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Tonix Pharmaceuticals Holding Corp. (TNXP)

Tonix Pharmaceuticals Holding Corp. is a biopharmaceutical firm primarily operating in the clinical development stage. Its overarching mission involves the discovery, acquisition, advancement, and commercialization of novel therapeutic agents and diagnostic tools, all aimed at combating human illnesses and easing patient discomfort. The company boasts a comprehensive pipeline of potential treatments spanning several key medical fields: immunology, rare conditions, infectious diseases, and central nervous system (CNS) disorders. In the realm of immunology, Tonix is progressing with biologics designed to address organ transplant rejection, various autoimmune diseases, and certain forms of cancer. A prominent candidate here is TNX-1500, a humanized monoclonal antibody targeting CD40-ligand, which is being investigated for its utility in preventing both allograft and xenograft rejection, as well as in treating autoimmune disorders. Its rare disease initiatives include TNX-2900, a specific treatment candidate for Prader-Willi syndrome. The infectious disease segment features a diverse array of programs: TNX-801, a vaccine designed to offer protection against smallpox and monkeypox. TNX-1840 and TNX-1850, which are live virus vaccines based on the company's recombinant pox vaccine (RPV) platform, targeting COVID-19. TNX-3500, a small molecule antiviral drug for the treatment of acute COVID-19. TNX-102 SL, a small molecule medication under investigation for Long COVID, a persistent post-acute COVID-19 condition. Finally, the CNS portfolio encompasses both small molecules and biologics intended to manage pain, neurological conditions, psychiatric ailments, and addiction. Notably, TNX-102 SL is also in mid-Phase 3 development for alleviating fibromyalgia symptoms. Other CNS candidates include TNX-1900, which is being developed to prevent migraine headaches, and TNX-1300, a biologic aimed at treating cocaine intoxication. The company was established in 2007 and maintains its headquarters in Chatham, New Jersey.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Tonix Pharmaceuticals Holding Corp. logo

Tonix Pharmaceuticals Holding Corp.

NASDAQ:TNXPHealthcare
-3.41%$5.10
AH$5.11+0.20%vs close
Mkt Cap$87.47M
Float17.11M
O/S17.15M
Vol
$ Vol
RVOL
Inst Own55.2%
SI17.2%
Earnings
Dilution
Tonix Pharmaceuticals Holding Corp. logoNASDAQ:TNXP$5.10-3.41%
Phase Distribution
34 lead-sponsored trials·2 active·24 completed
Phase 112
Phase 210
Phase 2/31
Phase 311
(5 more as collaborator)
Status Overview
Recruiting1
Active, not recruiting1
Completed24
Stopped8

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 3
    Completed

    12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients

    TNX-102 SL

    Primary Fibromyalgia

    Enrollment
    158
    Start
    Dec 2013
    Primary Completion
    Aug 2015
    Completion
    Aug 2015
    NCT02015234
  • Phase 3
    Completed

    A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia

    TNX-102 SL Tablet, 2.8mg, Placebo SL Tablet

    Fibromyalgia, Myofascial Pain Syndromes +5

    Enrollment
    519
    Start
    Apr 2015
    Primary Completion
    Sep 2016
    Completion
    Sep 2016
    NCT02436096
  • Phase 3
    Completed

    A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients

    TNX-102 SL Tablet 2.8 mg

    Primary Fibromyalgia

    Enrollment
    375
    Start
    Aug 2015
    Primary Completion
    Sep 2016
    Completion
    Sep 2016
    NCT02589275
  • Phase 3
    Terminated

    Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia

    TNX-102 SL Tablet, 2.8 mg, Placebo SL Tablet

    Fibromyalgia, Myofascial Pain Syndromes +5

    Enrollment
    51
    Start
    Jul 2016
    Primary Completion
    Sep 2016
    Completion
    Sep 2016
    NCT02829814
  • Phase 3
    Terminated

    Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD

    TNX-102 SL, Placebo SL Tablet

    PTSD

    Enrollment
    358
    Start
    Mar 2017
    Primary Completion
    Jul 2018
    Completion
    Jul 2018
    NCT03062540
  • Phase 3
    Terminated

    12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients

    TNX-102 SL

    PTSD

    Enrollment
    190
    Start
    Jun 2017
    Primary Completion
    Jul 2018
    Completion
    Jul 2018
    NCT03110575
  • Phase 3
    Completed

    A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD

    TNX-102 SL 5.6 mg

    PTSD

    Enrollment
    93
    Start
    Apr 2018
    Primary Completion
    Sep 2019
    Completion
    Sep 2019
    NCT03508700
  • Phase 3
    Terminated

    A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD

    TNX-102 SL, Placebo SL Tablets

    PTSD

    Enrollment
    192
    Start
    Mar 2019
    Primary Completion
    Apr 2020
    Completion
    Apr 2020
    NCT03841773
  • Phase 3
    Completed

