Elagolix sodium
| Status | Pipeline |
| Development phase | |
| Therapeutic cat. | Other |
| Polymorphic form | Amorphous |
| CAS No. | 832720-36-2 |
| Reference Product | |
| Injectable Form | |
| EU DMF readiness |  |
| CEP | |
| CHINESE DMF | |
| JAPANESE DMF | |
| KOREAN DMF | |
| CANADIAN DMF | |
| CADIFA | |
| US DMF readiness | |
| OEB No. | |
| Samples |
Drug description
Elagolix belongs to a class of drugs called gonadotropin-releasing hormone (GnRH) receptor antagonist. It is an oral tablet used to help treat pain caused by endometriosis .Endometriosis is a condition where tissue that should line the uterus or womb, grows outside of the uterus forming lesions. It affects about 1 in 10 women of reproductive age. During your menstrual cycle these lesions grow in response to rising levels of a hormone called estrogen, then they break down and shed during your period. This can cause pain throughout your cycle. Elagolix helps to reduce the pain you experience by reducing the amount of estrogen you produce that encourages the lesions to grow. Elagolix works by binding to GnRH receptors in the pituitary gland, which suppresses luteinizing hormone (LH) and follicle-stimulating hormone (FSH) and leads to a decrease in estrogen.
Polpharma API
Disclaimer
Products protected by patents (SPC) in Poland are developed solely for the purpose of Regulatory Submissions or R&D purposes intended to support Regulatory Submissions. These products are not offered for sale or made available in countries where such products are subject to patent (SPC) protection and where the offer for sale or any related activity constitutes patent infringement. It is within the buyer’s responsibility and liability to check the patent situation of the product in the import market(s). Based on exemption under art. 5(2) of the Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products Apixaban, Dapagliflozin (amorphous), Linagliptin, Rivaroxaban and Ticagrelor, which are protected by SPCs in Poland, can be manufactured and offered only for the purpose of export to non-EU countries, provided all requirements of the Regulationare met.
