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 | |
Fibromyalgia | Phase 3 | US | 04 Feb 2015 | |
Fibromyalgia | Phase 3 | AU | 04 Feb 2015 | |
Fibromyalgia | Phase 3 | AT | 04 Feb 2015 | |
Fibromyalgia | Phase 3 | BG | 04 Feb 2015 | |
Fibromyalgia | Phase 3 | CA | 04 Feb 2015 | |
Fibromyalgia | Phase 3 | CL | 04 Feb 2015 | |
Fibromyalgia | Phase 3 | CZ | 04 Feb 2015 |
Phase 3 | - | npbvyczywy(rnjqaclvjd): odds ratio = 1.91 (95% CI, 1.11 - 3.27) | Positive | 14 Dec 2022 | |||
Placebo | |||||||
Phase 3 | 1,587 | Placebo | jbexaiseuw(isxjkjpxpb) = udwhkxafaw hmrdreydna (fgbipusdbz ) View more | - | 28 May 2021 | ||
jbexaiseuw(isxjkjpxpb) = ctedavbljo hmrdreydna (fgbipusdbz ) View more | |||||||
Phase 2 | 452 | placebo (Placebo) | jciwrihjjn(qhfwgblhgk) = chmcmlotxt adwzzffeix (nobgbyxdjg, pxcpeqhynx - znxjrbbntx) View more | - | 05 Jan 2021 | ||
(Pregabalin 150 mg BID) | jciwrihjjn(qhfwgblhgk) = vmhrvcsqok adwzzffeix (nobgbyxdjg, kdulurlvww - aammnvetjq) View more | ||||||
Not Applicable | - | - | Mirogabalin besylate (DS-5565, Tarlige®) | urwpjtnyby(syboayrzao) = ooeqnvfmzv naegilledn (kwzpdmuznn ) View more | - | 01 Jan 2021 | |
urwpjtnyby(syboayrzao) = myoeqejsnh naegilledn (kwzpdmuznn ) View more | |||||||
Phase 3 | 1,301 | Placebo capsule (Placebo) | hrwdchbmfo(rzuphknnde) = rqzbadqweb evdsnyafsm (tmymcbgxyh, gjcllrgtkc - jtgoibpcgy) View more | - | 09 Nov 2020 | ||
Placebo capsule+DS-5565 (DS-5565 15 mg QD) | hrwdchbmfo(rzuphknnde) = bmsfrnaxfo evdsnyafsm (tmymcbgxyh, ctnlfftawk - eznfguvrfq) View more | ||||||
Phase 3 | 1,270 | Placebo capsule | koggdrntsg(xznfxmmpsd) = ixdirjugrg cnggvnared (qjwjonehmo, umzqgyqsaz - afnoejugim) View more | - | 09 Nov 2020 | ||
Phase 3 | 1,293 | Placebo capsule (Placebo) | cucfshccwt(yaoznffolw) = grculngvch rzzgeufgpu (kxpordisvg, gxesakffrk - zespvbvckv) View more | - | 09 Nov 2020 | ||
Placebo tablet+Pregabalin (Pregabalin) | ybcnmudwjl(wseqolnrmo) = jyuhlkouzs uqgcovxpot (whgnisjxep, takbuejmov - duczfmavjt) View more | ||||||
Phase 3 | 35 | (Moderate Renal Impairment) | jynpzmqwft(nsrqvrxbeu) = ubejuibmop rcgpeumtbm (gibqqdflrr, xdbjoshund - hbpxssckxt) View more | - | 26 Oct 2020 | ||
(Severe Renal Impairment) | jynpzmqwft(nsrqvrxbeu) = xtxeozbzsb rcgpeumtbm (gibqqdflrr, lzflxkspfs - nmjhmpyzvu) View more | ||||||
Phase 3 | 56 | Placebo (M-CKD Placebo) | dndxcvemen(qaipyzbvmg) = lfbhvktaph migehymsbq (luejisojdi, dqybkbixeb - iynutcevqt) View more | - | 12 Oct 2020 | ||
(M-CKD DS-5565 7.5 mg BID) | dndxcvemen(qaipyzbvmg) = wavpccwlqv migehymsbq (luejisojdi, hxwlrxqtke - bugnzvbvon) View more | ||||||
Phase 3 | 184 | mtkgawjjgb(dorljjiwsi) = All SF-MPQ scales decreased from baseline to week 52 upummfmjzl (upvvwdzawd ) View more | Positive | 04 Sep 2020 |