Mirogabalin
Appearance
| Clinical data | |
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| Trade names | Tarlige |
| Other names | DS-5565; DS5565 |
| Routes of administration | Oral |
| Drug class | Gabapentinoid; Analgesic |
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| CAS Number | |
| PubChem CID | |
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| Chemical and physical data | |
| Formula | C12H19NO2 |
| Molar mass | 209.289 g·mol−1 |
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Mirogabalin (brand name Tarlige; developmental code name DS-5565) is a gabapentinoid medication developed by Daiichi Sankyo.[1] Gabapentin and pregabalin are also members of this class. As a gabapentinoid, mirogabalin binds to the α2δ subunit of voltage-gated calcium channel (1 and 2), but with significantly higher potency than pregabalin. It has shown promising results in Phase II clinical trials for the treatment of diabetic peripheral neuropathic pain.[2][3]
Phase III trial results:
- Effective: for post-herpetic neuralgia (trial: NEUCOURSE)
- Ineffective: for fibromyalgia (trial: ALDAY)[4]
- Effective: for diabetic peripheral neuropathic pain (trial: REDUCER)[5]
In Japan, the company submitted a marketing application for treatment of peripheral neuropathic pain.[6] The medication was approved for neuropathic pain and postherpetic neuralgia in Japan in January 2019.[7]
See also
[edit]References
[edit]- ↑ Salazar JK, Kaduk JA, Dosen A, Blanton TN (1 October 2026). "Mirogabalin, C12H19NO2, and mirogabalin besylate, C12H20NO2+·C6H5O3S−". Acta Crystallographica Section C: Structural Chemistry. 82 (10). International Union of Crystallography: 676–685. doi:10.1107/S205322962600923X. ISSN 2053-2296. PMID 42723564.
- ↑ Vinik A, Rosenstock J, Sharma U, Feins K, Hsu C, Merante D (December 2014). "Efficacy and safety of mirogabalin (DS-5565) for the treatment of diabetic peripheral neuropathic pain: a randomized, double-blind, placebo- and active comparator-controlled, adaptive proof-of-concept phase 2 study". Diabetes Care. 37 (12): 3253–3261. doi:10.2337/dc14-1044. PMID 25231896.
- ↑ Vinik A, Sharma U, Feins K, Hsu C, Merante D (2014). "DS-5565 for the Treatment Of Diabetic Peripheral Neuropathic Pain: Randomized, Double-Blind, Placebo- And Active Comparator-Controlled Phase II Study (S20.004)". Neurology. 82 (10): S20.004.
- ↑ "Daiichi Sankyo Announces Top-line Results from Phase 3 Global Clinical Development Program Evaluating Mirogabalin in Pain Syndromes". Daiichi Sankyo. 30 June 2017.
- ↑ "Daiichi Sankyo Announces Positive Top-line Results from Phase 3 Clinical Trial Evaluating Mirogabalin in Diabetic Peripheral Neuropathic Pain". Daiichi Sankyo. 31 August 2017.
- ↑ "Daiichi Sankyo Submits Marketing Application for Mirogabalin in Japan". Daiichi Sankyo. 15 February 2018.
- ↑ "Mirogabalin - Daiichi Sankyo Company - AdisInsight".
External links
[edit]- "Mirogabalin". Drug Information Portal. U.S. National Library of Medicine. 16 August 2022. Archived from the original on 24 October 2021.