BLASUBCUTANEOUSINJECTABLE
Approved
Sep 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
GONAL-F (follitropin alfa) by EMD Serono Research & Development Institute, Inc. is gonal-f stimulates ovarian follicular growth in women who do not have primary ovarian failure. First approved in 1997.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GONAL-F (follitropin alfa) is a recombinant human FSH injectable biologic used to stimulate ovarian follicular growth in women with infertility and spermatogenesis in men with hypogonadotropic hypogonadism. It works by mimicking the natural follicle-stimulating hormone to promote reproductive cell development. hCG must be co-administered to trigger final follicle maturation and ovulation.
LOE Approaching
Product is in late-stage lifecycle with moderate competitive pressure (30/100), signaling potential team consolidation or portfolio transition roles ahead.
Mechanism of Action
GONAL-f stimulates ovarian follicular growth in women who do not have primary ovarian failure. In order to bring about final maturation of the follicle and ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given, following the administration of GONAL-f,…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Investigate the Pharmacokinetics and Safety of KM04 Compared to United States (US)-Gonal-f Revised Formulation Female (RFF) Redi-ject and European Union (EU)-Gonal-f in Healthy Adult Female Volunteers
Started Oct 2026
42 enrolled
Healthy Female Adult Volunteers
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)
Started Feb 2026
266 enrolled
Infertility
A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants
Started Jul 2025
55 enrolled
Hypogonadism
Study on the Pharmacokinetics and Safety of QL1012D and Gonal-F® in Healthy Female Volunteers
Started Apr 2025
48 enrolled
Infertility, Female
A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China
Started Mar 2024
301 enrolled
Infertility, Female
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.