CLINICAL TRIALS PROFILE FOR ADDERALL 5

505(b)(2) Clinical Trials for ADDERALL 5

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00746733 ↗	Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC	Completed	Shire	Phase 1	2008-09-08	The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how much of the drug is absorbed into the body.

All Clinical Trials for ADDERALL 5

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00069927 ↗	Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression	Terminated	National Cancer Institute (NCI)	Phase 2	2003-08-01	RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help improve memory, attention, and thinking problems caused by central nervous system (CNS) treatment for cancer, and may help decrease depression. PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how well it works compared to methylphenidate in treating depression and problems with memory, attention, and thinking in children who have undergone CNS treatment for cancer. This trial will also study how often depression is seen and if these medications might help.
NCT00069927 ↗	Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression	Terminated	University of South Florida	Phase 2	2003-08-01	RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help improve memory, attention, and thinking problems caused by central nervous system (CNS) treatment for cancer, and may help decrease depression. PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how well it works compared to methylphenidate in treating depression and problems with memory, attention, and thinking in children who have undergone CNS treatment for cancer. This trial will also study how often depression is seen and if these medications might help.
NCT00247572 ↗	Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories	Completed	New River Pharmaceuticals	Phase 2	2005-09-01	This research is being done to evaluate if NRP 104 is a safe drug. The other purpose is to learn if NRP104, when injected into a vein, produces a high and any other effects like amphetamine and other stimulant drugs that are abused. This information will give some indication if NRP104 can be abused. Healthy people, between the ages of 18 and 55 with histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to treat narcolepsy (excessive sleepiness) and for weight loss.
NCT00248092 ↗	Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse	Completed	New River Pharmaceuticals	Phase 1/Phase 2	2006-01-01	This research is being done to evaluate if NRP104 is a safe drug. The other purpose is to learn if NRP104 produces a high and any other effects like amphetamine and other stimulant drugs that are abused. This information will give some indication if NRP104 can be abused. NRP104 is an investigational drug. This means that it has not been approved by the U.S. Food and Drug Administration (FDA). Healthy people, between the ages of 18 and 55 with histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to treat narcolepsy (excessive sleepiness) and for weight loss.
NCT00279409 ↗	Treatment of Children With ADHD Who do Not Fully Respond to Stimulants	Terminated	Bristol-Myers Squibb	Phase 2	2006-07-01	The purpose of this pilot is to initiate a program of research into the development of effective medication techniques to treat those children with ADHD who are referred because they are "partial" or "non-responders" to standard stimulant treatment.
NCT00279409 ↗	Treatment of Children With ADHD Who do Not Fully Respond to Stimulants	Terminated	National Institute of Mental Health (NIMH)	Phase 2	2006-07-01	The purpose of this pilot is to initiate a program of research into the development of effective medication techniques to treat those children with ADHD who are referred because they are "partial" or "non-responders" to standard stimulant treatment.

Clinical Trial Conditions for ADDERALL 5

Condition Name

Condition Name for ADDERALL 5
Intervention	Trials
Attention Deficit Hyperactivity Disorder	10
Attention Deficit Disorder With Hyperactivity	6
Attention Deficit Hyperactivity Disorder (ADHD)	3
Major Depressive Disorder	3

Condition MeSH

Condition MeSH for ADDERALL 5
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	23
Hyperkinesis	16
Disease	8
Depressive Disorder	4

Clinical Trial Locations for ADDERALL 5

Trials by Country

Trials by Country for ADDERALL 5
Location	Trials
United States	39
Canada	6

Trials by US State

Trials by US State for ADDERALL 5
Location	Trials
New York	9
Massachusetts	7
Alabama	2
Pennsylvania	2
Minnesota	2

Clinical Trial Progress for ADDERALL 5

Clinical Trial Phase

Clinical Trial Phase for ADDERALL 5
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	13
Phase 3	3

Clinical Trial Status

Clinical Trial Status for ADDERALL 5
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Not yet recruiting	4

Clinical Trial Sponsors for ADDERALL 5

Sponsor Name

Sponsor Name for ADDERALL 5
Sponsor	Trials
Shire	7
New York State Psychiatric Institute	5
National Institute on Drug Abuse (NIDA)	5

Sponsor Type

Sponsor Type for ADDERALL 5
Sponsor	Trials
Other	45
Industry	13
NIH	8

Last updated: April 28, 2026

What does “Adderall 5” cover in clinical trials, and how will the market likely move?

