Last reviewed 2026-04-20 · How we verify

Urofollitropin (FOLLITROPIN)

FOLLITROPIN works by mimicking the action of follicle-stimulating hormone to stimulate follicle growth and ovulation.

Follitropin, marketed by Serono, is a well-established ovulation induction therapy that mimics the action of follicle-stimulating hormone to promote follicle growth and ovulation. Its key strength lies in its long-standing market presence and the patent protection extending to 2028, which helps maintain its competitive edge against same-class drugs like chorionic gonadotrophin, lutropin alfa, and choriogonadotropin alfa. The primary risk to Follitropin's market position is the potential for increased competition as some of these same-class drugs have already received FDA approval and may gain further traction.

At a glance

Mechanism of action

Women:Follicle-stimulating hormone (FSH), the active component in Follistim AQ Cartridge, is required for normal follicular growth, maturation, and gonadal steroid production.In women, the level of FSH is critical for the onset and duration of follicular development, and consequently for the timing and number of follicles reaching maturity. Follistim AQ Cartridge stimulates ovarian follicular growth in women who do not have primary ovarian failure. In order to effect the final phase of follicle maturation, resumption of meiosis and rupture of the follicle in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following treatment with Follistim AQ Cartridge when patient monitoring indicates appropriate follicular development parameters have been reached.. Men:Follistim when administered with hCG stimulates spermatogenesis in men with hypogonadotropic hypogonadism. FSH, the active component of Follistim, is the pituitary hormo

Approved indications

• Ovulation induction

Common side effects

• Ovarian Hyperstimulation Syndrome
• Pelvic discomfort
• Abdominal discomfort
• Abdominal pain
• Ovarian cyst
• Headache
• Nausea
• Pelvic Pain
• Fatigue
• Injection site reaction
• Injection site pain
• Acne

Key clinical trials

• An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin (PHASE1)
• 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) (PHASE3)
• Plasma Relaxin Measurement Based on Endometrial Preparation for Embryo Transfer
• Testing the Addition of a New Anti-Cancer Drug, Niraparib, to the Usual Treatment (Hormone and Radiation Therapy) for Prostate Cancer With a High Chance of Recurring (PHASE1,PHASE2)
• Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE) (PHASE2)
• Comparison of Follitropin Delta and Follitropin Alfa in Combination With Menotropin
• Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation. (PHASE3)
• A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants (PHASE1)

Primary sources

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