GONAL-F
LOE Approachingfollitropin alfa
BLASUBCUTANEOUSINJECTABLE
Approved
Sep 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
GONAL-F (follitropin alfa) is gonal-f stimulates ovarian follicular growth in women who do not have primary ovarian failure. First approved in 1997.
Drug data last refreshed 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GONAL-f (follitropin alfa) is a recombinant human FSH (follicle-stimulating hormone) administered subcutaneously to stimulate ovarian follicular growth in women with infertility and anovulation, and to promote spermatogenesis in men with hypogonadotropic hypogonadism. It works by directly stimulating the gonads to produce sex hormones and mature gametes, typically used in conjunction with hCG for final oocyte maturation. The drug is foundational to assisted reproductive technology and ovulation induction protocols.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); declining team investment expected as biosimilar and generic entry strategies mature.
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 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
333 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
A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation
Started Jul 2022
302 enrolled
Infertility
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.