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Follitropin beta liquid formulation
Follitropin beta liquid formulation is a Gonadotropin; recombinant FSH Small molecule drug developed by Merck KGaA, Darmstadt, Germany. It is currently in Phase 3 development for Infertility in women undergoing assisted reproductive technology (ART), Infertility in men with hypogonadotropic hypogonadism. Also known as: Puregon.
Follitropin beta is a recombinant human follicle-stimulating hormone (FSH) that stimulates the growth and maturation of ovarian follicles in women and spermatogenesis in men.
Follitropin beta liquid formulation is a follicle-stimulating hormone receptor agonist, classified as an agonist drug. It is used to treat conditions such as infertility, ovulation induction, and in-vitro fertilization.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Merck KGaA, Darmstadt, Germany is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Follitropin beta liquid formulation |
|---|---|
| Also known as | Puregon |
| Sponsor | Merck KGaA, Darmstadt, Germany |
| Drug class | Gonadotropin; recombinant FSH |
| Target | FSH receptor (FSHR) |
| Modality | Small molecule |
| Therapeutic area | Reproductive Endocrinology / Fertility |
| Phase | Phase 3 |
Mechanism of action
Follitropin beta binds to FSH receptors on granulosa cells of ovarian follicles and Sertoli cells in the testes, triggering intracellular signaling cascades that promote follicular development and steroidogenesis. In women, this leads to estrogen production and ovulation; in men, it supports sperm production. The liquid formulation offers an alternative delivery method to powder formulations, potentially improving convenience and dose accuracy.
Approved indications
- Infertility in women undergoing assisted reproductive technology (ART)
- Infertility in men with hypogonadotropic hypogonadism
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Headache
- Injection site reactions
- Abdominal pain/bloating
- Nausea
Key clinical trials
- Pergoveris FD and Liquid China BE Study (PHASE1)
- Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization (PHASE3)
- To Evaluate the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Pen Compared With Follitropin Beta Liquid Pen (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:
- Follitropin beta liquid formulation CI brief — competitive landscape report
- Follitropin beta liquid formulation updates RSS · CI watch RSS
- Merck KGaA, Darmstadt, Germany portfolio CI
Frequently asked questions about Follitropin beta liquid formulation
What is Follitropin beta liquid formulation?
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Is Follitropin beta liquid formulation also known as anything else?
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Related
- Drug class: All Gonadotropin; recombinant FSH drugs
- Target: All drugs targeting FSH receptor (FSHR)
- Manufacturer: Merck KGaA, Darmstadt, Germany — full pipeline
- Therapeutic area: All drugs in Reproductive Endocrinology / Fertility
- Indication: Drugs for Infertility in women undergoing assisted reproductive technology (ART)
- Indication: Drugs for Infertility in men with hypogonadotropic hypogonadism
- Also known as: Puregon
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing