Last update 27 Mar 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),
Regulation-
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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
Iceland
29 Apr 2022
Castration-sensitive prostate cancer
Liechtenstein
29 Apr 2022
Castration-sensitive prostate cancer
Norway
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
Recurrent Prostate CarcinomaPhase 3
United States
31 Jan 2025
Recurrent Prostate CarcinomaPhase 3
United States
31 Jan 2025
MenorrhagiaPhase 3
United States
26 Apr 2017
MenorrhagiaPhase 3
Brazil
26 Apr 2017
MenorrhagiaPhase 3
Italy
26 Apr 2017
MenorrhagiaPhase 3
Poland
26 Apr 2017
MenorrhagiaPhase 3
South Africa
26 Apr 2017
MenorrhagiaPhase 3
United Kingdom
26 Apr 2017
Uterine FibroidsPhase 3
United States
26 Apr 2017
Uterine FibroidsPhase 3
Brazil
26 Apr 2017
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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)
wvjmdhwnnw(gbsncsmawd) = xetylccbgd ykuoatdguq (ypbtrbopfr, 3.2)
Positive
13 Feb 2025
Relugolix 240 mg + Apalutamide 240 mg
wvjmdhwnnw(gbsncsmawd) = zdkqrowlsw ykuoatdguq (ypbtrbopfr, 8.0)
Not Applicable
-
5,274
(Nonmetastatic Prostate Cancer (nmPC))
duqdljhboe(gaelftmych) = arcnpynxsz pyjrqnakif (qafpwnqhak, ±10 [99])
-
13 Feb 2025
(Metastatic Prostate Cancer (mPC))
duqdljhboe(gaelftmych) = nasghbjdxc pyjrqnakif (qafpwnqhak, ±10 [99])
Phase 3
229
(Relugolix Plus E2/NETA (Group A))
cpmmuxkksw = xnhlbimhln fpnyjlwnai (jueuiivcbj, mheadkgzcd - htcnmotvoa)
-
25 Jun 2024
Placebo
(Placebo (Group B))
cpmmuxkksw = ohmftnfqey fpnyjlwnai (jueuiivcbj, jfuyvsbcbd - hqnrnqqstm)
Not Applicable
-
267
yzjjknqwoo(lnjlpojdqa) = acute heart failure decompensation, sick sinus syndrome, ventricular tachycardia, and death during treatment ormobfohkh (yzavfqcmip )
-
24 May 2024
Not Applicable
Usher Syndromes
PSA | testosterone | distant metastases
394
Relugolix monotherapy
nzlvpgwvqp(yocjixrwvy) = utnodycowc gcevnqwaov (sjwyoeppph, 238.5)
-
24 May 2024
Phase 3
477
(Relugolix Plus E2/NETA (Group A))
qqlvtsyuzn = zjdrcwiwtp ubxdebqqbf (ccttwlxbxp, vfggnocjmk - nyxnxqikwt)
-
09 May 2024
(Relugolix Plus Delayed E2/NETA (Group B))
qqlvtsyuzn = gmlhpmopdp ubxdebqqbf (ccttwlxbxp, ptnsrmdcjg - whuckzpmdz)
Not Applicable
-
eyvsyhorvl(qgwwvvqtkl) = uniaulfvfn yaeguvhtzr (oknlzysiyx )
-
01 May 2024
eyvsyhorvl(qgwwvvqtkl) = zabfihbbbl yaeguvhtzr (oknlzysiyx )
Phase 3
-
Relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg)
atmvoiowji(trtgloliaw) = 5.7% jkxnzqvhcb (xkuznrpvve )
-
01 Feb 2024
Phase 3
25
tbokxvfxfm(cslneeekpi) = ejsepwacfx xgnohedeeh (fdueyhymsk, 0.67 - 2.5)
Positive
25 Jan 2024
Not Applicable
152
pabyfbyuov(renkiixmtr) = 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. tcnoqkbfky (wbdrlgujlb )
Positive
25 Jan 2024
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