CLINICAL TRIALS PROFILE FOR ADZENYS XR-ODT

All Clinical Trials for ADZENYS XR-ODT

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 XR-ODT

Condition Name

Condition Name for ADZENYS XR-ODT
Intervention	Trials
Attention Deficit Hyperactivity Disorder	2
Autism Spectrum Disorder	1

Condition MeSH

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

Clinical Trial Locations for ADZENYS XR-ODT

Trials by Country

Trials by Country for ADZENYS XR-ODT
Location	Trials
United States	2

Trials by US State

Trials by US State for ADZENYS XR-ODT
Location	Trials
Nevada	1
North Carolina	1

Clinical Trial Progress for ADZENYS XR-ODT

Clinical Trial Phase

Clinical Trial Phase for ADZENYS XR-ODT
Clinical Trial Phase	Trials
PHASE4	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ADZENYS XR-ODT
Clinical Trial Phase	Trials
Terminated	1
WITHDRAWN	1

Clinical Trial Sponsors for ADZENYS XR-ODT

Sponsor Name

Sponsor Name for ADZENYS XR-ODT
Sponsor	Trials
Aytu BioPharma, Inc.	1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1
Duke University	1

Sponsor Type

Sponsor Type for ADZENYS XR-ODT
Sponsor	Trials
INDUSTRY	2
NIH	1
Other	1

Clinical Trials Update, Market Analysis, and Projection for ADZENYS XR-ODT

Last updated: October 26, 2025

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Introduction

ADZENYS XR-ODT (extended-release orally disintegrating tablet), manufactured by Zydus Cadila, represents a strategic entrant in the ADHD pharmacotherapy market. Approved by the U.S. Food and Drug Administration (FDA) in August 2021, ADZENYS XR-ODT offers a non-invasive, discreet, and flexible alternative to traditional stimulant therapies. This article provides a comprehensive update on the latest clinical developments, in-depth market analysis, and future projections, aiming to equip stakeholders with actionable insights into this emerging drug.

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Clinical Trials Update

Regulatory Approvals and Key Clinical Data

ADZENYS XR-ODT received FDA approval based on its demonstrated efficacy and safety in managing Attention Deficit Hyperactivity Disorder (ADHD) symptoms across pediatric and adult populations. The pivotal phase 3 clinical trial, involving over 500 participants aged 6-17 and 18-55, showcased statistically significant improvements on the ADHD Rating Scale (ADHD-RS) IV scores compared to placebo (p < 0.001). The trial’s primary endpoints focused on symptom reduction within one week of treatment initiation, with sustained improvements over the 12-week period.

Pharmacokinetics and Safety Profile

The drug's pharmacokinetic profile indicates a rapid onset, with symptom relief typically observed within 30 minutes post-administration, aligning with the product’s milligram release profile. Notably, the extended-release formulation curtails identical peak plasma concentrations seen in immediate-release formulations, minimizing potential side effects.

Adverse events reported were generally mild, with decreased appetite, insomnia, and irritability being most common. No new safety signals emerged during the trials, affirming the drug’s tolerability. Importantly, the clinical data underscore its comparable efficacy to existing stimulant medications such as methylphenidate and amphetamine-based therapies, reaffirming its positioning in the stimulant class.

Ongoing and Future Studies

Post-marketing commitments include phase 4 studies focusing on long-term safety, particularly in adolescent subpopulations and comorbid conditions like autism spectrum disorder (ASD). Zydus Cadila also plans to explore ADZENYS XR-ODT in adult ADHD in expanded studies, seeking to capitalize on the underserved adult segment.

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Market Analysis

Current Market Landscape

The global ADHD therapeutics market was valued at approximately USD 12 billion in 2022, with a CAGR forecast of 6.2% through 2030 (Grand View Research). The U.S. remains the dominant market, accounting for over 70% of revenue, driven by high diagnosis rates, insurance coverage, and a strong preference for stimulant therapies.

The ADHD stimulant segment is highly competitive, with market leaders including Shire’s (now Takeda’s) Vyvanse, Eli Lilly’s Quillivant XR, and Johnson & Johnson’s Concerta. However, a rising demand for patient-centric formulations—such as orally disintegrating tablets—provides a niche for innovations like ADZENYS XR-ODT.

Competitive Advantages

ADZENYS XR-ODT’s key differentiators include its fast-acting onset, ease of administration in various settings, and improved compliance, especially among children resistant to swallowing pills. The formulation's ability to deliver extended symptom control positions it favorably within unmet clinical needs.

Zydus Cadila’s existing infrastructure and experience in branded generics afford a cost advantage, facilitating competitive pricing strategies. Regulatory pathways in other major markets, such as Europe and emerging economies, are under exploration, aiming to diversify geographic revenue streams.

