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NCT06413420RECRUITING

SUNOSI® (Solriamfetol) Pregnancy Registry

Study Summary

The SUNOSI (solriamfetol) Pregnancy Registry is a prospective, multi-country, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).

Conditions
NarcolepsyObstructive Sleep ApneaPregnant Women and Their Offspring
Interventions / Drugs
Sunosi (solriamfetol)Other prescription wake-promoting medications or stimulantsNo treatment
View on ClinicalTrials.gov ↗
Sponsor
AXSM
Axsome Therapeutics
Neuroscience
D49/100
Study Details
Enrollment1731 participants
Primary Completion—
Lead SponsorAxsome Therapeutics, Inc.
Data Retrieved2026-04-11 04:06:36.562709+00:00
What This Trial Means for Biotech Investors
Trial Phase Context
Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 1,731 participants
Sponsor Catalyst Profile

Axsome Therapeutics (AXSM) is the sponsoring company for this trial. BiotechSign currently grades this company D (49/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

AXSM Full Pipeline →All Companies →
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