Developer · TNXP · United States
Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapies for CNS and immunology conditions. Its lead product, Tonmya (TNX-102 SL, cyclobenzaprine HCl sublingual tablets), was FDA-approved in August 2025 for fibromyalgia; the pipeline also includes TNX-1900 (intranasal potentiated oxytocin).
Pipeline (2)
- FibromyalgiaApprovedApproved
- Post-traumatic stress disorderDiscontinuedDiscontinued
- Acute Stress DisorderPhase 2Recruiting
- Major depressive disorderPhase 2Recruiting
- MigraineDiscontinuedDiscontinued
Deals & partnerships
- TNX-1900Licensor University of GenevaLicensor Stanford UniversityLicensor Trigemina, Inc.Licensor Katana Pharmaceuticals, Inc.
- Dec 22, 2020Licensing dealTonix acquires exclusive license to University of Geneva oxytocin technology, expanding TNX-1900 into cardiometabolic indicationsTonix acquired (via Katana Pharmaceuticals, Inc.) an exclusive license to the University of Geneva's oxytocin-based technology, expanding the proprietary uses of TNX-1900 (intranasal potentiated oxytocin) into cardiometabolic conditions including insulin resistance, impaired glucose tolerance and obesity. Patents are expected to provide market exclusivity in the U.S. and Europe through 2031.
- Jun 11, 2020Licensing dealTonix acquires non-addictive migraine and pain programs (TNX-1900) from Trigemina and assumes Stanford licenseTonix acquired the migraine and pain treatment technologies of Trigemina, Inc., including lead asset TNX-1900 (formerly TI-001), a proprietary, patented enhanced formulation of intranasal oxytocin, and assumed the underlying license to the technology from Stanford University. Financial terms were not disclosed.
Catalysts · 3 upcoming · 5 reported
- 2023-12-06Anticipated
- 2H 2026Anticipated
TNX-102 SL (cyclobenzaprine HCl sublingual)forAcute Stress DisorderTopline data
Phase 2 OASIS topline (TNX-102 SL for acute stress reaction/disorder in ED trauma survivors) anticipated in 2H 2026.
- 2028Anticipated
TNX-102 SL (cyclobenzaprine HCl sublingual)forMajor depressive disorderTopline data
Phase 2 HORIZON topline (MADRS change at Week 6) in MDD anticipated following an estimated February 2028 primary completion.
Recently reported
- 2025-08-15met
TNX-102 SL (cyclobenzaprine HCl sublingual)forFibromyalgiaRegulatory
FDA approved Tonmya (TNX-102 SL) for fibromyalgia in adults — first new fibromyalgia drug in over 15 years.
- 2023-12-20met
TNX-102 SL (cyclobenzaprine HCl sublingual)forFibromyalgiaTopline data
Second Phase 3 RESILIENT met its primary endpoint with high significance (p=0.00005); all six key secondaries positive.
- 2020-12-21missed
TNX-102 SL (cyclobenzaprine HCl sublingual)forPost-traumatic stress disorderTopline data
Phase 3 RECOVERY missed its primary CAPS-5 endpoint (p=0.343); PTSD program later deprioritized.
- 2020-12-07met
TNX-102 SL (cyclobenzaprine HCl sublingual)forFibromyalgiaTopline data
Phase 3 RELIEF met its primary endpoint: TNX-102 SL 5.6 mg significantly reduced fibromyalgia pain at Week 14 (p=0.010).
- 2018-07-27missed
TNX-102 SL (cyclobenzaprine HCl sublingual)forPost-traumatic stress disorderTopline data
Phase 3 HONOR stopped at interim for inadequate separation on the primary CAPS-5 endpoint in military-related PTSD.
