Tonix wins FDA clearance to launch phase 2 trial for major depressive disorder
Update: 2025-12-03
Description
Tonix Pharmaceuticals Holdings CEO Dr. Seth Lederman joined Steve Darling from Proactive to announce that the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug (IND) application for TNX-102 SL, enabling Tonix to begin clinical development of the drug for major depressive disorder (MDD) in adults.
Dr. Lederman explained that the IND clearance allows Tonix to initiate the potentially pivotal Phase 2 HORIZON study — a 6-week, randomized, double-blind, placebo-controlled trial evaluating TNX-102 SL as a first-line monotherapy. The study will enroll approximately 360 adults across about 30 U.S. clinical sites. Participants must be 18 years or older and currently experiencing a moderate to severe major depressive episode.
The trial will compare TNX-102 SL 5.6 mg, taken sublingually at bedtime, against placebo. The primary endpoint is change from baseline at Week 6 on the MADRS or Montgomery–Åsberg Depression Rating Scale total score. Secondary measures include global impression scores, anxiety assessments, and indicators of sleep disturbance. Tonix expects to begin enrolling patients in mid-2026.
Dr. Lederman emphasized the significant need for new treatment options in MDD — a serious and widespread psychiatric condition affecting more than 21 million adults in the United States each year. Symptoms commonly include persistent sadness or loss of interest, sleep and appetite disruption, fatigue, impaired concentration, and feelings of worthlessness. These symptoms must be present for at least two weeks and cause meaningful impairment to daily life.
Tonix aims to advance TNX-102 SL as a novel therapeutic option to address this substantial unmet medical need.
#proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #Biotech #kidneydisease #massachusettsgeneralhospital #massgeneral #VaccineDevelopment #ClinicalTrials #PharmaceuticalNews #MedicalResearch #WHO #GlobalHealth #InfectiousDiseases #Biopharma #DepressionTreatment #TNX102SL #MajorDepressiveDisorder #MentalHealthInnovation #SleepTherapy #FDAApproval #BiotechNews
Dr. Lederman explained that the IND clearance allows Tonix to initiate the potentially pivotal Phase 2 HORIZON study — a 6-week, randomized, double-blind, placebo-controlled trial evaluating TNX-102 SL as a first-line monotherapy. The study will enroll approximately 360 adults across about 30 U.S. clinical sites. Participants must be 18 years or older and currently experiencing a moderate to severe major depressive episode.
The trial will compare TNX-102 SL 5.6 mg, taken sublingually at bedtime, against placebo. The primary endpoint is change from baseline at Week 6 on the MADRS or Montgomery–Åsberg Depression Rating Scale total score. Secondary measures include global impression scores, anxiety assessments, and indicators of sleep disturbance. Tonix expects to begin enrolling patients in mid-2026.
Dr. Lederman emphasized the significant need for new treatment options in MDD — a serious and widespread psychiatric condition affecting more than 21 million adults in the United States each year. Symptoms commonly include persistent sadness or loss of interest, sleep and appetite disruption, fatigue, impaired concentration, and feelings of worthlessness. These symptoms must be present for at least two weeks and cause meaningful impairment to daily life.
Tonix aims to advance TNX-102 SL as a novel therapeutic option to address this substantial unmet medical need.
#proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #Biotech #kidneydisease #massachusettsgeneralhospital #massgeneral #VaccineDevelopment #ClinicalTrials #PharmaceuticalNews #MedicalResearch #WHO #GlobalHealth #InfectiousDiseases #Biopharma #DepressionTreatment #TNX102SL #MajorDepressiveDisorder #MentalHealthInnovation #SleepTherapy #FDAApproval #BiotechNews
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