Peptide · TNX-1900

TNX-1900

DiscontinuedTonix Pharmaceuticals Holding Corp. (TNXP)

Intranasal potentiated oxytocin (oxytocin formulated with magnesium) developed by Tonix Pharmaceuticals as a preventive treatment for chronic migraine. Magnesium is reported to potentiate oxytocin's action at the oxytocin receptor; the proposed mechanism includes inhibition of calcitonin gene-related peptide (CGRP) release from trigeminal neurons. The Phase 2 PREVENTION study failed to separate from placebo and the program was not advanced.

Also known as: TNX-1900, intranasal potentiated oxytocin, oxytocin, 50-56-6

Data current as of

Modality
Peptide
Chemical class
peptide, nonapeptide
DEA schedule
Unscheduled
Chemistry
Single enantiomer
Mechanism
Oxytocin receptor agonist
Highest phase
Discontinued
Lead indication
Migraine
Developer
Tonix Pharmaceuticals Holding Corp. (TNXP)
Trials
1 tracked · 26 sites
Next catalyst
2023-12-06 — Topline data (Migraine)

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.

TargetActionAffinity
Oxytocin receptorprimaryOXTRAgonist—ⓘ

Formulations

FormulationRouteRegimenPharmacokinetics
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
IntranasalTwice daily—

Development timeline

DiscontinuedOct 2023 – Dec 2023
  1. Upcoming
  2. 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.
Phase 2Dec 2022 – Oct 2023
  1. PREVENTION study completed (primary completion 2023-10-08; study completion 2023-10-23). Tonix announced completion of the clinical stage on 2023-10-26.↗
  2. Phase 2 PREVENTION study (NCT05679908) started; first participant period. Double-blind, randomized, multicenter, placebo-controlled three-arm study.

TNX-1900 for Migraine

DiscontinuedDiscontinuedMigraine indication →

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.

Readouts

  • 2023-12-06AnticipatedTopline data

Clinical trials

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)

Started Dec 2022· Primary completion Oct 2023· 📍 26 sites across 1 country (United States)

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.

Conference coverage

TNX-1900 appears in 2 CNS Pulse conference abstracts:

Related compounds

More from Tonix Pharmaceuticals Holding Corp.

Identifiers

Sources

  1. A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine — ClinicalTrials.gov
  2. A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine (PREVENTION) — ClinicalTrials.gov
  3. OT receptor (oxytocin receptor) | Vasopressin and oxytocin receptors — IUPHAR/BPS Guide to PHARMACOLOGY
  4. 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.