99% API Active Pharmaceutical Ingredient Elagolix Sodium 832720-36-2

Product Description

Elagolix Sodium 99% Cas 832720-36-2 treatment of endometriosis and uterine fibroids API manufacturer with top quality from China !

What is Elagolix Sodium?

Elagolix is a white powder. Elagolix is an organic substance with chemical formula C32H30F5N3O5. Elagolix is mainly used to promote gonadal hormone releasing hormone antagonists.

Elagolix sodium was approved by the U.S. Food and Drug Administration (FDA) on July 23, 2018 under the brand name Orilissa®. The compound was originally developed by Neurocrine Biosciences and subsequently licensed to AbBVie worldwide to develop and commercialize the drug. Abbvie submitted its marketing application to FDA in November 2017.

Elagolix sodium is a GnRH receptor antagonist approved for the treatment of endometriosis with moderate to severe pain. Elagolix is the first drug to be approved by the FDA for this indication by oral administration in more than a decade, and this approval was obtained through a priority review pathway. In addition, a phase III clinical study of this compound for the control of severe menstrual bleeding associated with uterine fibroids is also in progress [13].

Endometriosis is one of the most common gynecological disorders in the United States, affecting more than 5.5 million women in North America alone. The two most common symptoms of endometriosis are pain and infertility. The pain is so intense that it can affect a woman's quality of life, from relationships to daily activities. Some women have no symptoms of endometriosis until they have difficulty conceiing [14].

Treatment options for endometriosis-related pain commonly include oral contraceptives, non-steroidal anti-inflammatory drugs (NSAIDs), opioid pain relievers, hormone therapy, and surgery. These drugs are effective for pain relief in some women, but rarely for endometriosis. Often surgical (such as laparotomy, laparoscopy, or hysterectomy) therapy is the best choice for patients with severe pain in endometriosis, but not all patients can be cured by surgery [15]. Therefore, scientists need to develop a new drug, can cure or even prevent this painful disease.

Elagolix is a GnRH receptor antagonist that inhibits endogenous GnRH signaling by competitively binding to GnRH receptors in the pituitary gland. The use of Elagolix can lead to dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, resulting in decreased blood concentrations of ovarian sex hormones, estradiol and progesterone [16].

The efficacy of Elagolix 150 mg once daily and 200 mg twice daily for the treatment of moderate to severe pain associated with endometriosis was based on two multicenter, double-blind, placebo-controlled phase III trials, Em-1 study (NCT01620528) and EM-2 study (NCT01931670), involving a total of 1686 patients with endometriosis [16].

Results from clinical trials showed that Elagolix significantly reduced the three most common types of endometriosis pain: daily menstrual pelvic pain, non-menstrual pelvic pain, and pain during sexual intercourse. Women who received Elagolix 150 mg once daily and 200 mg twice daily had higher rates of dose-dependent relief of daily menstrual pain and non-menstrual pelvic pain at month 3 compared with placebo.

The mean reduction in daily menstrual pain and non-menstrual pelvic pain relative to baseline was significantly higher in the two Elagolix treated groups at 6 months compared with placebo, and was statistically significant. Women in the Phase III study also self-assessed their endometriosis pain daily using the Digital Rating Scale (NRS). At 3 months, the Elagolix group had a significantly lower NRS score from baseline than the placebo group (P & LT; 0.001). In addition, women who took Elagolix 200 mg twice daily experienced a significant reduction in pain during intercourse [15].

Elagolix's approval provides physicians with an alternative treatment option that can be tailored to a woman's specific type and severity of endometriosis pain, preventing delays in the optimal time for treatment. Elagolix could be used to save more patients from the pain of surgical treatment, and is more convenient and compliant to the treatment of endometrioid-related pain by oral administration. Overall, Elagolix has great implications for patients with endometriosis and for doctors who treat the condition.