Trial Profile

Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in the treatment of suicidal depression

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 01 Aug 2024

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At a glance

01 Aug 2024 New trial record
30 Jul 2024 According to a NRx Pharmaceuticals media release, NRx and HOPE Therapeutics will commit to conducting a clinical trial of NRX-100 in adolescents aged 9-17 with suicidal depression, but will not be required to study the effects of NRX-100 in younger age groups, following initial approval of NRX-100 in adults.
30 Jul 2024 According to a NRx Pharmaceuticals media release, company announced a communication from the US Food and Drug Administration (FDA) providing feedback and alignment on NRx's proposed initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in the treatment of suicidal depression.

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