Tonix Pharmaceuticals Holding Corp. began dosing the first participant in a Phase 1 investigator‑initiated study of its intranasal oxytocin formulation, TNX‑1900, on March 26, 2026. The study, led by Professor Antoinette Maassen van den Brink of Erasmus University Medical Center, will assess the drug’s ability to blunt trigeminal‑nerve‑mediated vasodilation of the forehead using capsaicin and electrical stimulation.
TNX‑1900 is designed to block the release of calcitonin gene‑related peptide (CGRP) in the trigeminal ganglion, a mechanism distinct from the receptor‑blocking action of approved CGRP inhibitors and from triptans. By targeting the upstream release of CGRP, the candidate could offer a non‑opioid therapeutic option for migraine and craniofacial pain, addressing unmet needs in a market that serves roughly 39 million Americans and 1.2 billion people worldwide.
The trial marks a significant expansion of Tonix’s central nervous system pipeline beyond its commercial product, TONMYA, which was launched in November 2025. As a clinical‑stage company, Tonix continues to invest heavily in research and development, but it maintains a strong cash position relative to its debt, giving it the financial flexibility to pursue this and other CNS candidates such as those for acute stress disorder, long COVID, PTSD, and Alzheimer’s disease agitation.
"We are excited to collaborate with Professor Maassen van den Brink on this proof‑of‑concept study investigating the potential for TNX‑1900 for treating migraine, craniofacial pain, and other related conditions. While there are several CGRP inhibitors approved for the treatment of migraine, TNX‑1900's oxytocin treatment affects a distinct pathway that could address unmet needs. The results of the new study will guide future development of this potential non‑opioid treatment for migraine and other craniofacial pain conditions," said CEO Seth Lederman. "We are excited to be using LSCI in this study of TNX‑1900, which adds to our established model by providing real‑time and higher resolution dermal blood flow measurements, compared to Laser Doppler Perfusion Imaging used in earlier studies. Oxytocin represents a potential new therapeutic option, targeting a pathway in migraine and craniofacial pain that is distinct from both the triptan and CGRP inhibitor migraine treatment drug classes," added Professor Maassen van den Brink.
The announcement did not trigger a documented market reaction, and no analyst guidance or financial results were reported in connection with this milestone.
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