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New combo pill aims to knock out cold and flu symptoms faster

NCT ID NCT05118672

Symptom relief Sponsor: Eurofarma Laboratorios S.A. Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether a single pill containing paracetamol (pain reliever/fever reducer), fexofenadine (antihistamine), and phenylephrine (decongestant) works better than a placebo for treating cold and flu symptoms. 567 adults in Brazil took the combo pill or a placebo every 8 hours for up to 3 days. Researchers measured symptom relief using a questionnaire that tracked nasal congestion, runny nose, sneezing, headache, muscle aches, sore throat, cough, and fever.

What this could mean

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

Active substance
paracetamol, fexofenadine, and phenylephrine combination pill
What this could lead to
If it works, this could provide a more effective over-the-counter option for relieving multiple cold and flu symptoms at once.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The combination may not be significantly better than existing treatments or placebo, and individual ingredients have known side effects like drowsiness or increased blood pressure.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

567 people

The number who actually took part.

Started

Mar 2025

Finished

Aug 2025

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: * Common cold: presence of moderate to severe nasal congestion AND moderate to severe runny nose AND at least one (01) of the following moderate to severe symptoms: sneezing, headache, myalgia, sore throat, throat pain, dysphonia, cough and fever. Duration of symptoms ≤ 48 hours at screening. Informed Consent Form (ICF) signed before carrying out any study procedure. Exclusion Criteria: * Presence of significant septum deviation, compatible with impaired nasal ventilatory function, at the investigator's discretion. * Presence of nasal polyposis to previous rhinoscopy. * Known hypersensitivity to any component of the experimental drug formulation. * Required antibiotic therapy for upper airway infection treatment

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease common cold influenza

As listed by the trial registrant

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

COLD Flu symptom

Contacts and locations

Locations

  • Clinica de Alergia Martti Antila

    Sorocaba, São Paulo, Brazil

  • Eurofarma Laboratórios S.A

    São Paulo, São Paulo, 06696-000, Brazil

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