Newron Pharmaceuticals S.p.A.

Pipeline (1)

• EvenamideSmall moleculePresynaptic glutamate release (voltage-gated Na+ channels) Inhibitor
  • SchizophreniaPhase 3Active

Deals & partnerships

• Feb 16, 2026FinancingNewron secures up to EUR 38 million in tranched equity to advance the Phase 3 evenamide programEquity investment from a group of existing and new shareholders from Europe and Asia in three tranches: up to EUR 15 million immediately (779,624 new shares at EUR 19.24), EUR 11 million on ENIGMA-TRS 1 and 2 progress toward 12-week results (expected Q4 2026, no later than 2026-11-30), and EUR 12 million conditional on disclosure of positive ENIGMA-TRS results. Proceeds fund the global ENIGMA-TRS studies and extend the cash runway beyond the pivotal 12-week readouts.Evenamidesource ↗
• Jan 9, 2025Licensing dealNewron licenses evenamide to Myung In Pharm for South KoreaMyung In Pharm Co. Ltd. will develop, manufacture and commercialize evenamide for treatment-resistant schizophrenia in South Korea, contribute 10% of patients to Newron's pivotal Phase 3 trial, and bear a share of eligible global development costs plus all Korean regulatory and commercialization costs. Newron receives an upfront payment, development/regulatory milestones, and royalties on net sales (amounts undisclosed).Evenamidesource ↗
• Dec 13, 2024Licensing dealNewron licenses evenamide to EA Pharma (Eisai subsidiary) for Japan and other Asian territoriesEA Pharma will develop, manufacture and commercialize evenamide in Japan and other designated Asian territories. Newron receives up to EUR 117 million in total, including a EUR 44 million upfront payment, financial contributions to the Phase 3 one-year TRS study (to be run outside the licensed territories), regulatory and commercialization milestones, plus tiered royalties up to a double-digit percentage of net sales.Evenamidesource ↗

Catalysts · 2 upcoming · 3 reported

• Q4 2026Anticipated

  EvenamideforSchizophreniaTopline data

  ENIGMA-TRS 1 12-week primary efficacy results (evenamide 15/30 mg bid vs placebo, >=600 TRRIP-criteria TRS patients on SGAs including clozapine), expected Q4 2026.

  source ↗

• Q4 2026Anticipated

  EvenamideforSchizophreniaTopline data

  ENIGMA-TRS 2 topline (evenamide 15 mg bid vs placebo, 12 weeks, >=400 documented-TRS patients; NCT07184619), guided for Q4 2026 — timing at risk from the US enrollment hold in effect since April 2026.

  NCT07184619source ↗

Recently reported

• 2024-04-30met

  EvenamideforSchizophreniaTopline data

  Study 008A topline (N=291): evenamide 30 mg bid add-on met the PANSS primary endpoint in chronic schizophrenia inadequately responding to a second-generation antipsychotic (PANSS -10.2 vs -7.6 on placebo at day 29, p<0.05, Cohen's d 0.33), with the key secondary CGI-S also positive and good tolerability.

  source ↗

• 2024-01-04met

  EvenamideforSchizophreniaFull results

  Study 014/015 final 1-year results in TRS: PANSS improvement increased over time (-9.4 at 6 weeks, -12.7 at 6 months, -14.7 at 1 year; p<0.001), responder rate rose to 47.4% at 1 year, 75% completed 1 year of treatment, no psychotic relapses on treatment.

  source ↗

• 2023-03-20met

  EvenamideforSchizophreniaTopline data

  Study 014 topline (all 161 TRS patients): evenamide add-on to antipsychotics well tolerated with clinically important benefit at 6 weeks; 95% completed the 6-week phase and 89% continued into the 46-week extension.

  source ↗

Recent activity

• Aug 12, 2025Phase changeEvenamide·SchizophreniaPhase 3Newron announced enrollment had begun in the pivotal Phase 3 ENIGMA-TRS program: ENIGMA-TRS 1, an international, 52-week, randomized, double-blind, placebo-controlled study of evenamide 15 and 30 mg bid vs placebo in >=600 TRS patients (TRRIP criteria, on SGAs including clozapine) across Europe, Asia, Latin America and Canada, with the primary efficacy assessment at 12 weeks (results guided for Q4 2026). Regulatory approvals for the two-study program, including FDA clearance of ENIGMA-TRS 2, had been announced 2025-05-12.source ↗
• Apr 30, 2024ReadoutEvenamide·SchizophreniametStudy 008A topline (N=291): evenamide 30 mg bid add-on met the PANSS primary endpoint in chronic schizophrenia inadequately responding to a second-generation antipsychotic (PANSS -10.2 vs -7.6 on placebo at day 29, p<0.05, Cohen's d 0.33), with the key secondary CGI-S also positive and good tolerability.source ↗
• Jan 4, 2024ReadoutEvenamide·SchizophreniametStudy 014/015 final 1-year results in TRS: PANSS improvement increased over time (-9.4 at 6 weeks, -12.7 at 6 months, -14.7 at 1 year; p<0.001), responder rate rose to 47.4% at 1 year, 75% completed 1 year of treatment, no psychotic relapses on treatment.source ↗
• Mar 20, 2023ReadoutEvenamide·SchizophreniametStudy 014 topline (all 161 TRS patients): evenamide add-on to antipsychotics well tolerated with clinically important benefit at 6 weeks; 95% completed the 6-week phase and 89% continued into the 46-week extension.source ↗
• Dec 1, 2015Phase changeEvenamide·SchizophreniaPhase 2Phase 2a randomized, double-blind study 002 (NCT02624167, NW-3509A/002/II/2015) started December 2015 in 90 chronic schizophrenia patients not responding to their current antipsychotic, 15–25 mg bid titration vs placebo (month precision; day set to the 1st). Later Phase 2 studies: 008 (NCT04461119, 2020, EEG/safety, 138 patients) and the open-label 1-year TRS study 014/015 (161 patients).source ↗
• Jun 1, 2013Phase changeEvenamide·SchizophreniaPhase 1First-in-human Phase 1 sequential-cohort maximum-tolerated-dose study in healthy male volunteers (NCT01955564, NW-3509A/001/I/2011) started June 2013 per ClinicalTrials.gov (month precision; day set to the 1st).source ↗

Trials recruiting · 2 recruiting of 8 sponsored

• Phase 3Evenamiden=40010 sites · United States, India

  ENIGMA-TRS 2: A Phase III, 12-week, Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Determine the Efficacy, Safety, and Tolerability of a Dose of 15 mg Bid of Evenamide as Add-on in Patients With Documented Treatment-resistant Schizophrenia

  Treatment-resistant SchizophreniaNCT07184619 ↗

Showing 1 of 2 recruiting trials.

Competitive landscape

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