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DS-5565
DS-5565 is a selective sodium channel inhibitor that reduces neuronal excitability by blocking voltage-gated sodium channels.
DS-5565 is a selective sodium channel inhibitor that reduces neuronal excitability by blocking voltage-gated sodium channels. Used for Neuropathic pain, Diabetic peripheral neuropathic pain.
At a glance
| Generic name | DS-5565 |
|---|---|
| Also known as | mirogabalin, Investigational product, Mirogabalin, Experimental drug, SUB60040 |
| Sponsor | Daiichi Sankyo Co., Ltd. |
| Drug class | Selective sodium channel inhibitor |
| Target | Voltage-gated sodium channels (Nav) |
| Modality | Small molecule |
| Therapeutic area | Neurology / Pain Management |
| Phase | Phase 3 |
Mechanism of action
DS-5565 selectively inhibits sodium channels in the nervous system, thereby reducing the firing of pain-transmitting neurons. This mechanism is intended to provide analgesia by dampening neuropathic pain signals without significantly affecting cardiac or skeletal muscle sodium channels. The drug is being developed primarily for neuropathic pain conditions.
Approved indications
- Neuropathic pain
- Diabetic peripheral neuropathic pain
Common side effects
- Dizziness
- Somnolence
- Ataxia
- Tremor
Key clinical trials
- The Analgesic Efficacy and Safety of Mirogabalin in Patients With Herpes Zoster (NA)
- Efficacy and Safety of Mirogabalin in Diabetic Peripheral Neuropathic Pain (PHASE4)
- The Efficacy and Safety of Pregabalin and Mirogabalin in Patients With Fibromyalgia (NA)
- Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA (NA)
- Phase I Study of BM2216 ER vs. Melogabalin Besilate: Safety, PK, and Food Effect in Healthy Adults (PHASE1)
- A Study to Evaluate the Safety and Effectiveness of Mirogabalin in Chinese Adult Patients With Diabetic Peripheral Neuropathic Pain (DPNP) in Real-world Clinical Practice Setting (ReMIssion Study)
- Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors (NA)
- Study of Mirogabalin for Central Neuropathic Pain (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DS-5565 CI brief — competitive landscape report
- DS-5565 updates RSS · CI watch RSS
- Daiichi Sankyo Co., Ltd. portfolio CI