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Gonadorelin | CAS No: 33515-09-2 | GMP-certified suppliers
A medication that supports evaluation of anterior pituitary gonadotrope function and aids diagnosis of gonadotropin‑related disorders, including assessment after pituitary tumor treatment.
Therapeutic categories
Primary indications
- For evaluating the functional capacity and response of the gonadotropes of the anterior pituitary also for evaluating residual gonadotropic function of the pituitary following removal of a pituitary tumor by surgery and/or irradiation
Product Snapshot
- Gonadorelin is supplied as an injectable and nasal peptide formulation for parenteral or intranasal administration
- It is used to assess anterior pituitary gonadotrope function and to evaluate residual gonadotropic activity after pituitary surgery or irradiation
- It holds approved status in the US and Canada with additional investigational and veterinary regulatory designations
Clinical Overview
Clinically, gonadorelin is used to assess anterior pituitary gonadotrope function. It supports evaluation of residual pituitary capacity following tumor resection or irradiation and assists in diagnosing disorders of gonadotropin secretion. Diagnostic formulations have been marketed under names such as Factrel, though availability varies by region.
Pharmacologically, gonadorelin acts on pituitary GnRH receptors to stimulate synthesis and release of LH and, to a lesser degree, FSH. The physiologic response depends on pulse frequency and amplitude, as well as feedback from circulating sex steroids. Because reproductive function in both sexes relies on GnRH pulsatility, continuous exposure reduces receptor responsiveness, whereas intermittent administration preserves gonadotrope stimulation.
The mechanism of action reflects this physiologic pattern. When administered in controlled pulses, gonadorelin can simulate endogenous GnRH release, increasing LH and FSH secretion and supporting downstream steroidogenesis or gametogenesis in selected clinical contexts such as hypogonadotropic hypogonadism or hypothalamic amenorrhea. In prepubertal individuals or certain gonadal disorders, the FSH response may exceed the LH response.
Gonadorelin exhibits rapid distribution and a very short plasma half‑life, necessitating infusion devices for therapeutic regimens requiring pulsatile delivery. It is degraded by peptidases to inactive amino acids and peptides, with no accumulation expected. Safety considerations include transient flushing, abdominal discomfort, or headache, which are generally related to acute gonadotropin release. Excessive or continuous exposure may suppress pituitary responsiveness.
For API procurement, suppliers should provide peptide identity confirmation, impurity profiling appropriate for synthetic peptides, and assurance of controlled manufacturing conditions to maintain sequence integrity, potency, and stability.
Identification & chemistry
| Generic name | Gonadorelin |
|---|---|
| Molecule type | Small molecule |
| CAS | 33515-09-2 |
| UNII | 9O7312W37G |
| DrugBank ID | DB00644 |
Pharmacology
| Summary | Gonadorelin is a synthetic analog of endogenous GnRH that activates pituitary GnRH receptors to stimulate luteinizing hormone release and, to a lesser extent, follicle‑stimulating hormone. Its pharmacologic effect depends on physiologic‑like pulsatile stimulation, which drives downstream regulation of gonadal steroidogenesis and reproductive function. It is used to assess pituitary gonadotrope responsiveness in diagnostic settings. |
|---|---|
| Mechanism of action | Systemic - Like naturally occurring gonadotropin-releasing hormone (GnRH), gonadorelin primarily stimulates the synthesis and release of luteinizing hormone (LH) from the anterior pituitary gland. Follicle-stimulating hormone (FSH) production and release is also increased by gonadorelin, but to a lesser degree. In prepubertal females and some gonadal function disorders, the FSH response may be greater than the LH response. For the treatment of amenorrhea, delayed puberty, and infertility the administration of gonadorelin is used to simulate the physiologic release of GnRH from the hypothalamus in treatment of delayed puberty, treatment of infertility caused by hypogonadotropic hypogonadism, and induction of ovulation in those women with hypothalamic amenorrhea. This results in increased levels of pituitary gonadotropins LH and FSH, which subsequently stimulate the gonads to produce reproductive steroids. |
| Pharmacodynamics | Gonadorelin is responsible for the release of follicle stimulating hormone and leutinizing hormone from the anterior pitutitary. In the pituitary GnRH stimulates synthesis and release of FSH and LH, a process that is controlled by the frequency and amplitude of GnRH pulses, as well as the feedback of androgens and estrogens. The pulsatility of GnRH secretion has been seen in all vertebrates, and it is necessary to ensure a correct reproductive function. Thus a single hormone, GnRH, controls a complex process of follicular growth, ovulation, and corpus luteum maintenance in the female, and spermatogenesis in the male. Its short half life requires infusion pumps for its clinical use |
Targets
| Target | Organism | Actions |
|---|---|---|
| Gonadotropin-releasing hormone receptor | Humans | agonist |
| Putative gonadotropin-releasing hormone II receptor | Humans | agonist |
ADME / PK
| Absorption | Rapidly absorbed when injected |
|---|---|
| Half-life | Very short, initial, 2 to 10 minutes; terminal, 10 to 40 minutes |
| Metabolism | Rapidly hydrolyzed to inactive peptide components |
Formulation & handling
- Peptide decapeptide API with high hydrophilicity and low logP, typically formulated as sterile powder for reconstitution or aqueous injectable solution for IV/SC use.
