Synthetic gonadotropin-releasing hormone (GnRH/LHRH); decapeptide identical to endogenous GnRH; GnRH receptor agonist
Gonadorelin
Approvedaka GnRH, LHRH, Factrel, Lutrepulse
Gonadorelin is the decapeptide identical to natural GnRH. It was approved and marketed as a diagnostic agent (for example, Factrel) to assess pituitary gonadotropin reserve, and, delivered in a pulsatile fashion (for example, Lutrepulse), to induce ovulation in women with hypothalamic amenorrhea. Many branded gonadorelin products have since been discontinued in some markets, and it is now frequently supplied through pharmacy compounding; approval status differs across regions.
Mechanism
In plain terms, gonadorelin is a copy of the brain hormone that tells the pituitary to release the hormones controlling the ovaries and testes. Technically, it is a decapeptide agonist of the GnRH receptor on pituitary gonadotrophs; when delivered in physiological pulses it stimulates secretion of luteinising hormone (LH) and follicle-stimulating hormone (FSH), whereas continuous (non-pulsatile) exposure paradoxically desensitises the receptor and suppresses gonadotropins, the principle exploited by long-acting GnRH analogues.
Regulatory Status by Region
- United States (FDA)Has a history of FDA approval: gonadorelin hydrochloride (Factrel) for evaluating pituitary gonadotropic function and gonadorelin acetate (Lutrepulse) for pulsatile induction of ovulation in hypothalamic amenorrhea. Several branded products have since been discontinued in the US (not for safety reasons), and gonadorelin is now commonly supplied via pharmacy compounding.
- Australia (TGA)Gonadorelin (native GnRH) has historically been used in Australia for diagnostic and fertility indications; whether a gonadorelin-specific product is currently on the ARTG is unclear. Related GnRH analogues such as leuprorelin and goserelin are registered.
- European Union (EMA)Gonadorelin has been marketed in European countries through national approvals (as a diagnostic agent and for pulsatile fertility therapy) rather than through a single centralised EMA authorisation.
- WADAProhibited in males under Section S2: WADA lists gonadotropin-releasing hormone (GnRH) agonists among luteinising-hormone releasing factors, and gonadorelin is explicitly named; it is not prohibited in females.
Key Studies
- Structure of the porcine LH- and FSH-releasing hormone (the amino acid sequence of GnRH/LHRH) (opens in a new tab) (Matsuo H, Baba Y, Nair RM, Arimura A, Schally AV. Biochem Biophys Res Commun. 1971.)
- Pregnancies following chronic intermittent (pulsatile) administration of Gn-RH in hypothalamic amenorrhea (opens in a new tab) (Leyendecker G, Wildt L, Hansmann M. J Clin Endocrinol Metab. 1980.)
Related Clinical Trials
- REGN21353 Alone or in Combination With Nezastomig for Metastatic Castration-Resistant Prostate Cancer in Adult ParticipantsPhase 1/Phase 2 · Not Yet Recruiting
- Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant SettingPhase 4 · Not Yet Recruiting
- RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Phase 2 · Not Yet Recruiting
- A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast CancerPhase 1 · Recruiting
- QL1706 Plus Neoadjuvant Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer With a Poor Response to Neoadjuvant ChemotherapyPhase 2 · Not Yet Recruiting
- Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast CancerPhase 2 · Not Yet Recruiting
- Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate CancerPhase 3 · Recruiting
- A Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix DP, a Gonadotropin-releasing Hormone (GnRH) Antagonist, in Patients With Advanced Prostate CancerPhase 2 · Not Yet Recruiting
Related News & Research
Latest research
- Is there a difference in ovarian hyperstimulation syndrome rates in freeze-all treatment cycles in high-risk patients treated with different GnRH agonist triggers? (opens in a new tab)
Human fertility (Cambridge, England) · Oct 5, 2026
Common Questions
- What is Gonadorelin?
- Gonadorelin is synthetic gonadotropin-releasing hormone (GnRH/LHRH), the decapeptide that signals the pituitary to release the reproductive hormones LH and FSH. It has a history of regulatory approval as a diagnostic agent (to test pituitary function) and, given in pulses, as a therapy for certain forms of infertility; availability varies by region and several branded products have been discontinued. In sport, gonadorelin is prohibited in males by WADA.
- Is Gonadorelin approved for medical use?
- Gonadorelin is approved for one or more medical uses in at least one major jurisdiction. United States (FDA): Has a history of FDA approval: gonadorelin hydrochloride (Factrel) for evaluating pituitary gonadotropic function and gonadorelin acetate (Lutrepulse) for pulsatile induction of ovulation in hypothalamic amenorrhea. Several branded products have since been discontinued in the US (not for safety reasons), and gonadorelin is now commonly supplied via pharmacy compounding. European Union (EMA): Gonadorelin has been marketed in European countries through national approvals (as a diagnostic agent and for pulsatile fertility therapy) rather than through a single centralised EMA authorisation. Australia (TGA): Gonadorelin (native GnRH) has historically been used in Australia for diagnostic and fertility indications; whether a gonadorelin-specific product is currently on the ARTG is unclear. Related GnRH analogues such as leuprorelin and goserelin are registered.
- How does Gonadorelin work?
- In plain terms, gonadorelin is a copy of the brain hormone that tells the pituitary to release the hormones controlling the ovaries and testes. Technically, it is a decapeptide agonist of the GnRH receptor on pituitary gonadotrophs; when delivered in physiological pulses it stimulates secretion of luteinising hormone (LH) and follicle-stimulating hormone (FSH), whereas continuous (non-pulsatile) exposure paradoxically desensitises the receptor and suppresses gonadotropins, the principle exploited by long-acting GnRH analogues.
- Is Gonadorelin legal in Australia?
- Gonadorelin in Australia (TGA): Gonadorelin (native GnRH) has historically been used in Australia for diagnostic and fertility indications; whether a gonadorelin-specific product is currently on the ARTG is unclear. Related GnRH analogues such as leuprorelin and goserelin are registered.
- Is Gonadorelin banned in sport?
- Gonadorelin under the World Anti-Doping Agency (WADA) code: Prohibited in males under Section S2: WADA lists gonadotropin-releasing hormone (GnRH) agonists among luteinising-hormone releasing factors, and gonadorelin is explicitly named; it is not prohibited in females.