A Phase 2 interventional study of TRX-100 and Standard of Care (SOC) in Influenza, sponsored by Traws Pharma, Inc.. Active, not recruiting at 1 site in Australia. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Traws Pharma, Inc. · Phase 2, Interventional, and Treatment
Among 99 studies in Influenza, Human with a site in Australia — 9 open to participants now, 12 under way, 3 of them phase 3. Influenza, Human · Australia.
Among the 99 studies in Influenza, Human with a site in Australia, this one is the 68th largest by planned enrollment of the 87 interventional ones, is one of 5 that started in 2025, is one of 27 in phase 2, reaches primary completion later than 6 of the 11 other live ones, and was the 94th registered.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's planned enrollment of 105 is below the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →9 of the 99 studies in Influenza, Human with a site in Australia are open now, in 12 countries. Each count lists the studies.
Of the 119 Influenza, Human studies recruiting now, 62 (52%) set no upper age limit and 47 (39%) stop at 75 or younger; 31 take children under 18; 65 take healthy volunteers.
This study: 18 Years to 64 Years · all sexes · no healthy volunteers.
The full table on the hub →99 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 5 started in 2025.
Median enrollment 363 across the 87 interventional studies, 1,000 across the 11 observational. Of the 81 that completed or were terminated, 31 (38%) have results posted.
85 of 99 have an industry lead sponsor. The 10 most frequent:
Traws Pharma, Inc. is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
Traws Pharma, Inc. has 3 studies filed under Influenza, Human — fewer than ten, so there is no comparison to draw.
4 of the studies in Influenza, Human with a site in Australia that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07159763Phase 3Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06) | 2027-06-30 |
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
| NCT07371650Traws Pharma, Inc.This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Tivoxavir Marboxil in Patients With Mild to Moderate Influenza | 2026-12 |
| NCT07516418SanofiStudy of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Participants 18 to 49 Years of Age | 2027-04-04 |
Among the 99 studies in Influenza, Human with a site in Australia, from their registry updates:
This is an early-stage clinical trial to determine a safe and effective dose for Tivoxavir Marboxil (TRX-100) in patients with mild to moderate Influenza. Participants will take a study drug as well as a standard therapy. A descriptive statistics will be used to present the study results.
This is a multicenter, open-label, randomized, Phase 2a study to evaluate the safety, tolerability, and pilot efficacy of different oral doses of TRX-100 in otherwise healthy participants with mild to moderate influenza. The study will also evaluate PK of TRX-100 and its major active metabolite, TRX-101, following single oral doses of TRX-100.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in this arm will receive a lower single oral dose of the investigational drug, TRX-100.
Drug: TRX-100
Participants in this arm will receive a higher single oral dose of the investigational drug, TRX-100.
Drug: TRX-100
Participants in this arm will not receive the investigational drug. Instead, they will receive the current standard of care treatment. This arm serves as a comparator to evaluate the effects of the investigational drug.
Drug: Standard of Care (SOC)
CEN inhibitor, dosage form - capsules, dosing regimen - QD
Standard of Care Influenza Antiviral therapy
Incidence of AE/SAE
Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs)
Time frame: up to Day 28
Incidence of abnormal laboratory tests results
Number of participants with abnormal laboratory tests results
Time frame: Up to Day 28
Incidence of abnormal clinically significant ECG results
Time frame: Up to 28 days
Number of participants with abnormal physical examinations findings
Time frame: Up to 28 days
Change from baseline in the total score of 7 influenza symptoms
Seven symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, and fatigue) will be assessed by the participant and recorded on a 4-point severity scale
Time frame: up to Day 15
Plasma Tmax
Time to reach the maximum plasma concentration of TRX-100.
Time frame: PK samples will be collected from Day 1 through Day 22.
Incidence of influenza-related complications
Time frame: Up to 28 days
Time to alleviation of influenza clinical symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, and fatigue)
Time frame: Up to 28 days
Time to resolution of fever to <37 C (axillary temperature)
Time frame: Up to 28 days
Percentage of participants with resolution of fever
Time frame: Up to 28 days
Time needed to return to pre-influenza health status based on assessment of activities score
Time frame: Up to 28 Days
Plasma Cmax
TRX-100 peak plasma concentration
Time frame: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-100
Time frame: PK samples will be collected from Day 1 through Day 22.
Plasma Cmax
TRX-101 peak plasma concentration
Time frame: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-101
Time frame: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)
Area under the plasma concentration-time curve from time zero to 24 hours post-dose for TRX-100.
Time frame: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)
Area under the plasma concentration-time curve from time zero to 24 hours post-dose for TRX-101.
Time frame: PK samples will be collected from Day through Day 22
Area under the plasma concentration-time curve from time zero extrapolated to infinity
A measure of total drug exposure from administration extrapolated to infinite time, estimated for TRX-100.
Time frame: PK samples will be collected from Day 1 through Day 22.
Area under the concentration-time curve extrapolated to infinity
A measure of total drug exposure from administration extrapolated to infinite time, estimated for TRX-101.
Time frame: PK samples will be collected from Day 1 through Day 22.
Terminal elimination half-life
The time required for the plasma concentration of TRX-100 to decrease by 50% in the terminal elimination phase.
Time frame: PK samples will be collected from Day 1 through Day 22.
Terminal elimination half-life
The time required for the plasma concentration of TRX-101 to decrease by 50% in the terminal elimination phase.
Time frame: PK samples will be collected from Day 1 through Day 22
Terminal elimination rate constant
The first-order rate constant associated with the terminal elimination phase of the plasma concentration-time curve for TRX-100.
Time frame: PK samples will be collected from Day 1 through Day 22
Terminal elimination rate constant.
The first-order rate constant associated with the terminal elimination phase of the plasma concentration-time curve for TRX-101.
Time frame: PK samples will be collected from Day 1 through Day 22
Apparent oral clearance (CL/F)
Apparent total clearance of TRX-100 from plasma following oral administration
Time frame: PK samples will be collected from Day 1 through Day 22
Apparent oral clearance (CL/F)
Apparent total clearance of TRX-101 from plasma following oral administration
Time frame: PK samples will be collected from Day 1 through Day 22
Apparent volume of distribution during the terminal phase
Apparent volume of distribution of TRX-100 during the terminal elimination phase following oral administration, calculated as Clearance (CL/F) divided by the elimination rate constant.
Time frame: PK samples will be collected from Day 1 through Day 22.
Apparent volume of distribution during the terminal phase
Apparent volume of distribution of TRX-101 during the terminal elimination phase following oral administration, calculated as Clearance (CL/F) divided by the elimination rate constant.
Time frame: PK samples will be collected from Day 1 through Day 22.
Plasma Tmax
Time to reach the maximum plasma concentration of TRX-101.
Time frame: Time Frame: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-101.
Time frame: PK samples will be collected from Day 1 through Day 22.
Change from Baseline in Viral Titer
Change of virus titer compared to pretreatment baseline sample
Time frame: up to Day 6
Change from Baseline in Viral Load
Change in virus load compared to pretreatment baseline sample
Time frame: up to Day 6
Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.
Of 86 industry-sponsored phase 2 interventional studies under Influenza, Human, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's planned 12 months is above that.
Counting every sponsor, half of 122 studies reached it within 10 months; a quarter within 5 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tivoxavir marboxil