Tonix Pharmaceuticals Holding Corp. announced that it has secured exclusive worldwide rights to TNX‑4900, a highly selective Sigma‑1 receptor antagonist, from Rutgers University. The compound binds the Sigma‑1 receptor with a nanomolar affinity (Ki = 7.5 nM) and shows more than 100‑fold selectivity over Sigma‑2, demonstrating durable pain relief in pre‑clinical models of diabetic and chemotherapy‑induced neuropathic pain without tolerance or motor impairment. Oral bioavailability is reported at approximately 28 %.
The licensing adds a promising non‑opioid analgesic to Tonix’s pipeline, complementing its FDA‑approved fibromyalgia drug TONMYA and its migraine portfolio. By expanding its portfolio of pain‑modulating agents, Tonix positions itself to capture a share of the growing market for safer, non‑addictive pain therapies—an opportunity driven by the ongoing opioid crisis and increasing demand for alternative treatments. The addition of TNX‑4900 strengthens the company’s strategic focus on central nervous system disorders and pain management.
Tonix plans to advance TNX‑4900 through expanded pharmacokinetic, formulation and safety studies to support an IND‑enabling application. The company’s recent milestones—including the U.S. commercial availability of TONMYA and an FDA IND clearance for a Phase 2 study of another CNS candidate—illustrate its capacity to move assets from discovery to clinical development. The new licensing agreement aligns with Tonix’s broader strategy of building a diversified pipeline of non‑opioid therapeutics that can generate future revenue streams while mitigating the risks associated with opioid‑based products.
CEO Seth Lederman expressed confidence in Tonix’s ability to develop TNX‑4900, citing the company’s experience with TONMYA and its expertise in translating pre‑clinical findings into clinical programs. He emphasized that the Sigma‑1 antagonist platform offers a novel mechanism of action that could address unmet needs in neuropathic pain, a condition with limited effective options. The company will use the licensing to conduct IND‑enabling studies, positioning TNX‑4900 for potential clinical evaluation in the coming years.
Financial terms of the licensing agreement were not disclosed. The deal nonetheless expands Tonix’s pipeline and reinforces its commitment to developing non‑opioid pain therapies, adding a high‑potential asset to its portfolio of CNS and pain‑focused products.
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