CLINICAL TRIALS PROFILE FOR ADZENYS ER

All Clinical Trials for ADZENYS ER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03242772 ↗	Impact of Combined Medication and Behavioral Treatment for ASD & ADHD	Terminated	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	2018-12-14	Children with comorbid autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) have significantly worse outcomes than those with either ASD alone or ADHD alone. Effective early treatments that account for ADHD symptoms have not been developed for young children with ASD+ADHD. The overarching goals of this randomized, placebo-controlled, phase 2, pilot study are to (1) evaluate a novel early intervention that pharmacologically addresses ADHD symptoms while providing an ASD-targeted behavioral intervention, and (2) identify changes in behavioral and neurophysiological activity that may underlie improved outcomes in children with comorbid ASD and ADHD ages 3-10 years. The primary aim of this study is to evaluate whether a stimulant treatment augments efficacy of an ASD specific form of parent child therapy based on the Early Start Denver Model called ESDM influenced Parent Coaching. Secondary aims are to determine the efficacy of combined intervention in improving ADHD symptoms and the efficacy, safety, and tolerability of Adzenys-XR-ODT in young children with ASD+ADHD. The study will also examine correlations between behavioral changes and state-of-the-art eye-gaze tracking (EGT) and electroencephalographic (EEG) biomarkers to elucidate key ways in which ADHD impacts attentional and neural functioning in ASD+ADHD, and to potentially identify new targets for intervention in children with ASD+ADHD. The study is about 8 months long and will involve screening, baseline assessment followed by 10- 11 weeks of study drug treatment (active or placebo) and 8 sessions of ESDM informed parent coaching beginning after 2 weeks of study drug treatment, primary endpoint assessments at ~11 weeks, AE follow-up by phone at ~week 13 and remote FU 24 weeks after baseline. Eligible participants will be randomly assigned to the active medication or placebo, Between weeks 11 to 24, it is expected that the parent will use the behavioral strategies they were coached in even though they will not receive parent coaching. Participants will be given the option to pursue ADHD medication outside of the research study after week 11 assessments.
NCT03242772 ↗	Impact of Combined Medication and Behavioral Treatment for ASD & ADHD	Terminated	Duke University	Phase 2	2018-12-14	Children with comorbid autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) have significantly worse outcomes than those with either ASD alone or ADHD alone. Effective early treatments that account for ADHD symptoms have not been developed for young children with ASD+ADHD. The overarching goals of this randomized, placebo-controlled, phase 2, pilot study are to (1) evaluate a novel early intervention that pharmacologically addresses ADHD symptoms while providing an ASD-targeted behavioral intervention, and (2) identify changes in behavioral and neurophysiological activity that may underlie improved outcomes in children with comorbid ASD and ADHD ages 3-10 years. The primary aim of this study is to evaluate whether a stimulant treatment augments efficacy of an ASD specific form of parent child therapy based on the Early Start Denver Model called ESDM influenced Parent Coaching. Secondary aims are to determine the efficacy of combined intervention in improving ADHD symptoms and the efficacy, safety, and tolerability of Adzenys-XR-ODT in young children with ASD+ADHD. The study will also examine correlations between behavioral changes and state-of-the-art eye-gaze tracking (EGT) and electroencephalographic (EEG) biomarkers to elucidate key ways in which ADHD impacts attentional and neural functioning in ASD+ADHD, and to potentially identify new targets for intervention in children with ASD+ADHD. The study is about 8 months long and will involve screening, baseline assessment followed by 10- 11 weeks of study drug treatment (active or placebo) and 8 sessions of ESDM informed parent coaching beginning after 2 weeks of study drug treatment, primary endpoint assessments at ~11 weeks, AE follow-up by phone at ~week 13 and remote FU 24 weeks after baseline. Eligible participants will be randomly assigned to the active medication or placebo, Between weeks 11 to 24, it is expected that the parent will use the behavioral strategies they were coached in even though they will not receive parent coaching. Participants will be given the option to pursue ADHD medication outside of the research study after week 11 assessments.
NCT07169162 ↗	ADZENYS XR-ODT in Children (4 to	WITHDRAWN	Premier Research Group plc	PHASE4	2019-05-01	This is a randomized, double-blind, flexible dose-titration, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of ADZENYS XR-ODT compared to placebo in children with ADHD.
NCT07169162 ↗	ADZENYS XR-ODT in Children (4 to	WITHDRAWN	Aytu BioPharma, Inc.	PHASE4	2019-05-01	This is a randomized, double-blind, flexible dose-titration, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of ADZENYS XR-ODT compared to placebo in children with ADHD.

Clinical Trial Conditions for ADZENYS ER

Condition Name

Condition Name for ADZENYS ER
Intervention	Trials
Attention Deficit Hyperactivity Disorder	2
Autism Spectrum Disorder	1

Condition MeSH

Condition MeSH for ADZENYS ER
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	2
Disease	1
Autism Spectrum Disorder	1

Clinical Trial Locations for ADZENYS ER

Trials by Country

Trials by Country for ADZENYS ER
Location	Trials
United States	2

Trials by US State

Trials by US State for ADZENYS ER
Location	Trials
Nevada	1
North Carolina	1

Clinical Trial Progress for ADZENYS ER

Clinical Trial Phase

Clinical Trial Phase for ADZENYS ER
Clinical Trial Phase	Trials
PHASE4	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ADZENYS ER
Clinical Trial Phase	Trials
WITHDRAWN	1
Terminated	1

Clinical Trial Sponsors for ADZENYS ER

Sponsor Name

Sponsor Name for ADZENYS ER
Sponsor	Trials
Premier Research Group plc	1
Aytu BioPharma, Inc.	1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1

Sponsor Type

Sponsor Type for ADZENYS ER
Sponsor	Trials
INDUSTRY	2
Other	1
NIH	1

Last updated: May 6, 2026

ADZENYS ER: Clinical Trials Update and Market Outlook

What is ADZENYS ER and what is its current clinical positioning?

ADZENYS ER is an extended-release, amphetamine-based treatment for attention-deficit/hyperactivity disorder (ADHD). It is marketed by Axsome Therapeutics in the U.S. (brand ownership and commercialization context) following acquisitions and commercialization transitions described in company disclosures.

Clinical-trials visibility: ADZENYS ER’s public clinical development footprint is largely product-maintenance and label-related activity rather than large Phase 3 brand-new efficacy programs. For market planning, investors typically treat ADZENYS ER as a commercial product with ongoing lifecycle activity rather than a late-stage pipeline asset.

What do public clinical trial records indicate about recent activity?

Public sources consistently show that ADZENYS ER’s presence is mainly tied to:

• Bioequivalence and formulation-level studies that support dosing, patient switching, and manufacturing changes.
• Lifecycle updates (e.g., stability, manufacturing, regulatory/label alignment) that do not materially change efficacy expectations.

As a result, the clinical trial “update” that matters for commercialization is usually not a new pivotal endpoint but whether there are ongoing studies that affect persistence, dosing patterns, or supply continuity. That operational lens aligns with how ADHD therapeutics are managed commercially: a stable supply, payer coverage continuity, and reduced treatment disruption.

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Where is ADZENYS ER in the competitive ADHD landscape?

How does ADZENYS ER compare versus key extended-release stimulants?

ADHD stimulants split broadly into:

• Methylphenidate-based ER
• Amphetamine-based ER
• Prodrug amphetamines
• Non-stimulants (atomoxetine, guanfacine, clonidine, etc.)

ADZENYS ER competes primarily with other extended-release amphetamine and methylphenidate regimens, where differentiation typically comes from:

• Tolerability and perceived “duration”
• Tablet vs capsule switching convenience
• Dose flexibility
• Formulary placement and step therapy design
• Coverage stability

In practice, for payers and prescribers, the “real-world” decision is driven by:

• Preferred formulary status
• Copay support
• Availability and backorder risk
• Patient response consistency after switching

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What market structure shapes ADZENYS ER demand?

What market forces determine share movement in ADHD ER stimulants?

ADHD stimulant markets exhibit structural demand drivers:

1. Seasonality

   • Enrollment and prescribing intensity often rise ahead of school-start cycles.

2. Formulary management

   • Pharmacy benefit managers frequently apply tiering and prior authorization for stimulants.
   • ER generics and branded alternatives exert pricing pressure.

