Tonix Pharmaceuticals Holding Corp. (TNXP) announced that it has received FDA clearance to conduct a phase 2 trial of TNX-102 SL, 5.6 mg, for the treatment of major depressive disorder in adults.
Major Depressive Disorder (MDD) is a serious psychiatric illness affecting more than 21 million U.S. adults each year. It is characterized by persistent sadness, loss of interest, and associated symptoms such as sleep disturbance, fatigue, and impaired concentration.
Current antidepressant therapies often fail to provide adequate relief or are discontinued due to side effects, underscoring the need for new treatment options.
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride designed to target disturbed sleep associated with depression. Prior studies in fibromyalgia and post-traumatic stress disorder showed promising signals for improvement in depressive symptoms.
The drug (TNX-102 SL) received FDA approval for the treatment of fibromyalgia in adults in August of this year and is marketed under the brand name TONMYA for fibromyalgia.
The planned phase 2 trial is a potential pivotal six-week, randomized, double-blind, placebo-controlled study that will enrol approximately 360 adults with moderate to severe MDD across 30 U.S. sites. The study, dubbed HORIZON, is expected to be initiated in mid-2026.
The primary endpoint will be the change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline at Week 6, with secondary endpoints including global impression scores, anxiety ratings, measures of sleep disturbance, and supportive assessments such as the Beck Depression Inventory-II (BDI-II).
CEO Seth Lederman, M.D., said, "There is a clear need for innovative therapies that address depression. We believe TNX-102 SL offers a promising approach for individuals suffering from MDD. Its unique pharmacological profile is designed to target the disruptive sleep that is often associated with depression." Chief Medical Officer Gregory Sullivan, M.D., added that TNX-102 SL has been generally well tolerated in registrational studies, with a low incidence of side effects common to traditional antidepressants.
The company's broader pipeline includes programs in PTSD, Long COVID, alcohol use disorder, Alzheimer's agitation, and infectious diseases, with patent protection until 2034, potentially extended to 2044 with method-of-use claims.
TNXP has traded in the range of $6.76 to $130 over the past year. The stock is currently trading in the pre-market at $15.77, down 2.05%.
For comments and feedback contact: editorial@rttnews.com
Business News
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.