Drugs / Luveris
Luveris
also known as
lutropin alfa · r-hLH · rLH · LH · LH hormone · rechLH · Recombinant Human-Luteinizing Hormone · recombinant LH · +1 more
Protein / enzyme biologic targets LHCGR via activation
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Luveris | — | 2000-11-29 | europa.eu ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| 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 | NCT04899193 | May 2021 → May 2022 | — | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT04189133 | Jan 2022 → Jan 2025 | hypogonadotropic hypogonadism | University Hospital of Modena | Unknown | No outcome recorded |
| Phase 2 | NCT01029470 | Dec 2009 → Oct 2010 | infertility disorder | Peking University Third Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01079949 | Nov 2007 → Oct 2010 | female infertility | Merck KGaA, Darmstadt, Germany | Terminated | Missed primary Stop: Enrollment |
| Phase 35 trials | ||||||
| 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 | NCT06227949 | Feb 2024 → Dec 2029 expected | — | Ellen Greenblatt | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03741699 | Feb 2019 → May 2024 | female infertility | Instituto Valenciano de Infertilidad, IVI Alicante | Completed | No outcome recorded |
| Phase 3 | NCT01497197 | May 2012 → Jan 2014 | infertility disorder, pituitary deficiency | Merck KGaA, Darmstadt, Germany | Terminated | No outcome recorded |
| Phase 3 | NCT01121991 | Sep 2004 → Sep 2005 | infertility disorder | EMD Serono | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT06571214 | Sep 2024 → Dec 2026 expected | infertility disorder | Nanjing University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05405686 | May → Aug 2023 | female infertility due to oocyte meiotic arrest | CRG UZ Brussel | Withdrawn | No outcome recorded |
| Phase 4 | NCT01504139 | Jan 2012 → Apr 2014 | infertility disorder | Regionshospitalet Viborg, Skive | Completed | No outcome recorded |
| Phase 4 | NCT00820482 | Jan → May 2009 | — | Instituto Valenciano de Infertilidad, IVI VALENCIA | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07128394 | Feb 2024 → Sep 2026 overdue | female infertility | Nanjing University | Recruiting | No outcome recorded |
| — | NCT01223079 | Dec 2005 → Dec 2007 | — | Reproductive Medicine Associates of New Jersey | Completed | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 1 | NCT01604044 Comparator | May 2012 → Sep 2013 | female infertility | Catholic University of the Sacred Heart | Completed | No outcome recorded |
| Phase 2 | NCT01204840 Comparator | Sep 2010 → May 2015 | infertility disorder, ovarian dysfunction | Ottawa Fertility Centre | 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 | NCT02992808 Comparator | Dec 2016 → Jan 2018 | female infertility | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02140515 Comparator | Nov 2012 → Dec 2015 | infertility disorder | Royan Institute | Unknown | No outcome recorded |
| Phase 4 | NCT00889512 Comparator | Apr 2009 → May 2013 | female infertility, functional hypothalamic amenorrhea, hyperprolactinemia | University Reproductive Associates | Terminated | No outcome recorded |
| Phase 4 | NCT00439829 Background | Feb 2007 → May 2010 | female infertility | University of Saskatchewan | Completed | No outcome recorded |
| Phase 4 | NCT00328926 Comparator | Mar 2006 → May 2012 | hypogonadotropic hypogonadism | EMD Serono | Terminated | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Luveris | “Participants will be administered with 450 IU of lutropin alfa (Luveris) as subcutaneous injection on Day 1 in investigation period 1 or investigation period 2 or investigation...” NCT04899193 ↗16“75UI/day of rFSH (Gonal®, Serono) + 75UI/day of rLH (Luveris®, Serono)” NCT00820482 ↗ “LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase” NCT01504139 ↗ “Luveris© (lutropin alfa, MERCK SERONO) which is LH only preparation.” NCT02992808 ↗ “Recombinant Human Lutropin alfa for Injection (r-hLH, Luveris®)” NCT06571214 ↗ “150 IU of recombinant luteinizing hormone (r-LH; Luveris)” NCT01204840 ↗ “The IMP is Luveris. The comparator is Gonasi HP.” NCT04189133 ↗ “Pre-treatment with rLH (Luveris 75 IU),” NCT03741699 ↗ “r-hLH (Luveris)” NCT01223079 ↗ |
| Known as | LH | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01504139 ↗ |
| Known as | LH hormone | “Luveris® (LH hormone) is a new drug approved for egg production and is used in IVF.” NCT00889512 ↗ |
| Known as | lutropin alfa | “Participants will be administered with 450 IU of lutropin alfa (Luveris) as subcutaneous injection on Day 1 in investigation period 1 or investigation period 2 or investigation...” NCT04899193 ↗10“Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection will be administered subcutaneously once daily at a constant dose of 150 IU” NCT01079949 ↗ “Luveris© (lutropin alfa, MERCK SERONO) which is LH only preparation.” NCT02992808 ↗ “lutropin alfa” NCT07128394 ↗ |
| Known as | r-hLH | “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 ↗3“Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection will be administered subcutaneously once daily at a constant dose of 150 IU” NCT01079949 ↗ “Recombinant Human Lutropin alfa for Injection (r-hLH, Luveris®)” NCT06571214 ↗ |
| Known as | rechLH | “Participants will receive fixed combination product of recombinant Follitropin alfa (rechFSH)/lutropin alfa (rechLH) in a 2:1 ratio.” NCT07340827 ↗ |
| Known as | Recombinant Human-Luteinizing Hormone | “Recombinant Human-Luteinizing Hormone (Luveris) has been found to be well tolerated in human pharmacokinetic and pharmacodynamic studies” NCT01121991 ↗ |
| Known as | recombinant LH | “Recombinant LH Prior to Ovarian Stimulation in Poor Ovarian Responders (PRE-LH)” NCT03741699 ↗ |
| Known as | Recombinant Luteinizing Hormone (rLH) | “Lutropin alfa: Luveris or Recombinant Luteinizing Hormone (rLH)” NCT02140515 ↗ |
| Known as | rLH | “75UI/day of rFSH (Gonal®, Serono) + 75UI/day of rLH (Luveris®, Serono)” NCT00820482 ↗ |
| Action | Activate | “LH is a partial agonist of the LHCGR” NCT04189133 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 IU will be administered subcutaneously once daily.” NCT00328926 ↗ |
| Route | Subcutaneous | “75 IU will be administered subcutaneously once daily.” NCT00328926 ↗ |
| Target | LHCGR | “LH is a partial agonist of the LHCGR” NCT04189133 ↗ |