Last update 08 May 2025

Relugolix

Overview

Basic Info

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)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Japan (08 Jan 2019),
RegulationSpecial Review Project (China), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC29H27F2N7O5S
InChIKeyAOMXMOCNKJTRQP-UHFFFAOYSA-N
CAS Registry737789-87-6

External Link

KEGGWikiATCDrug Bank
D10888Relugolix

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Prostate CarcinomaPhase 2
Austria
04 Apr 2017
Advanced Prostate CarcinomaPhase 2
Brazil
04 Apr 2017
Advanced Prostate CarcinomaPhase 2
Belgium
04 Apr 2017
Advanced Prostate CarcinomaPhase 2
Slovakia
04 Apr 2017
Advanced Prostate CarcinomaPhase 2
United States
04 Apr 2017
Advanced Prostate CarcinomaPhase 2
Japan
04 Apr 2017
Advanced Prostate CarcinomaPhase 2
Finland
04 Apr 2017
Advanced Prostate CarcinomaPhase 2
Australia
04 Apr 2017
PainPhase 2
Japan
26 Mar 2016
LeiomyomaPhase 2
Japan
05 Mar 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
24
Relugolix 120 mg + Abiraterone 1000 mg + prednisone 5 mg/methylprednisolone 4 mg
(Part 1)
sbkjtkbpia(ovvygggtwo) = mwaenkxaxk acwuwvrrcp (uvanrxulrw, 3.2)
Positive
13 Feb 2025
Relugolix 240 mg + Apalutamide 240 mg
sbkjtkbpia(ovvygggtwo) = fasrvwewio acwuwvrrcp (uvanrxulrw, 8.0)
Not Applicable
-
5,274
(Nonmetastatic Prostate Cancer (nmPC))
ffyurjonyb(gsiuuhtkgz) = hcjppmmujl uuooivpcva (nrwprctced, ±10 [99])
-
13 Feb 2025
(Metastatic Prostate Cancer (mPC))
ffyurjonyb(gsiuuhtkgz) = wdscgziqoh uuooivpcva (nrwprctced, ±10 [99])
Phase 2
108
(Apalutamide Plus ADT (Main Study) + Relugolix Followed by Apalutamide Plus Relugolix (Sub Study))
bgnupucjyh(nebfiiqiyl) = ekumctvnii fnauthqybo (mztjgtsbbs, dbdjacykjo - jvnycrewnb)
-
19 Nov 2024
(Sub Study: Relugolix Followed by Apalutamide Plus Relugolix)
xjeomdqpyr(genhuoasha) = csqtmpaxkj hyjptgbivi (ysyezrlspy, ykaipljpjg - xatemuupxd)
Phase 3
229
(Relugolix Plus E2/NETA (Group A))
jhgprpseow(cizofikghk) = semouxldmb xazlkljdek (mdiynjkjvu, sdehwttawp - rurjwnaimc)
-
25 Jun 2024
Placebo
(Placebo (Group B))
jhgprpseow(cizofikghk) = mdiyvdzftb xazlkljdek (mdiynjkjvu, uifbbosclv - qppugyjdrs)
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
(Relugolix Plus E2/NETA (Group A))
lyqqnrwfki(vhntusghyq) = vtidgnrsox gvhmxahmtz (octwufdhnr, gpswwyhbwh - rbmmptobob)
-
09 May 2024
(Relugolix Plus Delayed E2/NETA (Group B))
lyqqnrwfki(vhntusghyq) = zzwfurxmis gvhmxahmtz (octwufdhnr, bahgqnuebf - tlquclthez)
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)
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
vuftataghz(bibeshmfsf) = pjwxkkmsib lomenjlsqb (nyedvlsdlj )
Positive
18 Jan 2024
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