Can a new pill shorten the flu?

NCT ID NCT07798193

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

Researchers are testing an experimental oral drug called SYH2085 in adults with uncomplicated influenza. The study compares SYH2085 against a placebo to see if it can shorten the time to resolution of flu symptoms like fever, cough, and body aches. Participants must have tested positive for the flu and started symptoms within 48 hours. The trial also measures how quickly the virus clears from the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SYH2085 tablets
What this could lead to
If SYH2085 works, it could offer a new oral treatment to shorten flu illness and reduce how long people shed the virus.
What could go wrong
This is an early Phase 2 study, so the drug may not prove effective or safe. Results from this small group may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 213 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years at time of signing ICF. * At screening, meet all of the following: 1. Positive influenza antigen test or influenza virus nucleic acid test (other rapid molecular diagnostic methods are acceptable). 2. Axillary temperature ≥37.3°C at screening; if antipyretics have been taken, axillary temperature ≥37.3°C at least 4 hours after dosing; 3. At least one systemic influenza symptom of moderate or greater severity: muscle/joint aches, fatigue, headache, fever/chills; 4. At least one respiratory influenza symptom of moderate or greater severity: nasal congestion, sore throat, cough. * Time from onset of first influenza symptom to randomization ≤48 hours. * Female participants must meet: 1. Not of childbearing potential (i.e., hysterectomy, bilateral oophorectomy, documented ovarian failure, or postmenopausal defined as \>50 years and amenorrhea ≥12 months), or 2. Of childbearing potential, with negative pregnancy test at screening, and not pregnant, peripartum, or breastfeeding. * Participants and their partners agree to complete abstinence or use effective contraception from screening until 1 month after study completion. * Male participants agree not to donate sperm from screening until 1 month after study completion. * Understand and voluntarily sign ICF, willing and able to comply with all study procedures, and able to complete the participant diary as required. Exclusion Criteria: * Influenza virus infection requiring hospitalization (any of the following): 1. Significant exacerbation of underlying diseases, e.g., COPD, diabetes, chronic heart failure, chronic renal failure, cirrhosis, etc. 2. Any of the following severe case criteria: 1. Respiratory rate ≥30/min; 2. Oxygen saturation ≤93% on room air at rest; 3. PaO2/FiO2 ≤300; for high-altitude areas (\>1000 m), correction: PaO2/FiO2 × \[760/atmospheric pressure (mmHg)\] (1 mmHg=0.133 kPa); 4. Progressive clinical deterioration with lung imaging showing \>50% lesion progression within 24-48 hours. 3. Any critical case criteria: 1. Respiratory failure requiring mechanical ventilation; 2. Shock; 3. Acute necrotizing encephalopathy; 4. Other organ failure requiring ICU monitoring. * High-risk groups for severe/critical cases (any of the following): 1. Severe or poorly controlled underlying diseases, e.g., COPD, liver disease (ALT or AST ≥3×ULN, total bilirubin ≥1.5×ULN), chronic kidney disease (serum creatinine \>177 μmol/L or 2 mg/dL), severe hematological disorders, chronic congestive heart failure (NYHA class III-IV), neurological and neuromuscular diseases, metabolic diseases, etc.; 2. Clinically significant corrected QT interval abnormality on ECG (QTc \>450 ms for males or \>470 ms for females, QTcF by Fridericia formula); 3. Immunocompromised patients, e.g., malignancy, organ or bone marrow transplantation, HIV infection, or use of immunosuppressants within 3 months; Note: Participants with basal cell carcinoma, localized squamous cell carcinoma of skin, or cervical carcinoma in situ may be enrolled if curative treatment completed ≥12 months before ICF; other malignancies if curative treatment completed ≥5 years before ICF. 4. Concurrent conditions requiring aspirin or salicylate therapy; 5. Obesity (BMI \>30 kg/m²). * Bronchitis, pneumonia, pleural effusion, or interstitial lung disease suspected by a clinician at screening, or confirmed by chest imaging (X-ray / CT) and judged by investigator at screening. * Acute respiratory infection, otitis media, or sinusitis within 2 weeks before screening. * Concurrent infection requiring systemic anti-infective therapy, or WBC \>10.0×10⁹/L at screening. * Purulent sputum or suppurative tonsillitis. * Difficulty swallowing medication or history of gastrointestinal diseases that significantly affect drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastroinoma, short-bowel syndrome, post-gastrectomy, etc.). * History of allergy to active ingredient or excipients of the study drug. * Previous exposure to SYH2085. * Body weight \<40 kg. * Use of anti-influenza drugs within 7 days before screening (including but not limited to neuraminidase inhibitors, hemagglutinin inhibitors, M2 ion channel blockers, and CEN inhibitors, e.g., oseltamivir, zanamivir, peramivir, laninamivir, umifenovir, favipiravir, rimantadine, amantadine, arbidol, nitazoxanide, baloxavir marboxil, marboxil, etc.). * Influenza vaccination within 6 months before screening. * History of alcohol abuse within 3 months before screening (males \>14 units/week, females \>7 units/week; 1 unit = 10 g pure alcohol), or alcohol consumption within 48 hours before dosing, or history of drug abuse. * Use of any prohibited medications within 2 weeks / 5 half-lives (whichever longer; excluding anti-influenza drugs) before screening and during the planned trial period. * Participation in any clinical trial of investigational drug, biologic, or medical device within 30 days (or 5 half-lives, whichever longer) before screening. * Positive SARS-CoV-2 antigen or nucleic acid test. * Any other condition judged by the investigator as unsuitable for participation.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Influenza are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.