“Adderall 5” is not a standard global product/strength identifier used consistently across regulators and databases. In practice, market and clinical-trial reporting for “Adderall” refers to mixed amphetamine salts (MAS) immediate-release tablets sold under brand names, while “Adderall 5” typically denotes 5 mg strength within that MAS portfolio. This update therefore maps to the Adderall (mixed amphetamine salts) IR commercial class and its ongoing evidence base for ADHD and related indications.

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Which clinical-trial programs matter for Adderall mixed amphetamine salts today?

What conditions have active or recently reported MAS evidence?

Clinical development for MAS is dominated by:

• ADHD (primary indication)
• Pediatric and adolescent titration studies and dose-ranging work
• Switching or bioequivalence work between formulations and generic entrants
• Safety and tolerability studies tied to labeling maintenance

For “Adderall 5,” the key practical point is that dose strength does not usually define a separate development program. Instead, 5 mg is part of the dose ladder used in trials that validate dosing strategies across age groups and severity strata.

What is the most common trial structure used in MAS studies?

Across ADHD stimulant programs (including MAS), trials typically rely on:

• Randomized, double-blind, placebo-controlled designs in short windows (weeks)
• Dose titration cohorts to establish symptom-response curves and adverse-event rates
• Standardized ADHD scales (often investigator-rated) and pre-specified primary endpoints
• Daytime functional outcomes (in some later-stage or enriched cohorts)

How does this translate into “Adderall 5” relevance?

If a trial includes MAS dose titration and multiple fixed strengths, the 5 mg arm functions as:

• An early titration dose for tolerability and tolerability-led up-titration
• A low-dose comparator for discontinuation risk and adverse-event burden
• A bridge strength for patients with slower titration needs (common in pediatric practice)

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Are there brand-led “new” clinical trials for Adderall 5 specifically?

Evidence is mostly incremental, not brand-new

For older established products such as Adderall (MAS), clinical updates tend to be:

• Generic/ANDA bioequivalence packages
• Formulation-specific or regimen-specific studies
• Label maintenance submissions tied to post-marketing pharmacovigilance

That pattern means “Adderall 5” is typically supported by the broader MAS ADHD evidence base, not by a standalone trial franchise at 5 mg.

What is still actively monitored in MAS development/regulatory work?

The ongoing clinical and regulatory focus for MAS includes:

• Cardiovascular safety monitoring (baseline screening and on-treatment vigilance)
• Growth/weight effects in pediatric populations
• Psychiatric adverse events and misuse risk controls
• Long-term tolerability for sustained treatment regimens

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How big is the Adderall market, and what drives demand?

Market definition

For investment and R&D planning, the relevant market is:

• ADHD stimulant therapy, centered on oral amphetamine-based treatment
• Includes immediate-release and extended-release schedules
• Competitive set includes methylphenidate-based stimulants and non-stimulants (as substitution pressure)

Demand drivers

1. Prevalence and diagnosis rates in ADHD
2. Adherence to titration and persistence (stimulants drive repeat dispensing)
3. Formulary position and payer controls
4. Supply reliability and controlled-substance constraints
5. Competitive switching dynamics between MAS and methylphenidate options

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What market constraints weigh on near-term projections?

Supply, pricing, and payer pressure

The near-term market outlook for MAS is constrained by:

• Controlled-substance supply chain variability
• Generic penetration and net price erosion across strengths
• Prior authorization patterns and step therapy
• Substitution risk to methylphenidate or non-stimulant regimens when payers narrow access

Clinical substitution dynamics

Even when “Adderall 5” is the prescribed entry dose, patients often switch:

• Within MAS (IR to ER or vice versa)
• From MAS to methylphenidate-based alternatives
• From stimulants to non-stimulants if adverse events or inadequate response occurs

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Market projection: what’s the most likely trajectory for Adderall 5?

Projection framework

For an older, widely marketed ADHD product, projections usually track three layers:

• Category growth (ADHD treated population and persistence)
• Share shifts (MAS vs methylphenidate; brand vs generic)
• Net price (rebates, payer constraints, and volume mix)

Base case (most likely)

• Volume: modest expansion driven by persistence, with dosing ladder effects sustaining demand for lower strengths like 5 mg in titration
• Net sales: restrained growth or flat-to-moderate decline depending on generic share and pricing
• Formulation mix: gradual shift toward longer-acting regimens in some segments, offset by IR in others

Bull case

• Improved payer access and supply stability
• Stronger persistence in pediatric and adolescent cohorts
• Slower generic erosion due to contracting advantages and formulary stickiness
• Higher continued utilization of small-dose titration where clinically required

Bear case

• Intensified payer restrictions
• Accelerated generic price compression
• Increased switching due to adverse events, shortage-driven substitution, or step therapy policy changes
• Higher regulatory scrutiny on stimulant prescribing and diversion controls impacting logistics

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Competitive landscape: how does Adderall 5 fight for share?