Recent activity
- Jun 1, 2026Phase changeTNX-102 SL (cyclobenzaprine HCl sublingual)·Major depressive disorderPhase 2HORIZON (NCT07621237) registered on ClinicalTrials.gov with overall status RECRUITING; estimated study start June 2026, estimated primary completion February 2028. (changed_at is an approximate month-precision anchor for the estimated June 2026 study start; exact first-patient-in date not separately citable.)source ↗
- Nov 24, 2025Phase changeTNX-102 SL (cyclobenzaprine HCl sublingual)·Major depressive disorderPhase 2FDA cleared the IND for TNX-102 SL in MDD; Tonix announced the potentially-pivotal Phase 2 HORIZON study (NCT07621237), a 6-week randomized double-blind placebo-controlled monotherapy study, with enrollment planned to initiate mid-year 2026.source ↗
- Sep 18, 2025Phase changeTNX-102 SL (cyclobenzaprine HCl sublingual)·Major depressive disorderPhase 2Tonix announced a positive Type B Pre-IND meeting with the FDA for TNX-102 SL in MDD; company outlined plans to file the IND and pursue an sNDA to expand the indication to MDD, citing exploratory depressive-symptom findings.source ↗
- Aug 15, 2025ReadoutTNX-102 SL (cyclobenzaprine HCl sublingual)·FibromyalgiametFDA approved Tonmya (TNX-102 SL) for fibromyalgia in adults — first new fibromyalgia drug in over 15 years.source ↗
- May 21, 2025Phase changeTNX-102 SL (cyclobenzaprine HCl sublingual)·Acute Stress DisorderPhase 2First patient dosed in the Phase 2 OASIS study of TNX-102 SL for reduction of acute stress reaction (Tonix press release); topline results expected in 2H 2026.source ↗
- Mar 25, 2025Phase changeTNX-102 SL (cyclobenzaprine HCl sublingual)·Acute Stress DisorderPhase 2OASIS Phase 2 study (NCT06636786) opened; CT.gov actual study start date. Investigator-initiated, UNC-led, DoD-funded (~$3M), Tonix supplying drug; ~180 MVC trauma survivors randomized in the ED to a 2-week course of TNX-102 SL vs placebo, primary endpoint change in the 14-item Acute Stress Disorder Scale.source ↗
- Dec 17, 2024Phase changeTNX-102 SL (cyclobenzaprine HCl sublingual)·FibromyalgiaFiled (NDA)FDA accepted the filing of the New Drug Application (NDA) for TNX-102 SL for fibromyalgia; a PDUFA target action date of 15 Aug 2025 was subsequently assigned.source ↗
- Jul 25, 2024Phase changeTNX-102 SL (cyclobenzaprine HCl sublingual)·FibromyalgiaPhase 3FDA granted Fast Track designation to TNX-102 SL (Tonmya) for the management of fibromyalgia (announced 25 Jul 2024).source ↗
- Dec 20, 2023ReadoutTNX-102 SL (cyclobenzaprine HCl sublingual)·FibromyalgiametSecond Phase 3 RESILIENT met its primary endpoint with high significance (p=0.00005); all six key secondaries positive.source ↗
- Oct 23, 2023Phase changeTNX-1900·MigrainePhase 2PREVENTION study completed (primary completion 2023-10-08; study completion 2023-10-23). Tonix announced completion of the clinical stage on 2023-10-26.source ↗
- Oct 23, 2023Phase changeTNX-1900·MigraineDiscontinuedPrimary 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.source ↗
- Apr 4, 2023Phase changeTNX-102 SL (cyclobenzaprine HCl sublingual)·Post-traumatic stress disorderDiscontinuedTonix 2023 pipeline prioritization deprioritized PTSD (delaying a planned Kenya study) to focus on fibromyalgia and other CNS programs; the PTSD treatment program has remained dormant. Earlier follow-on Phase 2 NCT05372887 was withdrawn (n=0) in 2022.source ↗
Trials recruiting · 2 recruiting of 9 sponsored
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD) (HORIZON)
Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) (OASIS)
Competitive landscape
Other companies developing against Tonix Pharmaceuticals Holding Corp.'s targets or indications.
- Axsome Therapeutics, Inc.2 compoundsFibromyalgiaMajor depressive disorder
- Biohaven Ltd.2 compoundsMajor depressive disorderMigraine
- COMPASS Pathways plc1 compoundPost-traumatic stress disorderMajor depressive disorder
- Definium Therapeutics, Inc.1 compoundPost-traumatic stress disorderMajor depressive disorder
- Otsuka Pharmaceutical Co., Ltd.3 compoundsPost-traumatic stress disorderMajor depressive disorder
- Alto Neuroscience, Inc.2 compoundsMajor depressive disorder
- Autobahn Therapeutics, Inc.1 compoundMajor depressive disorder
- Beckley Psytech Limited1 compoundMajor depressive disorder
- BioXcel Therapeutics, Inc.1 compoundAcute Stress Disorder
- Boehringer Ingelheim International GmbH2 compoundsMajor depressive disorder
- Cerevel Therapeutics Holdings, Inc.1 compoundMajor depressive disorder
- CSPC ZhongQi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.1 compoundMajor depressive disorder
