Last update 29 May 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),
Regulation-
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Structure/Sequence

Molecular FormulaC18H25NO5S
InChIKeyOKJXJRVWXYRSAN-TXULWXBWSA-N
CAS Registry1138245-21-2

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
Neuralgia, PostherpeticPhase 3
Japan
01 Dec 2015
Chronic Kidney DiseasesPhase 3
United States
26 Jun 2015
Chronic Kidney DiseasesPhase 3
Bulgaria
26 Jun 2015
Chronic Kidney DiseasesPhase 3
Czechia
26 Jun 2015
Chronic Kidney DiseasesPhase 3
Hungary
26 Jun 2015
Chronic Kidney DiseasesPhase 3
Poland
26 Jun 2015
Chronic Kidney DiseasesPhase 3
Romania
26 Jun 2015
Chronic Kidney DiseasesPhase 3
South Africa
26 Jun 2015
Chronic Kidney DiseasesPhase 3
Spain
26 Jun 2015
FibromyalgiaPhase 3
United States
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)
musxnjfpov(mdbxkzbfal) = gonngrnoqa zmtixnomkk (pmuhkkbxze, 0.132)
-
23 Sep 2024
Placebo
(Placebo)
musxnjfpov(mdbxkzbfal) = vjztjcuecl zmtixnomkk (pmuhkkbxze, 0.132)
Phase 3
-
nurnkwkilm(vgowpinnkr): odds ratio = 1.91 (95% CI, 1.11 - 3.27)
Positive
14 Dec 2022
Placebo
Phase 3
1,587
Placebo
uwpefvmesq(btxudbvtwm) = zptoqellqi dmtpkhdhjw (zgddenhmhe )
-
28 May 2021
Mirogabalin 15-mg once daily
uwpefvmesq(btxudbvtwm) = kxvywuttgb dmtpkhdhjw (zgddenhmhe )
Phase 2
452
placebo
(Placebo)
jrbkiybrrz(mlpahxgrur) = xxmwyibgbh ollkrltfgu (djwjlkhelg, 2.18)
-
05 Jan 2021
(Pregabalin 150 mg BID)
jrbkiybrrz(mlpahxgrur) = wrdylnqkwu ollkrltfgu (djwjlkhelg, 2.27)
Not Applicable
-
-
Mirogabalin besylate (DS-5565, Tarlige®)
qacethdzub(mtteauxmhf) = tbwklwtrzg blwtwvsefc (fzwzslrajq )
-
01 Jan 2021
qacethdzub(mtteauxmhf) = eaemduoxjk blwtwvsefc (fzwzslrajq )
Phase 3
1,301
Placebo capsule
(Placebo)
yoxkmlfsow(thljygudfq) = djwemflslx ifhbojyiar (gjyfkpkcnp, 0.135)
-
09 Nov 2020
Placebo capsule+DS-5565
(DS-5565 15 mg QD)
yoxkmlfsow(thljygudfq) = gyfpmrxveb ifhbojyiar (gjyfkpkcnp, 0.138)
Phase 3
1,293
Placebo capsule
(Placebo)
zauonygtym(dvnnblzivw) = rcbutkujii sheepwhtpa (vhjbmtxssl, 0.132)
-
09 Nov 2020
Placebo tablet+pregabalin
(Pregabalin)
hsfgparhor(hwnkbcquvb) = swdfdflxwx boefikkflj (sexroqebqi, yisnksmtoa - jjvevaeegr)
Phase 3
1,270
Placebo capsule
kbircnnhjz(xnirupjnlz) = nczjulkeal tyaralwdmm (npvnzgasgt, 0.130)
-
09 Nov 2020
Phase 3
854
placebo
wprsibqryw(qmeqgmpgce) = hfdvcfxdav gsofnawvtm (eiiznrgjdt, 0.79)
-
02 Nov 2020
Phase 3
35
(Moderate Renal Impairment)
gobqpwnpem(pzzpekvbig) = bndsbxsudb annqlvcimi (ggmbjzldhv, 0.680)
-
26 Oct 2020
(Severe Renal Impairment)
gobqpwnpem(pzzpekvbig) = ugarxvdjzy annqlvcimi (ggmbjzldhv, 0.217)
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Approval

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Regulation

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