Drugs / Evenamide
Evenamide
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | treatment-refractory schizophrenia | 2026-04-29 | “FDA has placed a hold on the enrollment of new patients in the US sites of its Phase III ENIGMA-TRS 2 study of evenamide” newron.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03446274 | Apr 2018 | — | Newron Pharmaceuticals SPA | Unknown | No outcome recorded |
| Phase 1 | NCT01955564 | Jun 2013 → Sep 2014 | schizophrenia | Newron Pharmaceuticals SPA | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT04461119 | Jun 2020 → Feb 2021 | schizophrenia | Newron Pharmaceuticals SPA | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT07184619 | Jan → Dec 2026 expected | treatment-refractory schizophrenia | Newron Pharmaceuticals SPA | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT02624167 Comparator | Dec 2015 → Dec 2016 | schizophrenia | Newron Pharmaceuticals SPA | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2026-04-29 | Newron Pharmaceuticals SPA | Regulatory Newron reports a pause in enrollment of new study participants in US centers of ENIGMA-TRS 2 study newron.com ↗
Newron is working closely with the FDA and intends to provide the requested information to support resolution of the hold and the resumption of enrollment at U.S. sites for the ENIGMA-TRS 2 study. |
| 2026-02-03 | Newron Pharmaceuticals SPA | Results Newron Notes Publication Highlighting Clinically Meaningful Benefits of Evenamide as an Adjunctive Treatment in Schizophrenia newron.com ↗
The publication synthesizes results from multiple randomized clinical trials and provides a scientific mechanistic rationale for the use of evenamide as a unique approach that targets disease mechanisms not addressed by existing antipsychotics. |
| 2025-10-02 | Newron Pharmaceuticals SPA | Results Newron to present new analyses from and updates on its clinical program evaluating evenamide as an add-on treatment for schizophrenia at the 38th European College of Neuropsychopharmacology (ECNP) Congress 2025 newron.com ↗
Additional post-hoc analyses from data of these studies further support the unique long-lasting efficacy of evenamide. |
| 2025-09-05 | Newron Pharmaceuticals SPA | Results Newron to present data and updates on its clinical program evaluating evenamide as an add-on treatment for schizophrenia at the 2025 World Congress of Biological Psychiatry (WCBP) newron.com ↗
The results of Study 008A indicate for the first time that glutamate modulation, in this case through addition of evenamide, is associated with clinically meaningful and statistically significant efficacy. |
| 2025-08-11 | Newron Pharmaceuticals SPA | Results Newron notes the publication of new preclinical research suggesting evenamide ameliorates schizophrenia-related dysfunction newron.com ↗ |
| 2025-05-12 | Newron Pharmaceuticals SPA | Regulatory Newron announces approval for pivotal Phase III ENIGMA-TRS program with evenamide as add-on therapy in patients with treatment-resistant schizophrenia (TRS) newron.com ↗
today announced the approval for its pivotal ENIGMA-TRS Phase III development program evaluating evenamide as an add-on therapy to current antipsychotics, including clozapine, in patients with treatment-resistant schizophrenia (TRS). |
| 2024-06-25 | Newron Pharmaceuticals SPA | Results Newron Pharmaceuticals reports on its 2024 Investor Day in New York City newron.com ↗
Long-term benefits of evenamide as an add-on therapy were presented: 25% of treated patients met the criteria for remission suggesting evenamide may positively affect the long-term course of schizophrenia in TRS patients |
| 2024-05-13 | Newron Pharmaceuticals SPA | Results Newron reports compelling additional data documenting the efficacy of evenamide in pivotal study 008A in poorly responding schizophrenia patients newron.com ↗
Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), presents additional results from the international, randomized, double-blind, placebo-controlled study 008A that evaluated the efficacy and safety of evenamide (30 mg bid) as add-on treatment in 291 patients not benefitting from their second-generation antipsychotic medication, including clozapine. |
| 2024-04-30 | Newron Pharmaceuticals SPA | Results Newron announces positive top-line results from potentially pivotal Phase II/III study 008A with evenamide in schizophrenia patients newron.com ↗
The study met its primary endpoint of improvement on the Positive and Negative Syndrome Scale (PANSS) Total Score as well as the key secondary endpoint of improvement of the Clinical Global Impression of Severity (CGI-S). |
| 2024-04-08 | Newron Pharmaceuticals SPA | Results Data from Newron’s study 014/015 and an evenamide clinical development outlook presented at the 2024 Annual Congress of the Schizophrenia International Research Society (SIRS) newron.com ↗
Treatment with evenamide was associated with sustained, clinically significant benefit that increased throughout the one-year course of treatment. |
| 2024-01-04 | Newron Pharmaceuticals SPA | Results Newron reports exceptional one-year results of study 014/15 with evenamide in treatment-resistant schizophrenia (TRS) newron.com ↗
The data demonstrated that treatment with evenamide was associated with sustained clinically significant benefit that increased throughout the one-year course of treatment. |
| 2023-10-09 | Newron Pharmaceuticals SPA | Results Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria newron.com ↗
The data, which demonstrated that evenamide treatment was associated with an increasing, sustained, and clinically significant improvement of symptoms were presented at the 36th European Clinical Neuropsychopharmacology Congress (ECNP) in Barcelona, Spain. |
