THERAPY DOSSIER · th-7e2885a8afec

Flupirtine maleate

Drug · Centrally acting non-opioid analgesic; Kv7/KCNQ potassium channel opener (no ChEMBL mechanism record). Withdrawn from EU market (hepatotoxicity).

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Evidence & regulatory context

Mechanism: Centrally acting non-opioid analgesic; Kv7/KCNQ potassium channel opener (no ChEMBL mechanism record). Withdrawn from EU market (hepatotoxicity).
Target: Not recorded
Injury models: Ischaemia-reperfusion
Reported indication: Centrally-acting non-opioid analgesic (Kv7/KCNQ opener) formerly approved in EU (e.g., Germany) for acute pain; never FDA-approved
First approval: Not recorded
Development stage: Formerly approved (EU) for acute pain; marketing authorisation withdrawn 2018 for hepatotoxicity
ChEMBL record: CHEMBL255044 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Katadolon; W-2964
Note: Not recorded

Clinical trials 4

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT00623415 ↗PHASE2terminated

Flupirtine add-on to Interferon-beta1b in Relapsing Remitting MS

Relapsing Remitting Multiple Sclerosis

Enrolment: 30 · Results not recorded

NCT06971250 ↗EARLY_PHASE1completed

Peripheral KV7 Activation for Pain Relief Using Flupirtine

Pain

Enrolment: 32 · Results not recorded

NCT01676246 ↗PHASE1completed

PK/Metabolism/Analgesic Effects of Flupirtine in Healthy Subjects

Pain

Enrolment: 36 · Results not recorded

NCT01450865 ↗PHASE1completed

Flupirtine Effect on Excitability of Human Peripheral Myelinated Axons

Pain

Enrolment: 20 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 31896131 ↗2020Mixed findings

Effects of a potassium channel opener on brain injury and neurologic outcomes in an animal model of neonatal hypoxic-ischemic injury.

RatIschaemia-reperfusionCerebral (MCAO/stroke)Sprague-DawleyMalen = n = 12 vehicle-treated hypoxia-ischaemia rats used for corr…Intraperitoneal25 mg/kg per dose (12 mg flupirtine maleate in 1 ml DMSO, f…First dose 5 minutes after return to room air at the end of the 2 h hypoxia, th…

Model: Rice-Vannucci neonatal hypoxia-ischaemia: double ligation of the right common carotid artery under isoflurane, 2 h recovery with the dam, then 2 h hypoxia at 8 to 8.3 percent oxygen, 36.5 degrees C, 60 to 70 percent humidity

Flupirtine reduced acute hippocampal tissue loss (28.71 versus 60.66 percent, P = 0.007) and cortical tissue loss (14.4 versus 27.54 percent, P = 0.037) and partially reversed spatial learning deficits and contralateral hippocampal volume loss, but did not improve motor grip strength or chronic ips…

Extraction: extract · Subtype source: llm · Supplied extraction confidence: 0.9. Machine-extracted fields require source verification.

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