Drugs / Pergoveris
Pergoveris
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Pergoveris | — | 2007-06-25 | europa.eu ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04899193 | May 2021 → May 2022 | — | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 32 trials · 2 missed | ||||||
| Phase 3 | NCT02047227 | Jan 2014 → Aug 2015 | infertility disorder | Merck KGaA, Darmstadt, Germany | Completed | Missed primary |
| Phase 3 | NCT01297465 | May 2011 → Oct 2012 | — | Merck KGaA, Darmstadt, Germany | Completed | Missed primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT03400722 | Dec 2017 → Aug 2018 | female infertility, ovarian hyperstimulation syndrome | Nova Clinic, Russia | Unknown | No outcome recorded |
| Phase not applicable1 trial · 1 missed | ||||||
| — | NCT01623570 | Mar 2011 → May 2012 | hypogonadotropic hypogonadism | Centro Riproduzione e Andrologia | Completed | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 4 | NCT02992808 Comparator | Dec 2016 → Jan 2018 | female infertility | Sheba Medical Center | Unknown | No outcome recorded |
| — | NCT01565265 Comparator | Apr → Dec 2012 | female infertility | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-02-06 | EMD Serono Research & Development Institute, Inc. | Regulatory EMD Serono Advances Patient Access to IVF Medicines in the U.S., Aligned with National Health Priorities emdserono.com ↗
EMD Serono received the FDA's Commissioner's National Priority Voucher (CNPV) for one of its fertility products that is available in many countries outside of the U.S., known as Pergoveris® (follitropin alfa/lutropin alfa), a potential therapeutic option for follicular development in women undergoing ovarian stimulation and who are candidates for concurrent therapy with FSH (follicle stimulating hormone) and LH (luteinizing hormone). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-06 | EMD Serono Research & Development Institute, Inc. | EMD Serono Advances Patient Access to IVF Medicines in the U.S., Aligned with National Health Priorities emdserono.com ↗ |
| 2014-03-27 | Merck KGaA, Darmstadt, Germany | Merck anuncia início do estudo de fertilidade Fase III com Pergoveris em pacientes com baixa resposta ovariana prnewswire.com ↗ |
| 2014-03-27 | Merck KGaA, Darmstadt, Germany | Merck anuncia el inicio de la Fase III del Estudio de Fertilidad con Pergoveris en pacientes con respuesta ovárica deficiente prnewswire.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pergoveris | “As the recombinant preparation we will use Pergoveris© (follitropin alfa/lutropin alfa, MERCK SERONO) which contains 150 units of FSH + 75 units of LH and Luveris© (lutropin...” NCT02992808 ↗ |
| Known as | follitropin alfa/lutropin alfa | “Pergoveris© (follitropin alfa/lutropin alfa, MERCK SERONO) which contains 150 units of FSH + 75 units of LH” NCT02992808 ↗ |
| Known as | Pergoveris FD | “Drug: Pergoveris FD” NCT04899193 ↗ |
| Known as | Pergoveris Liquid | “Drug: Pergoveris Liquid” NCT04899193 ↗ |
| Modality | Protein / enzyme biologic | “recombinant human FSH (rhFSH) plus recombinant human luteinizing hormone (rhLH)” PMID 26194884 ↗ Jun 2015 |
| Route | Subcutaneous | “Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG)...” NCT01297465 ↗ |