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New cough drug shows promise in early trial

NCT ID NCT04866563

Symptom relief Sponsor: Axalbion SA 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This Phase 2 study tested a new drug called AX-8 in 108 adults with chronic cough that either has no known cause or doesn't get better with treatment. The goal was to see if AX-8 could reduce how often people cough. Participants took either AX-8 or a placebo, and coughs were counted using a recording device. The study is now complete, and results will help decide if larger trials are needed.

What this could mean

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

Active substance
AX-8 (orally disintegrating tablet)
What this could lead to
If successful, AX-8 could offer a new treatment option to reduce coughing in people with chronic cough that has no clear cause or hasn't responded to other treatments.
What could go wrong
This is an early Phase 2 trial with only 108 people, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

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

108 people

The number who actually took part.

Started

Aug 2021

Finished

Jun 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 to 80 years

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: * Chest radiograph or computed tomography (CT) of the thorax approximately 12 months before screening not demonstrating any abnormality considered to be significantly contributing to the chronic cough * Have a diagnosis of refractory chronic cough (RCC) or unexplained chronic cough (UCC) for at least one year * Women of childbearing potential and their male partners must use 2 acceptable methods of contraception * Male subjects and their female partners of childbearing potential must use 2 acceptable methods of contraception * Have provided written informed consent Exclusion Criteria: * Positive diagnostic nucleic acid test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) * Current smoker (including e-cigarettes), individuals who have given up smoking within the past 12 months, or individuals with a smoking history of 20 pack-years * Treatment with an ACE-inhibitor as the potential cause of a subject's cough or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Baseline Visit * History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks * History of cystic fibrosis * Positive test for any drug of abuse * History of malignancy within 5 years prior to the Baseline Visit * History of infection or known active infection with human immunodeficiency (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) * History of hypersensitivity or intolerance to AX-8 or other TRPM8 agonists or any of the excipients

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Conditions

The condition(s) this trial relates to.

Chronic Cough

As listed by the trial registrant

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

Chronic cough

Contacts and locations

Locations

  • Axalbion Study Site 4401

    London, England, SE5 9RS, United Kingdom

  • Axalbion Study Site 4402

    London, England, SW3 6HP, United Kingdom

  • Axalbion Study Site 4403

    Manchester, England, M23 9LT, United Kingdom

  • Axalbion Study Site 4404

    Broughton, England, DN20 0HR, United Kingdom

  • Axalbion Study Site 4405

    North Shields, England, NE29 8NH, United Kingdom

  • Axalbion Study Site 4406

    Birmingham, England, B9 5SS, United Kingdom

  • Axalbion Study Site 4407

    Oxford, England, OX3 9DU, United Kingdom

  • Axalbion Study Site 4408

    Newport, Wales, NP20 2EF, United Kingdom

  • Axalbion Study Site 4409

    Chelmsford, England, CM1 7ET, United Kingdom

  • Axalbion Study Site 4410

    London, England, W2 1NY, United Kingdom

  • Axalbion Study Site 4411

    Preston, England, PR2 9HT, United Kingdom

  • Axalbion Study Site 4412

    Shipley, England, BD18 3SA, United Kingdom

  • Axalbion Study Site 4413

    Coventry, England, CV3 4FJ, United Kingdom

  • Axalbion Study Site 4414

    Belfast, BT9 7AB, United Kingdom

  • Axalbion Study Site 4415

    Northwood, HA6 2RN, United Kingdom

  • Axalbion Study Site 4417

    Orpington, England, BR5 3QG, United Kingdom

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