    A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

    TNX-102 SL, Placebo SL Tablet

    Fibromyalgia

    Enrollment
    503
    Start
    Dec 2019
    Primary Completion
    Oct 2020
    Completion
    Oct 2020
    NCT04172831
  • Phase 3
    Completed

    A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

    TNX-102 SL, Placebo SL Tablet

    Fibromyalgia

    Enrollment
    514
    Start
    Jul 2020
    Primary Completion
    Nov 2021
    Completion
    Nov 2021
    NCT04508621
  • Phase 3
    Completed

    A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia

    TNX-102 SL Tablet, 5.6 mg, Placebo SL Tablet

    Fibromyalgia

    Enrollment
    457
    Start
    Apr 2022
    Primary Completion
    Nov 2023
    Completion
    Nov 2023
    NCT05273749
  • Phase 2/3
    Completed

    BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)

    TNX-102 SL 2.8mg, Placebo

    Primary Fibromyalgia

    Enrollment
    205
    Start
    Sep 2013
    Primary Completion
    Jul 2014
    Completion
    Sep 2014
    NCT01903265
  • Phase 2
    Completed

    Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions

    TNX-102 SL, Placebo

    PTSD

    Enrollment
    245
    Start
    Oct 2014
    Primary Completion
    May 2016
    Completion
    May 2016
    NCT02277704
  • Phase 2
    Completed

    Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions

    TNX-102 SL

    PTSD

    Enrollment
    159
    Start
    Apr 2015
    Primary Completion
    May 2016
    Completion
    May 2016
    NCT02421679
  • Phase 2
    Completed

    Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache

    TNX-201, Placebo

    Tension-Type Headache

    Enrollment
    165
    Start
    Jun 2015
    Primary Completion
    Feb 2016
    Completion
    Feb 2016
    NCT02423408
  • Phase 2
    Withdrawn

    An Open-Label, Randomized Pilot Study Comparing the Safety of a Single Dose of TNX-1300 to Usual Care (UC) Alone for the Treatment of Signs and Symptoms of Acute Cocaine Intoxication in Male Emergency Department (ED) Subjects

    TNX-1300

    Cocaine Intoxication

    Enrollment
    0
    Start
    Sep 2021
    Primary Completion
    Jun 2022
    Completion
    Jun 2022
    NCT04996056
  • Phase 2
    Withdrawn

    Safety and Efficacy Study of TNX-102 SL in Participants With PTSD

    TNX-102 SL, Placebo

    PTSD

    Enrollment
    0
    Start
    Oct 2022
    Primary Completion
    Nov 2022
    Completion
    Nov 2022
    NCT05372887
  • Phase 2
    Completed

    A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection

    TNX-102 SL, Placebo SL Tablet

    Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection, COVID-19 +2

    Enrollment
    63
    Start
    Aug 2022
    Primary Completion
    Jul 2023
    Completion
    Jul 2023
    NCT05472090
  • Phase 2
    Completed

    A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine

    TNX-1900, Placebo Nasal Spray

    Chronic Migraine, Chronic Migraine, Headache +2

    Enrollment
    88
    Start
    Dec 2022
    Primary Completion
    Oct 2023
    Completion
    Oct 2023
    NCT05679908
  • Phase 2
    Completed

    Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)

    TNX-601 ER, Placebo

    Depression, Depressive Disorder +4

    Enrollment
    132
    Start
    Mar 2023
    Primary Completion
    Sep 2023
    Completion
    Sep 2023
    NCT05686408
  • Phase 2
    Terminated

    Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)

    TNX-1300 (Injection), Placebo (Injection)

    Cocaine Use, Cocaine Intoxication +3

    Enrollment
    3
    Start
    Aug 2024
    Primary Completion
    Apr 2025
    Completion
    Apr 2025
    NCT06045793
  • Phase 2
    Recruiting

    A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)

    TNX-102 SL, Placebo sublingual tablet

    Major Depressive Episode (MDE), Major Depressive Disorder (MDD) +1

    Enrollment
    360
    Start
    Jun 2026
    Primary Completion
    Feb 2028est.
    Completion
    Feb 2028est.
    NCT07621237
  • Phase 1
    Completed

    A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.

    Treatment A, Treatment B

    Healthy

    Enrollment
    30
    Start
    Nov 2011
    Primary Completion
    Dec 2011
    Completion
    Dec 2011
    NCT01490788
  • Phase 1
    Completed

    Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults

    SL TNX-102 2.4 mg at pH 3.5, SL TNX-102 2.4 mg at pH 7.1

    Healthy Adults

    Enrollment
    24
    Start
    Jun 2012
    Primary Completion
    Sep 2013
    Completion
    Jan 2014
    NCT01634412
  • Phase 1
    Completed

    Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults

    SL TNX-102 at 2.4 mg, SL TNX-102 at 4.8 mg

    Healthy Adults

    Enrollment
    24
    Start
    Sep 2012
    Primary Completion
    Dec 2013
    Completion
    Mar 2014
    NCT01689259

1-25 of 34

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