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PN6047 hydrochloride is a chemically synthesised substance classified under nervous system diseases in the EU Clinical Trials Information System.[1] It is an investigational medicine, meaning it has no marketing authorisation in the product records and is not yet approved for routine clinical use.[1] The substance is supplied by PharmNovo AB.[1]
The registry data does not describe the mechanism of action of PN6047 hydrochloride. It is being investigated for its potential to affect peripheral neuropathic pain, specifically pain accompanied by mechanical allodynia, which is pain caused by a stimulus that does not normally provoke pain.[1]
PN6047 hydrochloride is given as a capsule taken orally.[1] In the authorised trial, the dose under investigation is 300 mg.[1]
One Phase 2 trial of PN6047 hydrochloride is currently authorised in the EU Clinical Trials Information System.[1] The trial plans to enroll 65 participants with peripheral neuropathic pain characterised by mechanical allodynia.[1] Participants will receive either PN6047 hydrochloride at a dose of 300 mg orally or a matched placebo.[1]
The primary outcomes focus on safety parameters, including laboratory values, vital signs, physical and neurological examinations, electrocardiogram (ECG) findings, and adverse events assessed for intensity, seriousness, and causality.[1] The trial title also indicates that efficacy will be evaluated.[1]
The trial is currently authorised, meaning it has received regulatory approval to proceed but may not yet be recruiting participants.[1]
No side effect data for PN6047 hydrochloride is available from the provided sources. The authorised trial is specifically designed to investigate safety and tolerability, including monitoring of adverse events, laboratory values, vital signs, and ECG findings.[1]
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