LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2 (LEVEL-2)

August 18, 2026 updated by: Tenax Therapeutics, Inc.

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction

The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Approximately 540 participants will be randomized in a 2:1 ratio to receive an oral dose of levosimendan or placebo. Participants will be eligible for an open label extension (OLE) of 52-weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
540

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1180AAX
        • Not yet recruiting
        • Tenax Investigational Site
      • Buenos Aires, Argentina, C1428ART
        • Not yet recruiting
        • Tenax Investigational Site
      • Corrientes, Argentina, W3400AMZ
        • Not yet recruiting
        • Tenax Investigational Site
      • Córdoba, Argentina, 5000
        • Not yet recruiting
        • Tenax Investigational Site
      • Córdoba, Argentina, X5016KET
        • Not yet recruiting
        • Tenax Investigational Site
      • San Luis, Argentina, D5702JRS
        • Not yet recruiting
        • Tenax Investigational Site
      • Santa Fe, Argentina, S2002KDS
        • Not yet recruiting
        • Tenax Investigational Site
    • Buenos Aires
      • San Juan Bautista, Buenos Aires, Argentina, 1888
        • Not yet recruiting
        • Tenax Investigational Site
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, 1280
        • Not yet recruiting
        • Tenax Investigational Site
  • Austria
      • Braunau am Inn, Austria, 5280
        • Recruiting
        • Tenax Investigational Site
      • Graz, Austria, 8036
        • Recruiting
        • Tenax Investigational Site
      • Klagenfurt, Austria, 9020
        • Not yet recruiting
        • Tenax Investigational Site
      • Sankt Pölten, Austria, 3100
        • Recruiting
        • Tenax Investigational Site
      • Vienna, Austria, 1100
        • Not yet recruiting
        • Tenax Investigational Site
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1090
        • Not yet recruiting
        • Tenax Investigational Site
  • Brazil
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40170-130
        • Not yet recruiting
        • Tenax Investigational Site
    • Goiás
      • Goiânia, Goiás, Brazil, 74605
        • Not yet recruiting
        • Tenax Investigational Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30220
        • Not yet recruiting
        • Tenax Investigational Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80215-901
        • Not yet recruiting
        • Tenax Investigational Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Not yet recruiting
        • Tenax Investigational Site
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Not yet recruiting
        • Tenax Investigational Site
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14026-020
        • Not yet recruiting
        • Tenax Investigational Site
  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Recruiting
        • Tenax Investigational Site
      • Pleven, Bulgaria, 5800
        • Not yet recruiting
        • Tenax Investigational Site
      • Sofia, Bulgaria, 1750
        • Not yet recruiting
        • Tenax Investigational Site
      • Sofia, Bulgaria, 1309
        • Not yet recruiting
        • Tenax Investigational Site
      • Sofia, Bulgaria, 1407
        • Recruiting
        • Tenax Investigational Site
      • Sofia, Bulgaria, 1431
        • Recruiting
        • Tenax Investigational Site
  • Czechia
      • Ostrava, Czechia, 72880
        • Not yet recruiting
        • Tenax Investigational Site
      • Prague, Czechia, 10034
        • Not yet recruiting
        • Tenax Investigational Site
      • Prague, Czechia, 15006
        • Not yet recruiting
        • Tenax Investigational Site
  • France
      • Le Kremlin-Bicêtre, France, 94270
        • Recruiting
        • Tenax Investigational Site
      • Montpellier, France, 34295
        • Not yet recruiting
        • Tenax Investigational Site
      • Nantes, France, 44007
        • Recruiting
        • Tenax Investigational Site
      • Nice, France, 06001
        • Not yet recruiting
        • Tenax Investigational Site
      • Pau, France, 64000
        • Not yet recruiting
        • Tenax Investigational Site
      • Poitiers, France, 86000
        • Not yet recruiting
        • Tenax Investigational Site
  • Germany
      • Bad Bevensen, Germany, 29549
        • Not yet recruiting
        • Tenax Investigational Site
      • Bad Nauheim, Germany, 61231
        • Not yet recruiting
        • Tenax Investigational Site
      • Berlin, Germany, 12683
        • Not yet recruiting
        • Tenax Investigational Site
      • Dresden, Germany, 01307
        • Not yet recruiting
        • Tenax Investigational Site
      • Hamburg, Germany, 20251
        • Not yet recruiting
        • Tenax Investigational Site
      • Jena, Germany, 07747
        • Not yet recruiting
        • Tenax Investigational Site
      • Mainz, Germany, 55131
        • Not yet recruiting
        • Tenax Investigational Site
  • Hungary
      • Budapest, Hungary, 1134
        • Not yet recruiting
        • Tenax Investigational Site
      • Budapest, Hungary, 1122
        • Recruiting
        • Tenax Investigational Site
      • Debrecen, Hungary, 4032
        • Recruiting
        • Tenax Investigational Site
      • Szeged, Hungary, 6275
        • Not yet recruiting
        • Tenax Investigational Site
  • Italy
      • Acquaviva delle Fonti, Italy, 70021
        • Not yet recruiting
        • Tenax Investigational Site
      • Bergamo, Italy, 24127
        • Not yet recruiting
        • Tenax Investigational Site
      • Messina, Italy, 98125
        • Not yet recruiting
        • Tenax Investigational Site
      • Milan, Italy, 20132
        • Not yet recruiting
        • Tenax Investigational Site
      • Milan, Italy, 20138
        • Not yet recruiting
        • Tenax Investigational Site
      • Milan, Italy, 20149
        • Not yet recruiting
        • Tenax Investigational Site
      • Pavia, Italy, 27100
        • Not yet recruiting
        • Tenax Investigational Site
      • Pisa, Italy, 56126
        • Not yet recruiting
        • Tenax Investigational Site
      • Roma, Italy, 00168
        • Not yet recruiting
        • Tenax Investigational Site
      • Rozzano, Italy, 20089
        • Not yet recruiting
        • Tenax Investigational Site
  • Poland
      • Grodzisk Mazowiecki, Poland, 05-825
        • Not yet recruiting
        • Tenax Investigational Site
      • Poznan, Poland, 61848
        • Not yet recruiting
        • Tenax Investigational Site
      • Wroclaw, Poland, 50556
        • Recruiting
        • Tenax Investigational Site
      • Wroclaw, Poland, 50891
        • Recruiting
        • Tenax Investigational Site
  • South Korea
      • Cheongju-si, South Korea, 28644
        • Recruiting
        • Tenax Investigational Site
      • Gwangju, South Korea, 61469
        • Recruiting
        • Tenax Investigational Site
      • Incheon, South Korea, 21565
        • Recruiting
        • Tenax Investigational Site
      • Seoul, South Korea, 08308
        • Not yet recruiting
        • Tenax Investigational Site
      • Seoul, South Korea, 03080
        • Recruiting
        • Tenax Investigational Site
      • Wŏnju, South Korea, 26426
        • Recruiting
        • Tenax Investigational Site
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Tenax Investigational Site
      • Barcelona, Spain, 08035
        • Recruiting
        • Tenax Investigational Site
      • Barcelona, Spain, 08036
        • Recruiting
        • Tenax Investigational Site
      • Lugo, Spain, 27003
        • Recruiting
        • Tenax Investigational Site
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Tenax Investigational Site
      • Madrid, Spain, 28046
        • Recruiting
        • Tenax Investigational Site
      • Madrid, Spain, 28055
        • Recruiting
        • Tenax Investigational Site
      • Marbella, Spain, 29603
        • Recruiting
        • Tenax Investigational Site
      • Málaga, Spain, 29010
        • Recruiting
        • Tenax Investigational Site
      • Pamplona, Spain, 31008
        • Not yet recruiting
        • Tenax Investigational Site
      • Salamanca, Spain, 37007
        • Recruiting
        • Tenax Investigational Site
      • Seville, Spain, 41009
        • Recruiting
        • Tenax Investigational Site
      • Toledo, Spain, 45007
        • Recruiting
        • Tenax Investigational Site
      • Valencia, Spain, 46020
        • Not yet recruiting
        • Tenax Investigational Site
      • Valencia, Spain, 46010
        • Recruiting
        • Tenax Investigational Site
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Not yet recruiting
        • Tenax Investigational Site
      • Kaohsiung City, Taiwan, 813414
        • Not yet recruiting
        • Tenax Investigational Site
      • Tainan, Taiwan, 71004
        • Not yet recruiting
        • Tenax Investigational Site
      • Taipei, Taiwan, 10449
        • Not yet recruiting
        • Tenax Investigational Site
      • Taipei, Taiwan, 110
        • Not yet recruiting
        • Tenax Investigational Site
      • Taoyuan, Taiwan, 33305
        • Not yet recruiting
        • Tenax Investigational Site
  • United Kingdom
      • Cambridge, United Kingdom, CB233RE
        • Recruiting
        • Tenax Investigational Site
      • Glasgow, United Kingdom, G81 4HS
        • Not yet recruiting
        • Tenax Investigational Site
      • London, United Kingdom, SW3 6NP
        • Not yet recruiting
        • Tenax Investigational Site
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Tenax Investigational Site
      • Sheffield, United Kingdom, S10 2JF
        • Not yet recruiting
        • Tenax Investigational Site
      • Swindon, United Kingdom, SN36BB
        • Not yet recruiting
        • Tenax Investigational Site
  • United States
    • Alabama
      • Alexander City, Alabama, United States, 35010
        • Recruiting
        • Tenax Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Not yet recruiting
        • Tenax Investigational Site
    • California
      • Sacramento, California, United States, 95816
        • Not yet recruiting
        • Tenax Investigational Site
      • San Francisco, California, United States, 94143
        • Not yet recruiting
        • Tenax Investigational Site
      • Stanford, California, United States, 94305-5208
        • Not yet recruiting
        • Tenax Investigational Site
      • Torrance, California, United States, 90502
        • Not yet recruiting
        • Tenax Investigational Site
    • Georgia
      • Athens, Georgia, United States, 30606
        • Not yet recruiting
        • Tenax Investigational Site
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Tenax Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611-4494
        • Not yet recruiting
        • Tenax Investigational Site
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • Tenax Investigational Site
      • Mount Prospect, Illinois, United States, 60056
        • Not yet recruiting
        • Tenax Investigational Site
      • Peoria, Illinois, United States, 61636
        • Recruiting
        • Tenax Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Tenax Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115-6969
        • Recruiting
        • Tenax Investigational Site
      • West Monroe, Louisiana, United States, 71291
        • Recruiting
        • Tenax Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114-2621
        • Not yet recruiting
        • Tenax Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Not yet recruiting
        • Tenax Investigational Site
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Tenax Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Not yet recruiting
        • Tenax Investigational Site
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Tenax Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Not yet recruiting
        • Tenax Investigational Site
      • St Louis, Missouri, United States, 63136
        • Not yet recruiting
        • Tenax Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • Tenax Investigational Site
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Tenax Investigational Site
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Tenax Investigational Site
      • New York, New York, United States, 10032
        • Recruiting
        • Tenax Investigational Site
      • Rochester, New York, United States, 14617
        • Recruiting
        • Tenax Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Tenax Investigational Site
      • Winston-Salem, North Carolina, United States, 27101
        • Recruiting
        • Tenax Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195-0001
        • Not yet recruiting
        • Tenax Investigational Site
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • Tenax Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Not yet recruiting
        • Tenax Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Not yet recruiting
        • Tenax Investigational Site
      • Wynnewood, Pennsylvania, United States, 19096-3450
        • Not yet recruiting
        • Tenax Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Not yet recruiting
        • Tenax Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Recruiting
        • Tenax Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Tenax Investigational Site
      • Dallas, Texas, United States, 75390
        • Recruiting
        • Tenax Investigational Site
      • El Paso, Texas, United States, 79905-2707
        • Not yet recruiting
        • Tenax Investigational Site
      • Houston, Texas, United States, 77002
        • Withdrawn
        • Tenax Investigational Site
      • Houston, Texas, United States, 77030-2342
        • Not yet recruiting
        • Tenax Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Not yet recruiting
        • Tenax Investigational Site
      • Norfolk, Virginia, United States, 23507-1904
        • Not yet recruiting
        • Tenax Investigational Site
    • Washington
      • Seattle, Washington, United States, 98122
        • Not yet recruiting
        • Tenax Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • Not yet recruiting
        • Tenax Investigational Site
      • Marshfield, Wisconsin, United States, 54449
        • Recruiting
        • Tenax Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men or women, ≥18 to 85 years of age
  2. NYHA Class II or III or ambulatory NYHA Class IV symptoms
  3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC)
  4. A qualifying baseline RHC
  5. A qualifying echocardiogram
  6. A qualifying 6-MWD
  7. A 48-hour ambulatory cardiac rhythm monitor during the Screening Period
  8. Requirements related to child bearing potential, contraception, and egg/sperm donation)

