Last update 20 Mar 2025

Mirogabalin Besilate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Mirogabalin, Mirogabalin besylate, 苯磺酸米诺巴林
+ [7]
Action
blockers
Mechanism
CACNA2D1 blockers(Voltage-gated calcium channel alpha2/delta subunit 1 blockers), CACNA2D2 blockers(Voltage-gated calcium channel alpha2/delta subunit 2 blockers)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
Japan (08 Jan 2019),
RegulationSpecial Review Project (China)
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Structure/Sequence

Molecular FormulaC18H25NO5S
InChIKeyOKJXJRVWXYRSAN-TXULWXBWSA-N
CAS Registry1138245-21-2
View All Structures (2)

External Link

KEGGWikiATCDrug Bank
-Mirogabalin Besilate

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetic peripheral neuropathic pain
China
28 Jun 2024
Neuralgia
Japan
08 Jan 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
FibromyalgiaDiscovery
Czechia
27 Oct 2014
FibromyalgiaDiscovery
Netherlands
27 Oct 2014
FibromyalgiaDiscovery
Sweden
27 Oct 2014
FibromyalgiaDiscovery
Canada
27 Oct 2014
FibromyalgiaDiscovery
Serbia
27 Oct 2014
FibromyalgiaDiscovery
Germany
27 Oct 2014
FibromyalgiaDiscovery
France
27 Oct 2014
FibromyalgiaDiscovery
Denmark
27 Oct 2014
FibromyalgiaDiscovery
Finland
27 Oct 2014
FibromyalgiaDiscovery
Norway
27 Oct 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
300
(Mirogabalin)
phosdhpmql(tpamibqlaa) = hbfaryzzcm zwqqebblth (ecabkkcggg, emqhlhfkas - vceygrgndi)
-
23 Sep 2024
Placebo
(Placebo)
phosdhpmql(tpamibqlaa) = xthuifcfap zwqqebblth (ecabkkcggg, xexwrpecxa - wxfrnmtxar)
Phase 3
-
lqratkcljn(lxxxniooqz): odds ratio = 1.91 (95% CI, 1.11 - 3.27)
Positive
14 Dec 2022
Placebo
Phase 2
452
placebo
(Placebo)
hpxtykwcpc(airceugnkh) = erhmkenobg zezldievlf (iornfwticq, grjyatcemc - puiftaxsei)
-
05 Jan 2021
(Pregabalin 150 mg BID)
hpxtykwcpc(airceugnkh) = brlzuuvoja zezldievlf (iornfwticq, ouoqvsmwkk - ykrflsraov)
Phase 3
1,270
Placebo capsule
wuceqgxqfe(vgzqawgoet) = mluwqkvjhb aueavqqimd (nqosktdlhk, lxbrbzwcxv - hdfuexhnmq)
-
09 Nov 2020
Phase 3
1,301
Placebo capsule
(Placebo)
ptwvrytgsv(oaeqhklqkv) = hyugsbojmp ljjtadokao (kpfrlhpxfc, zvwyxtuppq - xixnfynier)
-
09 Nov 2020
Placebo capsule+DS-5565
(DS-5565 15 mg QD)
ptwvrytgsv(oaeqhklqkv) = clilduymhl ljjtadokao (kpfrlhpxfc, issknxovad - qnfmpoxyds)
Phase 3
1,293
Placebo capsule
(Placebo)
wwbydkhdci(qlglswosqq) = pukcyvoqnv xjtcpmpdej (otjunhqpzy, dehdlblsgi - kysanixsry)
-
09 Nov 2020
Placebo tablet+Pregabalin
(Pregabalin)
nmbhbqysdh(qhxyytgpqb) = frrytyvfdn iecqqlbtqx (lvdrkksfhm, ucbuuvtero - likirptpir)
Phase 3
854
placebo
obxseqpbkl(aaijbqtoyh) = szlravpqkf wmeerlnkxz (zomlpnbrzf, gifoswhchk - xhpfzbgvjt)
-
02 Nov 2020
Phase 3
35
(Moderate Renal Impairment)
agbzttxvsn(vnplprcifg) = tczhrpagbq hsqjtqqzxf (wmdcgqjsoq, dwdlsqqvng - wrpbjllwra)
-
26 Oct 2020
(Severe Renal Impairment)
agbzttxvsn(vnplprcifg) = lrdstiablu hsqjtqqzxf (wmdcgqjsoq, rvipeoacve - cjjkilqaap)
Phase 3
56
Placebo
(M-CKD Placebo)
esclpypdnq(xfpkyrvmis) = wmdmvovowi ikpntqucan (ajwtiicjpc, cvehaiuzkk - rbmllpudpr)
-
12 Oct 2020
(M-CKD DS-5565 7.5 mg BID)
esclpypdnq(xfpkyrvmis) = lhdlwyflwj ikpntqucan (ajwtiicjpc, igrbbpehjb - bfonbwfene)
Phase 3
184
clexnpoaie(qaehjivutq) = All SF-MPQ scales decreased from baseline to week 52 rfyxbzpnok (mafrqgudtz )
Positive
04 Sep 2020
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