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Long acting FSH and GnRH antagonist
Long acting FSH and GnRH antagonist is a GnRH antagonist / FSH receptor agonist combination Small molecule drug developed by Bioroma. It is currently FDA-approved for Controlled ovarian hyperstimulation in assisted reproductive technology (ART) / in vitro fertilization (IVF).
This drug combines long-acting FSH (follicle-stimulating hormone) activity with GnRH antagonism to modulate reproductive hormone signaling for extended periods.
This drug combines long-acting FSH (follicle-stimulating hormone) activity with GnRH antagonism to modulate reproductive hormone signaling for extended periods. Used for Controlled ovarian hyperstimulation in assisted reproductive technology (ART), Male infertility due to hypogonadism or spermatogenesis disorders.
At a glance
| Generic name | Long acting FSH and GnRH antagonist |
|---|---|
| Sponsor | Bioroma |
| Drug class | GnRH antagonist / FSH receptor agonist combination |
| Target | GnRH receptor, FSH receptor |
| Modality | Small molecule |
| Therapeutic area | Reproductive Endocrinology / Fertility |
| Phase | FDA-approved |
Mechanism of action
The FSH component stimulates follicle development in the ovaries, while the GnRH antagonist suppresses endogenous GnRH signaling to prevent premature LH surge and control the timing of ovulation. This dual mechanism allows sustained hormonal control over multiple days or weeks with a single administration, improving convenience in assisted reproductive therapy.
Approved indications
- Controlled ovarian hyperstimulation in assisted reproductive technology (ART) / in vitro fertilization (IVF)
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Headache
- Injection site reactions
- Abdominal pain/discomfort
- Nausea
Key clinical trials
- Ovarian Response Prediction in In Vitro Fertilization (IVF) Patients
- D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists (PHASE4)
- Long Acting FSH Plus Antagonist Versus Daily FSH Plus Antagonist Versus Short Agonist Protocol in Poor Responders Undergoing IVF (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:
- Long acting FSH and GnRH antagonist CI brief — competitive landscape report
- Long acting FSH and GnRH antagonist updates RSS · CI watch RSS
- Bioroma portfolio CI
Frequently asked questions about Long acting FSH and GnRH antagonist
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Related
- Drug class: All GnRH antagonist / FSH receptor agonist combination drugs
- Target: All drugs targeting GnRH receptor, FSH receptor
- Manufacturer: Bioroma — full pipeline
- Therapeutic area: All drugs in Reproductive Endocrinology / Fertility
- Indication: Drugs for Controlled ovarian hyperstimulation in assisted reproductive technology (ART) / in vitro fertilization (IVF)
- Compare: Long acting FSH and GnRH antagonist vs similar drugs
- Pricing: Long acting FSH and GnRH antagonist cost, discount & access