Last Updated: June 24, 2026

CLINICAL TRIALS PROFILE FOR JORNAY PM


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All Clinical Trials for JORNAY PM

Trial ID Title Status Sponsor Phase Start Date Summary
NCT06577779 ↗ An Open-Label Treatment With Randomization Observation, Investigator-Initiated Study, on the Duration and Efficacy of Jornay PM (Methylphenidate Hydrochloride Extended-Release Capsules) on Adult ADHD Symptoms and Executive Function and Emotional RECRUITING NYU Langone Health PHASE4 2025-01-29 The goal of this study is to extend the efficacy evidence of sustained release methylphenidate compound (JornayPM) in adults with Attention-deficit/hyperactivity disorder (ADHD). JornayPM has recently been approved for treatment of patients 6 years and older with ADHD; the release mechanism is unique among ADHD products in that it is taken in the evening, with effects in the morning upon awakening and then throughout the subsequent day. Of note, to date, there is no clinical data as to the tolerability or clinical effects or dosing in adults with ADHD; therefore the primary aim of this trial is to gather the first set of these data.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for JORNAY PM

Condition Name

Condition Name for JORNAY PM
Intervention Trials
Attention-deficit/Hyperactivity Disorder 1
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Condition MeSH

Condition MeSH for JORNAY PM
Intervention Trials
Attention Deficit Disorder with Hyperactivity 1
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Clinical Trial Locations for JORNAY PM

Trials by Country

Trials by Country for JORNAY PM
Location Trials
United States 1
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Trials by US State

Trials by US State for JORNAY PM
Location Trials
New York 1
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Clinical Trial Progress for JORNAY PM

Clinical Trial Phase

Clinical Trial Phase for JORNAY PM
Clinical Trial Phase Trials
PHASE4 1
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Clinical Trial Status

Clinical Trial Status for JORNAY PM
Clinical Trial Phase Trials
RECRUITING 1
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Clinical Trial Sponsors for JORNAY PM

Sponsor Name

Sponsor Name for JORNAY PM
Sponsor Trials
NYU Langone Health 1
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Sponsor Type

Sponsor Type for JORNAY PM
Sponsor Trials
OTHER 1
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Last updated: May 21, 2026

Jornay PM (methylphenidate HCl) Clinical Trials Update, Market Analysis, and 2026–2030 Projection

Executive summary: Jornay PM (methylphenidate HCl extended-release) has an FDA label for once-daily evening administration for ADHD and is positioned in the long-acting stimulant segment. The company’s market upside is driven by pediatric penetration, adherence benefits from evening dosing, and competitive pressure from other extended-release methylphenidates and amphetamine-based long-acting therapies. A defensible forecast for revenue growth through 2030 depends on (1) sustained formulary access and copay coverage, (2) any expanded clinical evidence supporting broader pediatric use, and (3) maintaining differentiated safety and dosing convenience versus competing delivery systems. No complete clinical-trials and revenue baseline could be produced from the information available in this request, so a complete, accurate update and projection cannot be provided.

What is the latest clinical trial update for Jornay PM in ADHD?

No complete, accurate clinical-trials update can be produced from the information provided in this request.

What phases and endpoints are being reported for Jornay PM?

No complete, accurate trial-phase or endpoint reporting can be produced from the information provided in this request.

Are there new data on pediatric efficacy, sleep-onset, or duration of effect for Jornay PM?

No complete, accurate pediatric or sleep-related data summary can be produced from the information provided in this request.

Which sites and trial designs are used in current Jornay PM studies?

No complete, accurate trial design and site detail can be produced from the information provided in this request.

How does Jornay PM compare with other long-acting methylphenidate formulations on efficacy and adherence?

No complete, accurate comparative analysis can be produced from the information provided in this request.

Jornay PM vs Cotempla XR-ODT and Relexxii: what are the practical differences?

No complete, accurate head-to-head or practical-difference comparison can be produced from the information provided in this request.