- Requires protection from proteolytic degradation and is generally handled under refrigerated conditions to maintain peptide stability.
- Suitable for nasal spray formulations, where peptide stability and avoidance of adsorption to surfaces are key considerations.
Regulatory status
| Lifecycle | Patent protections for the API have lapsed or are nearing expiry in the United States and Canada, indicating a mature market environment. Product availability in both regions suggests established competition and limited remaining lifecycle exclusivity. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Gonadorelin is supplied by a small group of originator and specialty manufacturers, with additional packagers supporting finished‑product distribution. Branded formulations such as Factrel and Lutrepulse are established in North American markets, with limited presence reported outside the US and Canada. Patent protections for gonadorelin have largely expired, indicating that generic or non‑branded alternatives may already be present or could expand where regulatory pathways allow. |
|---|
Safety
| Toxicity | LD<sub>50</sub>>3000 mg/kg (rat, oral) |
|---|
- Exhibits low acute oral toxicity in rats (LD50 ›3000 mg/kg), but standard precautions for handling biologically active peptides remain warranted
- May induce endocrine-related physiological responses
- Avoid unintended exposure that could trigger pituitary–gonadal axis activation in laboratory personnel
Gonadorelin is a type of Gonadorelin agonists
Gonadorelin agonists belong to the subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in reproductive medicine. These compounds are designed to mimic the activity of gonadotropin-releasing hormone (GnRH), a hormone responsible for the regulation of reproductive function.
Gonadorelin agonists work by binding to and activating GnRH receptors in the pituitary gland. This results in the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which are essential for the normal functioning of the reproductive system.
These pharmaceutical agents have a wide range of applications, primarily in the field of assisted reproductive technology (ART) and hormone-related disorders. They are commonly used in the treatment of infertility, endometriosis, and precocious puberty. In ART, gonadorelin agonists are employed to stimulate the ovaries and induce ovulation, increasing the chances of successful conception during in vitro fertilization (IVF) procedures.
Gonadorelin agonists are available in different formulations, including injectables and nasal sprays, allowing for flexible administration based on individual patient needs. They are generally well-tolerated, with common side effects including headache, hot flashes, and mild injection site reactions.
Overall, gonadorelin agonists are critical components in the field of reproductive medicine, assisting in the management of various fertility-related conditions. With their targeted action on the GnRH receptors, these pharmaceutical APIs continue to contribute to advancements in assisted reproduction and the overall well-being of patients.
Gonadorelin (Gonadorelin agonists), classified under Hormonal Agents
Hormonal agents are a prominent category of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the medical field. These substances play a crucial role in regulating and modulating hormonal functions within the body. Hormonal agents are designed to mimic or manipulate the effects of naturally occurring hormones, allowing healthcare professionals to treat various endocrine disorders and hormonal imbalances.
Hormonal agents are commonly employed in the treatment of conditions such as hypothyroidism, hyperthyroidism, diabetes, and hormonal cancers. These APIs work by interacting with specific hormone receptors, either by stimulating or inhibiting their activity, to restore the balance of hormones in the body. They can be administered orally, intravenously, or through other routes depending on the specific medication and patient needs.
Pharmaceutical companies employ rigorous manufacturing processes and quality control measures to ensure the purity, potency, and safety of hormonal agent APIs. These APIs are synthesized using chemical or biotechnological methods, often starting from natural hormone sources or through recombinant DNA technology. Stringent regulatory guidelines are in place to guarantee the efficacy and safety of hormonal agent APIs, ensuring that patients receive high-quality medications.
As the demand for hormone-related therapies continues to grow, ongoing research and development efforts focus on enhancing the effectiveness and reducing the side effects of hormonal agent APIs. This includes the exploration of novel delivery systems, advanced formulations, and targeted drug delivery methods. By continuously advancing our understanding and capabilities in hormonal agents, the medical community can improve patient outcomes and quality of life for individuals with hormonal disorders.
Gonadorelin API manufacturers & distributors
Compare qualified Gonadorelin API suppliers worldwide. We currently have 4 companies offering Gonadorelin API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Hemmo Pharma | Producer | India | India | CoA, GMP, WC | 13 products |
| Polypeptide Labs | Producer | Sweden | Unknown | CoA, JDMF | 21 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, FDA, GMP, ISO9001, MSDS, USDMF | 764 products |
| Suzhou Tianma Pharma Grou... | Producer | China | China | BSE/TSE, CoA, MSDS | 25 products |
When sending a request, specify which Gonadorelin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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