Gonadorelin Acetate

Gonadorelin Acetate

H-4005-GMP, 4008614

Regulatory Documentation

CEP, DMF

CAS-Number

33515-09-2 (net), 34973-08-5 (acetate)

Synonyms

GnRH; Gonadotropin-Releasing Hormone; LHRH; Luliberin;
Luteinizing Hormone-Releasing Factor

Sequence

Pyr-His-Trp-Ser-Tyr-Gly-Leu-Arg-Pro-Gly-NH2 acetate salt

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What is gonadorelin acetate?

Gonadorelin acetate is a synthetic version of the naturally occurring gonadotropin-releasing hormone (GnRH). It’s a decapeptide (composed of 10 amino acids) that interacts primarily with the pituitary gland. When administered, it stimulates the pituitary’s gonadotrope cells to release two key reproductive hormones:

  • Luteinizing hormone (LH)
  • Follicle-stimulating hormone (FSH)

Due to its ability to influence reproductive hormone production, it’s used medically to treat various reproductive disorders.

Gonadorelin acetate mechanism of action 

Gonadorelin acetate works by binding to GnRH receptors on gonadotrope cells in the anterior pituitary gland. This binding triggers a signaling cascade that leads to the release of stored luteinizing hormone (LH) and follicle-stimulating hormone (FSH), increased synthesis of new LH and FSH, and upregulation of GnRH receptor expression. The released gonadotropins (LH and FSH) then travel through the bloodstream to target reproductive organs. 

The drug must be administered in a pulsatile manner to effectively mimic the body’s natural hormone release patterns and achieve optimal therapeutic outcomes. Continuous administration, however, can lead to receptor desensitisation and will reduce its effectiveness.

What is gonadorelin acetate used for?

Gonadorelin acetate has several therapeutic applications in reproductive medicine. In women, it is primarily used to treat infertility caused by hypothalamic dysfunction, helping to induce ovulation and support pregnancy outcomes. It can also be valuable in diagnosing reproductive disorders by testing the pituitary gland’s response to GnRH stimulation.

In male patients, gonadorelin acetate is employed to treat hypogonadotropic hypogonadism, a condition where the body doesn’t produce sufficient sex hormones due to pituitary or hypothalamic dysfunction. The medication helps stimulate testosterone production and support normal reproductive function.

In veterinary medicine, particularly in cattle breeding, gonadorelin acetate is used to treat ovarian follicular cysts and to synchronize estrous cycles. It can also help treat delayed ovulation and improve reproductive efficiency in dairy herds.

Why choose to partner with Bachem?

Bachem is an established industry leader in peptide manufacturing. We bring decades of expertise to your Gonadorelin Acetate API production needs. Our advanced manufacturing capabilities guarantee high-yield production with exceptional batch-to-batch consistency, whilst our robust supply chain management ensures uninterrupted availability.

Our commitment to quality and regulatory compliance is exemplified through our GMP-certified manufacturing processes and comprehensive documentation support. 

We also understand the critical importance of timing and quality in your success, which is why we offer streamlined customer service and flexible ordering options. In addition, our clients benefit from rapid shipping through our well-maintained inventory, expedited registration supported by readily accessible Drug Master Files (DMFs) and Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs), alongside comprehensive impurity management services.

How do we simplify the gonadorelin manufacturing process for our customers?

At Bachem, we simplify the manufacturing process for our customers by providing comprehensive support and tailored services throughout the entire journey of developing active pharmaceutical ingredients (APIs). Our expertise allows you to concentrate on perfecting your drug product while we manage every aspect of API manufacturing, from rigorous quality control to timely delivery.

Our complete API packages ensure you have all the necessary documentation and quality assurance, making your launch seamless and efficient. By manufacturing some of our starting materials in-house, we create a secure and sustainable supply chain that guarantees purity and consistent batch-to-batch quality.

Utilising the latest technology and manufacturing techniques, we eliminate barriers to producing cost-effective medicines. We also offer scalable production options, accommodating orders from grams to hundreds of kilos. 

With a strong commitment to customer service and excellence, we’re dedicated to helping you succeed in bringing high-quality generics to market.

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Trust in our proven track record: we’ve commercialised one-third of the 80 approved peptide APIs in new chemical entities (NCEs) and generics available globally. With our resources and expertise, we can help make your ingredients a global success.

Fields of Application

Ovarian follicular cysts (veterinary medicine)
Use in reproduction medicine
Diagnosis of the hypothalamic-pituitary-gonadal axis function
Cryptorchism
Synchronization of ovulation (veterinary medicine)

Active Substance

Gonadorelin, also known as GnRH or LHRH, is produced by neuroendocrine cells within the hypothalamus. The hormone is secreted pulsatilely. Gonadorelin induces the release of LH and FSH from the anterior pituitary.
After a transient increase, continuous administration of gonadorelin results in downregulation of LH and FSH levels followed by a suppression of ovarian and testicular steroid biosynthesis.

Molecular Information

Molecular Formula

C55H75N17O13

Relative Molecular Mass

1182.31 g/mol

Long-term Storage

-20 ± 5°C

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