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New asthma pill shows promise in early trial

NCT ID NCT07301255

Symptom relief Sponsor: Enveda Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Updated 3 times

Summary

This study tests an experimental oral drug called ENV-294 in 50 adults with moderate-to-severe asthma who already use standard inhalers. Participants take either the drug or a placebo once daily for 12 weeks. The goal is to see if the drug improves asthma control and lung function safely.

What this could mean

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

Active substance
ENV-294 (an oral drug taken as a tablet once daily)
What this could lead to
If successful, this could lead to a new daily pill that helps control asthma symptoms and reduce flare-ups in people with moderate-to-severe asthma.
What could go wrong
This is an early Phase 2 trial with only 50 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are possible.

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 50 people

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

Started

Jan 2026

Expected to finish

Jan 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 to 75 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: * Able to read, understand, and sign an informed consent form before any study procedures * Male or female adults aged 18 to 75 years with a physician diagnosis of moderate to severe asthma for at least 12 months * Receiving stable treatment with an inhaled corticosteroid (ICS) plus a long-acting beta₂-agonist (LABA) for at least 2 months before screening * Pre-bronchodilator FEV₁ between 50% and 80% of predicted normal at screening and baseline * Demonstrated bronchodilator reversibility * ACQ-5 score ≥1.25 to ≤3.0 at screening and baseline * History of at least one asthma exacerbation in the past 12 months requiring systemic corticosteroids or hospitalization/emergency care Exclusion Criteria: * Recent moderate or severe asthma exacerbation (within 4 weeks before screening) * History of life-threatening asthma * Other significant pulmonary disease * Recent bronchial thermoplasty (within 2 years) * Uncontrolled current or recurrent concomitant illness * Recent use of biologic therapies for asthma (within 6 months or 5 half-lives) * Require immunosuppressive medications or frequent systemic corticosteroids * Current smokers or former smokers with significant smoking history * Uncontrolled hypertension * Significant hepatic impairment

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

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

Asthma

How to take part

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

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Enveda Investigative Site

    RECRUITING

    Birmingham, Alabama, 35209, United States

  • Enveda Investigative Site

    RECRUITING

    Los Angeles, California, 90025, United States

  • Enveda Investigative Site

    RECRUITING

    San Jose, California, 95117, United States

  • Enveda Investigative Site

    RECRUITING

    West Hills, California, 91307, United States

  • Enveda Investigative Site

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

  • Enveda Investigative Site

    RECRUITING

    Hialeah, Florida, 33012, United States

  • Enveda Investigative Site

    RECRUITING

    Miami, Florida, 33135, United States

  • Enveda Investigative Site

    RECRUITING

    Albany, Georgia, 31707, United States

  • Enveda Investigative Site

    RECRUITING

    Maryville, Illinois, 62062, United States

  • Enveda Investigative Site

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Enveda Investigative Site

    RECRUITING

    Owensboro, Kentucky, 42301, United States

  • Enveda Investigative Site

    RECRUITING

    Southfield, Michigan, 48075, United States

  • Enveda Investigative Site

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Enveda Investigative Site

    RECRUITING

    Clackamas, Oregon, 97015, United States

  • Enveda Investigative Site

    RECRUITING

    Medford, Oregon, 97504, United States

  • Enveda Investigative Site

    RECRUITING

    North Charleston, South Carolina, 29406, United States

  • Enveda Investigative Site

    RECRUITING

    McKinney, Texas, 75069, United States

  • Enveda Investigative Site

    NOT_YET_RECRUITING

    Madison, Wisconsin, 53792, United States

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