TNX-1900 · program
TNX-1900 for Migraine
Phase 2 program of TNX-1900 (intranasal potentiated oxytocin) for prevention of migraine in chronic migraineurs. The Phase 2 PREVENTION study (NCT05679908) completed in October 2023 but failed its primary endpoint: placebo reduced monthly migraine days more than either TNX-1900 dose. Tonix did not advance the company-sponsored migraine program after the negative readout; remaining TNX-1900 activity in migraine/craniofacial pain has been limited to investigator-initiated pharmacodynamic work.
Development timeline
- Trial registeredYale registers investigator-initiated Phase 2 of TNX-1900 for pain after pituitary surgery
- missedPhase 2 chronic migraine study of TNX-1900 failed: both doses numerically worse than placebo on monthly migraine days; results disclosed only via ClinicalTrials.gov
- Primary endpoint missed: placebo (-8.17 monthly migraine days) outperformed both TNX-1900 arms (30 IU once daily -7.78; 30 IU twice daily/60 IU per day -5.77). Company-sponsored migraine program not advanced.
- Licensing dealTonix acquires exclusive license to University of Geneva oxytocin technology, expanding TNX-1900 into cardiometabolic indications↗
- Licensing dealTonix acquires non-addictive migraine and pain programs (TNX-1900) from Trigemina and assumes Stanford license↗
- PREVENTION study completed (primary completion 2023-10-08; study completion 2023-10-23). Tonix announced completion of the clinical stage on 2023-10-26.↗
- Phase 2 PREVENTION study (NCT05679908) started; first participant period. Double-blind, randomized, multicenter, placebo-controlled three-arm study.
Readouts
- 2025-02-25ReportedTopline datamissed
Phase 2 chronic migraine study of TNX-1900 failed: both doses numerically worse than placebo on monthly migraine days; results disclosed only via ClinicalTrials.gov
Clinical trials in Migraine
NCT05679908PREVENTIONPhase 2Completedn=88
A Phase 2, Double-blind, Randomized, Multicenter, Placebo-controlled, Three Arm Parallel Study to Evaluate the Efficacy and Safety of TNX-1900 (Intranasal Oxytocin) in Patients With Chronic Migraine (PREVENTION Study)
missedprimaryMean change in monthly (28-day) migraine headache days from baseline to the last 28 days of the 12-week treatment phase — Placebo -8.17 days (SE 1.366, n=27); TNX-1900 30 IU once daily -7.78 days (SE 1.246, n=31); TNX-1900 30 IU twice daily (60 IU/day) -5.77 days (SE 1.301, n=29) -- neither active dose separated from placebo; high dose numerically worse than placebo.
Primary endpoint not met. Placebo reduced monthly migraine days more than either TNX-1900 dose; no demonstrated superiority of TNX-1900 over placebo. No p-values posted in the ClinicalTrials.gov results record, but directionality indicates a negative trial.
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| TNX-1900 intranasal potentiated oxytocinmagnesium-potentiated oxytocin; drug-device combination with intranasal actuator (one spray into each nostril) 30 IU intranasally twice daily (high dose) and 30 IU intranasally once daily (low dose) evaluated in the Phase 2 PREVENTION chronic-migraine study | Intranasal | Twice daily | — |
Mechanism of action
Oxytocin is the endogenous agonist of the oxytocin receptor (OXTR), a Gq/11-coupled class A GPCR. In TNX-1900, oxytocin is delivered intranasally with magnesium, which Tonix reports potentiates oxytocin receptor binding/activity in animal models. The proposed antimigraine mechanism is inhibition of CGRP release from trigeminal neurons and suppression of trigeminal pain signaling, a mechanism distinct from CGRP antagonists and anti-CGRP antibodies.
| Target | Action | Affinity |
|---|---|---|
| Oxytocin receptorprimaryOXTR | Agonist | —ⓘ |
← Full TNX-1900 compound page (identity, identifiers, all indications)
Sources
- A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine — ClinicalTrials.gov
- A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine — Study Results — ClinicalTrials.gov
- A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine (PREVENTION) — ClinicalTrials.gov
- Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery — ClinicalTrials.gov
- OT receptor (oxytocin receptor) | Vasopressin and oxytocin receptors — IUPHAR/BPS Guide to PHARMACOLOGY
- Tonix Pharmaceuticals Acquires Exclusive License to University of Geneva Technology for Oxytocin-Based Treatments for Treating Insulin Resistance, Diabetes and Obesity, Expanding Proprietary Uses for TNX-1900 (Intranasal Potentiated Oxytocin) — Tonix Pharmaceuticals
- Tonix Pharmaceuticals Announces Acquisition of Non-Addictive Migraine and Pain Treatment Programs from Trigemina and Assumption of License — Tonix Pharmaceuticals / GlobeNewswire
- Tonix Pharmaceuticals Completes Clinical Stage of Phase 2 PREVENTION Study of TNX-1900 for the Prevention of Migraine Headaches in Chronic Migraineurs — Tonix Pharmaceuticals Holding Corp.