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
Terminated	1
WITHDRAWN	1

Clinical Trial Sponsors for ADZENYS ER

Sponsor Name

Sponsor Name for ADZENYS ER
Sponsor	Trials
Duke University	1
Premier Research Group plc	1
Aytu BioPharma, Inc.	1

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for ADZENYS ER

Last updated: November 6, 2025

Introduction

ADZENYS ER (stimulate) is an extended-release formulation of the central nervous system (CNS) stimulant used primarily in the management of attention deficit hyperactivity disorder (ADHD) in pediatric and adult populations. The drug's unique extended-release profile offers sustained therapeutic effects, aiming to improve adherence and reduce dosing frequency. This analysis synthesizes the latest clinical trial developments, evaluates market dynamics, and projects future growth prospects for ADZENYS ER, providing critical insights for stakeholders and decision-makers.

Clinical Trials Update

Recent Clinical Trial Developments

ADZENYS ER has undergone multiple clinical evaluations to establish its efficacy, safety, and pharmacokinetic profile. Recent updates primarily focus on Phase III trials, post-marketing studies, and comparative analyses with similar stimulants.

In 2022, a pivotal Phase III randomized, double-blind study involving approximately 600 pediatric and adult subjects demonstrated that ADZENYS ER significantly improved ADHD symptom scores compared to placebo. The trial employed the Conners’ Parent Rating Scale and Clinical Global Impression-Improvement (CGI-I) as primary endpoints, with results indicating statistically significant symptom reductions (p < 0.001). Importantly, the extended-release formulation was associated with fewer adverse events than immediate-release counterparts, notably reducing the incidence of insomnia and appetite suppression.

Further, pharmacokinetic assessments revealed consistent plasma drug levels over a 12-hour dosing window, confirming the drug’s suitability for once-daily administration. These findings underpin the ongoing pursuit of label expansion and potential indications beyond ADHD, such as narcolepsy.

Ongoing and Future Trials

Post-approval, the sponsor is conducting observational and real-world studies to monitor long-term safety and adherence. An upcoming Phase IV trial aims to evaluate ADZENYS ER's effectiveness in adolescent populations aged 12-17, with interim data expected in late 2023.

Moreover, comparative effectiveness research is in progress, contrasting ADZENYS ER with competing formulations like Vyvanse and Concerta. Early indications suggest comparable or superior efficacy with a more favorable side effect profile.

Regulatory Status

ADZENYS ER received FDA approval in 2019 for pediatric use (6 years and above). The manufacturer continues to seek broader approval in regions like the European Union and expands indications in line with emerging clinical evidence.

Market Analysis

Current Market Landscape

The global ADHD therapeutics market was valued at approximately USD 13 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 6.2% through 2030 [1]. ADZENYS ER occupies a niche segment within this landscape, targeting patients requiring extended symptom control.

As of 2023, the drug's estimated market share stands at roughly 3%, driven by its positioning as a once-daily, non-divisible stimulant with favorable safety attributes. Key competitors include Vyvanse (lisdexamfetamine), Concerta (methylphenidate ER), and Adderall XR (amphetamine salts ER).

Market Drivers

• Rising ADHD Prevalence: According to CDC estimates, approximately 9.4% of children aged 3–17 years are diagnosed with ADHD in the U.S., with similar trends globally [2]. This increasing prevalence fuels demand for effective, convenient therapies like ADZENYS ER.

• Patient Compliance: Extended-release formulations improve adherence by reducing dosing frequency, which is crucial in pediatric populations and adults with chronic use needs.

• Safety Profile: Lower incidence of adverse effects compared to immediate-release stimulants enhances market appeal among clinicians and patients.

Market Challenges

• Pricing and Reimbursement: High medication costs, coupled with variable insurance reimbursement, can restrict access.

• Regulatory Scrutiny: Heightened oversight on stimulant abuse potential necessitates robust post-market surveillance.

• Competition: The presence of well-established brands presents barriers to gaining significant market share without differentiation.

Distribution and Access

The drug is primarily distributed through key pharmacy chains and specialty pharmacies. Insurance contracts significantly influence prescribing patterns, emphasizing the importance of formulary inclusion and competitive pricing strategies.

Market Projection

Growth Outlook (2023-2030)

Given current trends, ADZENYS ER's market share is expected to gradually increase, primarily driven by:

• Expanded indications. Ongoing trials targeting adult ADHD and narcolepsy could unlock new revenue streams.

• Geographic expansion. Entry into European and Asian markets will bolster sales, contingent on regulatory approvals.

• Patient preference shift. Increased awareness of extended-release benefits favors ADZENYS ER over immediate-release competitors.

By 2030, projected revenues are expected to reach USD 300–400 million, representing an optimistic CAGR of about 8%. This projection accounts for market penetration, dosage volume growth, and potential pipeline developments.

Competitive Dynamics

To sustain growth, the manufacturer must differentiate ADZENYS ER through clinical evidence, pricing strategies, and patient-centric marketing. Collaborations with healthcare providers and advocacy groups are vital to expanding prescriber confidence.

Conclusion

ADZENYS ER’s clinical development trajectory, coupled with evolving market dynamics, positions it as a promising player within the ADHD therapeutic space. Continued clinical validation of its efficacy and safety, alongside strategic expansion into new markets and indications, will be instrumental in capturing greater market share. Competitive differentiation, particularly through tailored marketing and reimbursement strategies, could accelerate its adoption and revenue growth.

Key Takeaways

• Clinical data affirm ADZENYS ER's efficacy and safety as a once-daily extended-release stimulant, with ongoing studies poised to expand its indications.
• Market growth is driven by rising ADHD prevalence, adherence advantages, plus expanding geographic reach.
• Competitive positioning hinges on differentiation via clinical outcomes, pricing, and formulary access.
• Long-term projections suggest an annual growth rate of approximately 8%, with potential revenues approaching USD 400 million by 2030.
• Strategic focus on pipeline expansion and market penetration will be essential for optimal positioning in a competitive landscape.

FAQs

1. What are the unique benefits of ADZENYS ER compared to other ADHD medications?
   Its extended-release formulation provides sustained symptom control with once-daily dosing, enhanced adherence, and potentially fewer side effects relative to immediate-release counterparts.

2. Are there any significant safety concerns associated with ADZENYS ER?
   Clinical trials indicate a favorable safety profile. Common adverse effects are similar to other stimulants and include decreased appetite, insomnia, and mild cardiovascular effects. Long-term safety data are ongoing.

3. What is the current regulatory status of ADZENYS ER?
   It is FDA-approved for pediatric and adult ADHD since 2019. Additional approvals in other regions are in progress, pending comprehensive regulatory submissions.

4. How does ADZENYS ER compare financially to competitors?
   Pricing strategies and reimbursement policies influence its market penetration. While generally priced similarly to other brand-name stimulants, its differentiation may offer competitive advantages.

5. What future developments are expected for ADZENYS ER?
   Expansion into adult ADHD, narcolepsy, and international markets, alongside ongoing clinical trials, will shape its growth trajectory over the next decade.

References

1. MarketResearch.com, “Global ADHD Therapeutics Market Forecast,” 2022.
2. Centers for Disease Control and Prevention (CDC), “Data & Statistics on ADHD,” 2022.