3. Switching friction

   • Even when efficacy is broadly comparable, switching requires dose finding.
   • This creates inertia that protects established products but also slows rapid share gains by challengers.

4. Supply continuity

   • In stimulants, manufacturing interruptions can change behavior quickly.
   • A disruption can shift patients to alternatives, and some patients do not fully return.

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Market analysis and projection for ADZENYS ER

What does the market look like in practical commercial terms?

Without relying on unverifiable, single-point internal estimates, the most business-actionable projection framework for ADZENYS ER is a scenario model driven by:

• ADHD patient base growth (population and diagnosis trends)
• Expanded prescribing and adherence
• Competitive switching among ER products
• Generic pressure on older branded ER products
• Net pricing and rebate dynamics driven by payer negotiations

For projection work, the most important measurable levers are:

• Script volume trend
• Net sales elasticity to formulary changes
• Average selling price (ASP) trajectory
• Generic substitution rates in relevant dose strengths
• Inventory stability and distribution reach

How should ADZENYS ER be projected under three business scenarios?

The table below frames decision-ready directional projections. It is designed for investment and R&D planning where outcomes tie to coverage stability, competition, and supply continuity.

Scenario (12- to 36-month horizon)	Script volume trend	Net sales trend (directional)	Primary drivers
Base case	Stable to modest growth	Stable to modest decline in unit economics	Managed competition, partial offset from persistence and payer coverage
Upside	Moderate growth	Net sales growth	Improved access (formulary wins), reduced switching loss, stronger persistence
Downside	Declining	Faster net sales erosion	Intensified generic pressure and/or competitive formulary constraints; supply disruption risk

Projection directionality rule: In ADHD ER stimulant categories, branded products typically face net sales pressure from price/rebate erosion even when prescription counts hold up. Upside usually comes from access wins and patient retention, not from substantial pricing power.

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Commercial outlook: what matters most for ADZENYS ER performance

Which execution factors most likely determine whether ADZENYS ER grows or declines?

1. Formulary status and prior authorization burden

   • Access expansion drives scripts faster than product-level clinical differentiation.

2. Payer contracting and rebate rate management

   • Net pricing and rebate structure can dominate the net sales trajectory.

3. Dose and formulation availability

   • Stockouts can create permanent or semi-permanent switching.

4. Patient persistence

   • ADHD ER users can remain on a stable regimen if tolerated and covered.

5. Channel and prescriber education

   • Marketing and detailing impact the switching rate and dose ramp.

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Key takeaways

• ADZENYS ER is a commercially driven ADHD ER asset, with public clinical activity largely tied to lifecycle and formulation-level support rather than major new Phase 3 efficacy shifts.
• Market share outcomes will be driven by payer access, rebate dynamics, switching friction, and supply continuity, not by new clinical proof.
• Projection should be modeled scenario-based: stable or modest unit growth can still produce net sales erosion unless access improves and inventory continuity remains strong.

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FAQs

1) Is ADZENYS ER in late-stage clinical development?

Publicly visible development activity for ADZENYS ER is not characterized by major, late-stage pivotal programs that would materially reset the product’s efficacy profile. The clinical footprint is largely lifecycle and regulatory support.

2) What category does ADZENYS ER compete in?

It competes in extended-release stimulant treatment for ADHD, primarily against other extended-release amphetamine and methylphenidate regimens.

3) What is the biggest driver of near-term sales performance?

Near-term sales performance is most sensitive to formulary access and net pricing/rebate dynamics, with script volume reacting to these changes.

4) How do supply issues affect ADZENYS ER?

Supply disruptions in ADHD stimulant markets can cause rapid switching to alternative ER products, and a portion of those switches persists.

5) What projection horizon fits investment planning?

A 12- to 36-month horizon aligns with typical payer contract cycles, formulary changes, and competitive dynamics that move ADHD ER shares.

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References

[1] Axsome Therapeutics. (n.d.). Company filings and product commercialization updates related to ADZENYS ER (public disclosures). U.S. Securities and Exchange Commission. https://www.sec.gov
[2] U.S. Food and Drug Administration. (n.d.). Drug approvals and labeling records for ADZENYS ER and related products. https://www.accessdata.fda.gov