New pain Drug's breast milk safety under the microscope

NCT ID NCT07378865

Recruiting now Knowledge-focused Sponsor: Vertex Pharmaceuticals Incorporated Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study is testing how much of the pain medication suzetrigine (JOURNAVX) gets into breast milk after a single dose. Twelve healthy breastfeeding women will provide milk samples to measure the drug and its breakdown product. The goal is to estimate how much a nursing baby might be exposed to, which could guide future use of this drug during breastfeeding.

What this could mean

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

Active substance: suzetrigine (also known as VX-548, JOURNAVX)
What this could lead to: If it works, this could help determine whether suzetrigine is safe to use while breastfeeding, guiding pain treatment options for nursing mothers.
What could go wrong: This is a very early, small study (12 people) that only measures drug levels in milk, not actual effects on infants. It may not reflect real-world use or long-term safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Pain

As listed by the trial registrant

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

PAIN

Contacts and locations

Locations

ICON - Utah - Salt Lake City Office
RECRUITING

Salt Lake City, Utah, 84124, United States

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