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Luveris fixed dose
Luveris is a recombinant luteinizing hormone (LH) that stimulates ovarian steroidogenesis and follicle development in women undergoing assisted reproductive technology.
Luveris is a recombinant luteinizing hormone (LH) that stimulates ovarian steroidogenesis and follicle development in women undergoing assisted reproductive technology. Used for Infertility in women undergoing assisted reproductive technology (ART) with LH deficiency, Controlled ovarian hyperstimulation in ART cycles.
At a glance
| Generic name | Luveris fixed dose |
|---|---|
| Sponsor | University Reproductive Associates |
| Drug class | Gonadotropin; Luteinizing hormone (LH) analog |
| Target | Luteinizing hormone receptor (LHCGR) |
| Modality | Small molecule |
| Therapeutic area | Reproductive Medicine / Fertility |
| Phase | FDA-approved |
Mechanism of action
Luveris provides exogenous LH activity to support the late stages of follicular development and estrogen production during controlled ovarian hyperstimulation. It is typically used in combination with follicle-stimulating hormone (FSH) in women with LH deficiency or in specific ovarian stimulation protocols. The fixed-dose formulation combines LH and FSH in a predetermined ratio for convenience in fertility treatment.
Approved indications
- Infertility in women with profound LH and FSH deficiency undergoing assisted reproductive technology
- Controlled ovarian hyperstimulation in women with LH deficiency during in vitro fertilization (IVF)
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Headache
- Injection site reactions
- Abdominal pain/discomfort
- Nausea
Key clinical trials
- An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin (PHASE1)
- A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA) (PHASE3)
- Pergoveris FD and Liquid China BE Study (PHASE1)
- The Luveris In Vitro Fertilization Trial (PHASE4)
- The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI (PHASE4)
- Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L]) (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Luveris fixed dose CI brief — competitive landscape report
- Luveris fixed dose updates RSS · CI watch RSS
- University Reproductive Associates portfolio CI