Primary competitor sets

1. Methylphenidate-based stimulants (alternative stimulant class for ADHD)
2. Other amphetamine-based products (different brands or controlled-substance schedules)
3. Non-stimulants (when payers or clinicians reduce stimulant use)

Why “5 mg strength” matters commercially

In retail and pharmacy benefit dynamics:

• 5 mg is used in initial titration workflows
• It can determine early persistence because discontinuations often occur early in treatment
• It can influence switch likelihood when a patient does not tolerate titration steps

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Regulatory and lifecycle: what IP or legal posture matters for “Adderall 5”?

IP is largely a maturity story

Adderall is an established MAS product. In a mature market, the “Adderall 5” identifier usually does not map to a standalone proprietary claim set. The commercial reality is shaped by:

• Brand history and any remaining marketing exclusivity (if applicable by jurisdiction)
• Generic penetration and settlement outcomes (if any)
• Labeling stability and controlled-substance enforcement

Implication for R&D investors

R&D spend for “Adderall 5” typically does not aim to create new IP around the 5 mg dose itself. Instead, it targets:

• Improved dosing comfort and adherence
• Formulation differentiation (IR/ER, release profile)
• Safety outcomes and adherence models in pediatric care

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What should decision-makers watch next for clinical and market inflection?

Clinical watch items

• New ADHD guideline updates that alter first-line stimulant selection or titration practices
• Safety signals tied to pediatric growth, cardiovascular risk screening, and psychiatric adverse events
• Label updates that affect dosing caps, age approvals, or switching rules

Market watch items

• Pharmacy benefit manager policy changes on amphetamine-based stimulant placement
• Generic net price movements by strength and tier
• Supply chain reliability for controlled-substance schedules
• Payer step therapy enforcement intensity

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Key Takeaways

• “Adderall 5” tracks the 5 mg strength within the mixed amphetamine salts (Adderall) immediate-release ADHD portfolio, and clinical evidence is generally strength-embedded rather than trial-franchised.
• Clinical activity for MAS is typically incremental: dose-ranging, formulation/regimen updates, and bioequivalence for generics, with continued safety monitoring focus on pediatric growth, cardiovascular screening, and psychiatric tolerability.
• Market trajectory is likely modest volume growth with constrained net price, driven by ADHD persistence and titration workflows, offset by generic penetration and payer restrictions.
• The near-term inflection points are payer policy shifts, supply stability, and switching dynamics versus methylphenidate and non-stimulants.

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FAQs

1) Does “Adderall 5” have separate clinical trial endpoints?

Typically no. Trials usually test dose-ranging and tolerability across a spectrum of MAS strengths, with 5 mg functioning as an early titration step rather than a standalone efficacy thesis.

2) What drives demand for a 5 mg dose specifically?

It is primarily used during titration in ADHD treatment initiation, so it benefits from persistence and early-adherence patterns more than from long-term maintenance switching.

3) Will generic erosion hit Adderall 5 the same way as other strengths?

Net price pressure often hits across strengths, but the magnitude depends on volume mix, formulary placement, and payer tiering. Lower strengths can experience both initiation demand and competitive substitution.

4) Are the biggest clinical risks for MAS tied to dose?

Risks such as cardiovascular effects, insomnia, appetite suppression, and psychiatric adverse events are dose-linked in practice and are monitored closely during titration phases where lower strengths like 5 mg are used.

5) What market events would change projections fastest?

Payer policy changes (step therapy/prior auth), controlled-substance supply reliability, and shifts in category preference toward methylphenidate or non-stimulants.

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References

[1] FDA. Drug Safety and Availability: Drug shortages and safety communications. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability
[2] FDA. Adderall (amphetamine mixed salts) labeling resources. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] NCBI. Clinical trials and evidence resources for ADHD stimulant therapies. National Center for Biotechnology Information. https://pubmed.ncbi.nlm.nih.gov/
[4] AACAP. Practice parameters and clinical guidance for ADHD assessment and treatment. American Academy of Child and Adolescent Psychiatry. https://www.aacap.org/