Clinical Trials

Mirogabalin (DS-5565) has been evaluated across numerous clinical trials spanning early to late phases to assess its efficacy, safety, and pharmacokinetics in chronic pain conditions, including diabetic peripheral neuropathic pain, post-herpetic neuralgia, fibromyalgia, osteoarthritis, and postoperative pain. Sponsored by pharmaceutical companies such as Daiichi Sankyo and Zhejiang Anglikang Pharmaceutical alongside academic institutions like Gangnam Severance Hospital and Beijing Tiantan Hospital, these studies encompass both completed late-phase trials and actively recruiting comparative evaluations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07307170 RECRUITING
Herpes Zoster; Mirogabalin; Pain
Beijing Tiantan Hospital
 2025-12-15
NCT07157852 RECRUITING
Fibromyalgia; Pregabalin; Mirogabalin; Pain
Beijing Tiantan Hospital
 2025-09-05
NCT07451431 RECRUITING
Diabetic Peripheral Neuropathic Pain (DPNP)
Bangladesh Medical University
 2025-10-01 PHASE4
NCT07803393 NOT_YET_RECRUITING
Bladder Pain Syndrome; Educational Behavioral Intervention; Urinary Urgency
Beijing Tiantan Hospital
 2026-09-20 PHASE1
NCT06328062 RECRUITING
Pain Postoperative; Osteoarthritis; Total Knee Arthroplasty
Thammasat University Hospital
 2024-04-01
NCT06711978 COMPLETED
CIPN; CIPN - Chemotherapy-Induced Peripheral Neuropathy; CIPN in Adjuvant Breast Cancer Patients; Duloxetine; Mirogabalin
Pusan National University Yangsan Hospital
 2024-12-01
NCT05938088 UNKNOWN
Hip Osteoarthritis
Gangnam Severance Hospital
 2023-07-20
NCT06846567 COMPLETED
Diabetic Neuropathies; Diabetes Mellitus
Zhejiang Anglikang Pharmaceutical Co., Ltd.
 2024-12-01 PHASE1
NCT04094662 COMPLETED
Diabetic Peripheral Neuropathic Pain
Daiichi Sankyo Co., Ltd.
 2019-09-18 PHASE3
NCT03901352 COMPLETED
Central Neuropathic Pain
Daiichi Sankyo Co., Ltd.
 2019-03-12 PHASE3
NCT02496884 COMPLETED
Fibromyalgia
Daiichi Sankyo
 2015-06-26 PHASE3
NCT02318706 COMPLETED
Diabetic Peripheral Neuropathic Pain
Daiichi Sankyo Co., Ltd.
 2015-01 PHASE3
NCT02318719 COMPLETED
Post-Herpetic Neuralgia
Daiichi Sankyo Co., Ltd.
 2015-01
NCT02234583 COMPLETED
Pain Associated With Fibromyalgia
Daiichi Sankyo
 2015-02-04 PHASE3
NCT02607280 COMPLETED
Diabetic Peripheral Neuropathic Pain; Post-herpetic Neuralgia
Daiichi Sankyo Co., Ltd.
 2015-12 PHASE3
NCT02187471 COMPLETED
Pain Associated With Fibromyalgia
Daiichi Sankyo
 2015-01-16 PHASE3
NCT02146430 COMPLETED
Pain Associated With Fibromyalgia
Daiichi Sankyo
 2014-10-27 PHASE3
NCT02187159 COMPLETED
Pain Associated With Fibromyalgia
Daiichi Sankyo
 2014-11 PHASE3
NCT02234583 Completed
Pain Associated With Fibromyalgia
Daiichi Sankyo
 2015-02-04 Phase 3
NCT02318719 Completed
Post-Herpetic Neuralgia
Daiichi Sankyo Co. Ltd.|SRL Medisearch Inc.|Quintiles Inc.|Daiichi Sankyo
 2015-01 Not Applicable
NCT02318706 Completed
Diabetic Peripheral Neuropathic Pain
Daiichi Sankyo Co. Ltd.|CMIC Co Ltd. Japan|Quintiles Inc.|Quintiles Malaysia Sdn. Bhd.|Daiichi Sankyo
 2015-01 Phase 3
NCT01504412 COMPLETED
Pain; Diabetic Peripheral Neuropathy
Daiichi Sankyo Co., Ltd.
 2012-01 PHASE2
NCT01496365 COMPLETED
Diabetic Peripheral Neuropathy
Daiichi Sankyo
 2011-11-28 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-03-19)

Check the Mirogabalin (DS-5565) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mirogabalin functions as a selective ligand for the alpha2delta-1 subunit of voltage-gated calcium channels, binding with high affinity to inhibit depolarized calcium influx into presynaptic terminals. This reduction in calcium entry suppresses the downstream release of excitatory neurotransmitters in nociceptive pathways, thereby dampening hyperexcitable neuronal activity and attenuating chronic pain symptoms associated with diabetic peripheral neuropathy, post-herpetic neuralgia, and fibromyalgia.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.