn | No outcome recorded |
| Phase 4 | NCT05815719 Comparator | Nov 2022 → Apr 2023 | infertility disorder | Instituto Bernabeu | Completed | No outcome recorded |
| Phase 4 | NCT04997525 Comparator | Apr 2021 → May 2024 | infertility disorder | Copenhagen University Hospital at Herlev | Completed | No outcome recorded |
| 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 | NCT02892942 Background | Jan 2017 → Feb 2019 | infertility disorder | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 4 | NCT03181685 Comparator | Dec 2016 → Dec 2019 | infertility disorder | Andros Day Surgery Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02140515 Comparator | Nov 2012 → Dec 2015 | infertility disorder | Royan Institute | Unknown | No outcome recorded |
| Phase 4 | NCT02108223 Comparator | Jan 2009 → Apr 2011 | infertility disorder | Sisli Hamidiye Etfal Training and Research Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00829244 Comparator | Aug 2008 → Jan 2010 | infertility disorder | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 4 | NCT01365936 Comparator | Jan → Jun 2008 | polycystic ovary syndrome | Zekai Tahir Burak Women's Health Research and Education Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00328926 Comparator | Mar 2006 → May 2012 | hypogonadotropic hypogonadism | EMD Serono | Terminated | No outcome recorded |
| Phase 4 | NCT00257556 Comparator | Oct 2005 → Jul 2008 | female infertility | Ferring Pharmaceuticals | Completed | Missed primary |
| — | NCT06481696 Comparator | Jun 2024 → Dec 2025 | infertility disorder | Andros Day Surgery Clinic | Unknown | No outcome recorded |
| — | NCT07128394 Background | Feb 2024 → Sep 2026 overdue | female infertility | Nanjing University | Recruiting | No outcome recorded |
| — | NCT03914651 Comparator | Apr 2019 → Dec 2022 | infertility disorder | Reproductive & Genetic Hospital of CITIC-Xiangya | Unknown | No outcome recorded |
| — | NCT03737253 Comparator | Sep 2016 → Dec 2021 | female infertility | Lund University | Completed | No outcome recorded |
| — | NCT02244866 Comparator | Oct 2012 → Apr 2014 | infertility disorder | Vietnam National University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-05-03 | Ferring Pharmaceuticals | Results Ferring Pharmaceuticals announces results of the IRIS Study: A comparative analysis of individualised vs.conventional recombinant follicular stimulating hormone dosing in Indian infertile patients ferring.com ↗
The study shows comparable efficacy and safety of individualized dosing of follitropin delta versus conventional dosing of follitropin alfa on ovarian stimulation, with reported rates of ongoing pregnancy rate and live birth rate in follitropin delta numerically higher. |
| 2021-06-29 | Ferring Pharmaceuticals | Results Ferring presents new data at ESHRE 2021 supporting the use of Rekovelle® (follitropin delta) for individualized fertility treatment ferring.com ↗
New study demonstrates that individualised dosing with Rekovelle® (follitropin delta) was comparable to conventional dosing with follitropin alfa in terms of ongoing pregnancy rate in a broad Asian population. |
| 2016-02-03 | Merck KGaA, Darmstadt, Germany | Regulatory Merck erhält Zulassung für neue Version der Pens zur Fertilitätsbehandlung prnewswire.com ↗
Merck, ein führendes Wissenschafts- und Technologieunternehmen, hat heute die europäische Zulassung für den vorgefüllten GONAL- f ® Pen 2.0 von der Europäischen Arzneimittelagentur (EMA) erhalten. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-05-03 | Ferring Pharmaceuticals | Ferring Pharmaceuticals announces results of the IRIS Study: A comparative analysis of individualised vs.conventional recombinant follicular stimulating hormone dosing in Indian infertile patients ferring.com ↗ |
| 2021-06-29 | Ferring Pharmaceuticals | Ferring presents new data at ESHRE 2021 supporting the use of Rekovelle® (follitropin delta) for individualized fertility treatment ferring.com ↗ |
| 2016-02-03 | Merck KGaA, Darmstadt, Germany | Merck erhält Zulassung für neue Version der Pens zur Fertilitätsbehandlung prnewswire.com ↗ |