| 2023-05-15 | Newron Pharmaceuticals SPA | Results Newron presents exciting new data from study 014/015 at CINP World Congress of Neuropsychopharmacology and the 2023 Congress of the Schizophrenia International Research Society (SIRS) newron.com ↗
Full data from first 100 patients at the one-year interim timepoint confirm significant and clinically important, sustained and gradually increasing efficacy on PANSS total, CGI-S and LOF |
| 2023-05-03 | Newron Pharmaceuticals SPA | Results Newron to present at the 34th CINP World Congress of Neuropsychopharmacology and the 2023 Congress of the Schizophrenia International Research Society (SIRS) newron.com ↗
Further data from study 014/015 of evenamide in treatment-resistant schizophrenia (TRS) confirms potentially relevant role of glutamatergic release modification when added to TRS patients not responding to marketed antipsychotics |
| 2023-03-28 | Newron Pharmaceuticals SPA | Results Newron presents six-month interim data from the first 100 patients randomized in study 014/015 at the 31st European Congress of Psychiatry newron.com ↗
The first poster presented full results from the cohort of the first 100 patients completing six months/endpoint of treatment with evenamide in study 014/015. |
| 2023-03-20 | Newron Pharmaceuticals SPA | Results Newron reports compelling topline results from all patients in Study 014, its Phase II clinical trial evaluating evenamide as add-on therapy for treatment-resistant schizophrenia newron.com ↗
The mean Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression of Severity (CGI-S) rating, and the Strauss-Carpenter Level of Functioning (LOF) total score significantly improved compared to baseline (p<0.001). |
| 2023-02-16 | Newron Pharmaceuticals SPA | Results Newron reports striking one-year interim efficacy results from its Phase II clinical trial evaluating evenamide as add-on therapy for patients with treatment-resistant schizophrenia newron.com ↗
Results in patients completing one year of treatment with evenamide provide further striking new evidence of the sustained efficacy of evenamide as an add-on to antipsychotics (excluding clozapine) in TRS patients, by demonstrating substantially greater benefit at one year than noted at six-week and six-month datapoints. |
| 2023-01-03 | Newron Pharmaceuticals SPA | Results Newron announces striking six-month interim results from its exploratory clinical trial evaluating evenamide as add-on therapy for patients with treatment-resistant schizophrenia newron.com ↗
These new results demonstrated a continued improvement in TRS symptoms after six months of treatment with evenamide, as well as a substantially greater proportion of patients experiencing a meaningful improvement when compared to six weeks of treatment. |
| 2022-06-07 | Newron Pharmaceuticals SPA | Results Newron presents encouraging interim results for evenamide in patients with Treatment-Resistant Schizophrenia (TRS) at the 33rd CINP Hybrid World Congress of Neuropsychopharmacology newron.com ↗
Interim results show improved symptoms of psychosis in patients with chronic TRS |
| 2021-04-01 | Newron Pharmaceuticals SPA | Results Newron announces results of explanatory studies with evenamide in healthy volunteers and patients with schizophrenia newron.com ↗
Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced initial results from two short-term explanatory studies in evenamide: study 010 in healthy volunteers and study 008 in patients with schizophrenia. |
| 2020-01-09 | Newron Pharmaceuticals SPA | Regulatory Newron announces initiation of new clinical trial with Evenamide in patients with schizophrenia, following approval of plan by FDA newron.com ↗
The FDA approved the plan proposed by Newron as well as the protocol for a first, four-week explanatory study in patients with schizophrenia, which is expected to start enrolling patients in the next few days. |
| 2019-05-28 | Newron Pharmaceuticals SPA | Regulatory Newron Pharmaceuticals provides update on regulatory status of evenamide for the treatment of schizophrenia newron.com ↗
This led the FDA to request Newron to delay initiation of the proposed Phase II/III pivotal studies with evenamide for the treatment of schizophrenia prior to completing additional short-term explanatory studies in rats and human subjects to address these concerns. |
| 2017-03-25 | Newron Pharmaceuticals SPA | Results Newron presents encouraging detailed results of its Phase IIa study with Evenamide in patients with schizophrenia newron.com ↗
Evenamide met study objectives of good tolerability, safety, and preliminary evidence of efficacy as an add-on therapy for the treatment of schizophrenia |
| 2017-01-03 | Newron Pharmaceuticals SPA | Results Evenamide met study objectives of good tolerability, safety, and preliminary evidence of efficacy as an add-on therapy for the treatment of schizophrenia- unique MoA newron.com ↗
Newron Pharmaceuticals S.p.A. (“Newron”), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, announced today preliminary results of a Phase IIa study with its unique sodium channel blocker, Evenamide (NW-3509), in patients with schizophrenia. |
All press releases naming this drug 41 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Evenamide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04461119 ↗ |
| Known as | Evenamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL3678076 ↗ |
| Known as | Nw-3509 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3678076 ↗ |
| Known as | NW-3509A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02624167 ↗ |
| Action | Inhibit | “potently blocks voltage-gated sodium channels (VGSCs) in vitro” NCT03446274 ↗ |
| Modality | Small molecule | “orally available small molecule” NCT03446274 ↗ |
| Route | Oral | “single escalating oral doses of NW-3509A” NCT01955564 ↗ |