ArticleHeadache2026
A phase 1 study of the breast milk and plasma pharmacokinetics of zavegepant 10 mg intranasal dose in healthy lactating women.
Article in Headache, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06453356 (A PHASE 1 SINGLE INTRANASAL DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF ZAVEGEPANT IN HEALTHY LACTATING WOMEN), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 1 single intranasal dose, open-label pharmacokinetic study of zavegepant in healthy lactating women
Who cites it
1 citing paper in PubMed.
- Safety and Effectiveness of Pain Medications for Migraine Management During Pregnancy and Lactation.Paediatric drugs · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
objectiveThis study evaluated the pharmacokinetics of zavegepant in human breast milk and plasma following a single, 10 mg dose of zavegepant nasal spray.
backgroundZavegepant nasal spray is a member of the gepant class of medications; small molecule inhibitors of the calcitonin gene-related peptide receptor. It is approved in the United States for the acute treatment of migraine with or without aura in adults. However, the transfer of zavegepant to human breast milk in lactating women has not been assessed previously.
methodsIn this Phase 1, open-label, single-arm, single-dose, pharmacokinetic study (NCT06453356), 12 healthy lactating women received a single intranasal dose of 10 mg zavegepant. Blood and breast milk samples were collected over 24 h postdose to assess zavegepant pharmacokinetics. Safety was also assessed. The study was conducted from June 10 to September 26, 2024 at a single-site in the United States.
resultsGeometric mean (geometric percent coefficient of variation [CV%]) milk-to-plasma zavegepant concentration ratios were 0.21 (102%), 0.16 (76%), and 0.04 (130%) for area under the concentration-time curve from time 0 to 24 h postdose, area under the concentration-time curve from time 0 extrapolated to infinity, and maximum concentration, respectively. The geometric mean (geometric CV%) body weight normalized infant dose was 0.05 μg/kg/day (120%) and the geometric mean (geometric CV%) body weight normalized maternal dose was 132.8 μg/kg/day (10%). This resulted in a geometric mean (geometric CV%) relative infant dose of 0.04% (128%). One treatment-emergent adverse event (TEAE; mild dizziness) was reported in one (8%) participant. This TEAE was considered mild in severity. No clinically meaningful abnormalities were observed for vital signs, clinical laboratory testing, and local nasal assessments.
conclusionA single intranasal dose of 10 mg zavegepant was generally safe and well tolerated in healthy lactating women and the estimated infant exposure to zavegepant via breast milk is very low.
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