1. Tonix licensed TNX-4900, a non-opioid analgesic with pain relief potential. 2. TNX-4900 shows efficacy in diabetic and chemotherapy-induced neuropathic pain models. 3. Strong safety profile supports advancement to IND-enabling studies. 4. Sigma-1 receptor antagonism is gaining traction as a non-addictive analgesic. 5. Tonix is positioned for growth with a focus on non-opioid pain management.
FAQ
Why Bullish?
The licensing of TNX-4900 highlights Tonix’s growth in pain management therapies, potentially increasing investor confidence. Similar product launches in the past led to significant stock increases for other biotech firms.
How important is it?
The focus on non-opioid solutions and the promising data for TNX-4900 could enhance Tonix’s market position, driving future sales and stock prices.
Why Long Term?
Development of TNX-4900 may take time; however, it aligns with market demand for safe pain relief. Extended studies often lead to increased valuation once efficacy is demonstrated.
Tonix Pharmaceuticals Licenses TNX-4900 for Chronic Pain Treatment
On December 16, 2025, Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced its exclusive worldwide licensing of TNX-4900, a selective Sigma-1 receptor (S1R) antagonist, aimed at providing a non-opioid solution for chronic neuropathic pain. This innovative therapeutic has shown significant analgesic efficacy in various preclinical models, including diabetic and chemotherapy-induced neuropathic pain.
Breakthrough Developments in Pain Management
Seth Lederman, M.D., President and CEO of Tonix Pharmaceuticals, remarked, “Sigma-1 receptor antagonism has generated considerable scientific interest as a promising class of non-opioid, non-addictive analgesics. With our extensive experience developing FDA-approved non-opioid analgesics, we are well-positioned to oversee this new development program. We believe TNX-4900 has the potential to be best-in-class.”
Scientific Foundation and Design
Dr. Youyi Peng, a co-inventor of TNX-4900 and former Senior Bioinformatics Specialist at the Rutgers Cancer Institute of New Jersey, highlighted the development process. “We used computer-aided and AI-driven approaches to design this new class of selective Sigma-1 receptor antagonists. TNX-4900 demonstrated robust analgesic efficacy and an encouraging safety profile.”
TNX-4900 was developed as part of a structure-based drug design initiative led by Dr. Peng and Dr. William Welsh at Rutgers University. The compound shows a strong binding affinity for the human Sigma-1 receptor (Ki = 7.5 nM), exhibits over 100-fold selectivity for the Sigma-1 receptor compared to the Sigma-2 receptor, and possesses favorable properties such as high blood-brain barrier penetration, along with oral bioavailability of approximately 28%.
Positive Outcomes in Preclinical Trials
Preclinical studies have demonstrated that in models of diabetic and chemotherapy-induced neuropathic pain, TNX-4900 led to significant and lasting reductions in pain behaviors after both acute and chronic dosing, without any evidence of tolerance or motor impairment. Tonix plans to further advance TNX-4900 through expanded pharmacokinetic studies, formulation optimization, and safety evaluation to support Investigational New Drug (IND)-enabling development.
Broader Impact of Tonix Pharmaceuticals
Tonix Pharmaceuticals is a fully-integrated biotechnology company with a comprehensive portfolio, including marketed products like TONMYA™, the first new FDA-approved non-opioid analgesic for fibromyalgia in over 15 years. Additionally, Tonix markets treatments for acute migraine and is actively developing candidates for various conditions, including CNS disorders, immunology, and rare diseases.
- TNX-102 SL: Investigational treatment for acute stress reaction.
- TNX-1500: Humanized monoclonal antibody for autoimmune diseases.
- TNX-2900: Aiming for Prader-Willi syndrome in 2026.
- TNX-801: Vaccine candidate targeting mpox and smallpox.
Looking Ahead
With the acquisition of TNX-4900, Tonix Pharmaceuticals (NASDAQ: TNXP) is making significant strides toward addressing the urgent need for safer alternatives in chronic pain management. The company remains committed to advancing its investigational candidates while focusing on innovative solutions in the biotech space.
For additional information, please visit www.tonixpharma.com.
Forward-Looking Statements
This announcement may contain forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Factors could cause actual results to materially differ from the expectations stated herein, including risks associated with clinical development and regulatory approvals. Investors are advised to review Tonix's risk factors detailed in its SEC filings.