CORAL Phase 3 MDD Enrollment Complete

SAGE·ZURZUVAE·Major Depressive Disorder·

Phase 3

·NCT04442490

current best date

JUN–JUN

2026

WINDOW32 days

Takeaway

Procedural milestone: enrollment finishes for the Phase 3 trial of zuranolone added to standard antidepressants in MDD. Anchors the Q1 2027 topline readout date.

What’s at stake

market · comparables · base rate · prior moves

Market opportunity

—

company filings

Peer comparables

1 readout

ClinicalTrials.gov

Stage base rate

~58%

BIO Industry Analysis 2023 (2011–2020)

Avg prior-readout move

—

historical price reactions

MoApositive allosteric modulator of GABA-A

ZURZUVAE (zuranolone) is a once-daily oral pill co-developed by Sage Therapeutics and Biogen that acts as a positive allosteric modulator of GABA-A receptors — the brain's primary inhibitory receptors — to rapidly restore neural balance during depressive episodes. Unlike traditional antidepressants that require continuous daily dosing, zuranolone is given as a short 14-day course intended to reset dysregulated neural circuits. It is the first oral therapy specifically approved for postpartum depression (PPD) and is also being studied as an adjunct to standard antidepressants in major depressive disorder (MDD).

Indication

Neurology

Major Depressive Disorder

MeSH · D003866

No primer in glossary yet.

Trial

active

NCT04442490 ↗

CORAL Phase 3 Zuranolone Adjunctive in MDD

Competitive landscape

2 peers in Neurology · ranked by indication + modality match

Drug	Company	Modality	Mechanism	Phase	Next catalyst
AUVELITYdextromethorphan-bupropion	AXSM	small molecule	NMDA antagonist + sigma-1 agonist		READOUT · May 26
LEQEMBIlecanemab	BIIB	mAb	humanized anti-amyloid beta protofibril mAb		CMC · Jul 26

Disclosure trail

1 observation · sorted by confidence

Apr 30, 2026·4h agopinned · highest confidence
HIGH confPR
top claim
JUN–JUN2026
WINDOW
“Sage Therapeutics today reaffirmed that enrollment for the CORAL Phase 3 study of zuranolone as adjunctive therapy for major depressive disorder is on pace to complete in mid-2026.”
conf 86%via llm

MethodologyEvery catalyst date is anchored to a primary source. Disclosures with confidence ≥ 0.85 auto-publish; the rest are reviewed by a human within 24 hours. We never interpret data — we organize public information.