| 2001-05-16 | Alkermes, Inc. | Alkermes and Serono to Proceed With Development of Long-acting Formulation of Recombinant Human Follicle Stimulating Hormone (R-hFSH) alkermes.com ↗ |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 76 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GONAL-F | “This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa)...” NCT02454556 ↗43“for ovarian stimulation both recombinant FSH (Puregon; Organon, Oss, Netherlands or Gonal F; Serono, Rome, Italy) and human menopausal gonadotrophin” NCT01590173 ↗ “Women randomized to the day 1 treatment group will be instructed to begin ovarian stimulation therapy (Gonal-f, Serono Canada) on day 1” NCT00439829 ↗ “On menstrual cycle day 2 or day 3, 300IU rFSH Gonal-F® will be administrated daily till the day of trigger.” NCT03914651 ↗ “stimulation with hMG (Menogon; Ferring Pharmaceuticals. Istanbul) or rFSH (Gonal-F; Serono Istanbul).” NCT01365936 ↗ “gonadotropin stimulation 412 IU recombinant follicle stimulating hormone (r-FSH; Gonal F)” NCT01204840 ↗ “Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6” NCT01497197 ↗ “Gonal-f 300 IU subcutaneously 3 times per week for 5 weeks.” NCT04134130 ↗ “recombinant FSH (Gonal-F, Serono, Aubonne, Switzerland)” NCT00823004 ↗ “Gonal-f®: follitropin alpha, administration of 300 U” NCT00575302 ↗ “Gonal-F is a recombinant FSH preparation.” NCT00335725 ↗ |
| Known as | AFOLIA-150 | “AFOLIA-150 (Follitropin alfa)” NCT01121666 ↗ |
| Known as | Domestic Recombinant Human Follitropin | “Domestic Recombinant Human Follitropin (Gonal-F) for Injection” NCT02335879 ↗ |
| Known as | FOLITIME | “This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa)...” NCT02454556 ↗ |
| Known as | Follitropin alfa | “One-hundred patients with a morphologic aspect of hypospermatogenesis at testicular cytology will take recombinant follitropin alfa 150UI i.m. 3 times/week for at least three month.” NCT02719093 ↗33“Significantly lower mean daily (121.5 versus 167.4 IU; P < 0.001) and total (1288.5 versus 1810.0 IU; P < 0.001) doses of follitropin alfa were administered in the CONSORT group.” PMID 25596910 ↗ Dec 2014 “Fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU will be administered subcutaneously for 7 days.” NCT00328926 ↗ “Follitropin alfa is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin” NCT02454556 ↗ “starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day” NCT01653743 ↗ “GONAL-F (Follitropin Alfa)” NCT05263388 ↗ “Follitropin alfa” NCT06864793 ↗ “follitropin alfa” NCT07128394 ↗ “Follitropin alfa” NCT06864793 ↗ |
| Known as | Follitropin alfa (r-hFSH) | “Follitropin alfa (r-hFSH)” NCT02454556 ↗ |
| Known as | follitropin alpha | “Ovulation is induced by recombinant follitropin alpha and recombinant choriogonadotropin” NCT02834117 ↗ |
| Known as | Ovaleap | “CC 50 mg/day (Omifin®) + rFSH 150 IU (Ovaleap®)” NCT04983173 ↗ |
| Known as | Primapur | “Follitropin alfa (Primapur)” NCT03857230 ↗1“Follitropin alfa (Primapur)” NCT03088137 ↗ |
| Known as | QL1012D | “Recombinant Human Follicle Stimulating Hormone Injection (QL1012D) and Gonal-F® in Healthy Female Volunteers” NCT06864793 ↗ |
| Known as | r-FSH | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02108223 ↗ |
| Known as | r-hFSH | “The purpose of this study is to assess the Pharmacokinetic (PK) of Recombinant human follicle-stimulating hormone (follitropin alfa) (r-hFSH) and Recombinant human luteinizing...” NCT07269327 ↗ |
| Known as | rechFSH | “Participants will receive fixed combination product of recombinant Follitropin alfa (rechFSH)/lutropin alfa (rechLH) in a 2:1 ratio.” NCT07340827 ↗ |
| Known as | recombinant Follicle Stimulating Hormone (rFSH) | “Follitropin alfa: Gonal-F or recombinant Follicle Stimulating Hormone (rFSH)” NCT02140515 ↗ |
| Known as | recombinant follicle-stimulating hormone | “recombinant follicle-stimulating hormone (r FSH)” PMID 24520446 ↗ Mar 2013 |
| Known as | recombinant FSH | “Human Menopausal Gonadotropin versus Recombinant FSH in Polycystic Ovary Syndrome Patients Undergoing In Vitro Fertilization.” PMID 24520446 ↗ Mar 2013 |
| Action | Activate | “for stimulation of the ovaries” NCT03737253 ↗ |
| Modality | Protein / enzyme biologic | “recombinant human follicle stimulating hormone (r-hFSH)” NCT00249834 ↗ |
| Route | Subcutaneous | “GONAL-f (follitropin alfa) will be administered subcutaneously” NCT00249834 ↗ |