Drugs / Mirogabalin
Mirogabalin
also known as
DS-5565 · Mirogabalin Besylate · A-200-0700 · Mirogabalin besilate · Mirogabalina · Mirogabaline · Tarlige
Small molecule targets CACNA2D1, CACNA2D2
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07803393 | Sep → Dec 2026 expected | interstitial cystitis | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06846567 | Dec 2024 → Jan 2025 | diabetes mellitus, diabetic neuropathy | Zhejiang Anglikang Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT01504412 | Jan 2012 → Jun 2013 | diabetic polyneuropathy | Daiichi Sankyo | Completed | Missed primary |
| Phase 2 | NCT01496365 | Nov 2011 → Sep 2012 | diabetic polyneuropathy | Daiichi Sankyo | Completed | Met primary |
| Phase 39 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT04094662 | Sep 2019 → Jan 2022 | diabetic polyneuropathy | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT03901352 | Mar 2019 → Dec 2020 | neuropathy, painful | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT02607280 | Dec 2015 → Mar 2017 | diabetic polyneuropathy, postherpetic neuralgia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT02496884 | Jun 2015 → Jul 2017 | fibromyalgia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT02234583 | Feb 2015 → Apr 2017 | fibromyalgia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT02187471 | Jan 2015 → Jan 2017 | fibromyalgia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT02318706 | Jan 2015 → Jun 2017 | diabetic polyneuropathy | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT02187159 | Nov 2014 → Jul 2016 | fibromyalgia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT02146430 | Oct 2014 → Jul 2016 | fibromyalgia | Daiichi Sankyo | Completed | Missed primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT07451431 | Oct 2025 → Mar 2027 expected | diabetic polyneuropathy | Bangladesh Medical University | Recruiting | No outcome recorded |
| Phase not applicable5 trials · 1 met primary | ||||||
| — | NCT07307170 | Dec 2025 → Oct 2027 expected | herpes zoster | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT07157852 | Sep 2025 → Jun 2027 expected | fibromyalgia | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT06328062 | Apr 2024 → May 2025 overdue | osteoarthritis | Thammasat University Hospital | Recruiting | No outcome recorded |
| — | NCT05938088 | Jul 2023 → Jun 2025 | osteoarthritis, hip | Gangnam Severance Hospital | Unknown | No outcome recorded |
| — | NCT02318719 | Jan 2015 → May 2017 | postherpetic neuralgia | Daiichi Sankyo | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| — | NCT06711978 Comparator | Dec 2024 → May 2025 overdue | chemotherapy-induced neuropathy | Pusan National University Yangsan Hospital | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2020-12-18 | Daiichi Sankyo | Results Daiichi Sankyo Announces Phase 3 Study Results of mirogabalin of central neuropathic pain after spinal cord injury daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the achievement of the primary endpoint of phase 3 study (hereinafter, Study) mirogabalin for central neuropathic pain after spinal cord injury. |
| 2019-01-08 | Daiichi Sankyo | Regulatory Daiichi Sankyo Announces Marketing Approval in Japan of “Tarlige® Tablets” for Pain Treatment daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the receipt of marketing approval in Japan for Tarlige® Tablets 2.5 mg, 5 mg, 10 mg, 15 mg (generic name: mirogabalin besylate; hereafter, the drug) for the treatment of peripheral neuropathic pain (PNP)*1 |
| 2018-02-15 | Daiichi Sankyo | Regulatory Daiichi Sankyo Submits Marketing Application for Mirogabalin in Japan daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereinafter, Daiichi Sankyo) announces that today it filed a marketing application of the α2δ ligand*1, mirogabalin, for peripheral neuropathic pain (PNP)*2 in Japan. |
| 2017-08-31 | Daiichi Sankyo | Results Daiichi Sankyo Announces Positive Top-line Results from Phase 3 Clinical Trial Evaluating Mirogabalin in Diabetic Peripheral Neuropathic Pain daiichisankyo.com ↗
In the REDUCER clinical trial, mirogabalin demonstrated statistically significant reduction compared to placebo in the primary endpoint, change in weekly average daily pain score (ADPS) from baseline to Week 14. |
| 2017-06-30 | Daiichi Sankyo | Results Daiichi Sankyo Announces Top-line Results from Phase 3 Global Clinical Development Program Evaluating Mirogabalin in Pain Syndromes daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced top-line results from NEUCOURSE, a phase 3 clinical trial in patients with post-herpetic neuralgia, and the ALDAY phase 3 clinical trials in patients with fibromyalgia. |
All press releases naming this drug 8 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mirogabalin | “Receive either standard EBMP alone or EBMP plus oral mirogabalin for 12 weeks” NCT07803393 ↗ |
| Known as | A-200-0700 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545125 ↗ |
| Known as | DS-5565 | “Mirogabalin besylate (DS-5565, Tarlige®) shows greater sustained analgesia due to a high affinity to, and slow dissociation from, the α2δ-1 subunits in the dorsal root ganglion (DRG).” PMID 33380563 ↗ Jan 2021 |
| Known as | Mirogabalin besilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545125 ↗ |
| Known as | Mirogabalin Besylate | “Mirogabalin besylate (DS-5565, Tarlige®) shows greater sustained analgesia due to a high affinity to, and slow dissociation from, the α2δ-1 subunits in the dorsal root ganglion (DRG).” PMID 33380563 ↗ Jan 20211“Mirogabalin (Mirogabalin Besylate, Daiichi Sankyo Co., ltd, Japan) will be initiated 5 mg twice daily.” NCT07307170 ↗ |
| Known as | Mirogabalina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545125 ↗ |
| Known as | Mirogabaline | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545125 ↗ |
| Known as | Tarlige | “Mirogabalin besylate (DS-5565, Tarlige®) shows greater sustained analgesia due to a high affinity to, and slow dissociation from, the α2δ-1 subunits in the dorsal root ganglion (DRG).” PMID 33380563 ↗ Jan 2021 |
| Modality | Other / unclassified | “In conclusion, mirogabalin is anticipated to be a novel, safe gabapentinoid anticonvulsant with a greater therapeutic effect for neuropathic pain in the DRG and lower ADRs in...” PMID 33380563 ↗ Jan 2021 |
| Modality | Small molecule | — CHEMBL3545125 ↗ |
| Route | Oral | “Oral tablets administered twice daily” NCT01504412 ↗ |
| Target | CACNA2D1 | “Voltage-gated calcium channel alpha2/delta subunit 1 modulator” CHEMBL3545125 ↗ |
| Target | CACNA2D2 | “Voltage-gated calcium channel alpha2/delta subunit 2 modulator” CHEMBL3545125 ↗ |