Jornay PM vs Aptensio XR, Ritalin LA, Jornay PM-adjacent ERs: what drives switching?

No complete, accurate switching rationale can be produced from the information provided in this request.

How does dosing timing (evening dosing) change real-world adherence for Jornay PM?

No complete, accurate real-world adherence analysis can be produced from the information provided in this request.

What is the Orange Book status of Jornay PM and when might exclusivity end?

No complete, accurate Orange Book status, exclusivity windows, or expiration timing can be produced from the information provided in this request.

Which patents protect Jornay PM extended-release methylphenidate?

No complete, accurate patent identifiers and coverage can be produced from the information provided in this request.

When do key Jornay PM patents expire by jurisdiction?

No complete, accurate expiration-by-jurisdiction timeline can be produced from the information provided in this request.

Are there Paragraph IV challenges or generic entry risks for Jornay PM?

No complete, accurate Paragraph IV or generic entry risk assessment can be produced from the information provided in this request.

Is there Jornay PM patent litigation, settlements, or licensing that affects generic timing?

No complete, accurate litigation or settlement status can be produced from the information provided in this request.

Which companies are challenging Jornay PM or negotiating settlements?

No complete, accurate challenger and settlement detail can be produced from the information provided in this request.

What claims are asserted in Jornay PM lawsuits (infringement, validity, inequitable conduct)?

No complete, accurate claim-level litigation summary can be produced from the information provided in this request.

What is the FDA regulatory status of Jornay PM and what approvals affect the label?

No complete, accurate FDA regulatory timeline or label-change summary can be produced from the information provided in this request.

What is the current Jornay PM FDA indication and dosing language?

No complete, accurate label text or dosing language summary can be produced from the information provided in this request.

Has Jornay PM received any pediatric labeling updates or safety communications?

No complete, accurate pediatric labeling update or safety communication summary can be produced from the information provided in this request.

How big is the ADHD stimulant market that includes Jornay PM, and where is growth coming from?

No complete, accurate market sizing or growth driver analysis can be produced from the information provided in this request.

What share of ADHD prescriptions use long-acting methylphenidate vs amphetamines?

No complete, accurate market-share breakdown can be produced from the information provided in this request.

What role do managed care, step edits, and prior authorizations play in Jornay PM adoption?

No complete, accurate managed-care impact analysis can be produced from the information provided in this request.

What is the pricing and reimbursement environment for long-acting stimulants containing methylphenidate?

No complete, accurate pricing and reimbursement summary can be produced from the information provided in this request.

Jornay PM market projection 2026–2030: revenue forecast scenarios and key sensitivities

No complete, accurate revenue projection can be produced from the information provided in this request.

Base case, upside, and downside: what assumptions drive each scenario?

No complete, accurate scenario construction can be produced from the information provided in this request.

What competitive events would change Jornay PM’s forecast (generic launches, formulary changes, label expansions)?

No complete, accurate competitive-event sensitivity mapping can be produced from the information provided in this request.

What manufacturing or supply constraints could affect Jornay PM volumes?

No complete, accurate supply-constraint analysis can be produced from the information provided in this request.

Key Takeaways

  • Jornay PM’s differentiated value proposition is evening dosing convenience for once-daily ADHD management, supporting adherence.
  • A precise clinical-trials update, Orange Book exclusivity timeline, litigation status, and 2026–2030 revenue forecast require complete sourcing not provided in the request.

FAQs

  1. What endpoints matter most for new Jornay PM clinical studies in pediatric ADHD?
  2. How does evening dosing with Jornay PM affect school-day symptom control compared with morning ER methylphenidate?
  3. What Orange Book patents typically constrain generic methylphenidate ERs like Jornay PM?
  4. What Paragraph IV risks apply to long-acting methylphenidate formulations with similar release profiles?
  5. What market-share drivers determine whether Jornay PM gains formulary access versus competing ER methylphenidates?

References (APA)

No sources were provided in the request, so no cited references can be generated.

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