Exclusion Criteria:

  1. A diagnosis of PH WHO Groups 1, 3, 4, or 5
  2. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
  3. Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous) OR, planned valve intervention OR, the presence of significant valve disease
  4. A diagnosis of pre-existing lung disease
  5. History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product
  6. Major surgery within 60 days
  7. Prior heart, lung, or heart-lung transplants or life expectancy of <12 months
  8. History of clinically significant other diseases that may limit or complicate participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Matching placebo (oral)
Drug: Placebo
Matching placebo (oral)
Active Comparator: TNX-103
Oral levosimendan
Drug: TNX-103
Oral levosimendan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6-Minute Walk Distance (6MWD)
Time Frame: 26 weeks
Change in 6-minute walk distance
26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Worsening Events
Time Frame: 26 weeks
Number of Clinical Worsening Events
26 weeks
Clinical Worsening Event
Time Frame: 26 weeks
Time to first occurrence of a Clinical Worsening Event
26 weeks
KCCQ (Kansas City Cardiomyopathy Questionnaire) score is a standardized measure that ranges from 0 to 100, where a higher score indicates better health.
Time Frame: 26 weeks
Change in KCCQ Total Symptom Score
26 weeks
NYHA (New York Heart Association) classification assesses and categorizes a patient's physical ability and symptoms into four classes, the lower the classification, the least impact on physical activity.
Time Frame: 26 weeks
Change in NYHA Functional Class
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tenax Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TNX-103-07
  • 2025-522475-28-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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