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A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring

Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring

Who can join

Ages 15 to 50 · Women

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.

About the study

The main objective of the study is to compare the maternal, fetal, and infant outcomes of pregnant women who are exposed to vonoprazan during pregnancy with outcomes of an internal comparison cohort of pregnant women who are unexposed to vonoprazan during pregnancy but who may be exposed to other products for the treatment of conditions for which vonoprazan may be prescribed.

What is being tested

• Vonoprazan (drug)

Sponsor: Phathom Pharmaceuticals, Inc. · Participants: 728 · Started: May 15, 2025

Contact the study team

• VOQUEZNA Pregnancy Registry · Phone: 1-866-609-1612

Official record on ClinicalTrials.gov — NCT06660342

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.