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Placebo RecFSH / follitropin alfa
Placebo RecFSH / follitropin alfa is a Gonadotropin; recombinant FSH Small molecule drug developed by Changchun GeneScience Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Infertility in women undergoing assisted reproductive technology (ART), Anovulation and ovulatory dysfunction in women.
Follitropin alfa is a recombinant human follicle-stimulating hormone (FSH) that stimulates ovarian follicle development and estrogen production in women.
Follitropin alfa is a recombinant human follicle-stimulating hormone (FSH) that stimulates ovarian follicle development and estrogen production in women. Used for Infertility in women undergoing assisted reproductive technology (ART), Anovulation and ovulatory dysfunction in women.
At a glance
| Generic name | Placebo RecFSH / follitropin alfa |
|---|---|
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
| Drug class | Gonadotropin; recombinant FSH |
| Target | FSH receptor (FSHR) |
| Modality | Small molecule |
| Therapeutic area | Reproductive/Fertility |
| Phase | Phase 3 |
Mechanism of action
Follitropin alfa mimics endogenous FSH by binding to FSH receptors on granulosa cells of ovarian follicles, promoting follicle growth, maturation, and increased estrogen secretion. This is used in assisted reproductive technology to induce controlled ovarian hyperstimulation, enabling retrieval of multiple oocytes for in vitro fertilization or other fertility treatments.
Approved indications
- Infertility in women undergoing assisted reproductive technology (ART)
- Anovulation and ovulatory dysfunction in women
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Headache
- Injection site reactions
- Abdominal pain/bloating
- Nausea
Key clinical trials
- To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (PHASE3)
- Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)
- Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)
- Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)
- A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787) (PHASE3)
- Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031) (PHASE3)
- To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001) (PHASE3)
- Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)
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:
- Placebo RecFSH / follitropin alfa CI brief — competitive landscape report
- Placebo RecFSH / follitropin alfa updates RSS · CI watch RSS
- Changchun GeneScience Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Placebo RecFSH / follitropin alfa
What is Placebo RecFSH / follitropin alfa?
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What is Placebo RecFSH / follitropin alfa used for?
Who makes Placebo RecFSH / follitropin alfa?
What drug class is Placebo RecFSH / follitropin alfa in?
What development phase is Placebo RecFSH / follitropin alfa in?
What are the side effects of Placebo RecFSH / follitropin alfa?
What does Placebo RecFSH / follitropin alfa target?
Related
- Drug class: All Gonadotropin; recombinant FSH drugs
- Target: All drugs targeting FSH receptor (FSHR)
- Manufacturer: Changchun GeneScience Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Reproductive/Fertility
- Indication: Drugs for Infertility in women undergoing assisted reproductive technology (ART)
- Indication: Drugs for Anovulation and ovulatory dysfunction in women
- Compare: Placebo RecFSH / follitropin alfa vs similar drugs
- Pricing: Placebo RecFSH / follitropin alfa cost, discount & access