Product Name: Linzagolix Choline API
Chemical Name: (2S)-2-amino-3-methylbutanoic acid; 4-[[(2R)-2-[[(2R)-2-[[(2R)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]butanoic acid; choline
Molecular Formula: C₃₄H₄₂N₄O₇ · C₅H₁₄NO
Molecular Weight: 698.82 g/mol (free base), 735.89 g/mol (choline salt)
CAS Number: 1637501-84-9 (free base), 1637501-85-0 (choline salt)
Therapeutic Category: Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist
Indication: Linzagolix choline is an investigational oral gonadotropin-releasing hormone (GnRH) receptor antagonist being developed for the treatment of hormone-dependent conditions such as uterine fibroids and endometriosis. It works by selectively blocking the GnRH receptor, thereby reducing the production of estrogen and progesterone, which are key drivers of these conditions.
Mechanism of Action: Linzagolix choline binds competitively to the GnRH receptor in the pituitary gland, inhibiting the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This suppression leads to decreased ovarian production of estrogen and progesterone, alleviating symptoms associated with uterine fibroids and endometriosis, such as heavy menstrual bleeding and pelvic pain.
Dosage Form: Linzagolix choline is supplied as an active pharmaceutical ingredient (API) for formulation into oral dosage forms, such as tablets or capsules.
Pharmacokinetics:
Absorption: Linzagolix choline is well-absorbed following oral administration, with peak plasma concentrations achieved within a few hours.
Distribution: It has a moderate volume of distribution, indicating good tissue penetration.
Metabolism: Linzagolix is primarily metabolized in the liver via enzymatic pathways, including cytochrome P450 enzymes.
Excretion: The drug and its metabolites are predominantly excreted in the urine.
Storage Conditions: Linzagolix choline API should be stored in a cool, dry place, protected from light.
Stability: Linzagolix choline is stable under recommended storage conditions. It should be protected from extreme temperatures and humidity to maintain its stability and efficacy.
Regulatory Status: Linzagolix choline is currently under clinical development and has not yet received approval for commercial use. It is being evaluated in various clinical trials to assess its safety and efficacy in treating uterine fibroids and endometriosis.
Packaging: Linzagolix choline API is supplied in sealed, light-resistant containers to ensure product integrity. The packaging is designed to protect the API from environmental factors that could compromise its quality.
Quality Standards: Linzagolix choline API is manufactured in compliance with current Good Manufacturing Practices (cGMP) and meets stringent quality control standards to ensure its purity, potency, and consistency.
Applications: Linzagolix choline API is intended for use in the development and production of pharmaceutical formulations aimed at treating hormone-dependent conditions such as uterine fibroids and endometriosis. It is suitable for use in both clinical trials and commercial pharmaceutical manufacturing.
Note: This product is intended for research and development purposes only. It is not for human or veterinary use unless specified by regulatory authorities.
Product Name: Linzagolix Choline API
Chemical Name: (2S)-2-amino-3-methylbutanoic acid; 4-[[(2R)-2-[[(2R)-2-[[(2R)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]butanoic acid; choline
Molecular Formula: C₃₄H₄₂N₄O₇ · C₅H₁₄NO
Molecular Weight: 698.82 g/mol (free base), 735.89 g/mol (choline salt)
CAS Number: 1637501-84-9 (free base), 1637501-85-0 (choline salt)
Therapeutic Category: Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist
Indication: Linzagolix choline is an investigational oral gonadotropin-releasing hormone (GnRH) receptor antagonist being developed for the treatment of hormone-dependent conditions such as uterine fibroids and endometriosis. It works by selectively blocking the GnRH receptor, thereby reducing the production of estrogen and progesterone, which are key drivers of these conditions.
Mechanism of Action: Linzagolix choline binds competitively to the GnRH receptor in the pituitary gland, inhibiting the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This suppression leads to decreased ovarian production of estrogen and progesterone, alleviating symptoms associated with uterine fibroids and endometriosis, such as heavy menstrual bleeding and pelvic pain.
Dosage Form: Linzagolix choline is supplied as an active pharmaceutical ingredient (API) for formulation into oral dosage forms, such as tablets or capsules.
Pharmacokinetics:
Absorption: Linzagolix choline is well-absorbed following oral administration, with peak plasma concentrations achieved within a few hours.
Distribution: It has a moderate volume of distribution, indicating good tissue penetration.
Metabolism: Linzagolix is primarily metabolized in the liver via enzymatic pathways, including cytochrome P450 enzymes.
Excretion: The drug and its metabolites are predominantly excreted in the urine.
Storage Conditions: Linzagolix choline API should be stored in a cool, dry place, protected from light.
Stability: Linzagolix choline is stable under recommended storage conditions. It should be protected from extreme temperatures and humidity to maintain its stability and efficacy.
Regulatory Status: Linzagolix choline is currently under clinical development and has not yet received approval for commercial use. It is being evaluated in various clinical trials to assess its safety and efficacy in treating uterine fibroids and endometriosis.
Packaging: Linzagolix choline API is supplied in sealed, light-resistant containers to ensure product integrity. The packaging is designed to protect the API from environmental factors that could compromise its quality.
Quality Standards: Linzagolix choline API is manufactured in compliance with current Good Manufacturing Practices (cGMP) and meets stringent quality control standards to ensure its purity, potency, and consistency.
Applications: Linzagolix choline API is intended for use in the development and production of pharmaceutical formulations aimed at treating hormone-dependent conditions such as uterine fibroids and endometriosis. It is suitable for use in both clinical trials and commercial pharmaceutical manufacturing.
Note: This product is intended for research and development purposes only. It is not for human or veterinary use unless specified by regulatory authorities.
