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NaV1.7 / SCN9A

Voltage-gated sodium channel·Moderate-HighImproving·Review recommended·TSTranslational Science· Updated 3 days ago
AI suggested pathAI-assisted
DPN appears to be the strongest feasibility path based on endpoint maturity and recruitment plausibility. IEM remains the cleanest mechanistic POC but recruitment is limited.
Segment comparison4 segments
SegmentSizeEvidenceBiomarkerEndpointRecruitmentRecommendationOpen caveat
Chronic peripheral neuropathic pain
Heterogeneous segment with broad NaV1.7 mechanistic relevance.
LargeModerate-HighLimitedModerateStrongConditionalHeterogeneity caveat — see detail.
Painful diabetic peripheral neuropathy (DPN)
Defined population; established regulatory pathway.
LargeModerateModerateStrongStrongYes
Post-herpetic neuralgia (PHN)
Defined etiology; cleaner phenotype.
MidModerateLimitedStrongModerateYes
Inherited erythromelalgia (IEM)
Niche; SCN9A gain-of-function patients; biomarker-rich.
NicheHighStrongModerateWeakConditionalMechanistic POC route; small N.
Selected segment
Painful diabetic peripheral neuropathy (DPN)
Rationale

Defined patient population; precedent regulatory pathway for non-opioid analgesia in DPN; some biomarker activity.

Trial design assumptions
  • Phase: Phase IIa
  • Endpoint: NRS-based
  • Geography: US / EU
  • Indication focus: Painful diabetic peripheral neuropathy

Phase IIa feasibility heatmap

Phase IIa, painful diabetic peripheral neuropathy, 12-week, NRS-based
Site availability
Strong
Recruitment plausibility
Strong
Endpoint maturity
Strong
Regulatory precedent
Strong
Biomarker readiness
Moderate
Time to readout
12-18 mo
Data gaps
  • • Patient size bands are sample values; epidemiology requires verification.
  • • Endpoint readiness for chronic peripheral neuropathic pain remains a field-wide challenge.
  • • Biomarker stratification limited outside IEM.
Suggested next validation step
Phase IIa NRS-based DPN study with pre-specified responder analysis.