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recombinant gonadotropins
recombinant gonadotropins is a Gonadotropin Small molecule drug developed by Sheba Medical Center. It is currently FDA-approved for Female infertility due to anovulation or low ovarian reserve (assisted reproductive technology), Male infertility due to hypogonadotropic hypogonadism or low sperm production. Also known as: Pergoveris & Luveris, Puregon, NV Organon, Oss, The Netherlands.
Recombinant gonadotropins are hormones that stimulate the ovaries or testes to produce eggs or sperm for reproductive purposes.
Recombinant gonadotropins, specifically recombinant human Follicle-Stimulating Hormone (r-FSH-alfa), are used to treat conditions such as female infertility, embryonic development, and pregnancy. They work by stimulating the ovaries to produce eggs, and are often used in combination with other medications like clomiphene citrate.
At a glance
| Generic name | recombinant gonadotropins |
|---|---|
| Also known as | Pergoveris & Luveris, Puregon, NV Organon, Oss, The Netherlands |
| Sponsor | Sheba Medical Center |
| Drug class | Gonadotropin |
| Target | FSH receptor, LH receptor |
| Modality | Small molecule |
| Therapeutic area | Reproductive Medicine / Fertility |
| Phase | FDA-approved |
Mechanism of action
Recombinant gonadotropins mimic naturally occurring follicle-stimulating hormone (FSH) and/or luteinizing hormone (LH) to promote gametogenesis. In females, they stimulate follicle development and ovulation; in males, they promote spermatogenesis. These are produced through recombinant DNA technology rather than extracted from biological sources.
Approved indications
- Female infertility due to anovulation or low ovarian reserve (assisted reproductive technology)
- Male infertility due to hypogonadotropic hypogonadism or low sperm production
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Headache
- Injection site reactions
- Abdominal pain or bloating
- Nausea
Key clinical trials
- PPOS vs GnRH Antagonist in Ovarian Stimulation (ProGanOS Study) (NA)
- INTEnsity of ovariaN Stimulation and Embryo Quality (PHASE4)
- Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (NA)
- 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)
- FET-LET-2x2: Clinical Pregnancy Rates After Frozen Embryo Transfer in Natural and Modified Natural Cycles (NA)
- rFSH vs rFSH+rLH in Dydrogesterone-Based Progestin Protocol: A Prospective Study
- Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation (PHASE2)
- 150 IU vs. 225 IU FSH in Normal Responders: The OPTIMAL-DOSE Trial (PHASE3)
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:
- recombinant gonadotropins CI brief — competitive landscape report
- recombinant gonadotropins updates RSS · CI watch RSS
- Sheba Medical Center portfolio CI
Frequently asked questions about recombinant gonadotropins
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Related
- Drug class: All Gonadotropin drugs
- Target: All drugs targeting FSH receptor, LH receptor
- Manufacturer: Sheba Medical Center — full pipeline
- Therapeutic area: All drugs in Reproductive Medicine / Fertility
- Indication: Drugs for Female infertility due to anovulation or low ovarian reserve (assisted reproductive technology)
- Indication: Drugs for Male infertility due to hypogonadotropic hypogonadism or low sperm production
- Also known as: Pergoveris & Luveris, Puregon, NV Organon, Oss, The Netherlands
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing