TNX-102 SL

Small molecule

TTonix Pharmaceuticals, Inc.

TNX-102 SL is one of 36 small molecule programs targeting Fibromyalgia. It is currently in development.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

FibromyalgiaActive, not recruiting

FibromyalgiaPhase 2/Phase 3

Active, not recruiting

Competition

Competitive Landscape

152 competitors in Fibromyalgia

#DrugCompanyPhaseTrials

Epidiolex

Jazz Pharmaceuticals

Phase 3

1 2

Namenda

AbbVie

Phase 3

1 3

Xyrem

Jazz Pharmaceuticals

Phase 3

1 4

Neurontin

VViatris Specialty LLC

Phase 3

3 5

Prozac

VVitae Pharmaceuticals Inc., an Allergan affiliate

Phase 3

1 6

Ultram

WWim Janssens

Phase 3

1 7

DS-5565

Daiichi Sankyo

Phase 3

4 8

Feosol

AAuerbach Hematology Oncology Associates P C

Saizen

1 10

Genotropin

EMD Serono

Phase 3

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Fibromyalgia8 trials

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

Completed·TTonix Pharmaceuticals, Inc.·Phase 3·NCT02015234·158 enrolled

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

Completed·TTonix Pharmaceuticals, Inc.·Phase 3·NCT04172831·503 enrolled

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

Completed·TTonix Pharmaceuticals, Inc.·Phase 3·NCT04508621·514 enrolled

Show 5 more trials

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

Completed·TTonix Pharmaceuticals, Inc.·Phase 2/3·NCT01903265·205 enrolled

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

Completed·TTonix Pharmaceuticals, Inc.·Phase 3·NCT05273749·457 enrolled

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

Completed·TTonix Pharmaceuticals, Inc.·Phase 3·NCT02436096·519 enrolled

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

Completed·TTonix Pharmaceuticals, Inc.·Phase 3·NCT02589275·375 enrolled

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

Terminated·TTonix Pharmaceuticals, Inc.·Phase 3·NCT02829814·51 enrolled

Safety and Efficacy4 trials

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

Completed·TTonix Pharmaceuticals, Inc.·Phase 2·NCT02277704·245 enrolled

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

Completed·TTonix Pharmaceuticals, Inc.·Phase 2·NCT02421679·159 enrolled

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

Withdrawn·TTonix Pharmaceuticals, Inc.·Phase 2·NCT05372887

Show 1 more trial

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

Terminated·TTonix Pharmaceuticals, Inc.·Phase 3·NCT03062540·358 enrolled

PTSD2 trials

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

Terminated·TTonix Pharmaceuticals, Inc.·Phase 3·NCT03110575·190 enrolled

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

Completed·TTonix Pharmaceuticals, Inc.·Phase 3·NCT03508700·93 enrolled

Randomized1 trial

A Single-Dose, Randomized, Open-Label, 2-Way Crossover Study to Evaluate the Dose-Proportionality, Safety, and Tolerability of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Japanese and Chinese Subjects

Completed·TTonix Pharmaceuticals, Inc.·Phase 1·NCT07464535·20 enrolled

Efficacy and Safety1 trial

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

Terminated·TTonix Pharmaceuticals, Inc.·Phase 3·NCT03841773·192 enrolled

5 more indications

MRI1 trial

Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules

Completed·TTonix Pharmaceuticals, Inc.·Phase 1·NCT03443960·60 enrolled

Elderly Participants1 trial

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine Hydrochloride Sublingual Tablet) In Non-Elderly Versus Elderly Participants

Active, not recruiting·TTonix Pharmaceuticals, Inc.·Phase 1·NCT07413367·50 enrolled

Adult1 trial

Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults

Completed·TTonix Pharmaceuticals, Inc.·Phase 1·NCT01889173·24 enrolled

SARS CoV 2 Infection1 trial

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

Completed·TTonix Pharmaceuticals, Inc.·Phase 2·NCT05472090·63 enrolled

Unspecified1 trial

Dose-Proportionality and Food Effect Study of TNX-102 SL

Completed·TTonix Pharmaceuticals, Inc.·Phase 1·NCT04164719·16 enrolled

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for TNX-102 SL. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — TNX-102 SL compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for TNX-102 SL. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Tonix Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: TTonix Pharmaceuticals, Inc.

TNX-102 SL

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Fibromyalgia8 trials

Safety and Efficacy4 trials

PTSD2 trials

Randomized1 trial

Efficacy and Safety1 trial

MRI1 trial

Elderly Participants1 trial

Adult1 trial

SARS CoV 2 Infection1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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