FDA Approved Sexual & Reproductive Health

Follitropin alfa

also known as: Gonal-f, Gonal-F RFF, Gonal-F RFF Redi-ject, rFSH alfa

EMD Serono's Gonal-f — the first recombinant human FSH approved by the FDA (1997). Used for ovulation induction, IVF controlled ovarian stimulation, and male hypogonadotropic hypogonadism fertility induction.

A recombinant human follicle-stimulating hormone produced in genetically engineered CHO cells, composed of a common alpha subunit (shared with LH, hCG, TSH) and an FSH-specific beta subunit glycosylated with complex biantennary and triantennary N-linked oligosaccharides. Amino acid sequence is identical to pituitary FSH; the glycosylation pattern differs modestly from urinary-derived FSH, yielding more consistent batch-to-batch potency. FDA-approved as Gonal-f (EMD Serono) in 1997; foundational for modern IVF practice.

Mechanism of action

Binds FSH receptor (FSHR) on ovarian granulosa cells (supporting follicle growth, estradiol synthesis, and granulosa-cell proliferation) and on testicular Sertoli cells (supporting spermatogenesis). In women, FSHR activation drives follicular recruitment and growth in the early-to-mid follicular phase; in men with hypogonadotropic hypogonadism, it supports seminiferous tubule maturation and sperm production.

Primary uses

  • Anovulatory infertility (non-primary-ovarian-failure)
  • Controlled ovarian stimulation in IVF/ICSI
  • Induction of spermatogenesis in male hypogonadotropic hypogonadism (co-administered with hCG)

Typical dosing

75–450 IU/day daily (subcutaneous)

Ovulation induction: starting dose typically 75 IU/day SC, increased stepwise based on ovarian response. IVF controlled ovarian stimulation: starting dose 150–300 IU/day SC; adjusted per follicular monitoring. Male HH: 150 IU 3× weekly SC with hCG after ≥6 months of hCG alone.

Regulatory status

FDA-approved as Gonal-f (follitropin alfa, EMD Serono, first approved September 1997) for induction of ovulation and pregnancy in anovulatory infertile women in whom the cause is not primary ovarian failure; development of multiple follicles in ovulatory women undergoing assisted reproductive technologies; and induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism. Available as lyophilized vials and as pre-filled multi-dose pens (Gonal-f RFF Redi-ject).

References

  1. [fda-pi] Gonal-f (follitropin alfa) Prescribing Information. EMD Serono.
  2. [pubmed] Out HJ, et al. "A prospective, randomized, assessor-blind, multicentre study comparing recombinant and urinary follicle stimulating hormone (Puregon versus Metrodin) in in-vitro fertilization." Hum Reprod, 1995;10:2534-2540.

Related peptides

Follitropin beta

Organon/Merck's Follistim AQ (Puregon internationally) — a recombinant human FSH produced independently of follitropin alfa but clinically equivalent; FDA-approved 1997 for ovulation induction and IVF controlled ovarian stimulation.

Follitropin delta

Ferring's Rekovelle — a recombinant human FSH produced in a human cell line (PER.C6), dosed via a personalized algorithm based on serum AMH and body weight. Approved in the EU, UK, Canada, Australia, Japan, and China, but received an FDA Complete Response Letter in February 2026 over manufacturing issues; not currently approved in the United States.

Urofollitropin

Ferring's Bravelle (and earlier Fertinex) — highly purified urinary-derived FSH used for ovulation induction and IVF controlled ovarian stimulation. FDA-approved 2002; branded Bravelle was withdrawn from the US market in 2015 due to manufacturing/potency concerns but the molecule class remains available via urinary-derived menotropin combination products.

Menotropin

Ferring's Menopur (and earlier Repronex, Humegon) — a urinary-derived FSH/LH combination used for ovulation induction and IVF controlled ovarian stimulation, particularly when LH supplementation is clinically desired.

HCG

An FDA-approved fertility and hypogonadism medication commonly discussed in peptide and TRT communities for post-cycle recovery and testicular preservation during testosterone therapy.

Cetrorelix

Merck Serono's Cetrotide — a GnRH antagonist used during IVF controlled ovarian stimulation to block premature LH surges. Unlike GnRH agonists, produces immediate gonadotropin suppression without a flare, shortening IVF cycles.
Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.