The present invention relates to relugolix hemihydrate and a process for its preparation. The invention also relates to a pharmaceutical composition comprising relugolix hemihydrate, preferably in a predetermined and/or effective amount and at least one pharmaceutically acceptable excipient. The pharmaceutical composition of the present invention can be used as a medicament, in particular for the treatment and/or prophylaxis of a condition selected from the group consisting of endometriosis, uterine fibroids and prostate cancer.
