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Country of origin : China
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Dossier type
CTD
Dossier status
Under development
Country of origin
China
GMP approvals
China
Comments
Indication: Trigeminal neuralgia (TN) — treatment of neuropathic facial pain Clinical stage: Phase 2 — randomised double-blind trial ongoing Modality: Small molecule (first-in-class GABRA5 negative allosteric modulator) Mechanism / Target: First-in-class GABA-A receptor α5 subunit (GABRA5) negative allosteric modulator (NAM); reduces trigeminal pain sensitisation caused by nerve root injury; selective mechanism targeting pathological central sensitisation while preserving normal GABA function and avoiding CNS depression Route / form: Oral Differentiation: First-in-class GABRA5 negative allosteric modulator; targets the root cause of trigeminal pain sensitisation (vs. carbamazepine/oxcarbazepine which only suppress neural firing); FDA Orphan Drug Designation; no CNS sedation; no approved targeted therapy for TN with novel mechanism;
Manufacturer #39345

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