Mirogabalin is a gabapentinoid pharmaceutical active ingredient developed for the management of neuropathic pain. It is a selective ligand of the α2δ subunit of voltage-gated calcium channels and has been investigated and used in pharmaceutical applications involving peripheral neuropathic pain. Mirogabalin has the molecular formula C₁₂H₁₉NO₂ and a molecular weight of 209.28 g/mol. Its CAS Number is 1138245-13-2.
Mirogabalin is commonly encountered pharmaceutically as mirogabalin besylate, the besylate salt of the active moiety. Mirogabalin besylate has the molecular formula C₁₈H₂₅NO₅S and a molecular weight of 367.5 g/mol. Its CAS Number is 1138245-21-2.
Mirogabalin selectively binds to the α2δ subunit of voltage-gated calcium channels. This pharmacological activity is associated with modulation of calcium-channel function and reduction of excessive neurotransmitter release involved in neuropathic pain signaling.
The compound has been studied in conditions including diabetic peripheral neuropathic pain and post-herpetic neuralgia. PubChem identifies these therapeutic areas among the clinical research applications associated with mirogabalin.
Mirogabalin is associated with the treatment and research of neuropathic pain conditions. Its mechanism involves selective binding to the α2δ subunit of voltage-gated calcium channels, which can modulate neuronal signaling associated with pain.
Mirogabalin has been studied for diabetic peripheral neuropathic pain and post-herpetic neuralgia. It has also been investigated in other pain-related conditions, including fibromyalgia-associated pain.
Mirogabalin acts primarily through selective binding to the α2δ subunit of voltage-gated calcium channels. Binding to this subunit is associated with modulation of calcium-channel activity and reduction of excitatory neurotransmitter release from nerve terminals.
This mechanism contributes to its pharmacological activity in neuropathic pain applications.
Mirogabalin API should be evaluated using appropriate validated analytical procedures for identity, assay, purity and related substances.
Depending on the applicable API specification, quality-control testing may include chromatographic purity, identification, water content, residual solvents, inorganic impurities and other relevant quality attributes.
For pharmaceutical manufacturing, the final acceptance criteria should be established according to the applicable validated specification and regulatory requirements.
Mirogabalin API should be stored and handled according to the applicable approved API specification, stability information and safety documentation.
The material should be protected from inappropriate environmental conditions and contamination during storage, handling and transportation.
Mirogabalin API can be packaged in suitable pharmaceutical-grade containers selected to protect the material from contamination and environmental exposure.
Packaging configuration and available quantities can be determined according to customer and pharmaceutical manufacturing requirements.
Mirogabalin has been investigated extensively for neuropathic pain applications, including diabetic peripheral neuropathic pain and post-herpetic neuralgia. Mirogabalin besylate is the salt form used in pharmaceutical products and has a distinct chemical identity from the free active moiety.
Regulatory status and approved indications may differ between countries, so applicable regional requirements should be considered for pharmaceutical development and commercialization.
Mirogabalin is a pharmaceutical active ingredient and selective α2δ ligand associated with the treatment and research of neuropathic pain.
The CAS Number of Mirogabalin is 1138245-13-2.
The molecular formula of Mirogabalin is C₁₂H₁₉NO₂.
Mirogabalin has a molecular weight of 209.28 g/mol.
Mirogabalin besylate is the besylate salt form of mirogabalin. It has the molecular formula C₁₈H₂₅NO₅S, molecular weight 367.5 g/mol, and CAS Number 1138245-21-2.
Mirogabalin is associated with pharmaceutical applications involving neuropathic pain, including diabetic peripheral neuropathic pain and post-herpetic neuralgia.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |