Primary completion· ClinicalTrials.gov
Allopregnanolone (Zuranolone) in Post-stroke Depression
Zuranolone History and Updates
16 events · 2022 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
3
FDA Approvals
1
Label Revisions
12
Trial Milestones
0
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-18Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Zuranolone since 2022, drawn from openFDA, ClinicalTrials.gov, and PubMed.
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of
Primary completion· ClinicalTrials.gov
A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone
Past events
2026
Label revision· FDA
WARNING: IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects [see Warnings and Precautions ( 5.1 , 5.2 )] . Advise patients
FDA approval (supplemental)· FDA
Sponsor: BIOGEN INC. Class: Labeling.
Trial registered· ClinicalTrials.gov
A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone
Trial started· ClinicalTrials.gov
Allopregnanolone (Zuranolone) in Post-stroke Depression
2025
Trial started· ClinicalTrials.gov
A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone
Trial registered· ClinicalTrials.gov
A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of
Trial started· ClinicalTrials.gov
A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of
Trial registered· ClinicalTrials.gov
Allopregnanolone (Zuranolone) in Post-stroke Depression
2024
Primary completion· ClinicalTrials.gov
Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)
FDA approval (supplemental)· FDA
Sponsor: BIOGEN INC. Class: Labeling.
2023
FDA approval· FDA
Sponsor: BIOGEN INC. Class: Type 1 - New Molecular Entity.
Trial started· ClinicalTrials.gov
Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)
2022
Trial registered· ClinicalTrials.gov
Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.