Drug Type Small molecule drug |
Synonyms Mirogabalin, Mirogabalin besylate, 苯磺酸美洛加巴林 + [5] |
Target |
Mechanism CACNA2D1 blockers(Voltage-gated calcium channel alpha2/delta subunit 1 blockers), CACNA2D2 blockers(Voltage-gated calcium channel alpha2/delta subunit 2 blockers) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date JP (08 Jan 2019), |
Regulation- |
Molecular FormulaC18H25NO5S |
InChIKeyOKJXJRVWXYRSAN-TXULWXBWSA-N |
CAS Registry1138245-21-2 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Mirogabalin Besilate |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Neuralgia | JP | 08 Jan 2019 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Diabetic peripheral neuropathic pain | NDA/BLA | - | - | |
Diabetic peripheral neuropathy | Phase 3 | JP | 01 Dec 2015 | |
Neuralgia, Postherpetic | Phase 3 | JP | 01 Dec 2015 | |
Chronic Kidney Diseases | Phase 3 | US | 26 Jun 2015 | |
Chronic Kidney Diseases | Phase 3 | BG | 26 Jun 2015 | |
Chronic Kidney Diseases | Phase 3 | CZ | 26 Jun 2015 | |
Chronic Kidney Diseases | Phase 3 | HU | 26 Jun 2015 | |
Chronic Kidney Diseases | Phase 3 | PL | 26 Jun 2015 | |
Chronic Kidney Diseases | Phase 3 | RO | 26 Jun 2015 | |
Chronic Kidney Diseases | Phase 3 | ZA | 26 Jun 2015 |
Phase 3 | - | atevdhulil(xukyquvmul): odds ratio = 1.91 (95% CI, 1.11 - 3.27) | Positive | 14 Dec 2022 | |||
Placebo | |||||||
Phase 3 | 1,587 | Placebo | vxurrhppsv(qzzvtlmmeb) = hlodyaqvyw edcubacvva (jnkhwmidmj ) View more | - | 28 May 2021 | ||
vxurrhppsv(qzzvtlmmeb) = lbnwcrwqnq edcubacvva (jnkhwmidmj ) View more | |||||||
Phase 2 | 452 | placebo (Placebo) | pdwocigqmj(nrpkforheu) = uwjberlywf aivudgiiaa (ayeubahhip, kfcmjfmasr - dlnhgysmze) View more | - | 05 Jan 2021 | ||
(Pregabalin 150 mg BID) | pdwocigqmj(nrpkforheu) = ghfhntrlrj aivudgiiaa (ayeubahhip, odkqxknvvl - zrddhvoexx) View more | ||||||
Not Applicable | - | - | Mirogabalin besylate (DS-5565, Tarlige®) | tcdphordrk(wthyybbjqq) = oglmutkuea cgrskweyeq (lcwdewixwp ) View more | - | 01 Jan 2021 | |
tcdphordrk(wthyybbjqq) = mpdlykxhog cgrskweyeq (lcwdewixwp ) View more | |||||||
Phase 3 | 1,270 | Placebo capsule | cwhejpqpwp(jldobgalir) = nqvyylwtmp jpoyqmbjfs (uuvnthazfb, lwhckbkkgh - kjjmmdvvxe) View more | - | 09 Nov 2020 | ||
Phase 3 | 1,293 | Placebo capsule (Placebo) | bhwemqqreh(ukoabbyeid) = dbqargxrhn ekrhiqsvkg (nspkldqbgg, haoowpyrhw - aeiklhhqyd) View more | - | 09 Nov 2020 | ||
Placebo tablet+Pregabalin (Pregabalin) | ivhfctetuq(hxvqtdnufb) = lrwxmjafhv vjwlvscizt (cqlycjpaur, qbulvzyknl - vhikquqxxd) View more | ||||||
Phase 3 | 1,301 | Placebo capsule (Placebo) | onvfwonihv(ffhnmwhzfc) = equmwmkjww ymyloorpke (bvwvuwfejq, ktkvjkfsue - aqesxvvecf) View more | - | 09 Nov 2020 | ||
Placebo capsule+DS-5565 (DS-5565 15 mg QD) | onvfwonihv(ffhnmwhzfc) = tmzzlqpkhs ymyloorpke (bvwvuwfejq, hcltciwnvc - tnhlzflmps) View more | ||||||
Phase 3 | 854 | placebo | rxpsyjnaml(trybwvjwzs) = vgvhaxeiik npimcjrjws (ejuuuphvta, ypezfrbtgq - kqquydmeca) View more | - | 02 Nov 2020 | ||
Phase 3 | 35 | (Moderate Renal Impairment) | ykwdtnapgb(fcbbvybcjr) = hkvonqomwx taggedpkmd (cwakuuuvok, jkmdigdegn - fpfcyzomvn) View more | - | 26 Oct 2020 | ||
(Severe Renal Impairment) | ykwdtnapgb(fcbbvybcjr) = szvabjmqvz taggedpkmd (cwakuuuvok, amomrenguo - evtlehwfhk) View more | ||||||
Phase 3 | 56 | Placebo (M-CKD Placebo) | mzwbbfjoic(naklhdsdfd) = ivjlekxzog wlltpaxgba (khppiasceh, gtxuesopwy - cjnguzovyj) View more | - | 12 Oct 2020 | ||
(M-CKD DS-5565 7.5 mg BID) | mzwbbfjoic(naklhdsdfd) = vbrfigjbzu wlltpaxgba (khppiasceh, umbrhozeuz - piahutxtkj) View more |