Gonadorelin: What It Is and Its U.S. Regulatory Status

What is gonadorelin?

Gonadorelin is a synthetic peptide with the same ten-amino-acid sequence as gonadotropin-releasing hormone (GnRH). The FDA approved two gonadorelin products for people, Factrel and Lutrepulse, but both have been discontinued. Today no FDA-approved gonadorelin product for people is marketed in the United States.

How it works

GnRH is made in the hypothalamus and released in pulses. It tells the pituitary gland to release two hormones, LH (luteinizing hormone) and FSH (follicle-stimulating hormone), which drive testosterone and estrogen production, sperm production and ovulation.

Timing matters. Short pulses of GnRH stimulate the pituitary, while constant exposure eventually has the opposite effect and shuts LH and FSH release down. That second effect is the basis of long-acting GnRH agonist drugs such as leuprolide.

Approval history

According to the FDA's Drugs@FDA database, two human gonadorelin products were approved:

  • September 30, 1982: Factrel (gonadorelin hydrochloride), used as a diagnostic test of how well the pituitary gland responds to GnRH.
  • October 10, 1989: Lutrepulse (gonadorelin acetate), given in pulses by a small pump to induce ovulation in women with primary hypothalamic amenorrhea, a lack of periods caused by too little natural GnRH.

As of September 2026, Drugs@FDA lists both products as discontinued.

Veterinary products

Gonadorelin is also the active ingredient in several FDA-approved animal drugs for cattle, sold under names such as Cystorelin, Factrel, Fertagyl and GONAbreed. They are labeled for ovarian follicular cysts in cattle, and some are also labeled for timing breeding in dairy and beef cows. These are animal drugs only and are not approved for people.

U.S. regulatory status

Current status: Formerly FDA-approved (Factrel, discontinued).

Because no approved human product is marketed, gonadorelin prescribed for people in the United States today generally comes from compounding pharmacies, which prepare medicines for individual patients with a prescription. Compounded drugs are not FDA-approved, which means the FDA does not review them for safety, effectiveness or quality before they are sold.

Products sold online as "research chemicals" or labeled "for research purposes only" are not approved medicines, and the FDA has not reviewed their identity, purity or quality.

Documented safety information

Because no approved gonadorelin product is marketed for people, there is no current FDA label for human use. Gonadorelin is a hormone that controls the reproductive system, so it changes levels of LH, FSH and sex hormones, and the body's response depends on the timing and pattern of exposure described above. Compounded versions have not been through FDA review for quality or safety.

Sport

The WADA 2026 Prohibited List names gonadotrophin-releasing hormone (GnRH, gonadorelin) and its agonist analogues under class S2 as testosterone-stimulating peptides prohibited in males. They are prohibited at all times, in and out of competition.

Why Peptide Labs does not sell gonadorelin

Peptide Labs does not sell this compound. This page is general information, not medical advice. We are not a pharmacy, we do not supply gonadorelin, and we do not point readers to anyone who does.

Because gonadorelin acts on the hormone system that controls fertility and sex hormones, personal questions about it are best taken to a licensed healthcare provider, such as an endocrinologist.

Related reading

See the full list of compound profiles in the Peptide Guide. For a related compound that acts one step earlier in the same hormone chain, see kisspeptin-10. Sermorelin is another peptide that was once FDA-approved and later discontinued. For the legal background, read whether peptides are legal in the U.S.