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Study breakdown

Zavegepant CGRP Blocker: Very Low Breast Milk Transfer Supports Safety in Nursing Mothers

evidence
The takeaway

Zavegepant nasal spray showed minimal breast milk transfer (RID <1%) after a single 10 mg dose, supporting potential safety for acute migraine treatment in breastfeeding women.

<1% reaches baby

Less than 1% of zavegepant dose transfers to breast milk — well below 10% safety threshold

What the researchers found

Zavegepant 10 mg nasal: RID <1% (well below 10% safety threshold); peak breast milk at 2-4 hours; rapid decline; supports breastfeeding safety.

Why it matters

Breastfeeding women need safe migraine treatment options. Minimal drug transfer to breast milk is the first step.

How the study worked

Phase 1 open-label pharmacokinetic study of breast milk and plasma zavegepant levels after single 10 mg nasal dose in lactating women.

What this study cannot tell us

Single-dose study. No infant outcomes. Small phase 1. Chronic dosing unknown.

How to read the evidence

Phase 1 PK study. Essential lactation safety data.

When this study was published

Published in 2025.

The bigger picture

Safety data for migraine drugs in breastfeeding is critically lacking. This fills a gap for the gepant class.

Questions still open

  • Would repeated dosing accumulate?
  • Should milk be discarded at peak?
  • Are other gepants similarly low?

Common questions

Can I take zavegepant while breastfeeding?
This study found <1% transfers to milk — well below safety threshold. Initial results are reassuring.
When does drug peak in breast milk?
2-4 hours after dose, then declines rapidly.

Read the original research

A phase 1 study of the breast milk and plasma pharmacokinetics of zavegepant 10 mg intranasal dose in healthy lactating women.

Headache

Citation

Jakate, Abhijeet; Weng, Yan; Shkrodova, Ani; Fisniku, Ogert; Ding, Ding; Morton, Kayce; Maligalig, Benjamin; Garnick, Pamela; Liu, Jing; Shahin, Mohamed H. (2026). A phase 1 study of the breast milk and plasma pharmacokinetics of zavegepant 10 mg intranasal dose in healthy lactating women.. Headache. https://doi.org/10.1111/head.70036