Mirogabalin (brand name Tarlige; developmental code name DS-5565) is a medication developed by
Daiichi Sankyo
is a global pharmaceutical company and the second-largest pharmaceutical company in Japan. It achieved JPY 981.8 billion in revenue in 2019. The company owns the American biotechnology company Plexxikon, American pharmaceutical company American R ...
, a
gabapentinoid.
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 trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, diet ...
s for the treatment of
diabetic peripheral neuropathic pain.
Phase III trial results:
* Effective: for
post-herpetic neuralgia
Postherpetic neuralgia (PHN) is neuropathic pain that occurs due to damage to a peripheral nerve caused by the reactivation of the varicella zoster virus (herpes zoster, also known as shingles). Typically, the nerve pain (neuralgia) is confined t ...
(trial: NEUCOURSE)
* Ineffective: for
fibromyalgia
Fibromyalgia (FM) is a medical condition defined by the presence of chronic widespread pain, fatigue, waking unrefreshed, cognitive symptoms, lower abdominal pain or cramps, and depression. Other symptoms include insomnia and a general hyp ...
(trial: ALDAY)
* Effective: for diabetic peripheral
neuropathic pain
Neuropathic pain is pain caused by damage or disease affecting the somatosensory system. Neuropathic pain may be associated with abnormal sensations called dysesthesia or pain from normally non-painful stimuli (allodynia). It may have continuous ...
(trial: REDUCER)
In Japan, the company submitted a marketing application for treatment of
peripheral neuropathic pain.
The medication was approved for
neuropathic pain
Neuropathic pain is pain caused by damage or disease affecting the somatosensory system. Neuropathic pain may be associated with abnormal sensations called dysesthesia or pain from normally non-painful stimuli (allodynia). It may have continuous ...
and
postherpetic neuralgia
Postherpetic neuralgia (PHN) is neuropathic pain that occurs due to damage to a peripheral nerve caused by the reactivation of the varicella zoster virus (herpes zoster, also known as shingles). Typically, the nerve pain (neuralgia) is confined ...
in Japan in January 2019.
References
External links
*
Amino acids
Analgesics
Calcium channel blockers
Cyclobutanes
Cyclopentenes
Daiichi Sankyo
GABA analogues
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