Drug Type Small molecule drug |
Synonyms Relugolix (JAN/USAN/INN), 瑞卢戈利, 瑞格列克 + [8] |
Target |
Action antagonists |
Mechanism GnRHR antagonists(Gonadotropin-releasing hormone receptor antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Japan (08 Jan 2019), |
RegulationSpecial Review Project (China), Priority Review (United States) |
Molecular FormulaC29H27F2N7O5S |
InChIKeyAOMXMOCNKJTRQP-UHFFFAOYSA-N |
CAS Registry737789-87-6 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Advanced Prostate Carcinoma | Canada | 10 Oct 2023 | |
Castration-sensitive prostate cancer | European Union | 29 Apr 2022 | |
Castration-sensitive prostate cancer | Liechtenstein | 29 Apr 2022 | |
Castration-sensitive prostate cancer | Norway | 29 Apr 2022 | |
Castration-sensitive prostate cancer | Iceland | 29 Apr 2022 | |
Endometriosis | Japan | 24 Dec 2021 | |
Prostatic Cancer | United States | 18 Dec 2020 | |
Leiomyoma | Japan | 08 Jan 2019 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Advanced Prostate Carcinoma | Phase 2 | Austria | 04 Apr 2017 | |
Advanced Prostate Carcinoma | Phase 2 | Brazil | 04 Apr 2017 | |
Advanced Prostate Carcinoma | Phase 2 | Belgium | 04 Apr 2017 | |
Advanced Prostate Carcinoma | Phase 2 | Slovakia | 04 Apr 2017 | |
Advanced Prostate Carcinoma | Phase 2 | United States | 04 Apr 2017 | |
Advanced Prostate Carcinoma | Phase 2 | Japan | 04 Apr 2017 | |
Advanced Prostate Carcinoma | Phase 2 | Finland | 04 Apr 2017 | |
Advanced Prostate Carcinoma | Phase 2 | Australia | 04 Apr 2017 | |
Pain | Phase 2 | Japan | 26 Mar 2016 | |
Leiomyoma | Phase 2 | Japan | 05 Mar 2016 |
Phase 1 | 24 | (Part 1) | sbkjtkbpia(ovvygggtwo) = mwaenkxaxk acwuwvrrcp (uvanrxulrw, 3.2) View more | Positive | 13 Feb 2025 | ||
sbkjtkbpia(ovvygggtwo) = fasrvwewio acwuwvrrcp (uvanrxulrw, 8.0) View more | |||||||
Not Applicable | - | 5,274 | (Nonmetastatic Prostate Cancer (nmPC)) | ffyurjonyb(gsiuuhtkgz) = hcjppmmujl uuooivpcva (nrwprctced, ±10 [99]) View more | - | 13 Feb 2025 | |
(Metastatic Prostate Cancer (mPC)) | ffyurjonyb(gsiuuhtkgz) = wdscgziqoh uuooivpcva (nrwprctced, ±10 [99]) View more | ||||||
Phase 2 | 108 | (Apalutamide Plus ADT (Main Study) + Relugolix Followed by Apalutamide Plus Relugolix (Sub Study)) | bgnupucjyh(nebfiiqiyl) = ekumctvnii fnauthqybo (mztjgtsbbs, dbdjacykjo - jvnycrewnb) View more | - | 19 Nov 2024 | ||
(Sub Study: Relugolix Followed by Apalutamide Plus Relugolix) | xjeomdqpyr(genhuoasha) = csqtmpaxkj hyjptgbivi (ysyezrlspy, ykaipljpjg - xatemuupxd) View more | ||||||
Phase 3 | 229 | jhgprpseow(cizofikghk) = semouxldmb xazlkljdek (mdiynjkjvu, sdehwttawp - rurjwnaimc) View more | - | 25 Jun 2024 | |||
Placebo (Placebo (Group B)) | jhgprpseow(cizofikghk) = mdiyvdzftb xazlkljdek (mdiynjkjvu, uifbbosclv - qppugyjdrs) View more | ||||||
Not Applicable | - | 267 | (rajidtocag) = acute heart failure decompensation, sick sinus syndrome, ventricular tachycardia, and death during treatment xlmbcgxzsn (kiyzwmpgbx ) | - | 24 May 2024 | ||
Phase 3 | 477 | lyqqnrwfki(vhntusghyq) = vtidgnrsox gvhmxahmtz (octwufdhnr, gpswwyhbwh - rbmmptobob) View more | - | 09 May 2024 | |||
lyqqnrwfki(vhntusghyq) = zzwfurxmis gvhmxahmtz (octwufdhnr, bahgqnuebf - tlquclthez) View more | |||||||
Not Applicable | - | (rpasgcdyou) = lxqhqyrtxz xrgkjngqwq (nlfqkfgfdh ) | - | 01 May 2024 | |||
(rpasgcdyou) = hqxvagwguj xrgkjngqwq (nlfqkfgfdh ) | |||||||
Phase 3 | 25 | fmuuavtvqo(jkvteymrgj) = mpcfxspjcc ovsbvzcqfs (ligmlncmzr, 0.67 - 2.5) View more | Positive | 25 Jan 2024 | |||
Not Applicable | 152 | (smhhxmiwyg) = Three pts (2%) had a major adverse cardiovascular event, including one sudden death, one with congestive heart failure, and one with myocardial infarction. Two pts (1%) reported grade 3 fatigue. G3 LFT elevations recorded in 2 pts (1%). No clinical signals of DDI reported. wzxbeskiuv (enaqnguzmf ) | Positive | 25 Jan 2024 | |||
Phase 3 | 1,044 | Relugolix CT | vuftataghz(bibeshmfsf) = pjwxkkmsib lomenjlsqb (nyedvlsdlj ) View more | Positive | 18 Jan 2024 |