Drugs / Breast milk

Trials 5

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT06746532 Feb 2025 → Jan 2028 expected brain hypoxia - ischemia, perinatal asphyxia Semmelweis University Recruiting No outcome recorded
Phase 11 trial
Phase 1 NCT07661992 Jul → Dec 2026 expected — Wake Forest University Health Sciences Not yet recruiting No outcome recorded
Phase not applicable3 trials · 1 met primary
— NCT04883931 May → Nov 2021 retinopathy of prematurity Baskent University Completed No outcome recorded
— NCT04259320 Feb → Jun 2020 — Karabuk University Completed Met primary
— NCT03633500 Aug → Dec 2018 neonatal sepsis Al Adan Hospital Kuwait Completed No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2026-01-15 Vaxart Results Vaxart Publishes Positive Data for its Oral Bivalent Norovirus Candidate in Lactating Women and Their Infants vaxart.com ↗
the newly published study additionally shows vaccine-induced functional norovirus-specific antibodies in breastmilk and serum from vaccinated women, and norovirus-specific IgA in the stool of their breastfed infants.
2025-01-27 Supernus Pharmaceuticals, Inc. Results Supernus Announces Label Update for Non-Stimulant ADHD Treatment, Qelbree®, Including New Pharmacodynamic Data and Information for Breastfeeding Women supernus.com ↗
These data support that the transfer of viloxazine into breastmilk is low.
2024-04-30 Vaxart Results Vaxart Announces Positive Results for Its Bivalent Norovirus Vaccine Candidate in Lactating Mothers vaxart.com ↗
Breastmilk VP1-specific IgA rose on average 4.0 fold in response to G1.1 and 6.0 fold in response to GII.4 in the high dose group.

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as Breast milk ClinicalTrials.gov intervention name — accepted as the source's own label NCT04259320 ↗
4

NCT06746532 ↗

NCT03633500 ↗

NCT04883931 ↗

NCT07661992 ↗

Modality Other / unclassified “Breast milk is a complex biological substance” NCT06746532 ↗
Route Oral “Effectiveness of Mother's Own Colostrum and Breast Milk as Oral Immunotherapy” NCT03633500 ↗