CLINICAL TRIALS PROFILE FOR ZURANOLONE

All Clinical Trials for ZURANOLONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05655507 ↗	SAGE-217 Pharmacokinetics (PK) and Safety Study Pediatric Participants With Major Depressive Disorder (MDD)	Not yet recruiting	Sage Therapeutics	Phase 1	2023-01-01	The primary purpose of this study is to evaluate the pharmacokinetics and safety of SAGE-217 in adolescents (ages 12 to 17 years) and children (ages 7 to 11 years) with MDD.
NCT06759558 ↗	Allopregnanolone (Zuranolone) in Post-stroke Depression	NOT_YET_RECRUITING	American Heart Association	PHASE2	2025-10-01	The goal of this Phase II clinical trial is to learn if the oral synthetic allopreganolone analog (zuranolone) is safe to take and is well tolerated by stroke survivors experiencing moderate to severe post-stroke depression and if it will help with the symptoms of depression. The main questions it will aim to answer are: * Is zuranolone safe to take by participants who have moderate to severe post-stroke depression? * Is zuranolone well-tolerated by participants who have moderate to severe post-stroke depression? * Does zuranolone treat moderate to severe post-stroke depression? The study will enroll six participants. All participants will be given 50 mg of zuranolone for 14 days. Participants will be asked to provide blood samples, complete some questionnaires including those related to mood and a cognitive assessment.
NCT06759558 ↗	Allopregnanolone (Zuranolone) in Post-stroke Depression	NOT_YET_RECRUITING	Duke University	PHASE2	2025-10-01	The goal of this Phase II clinical trial is to learn if the oral synthetic allopreganolone analog (zuranolone) is safe to take and is well tolerated by stroke survivors experiencing moderate to severe post-stroke depression and if it will help with the symptoms of depression. The main questions it will aim to answer are: * Is zuranolone safe to take by participants who have moderate to severe post-stroke depression? * Is zuranolone well-tolerated by participants who have moderate to severe post-stroke depression? * Does zuranolone treat moderate to severe post-stroke depression? The study will enroll six participants. All participants will be given 50 mg of zuranolone for 14 days. Participants will be asked to provide blood samples, complete some questionnaires including those related to mood and a cognitive assessment.

Clinical Trial Conditions for ZURANOLONE

Condition Name

Condition Name for ZURANOLONE
Intervention	Trials
Major Depressive Disorder	1
Post Stroke Depression	1

Condition MeSH

Condition MeSH for ZURANOLONE
Intervention	Trials
Disease	1
Depressive Disorder, Major	1
Depressive Disorder	1
Depression	1

Clinical Trial Locations for ZURANOLONE

Trials by Country

Trials by Country for ZURANOLONE
Location	Trials
United States	1

Trials by US State

Trials by US State for ZURANOLONE
Location	Trials
North Carolina	1

Clinical Trial Progress for ZURANOLONE

Clinical Trial Phase

Clinical Trial Phase for ZURANOLONE
Clinical Trial Phase	Trials
PHASE2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for ZURANOLONE
Clinical Trial Phase	Trials
Not yet recruiting	1
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for ZURANOLONE

Sponsor Name

Sponsor Name for ZURANOLONE
Sponsor	Trials
Sage Therapeutics	1
American Heart Association	1
Duke University	1

Sponsor Type

Sponsor Type for ZURANOLONE
Sponsor	Trials
OTHER	2
Industry	1

Zuranolone (Zurzuvae) Clinical Trials Update, Market Analysis, and Projection

Last updated: April 25, 2026

What is zuranolone’s current clinical and regulatory position?

Zuranolone (brand: Zurzuvae, Sage Therapeutics) is an oral, neuroactive steroid approved for postpartum depression. The commercial product label underpins ongoing market expectations and guides investor and competitive assessments.

Indication and regulatory anchor

• Approved indication: Postpartum depression
• Key product: Zurzuvae (oral zuranolone)

Commercial relevance: Any new clinical readout that expands the label (or supports new placements) directly affects peak sales assumptions and durability of revenue into later patent-protected periods.

What clinical trials are in flight, and what do they imply for label expansion?

A complete, point-in-time trials map requires a source-corroborated list of study identifiers, designs, endpoints, and readout windows. This response cannot be produced without full trial-specific inputs.

What does the current market for postpartum depression look like, and where does zuranolone fit?

The market for postpartum depression is shaped by:

• prevalence-driven demand
• payer willingness to cover branded oral therapies
• treatment sequencing and switching patterns
• prescriber comfort with time-to-effect and administration convenience
• safety and tolerability profile impacting repeat prescribing

Where zuranolone competes

Zuranolone’s competitive set in postpartum depression typically includes antidepressants used off-label or via other approved pathways, with market share depending on:

• speed of onset versus comparator regimens
• ease of administration (oral regimen)
• tolerability and discontinuation rates
• payer coverage criteria tied to guideline fit

How should investors model sales? (Core drivers and metrics)

A robust sales model for zuranolone needs measurable inputs, including:

• treated population size and diagnosis rate
• uptake curves (new prescriber adoption versus switching)
• duration of therapy under real-world practice
• payer coverage and step edits
• persistence and discontinuation linked to adverse events
• marketing reach and specialty channel dynamics
• competitive entries (new antidepressant approvals, generic erosion of comparators, and branded launches)

Key commercialization variables to track

• Share of eligible patients receiving zuranolone
• Time-to-market access by payer
• Net price and rebates by channel
• Discontinuation rate due to tolerability
• Real-world effectiveness versus trial outcomes

What are realistic market projections for zuranolone over time?

A precise projection requires numeric base case assumptions for:

• addressable postpartum depression patients
• proportion diagnosed and treated
• payer coverage penetration
• peak prescribing share
• net pricing trajectory
• forecast horizon (e.g., 5-year and 10-year)

This response cannot produce an accurate projection without those quantified inputs.

What are the main risks to the commercialization trajectory?

For zuranolone, the identifiable risk stack in commercialization forecasting typically includes:

• payer restriction intensity and prior authorization burden
• adverse-event signals that shift prescriber behavior
• competitive discounting versus branded antidepressants
• label expansion delays or failures that limit total addressable market
• safety monitoring requirements that affect clinic workflow

What signals should be watched next? (Business-readout checklist)

A market-facing monitoring program should track:

• payer coverage updates and formulary decisions
• prescribing trends by region and specialty
• post-approval safety surveillance outcomes
• new trial readouts that could expand indication scope
• any manufacturing, supply, or distribution constraints affecting fill rates

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Key Takeaways

• Zuranolone (Zurzuvae) is the currently approved branded option for postpartum depression, setting the commercial baseline.
• A complete clinical trials update and a quantified market projection require trial-level and market-level numeric inputs (endpoints, enrollment, readout timing, incidence, payer coverage, net pricing, and uptake metrics). Without those inputs, a precise forecast cannot be generated.

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FAQs

1) What is zuranolone approved for?
Zuranolone (Zurzuvae) is approved for postpartum depression.

2) What drives zuranolone sales growth in postpartum depression?
Treated-diagnosed population size, payer coverage and net price, uptake among prescribers, tolerability-driven persistence, and competition in antidepressant use patterns.

3) Are there label-expansion opportunities for zuranolone?
Clinical expansion depends on trial outcomes that must be mapped study-by-study with endpoints and readout dates.

4) What are the biggest forecast risks?
Coverage restrictions, safety and tolerability outcomes that affect prescribing, and competitive dynamics that alter net pricing and share.

5) How should net sales be modeled?
By combining addressable patients, share uptake curves, duration of use in real-world settings, and net price including rebates and discounts.

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References

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