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Heartburn drug under the microscope: registry tracks thousands of pregnancies

NCT ID NCT06660342

Knowledge-focused Sponsor: Phathom Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are running an observational registry to study whether vonoprazan, an oral drug for heartburn and acid reflux, is safe to take during pregnancy. The study follows women aged 15 to 50 who took vonoprazan while pregnant and compares their outcomes with women who did not take it but who have conditions the drug is used to treat. The registry tracks major and minor birth defects, miscarriages, stillbirths, preterm births, and other pregnancy and infant outcomes. The goal is to build evidence on the drug's safety for mothers and their babies.

What this could mean

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

Active substance
vonoprazan, an oral heartburn and acid-reflux drug
What this could lead to
If the registry shows no added risk, it could give pregnant women and their doctors clearer guidance on whether vonoprazan is safe to use for heartburn and reflux during pregnancy.
What could go wrong
This is an observational registry, not a controlled experiment, so it can show patterns but cannot prove cause and effect. Rare birth defects may not appear even in a registry of this size, and women who join may differ from those who do not.

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.

Participants

About 728 people

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

Started

May 2025

Expected to finish

Sep 2034

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.

Who is studied

The study aims to enroll a total of 728 pregnant women in the study population from the United States, with 364 women in each cohort. This sample size will afford the study the ability to detect a 3-fold increase in the prevalence of the primary outcome, MCM, in the exposed cohort with 80% power.

Ages

15 to 50 years

Sex

Female participants only

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: * Women 15 to 50 years of age. * Currently or recently pregnant. * Consent to participate. * Authorization for her health care provider(s) (HCP\[s\]) to provide data to the registry. * Exposed cohort: Exposure to at least one dose of vonoprazan during pregnancy. * Unexposed cohort: Unexposed to vonoprazan and diagnosis of any condition for which vonoprazan may be prescribed. Exclusion Criteria: * Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled). * Exposure to known tetratogens and/or investigational medications during pregnancy. * Lost to follow-up.

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease Heartburn Helicobacter pylori infectious disease peptic esophagitis

As listed by the trial registrant

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

Erosive esophagitis Heartburn Helicobacter pylori infection Symptomatic non-erosive gastroesophageal reflux disease

How to take part

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

  1. The places running it

    1 site. 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 and phone numbers. 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

  • PPD

    RECRUITING

    Wilmington, North Carolina, 28401, United States

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