Market Penetration and Adoption Drivers

Market penetration hinges on physician acceptance, patient education, and insurance reimbursement policies. Initial uptake in the U.S. has been incremental, partly limited by pandemic-related prescriptions slowdowns and the inertia of existing formulary choices.

The expansion of ADHD diagnosis in adults—who favor flexible, non-invasive formulations—serves as a catalyst. Additionally, the COVID-19 pandemic has heightened demand for at-home administration options, aligning with ADZENYS XR-ODT’s product profile.

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Market Projections and Future Outlook

Forecasted Growth and Revenue Potential

Based on current adoption trends and clinical strength, ADZENYS XR-ODT is projected to achieve USD 200-300 million in global sales by 2025, capturing approximately 2-3% of the stimulant ADHD market. This estimate considers:

• A gradual uptick in prescriptions as physicians gain familiarity.
• Expansion into adult ADHD segments projected to comprise nearly 40% of total sales by 2027.
• Possible formulations for comorbid conditions and extended label indications.

Strategic Factors Influencing Growth

Factors that could accelerate growth include:

• Expanded Indications: Trials evaluating use in treatment-resistant ADHD and comorbid neuropsychiatric conditions could broaden market scope.
• Global Approvals: Entry into European and Asian markets will diversify revenue sources, especially as ADHD awareness proliferates.
• Formulation Enhancements: Development of combination therapies or long-acting variants could improve adherence and efficacy, boosting adoption rates.

Conversely, patent challenges, market competition from existing generics, and reimbursement hurdles pose potential barriers.

Risks and Challenges

• Market Penetration: Overcoming established clinician prescribing patterns requires strategic targeted education.
• Pricing Pressures: Competitive pricing strategies are fundamental, especially in price-sensitive markets.
• Regulatory Delays: Future studies and filings may experience delays due to geopolitical or logistical reasons.

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Conclusion

ADZENYS XR-ODT embodies a significant advancement in ADHD pharmacotherapy, offering a convenient, effective, and safe alternative to traditional stimulants. Its clinical data underpin strong efficacy, and its market potential is buoyed by rising diagnosis rates, patient preferences, and unmet needs for flexible formulations. While cautious optimism is warranted, strategic efforts to expand indications, streamline regulatory approvals, and enhance clinician engagement could realize substantial commercial gains.

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Key Takeaways

• Robust Clinical Validation: ADZENYS XR-ODT has demonstrated efficacy with a favorable safety profile, further supported by ongoing long-term safety studies.
• Market Entry Advantage: Its unique formulation addresses unmet needs for ease of administration and rapid onset, making it attractive to both prescribers and patients.
• Growth Potential: The drug is positioned to capture a significant share of the ADHD stimulant market, especially among adult patients seeking non-invasive options.
• Strategic Expansion: Future studies and international filings are pivotal for broader market access and revenue diversification.
• Competitive Positioning: Cost advantages, formulation innovations, and targeted marketing are crucial for establishing a sustainable competitive edge.

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FAQs

1. How does ADZENYS XR-ODT compare to existing stimulant medications for ADHD?
ADZENYS XR-ODT offers comparable efficacy with a rapid onset of action and the convenience of an orally disintegrating tablet, facilitating administration in settings where swallowing pills is challenging. Its extended-release profile prolongs symptom control, aligning with patient needs for sustained management.

2. What are the primary safety concerns associated with ADZENYS XR-ODT?
The safety profile is consistent with other stimulant therapies. Common adverse events include decreased appetite, insomnia, and irritability. No new safety signals have emerged from clinical data; however, long-term safety remains under evaluation.

3. What market factors could influence ADZENYS XR-ODT’s success?
Clinician acceptance, insurance reimbursement policies, competitive pricing, and awareness campaigns are critical. Additionally, regulatory approvals in international markets can significantly impact sales growth.

4. Are there any plans to expand the indications for ADZENYS XR-ODT?
Yes. Post-marketing studies aim to evaluate its efficacy in treatment-resistant ADHD and comorbid neurodevelopmental disorders like ASD, which could broaden its market potential.

5. When can investors expect significant sales growth for ADZENYS XR-ODT?
Sales are projected to grow steadily over the next three to five years, with noticeable increases after wider physician adoption, regulatory expansions, and potential new indications are approved.

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References

[1] Grand View Research. ADHD therapeutics market analysis, 2022.
[2] U.S. Food and Drug Administration. FDA approval announcement for ADZENYS XR-ODT, August 2021.
[3] ClinicalTrials.gov. Study identifiers for ADZENYS XR-ODT trials.
[4] Zydus Cadila Annual Report, 2022.
[5] IQVIA Reports. Prescription trends in ADHD medications, 2022-2023.