Last Updated: April 30, 2026

CLINICAL TRIALS PROFILE FOR ADDERALL 15


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505(b)(2) Clinical Trials for Adderall 15

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Adderall 15

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Adderall 15

Condition Name

Condition Name for Adderall 15
Intervention Trials
Attention Deficit Hyperactivity Disorder 10
Attention Deficit Disorder With Hyperactivity 6
Attention Deficit Hyperactivity Disorder (ADHD) 3
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Condition MeSH

Condition MeSH for Adderall 15
Intervention Trials
Attention Deficit Disorder with Hyperactivity 23
Hyperkinesis 16
Disease 8
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Clinical Trial Locations for Adderall 15

Trials by Country

Trials by Country for Adderall 15
Location Trials
United States 39
Canada 6
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Trials by US State

Trials by US State for Adderall 15
Location Trials
New York 9
Massachusetts 7
Alabama 2
Pennsylvania 2
Minnesota 2
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Clinical Trial Progress for Adderall 15

Clinical Trial Phase

Clinical Trial Phase for Adderall 15
Clinical Trial Phase Trials
PHASE4 1
Phase 4 13
Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Adderall 15
Clinical Trial Phase Trials
Completed 21
Recruiting 7
Not yet recruiting 4
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Clinical Trial Sponsors for Adderall 15

Sponsor Name

Sponsor Name for Adderall 15
Sponsor Trials
Shire 7
New York State Psychiatric Institute 5
National Institute on Drug Abuse (NIDA) 5
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Sponsor Type

Sponsor Type for Adderall 15
Sponsor Trials
Other 45
Industry 13
NIH 8
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Adderall 15 Market Analysis and Financial Projection

Last updated: April 25, 2026

Adderall 15: What do the clinical-trial signals and market dynamics imply for near-term demand and pricing power?

What is “Adderall 15” in market and trial terms?

“Adderall 15” generally refers to amphetamine mixed salts immediate-release (IR) 15 mg tablets, sold as Adderall (and, depending on payer and channel, may be substituted by authorized generics). The product sits in the long-established ADHD stimulant segment, where utilization is driven by treated prevalence, persistence, formulary placement, and supply continuity.

Because “Adderall 15” is a dose-strength presentation rather than a distinct active substance or separable regulatory entity, clinical activity typically appears in one of two ways:

  • New formulations (e.g., extended-release schedules or novel delivery concepts under the same therapeutic franchise).
  • Incremental life-cycle studies tied to labeling updates, abuse-deterrence, or comparative exposure.

For forecasting, the dose strength matters operationally (prescription mix, titration patterns, and tablet split behavior), but regulatory and clinical signals typically map to the brand and formulation family, not to “15 mg” alone.


What clinical-trial updates matter for Adderall-related ADHD stimulants?

Which trial categories most move the market for Adderall franchise products?

For established stimulant brands like Adderall, trial updates that move demand tend to fall into these buckets:

  • Labeling changes that expand eligible use (patient age bands, comorbid indications, or titration language).
  • Formulation or abuse-deterrence programs that affect formulary access and payer utilization.
  • Comparative bioavailability / switch studies that reduce switching friction for prescribers and pharmacists.

What trial activity usually does not materially change Adderall 15 volumes?

  • Small PK refinements with no labeling expansion.
  • Studies limited to narrow subgroups without demonstrable practice change.
  • Trials that do not alter payer policy, formulary status, or substitution rules.

How big is the ADHD stimulant market relevant to Adderall 15?

What drives volume in the ADHD stimulant market?

Near-term demand for stimulant tablets is driven by four practical levers:

  1. Treated ADHD prevalence in children and adolescents, plus adult ADHD growth.
  2. Persistence and refill behavior, which for IR products ties to daily adherence.
  3. Formulary design and prior authorization intensity, which affects conversion from competing products.
  4. Supply continuity and competitive availability, which affects fill rates and switching.

What role does IR 15 mg play in prescriptions?

IR tablet strengths are used in titration regimes and dose optimization. In practice, “15 mg” acts as:

  • A common middle dose strength in titration pathways.
  • A routine prescription strength in stable patients.
  • A source of substitution risk when prescribers accept equivalent generic strengths at comparable cost.

What does market analysis imply for Adderall 15 pricing power and mix?

Pricing power is constrained by substitution economics

Adderall faces strong market pressure from:

  • Authorized generics and high generic penetration in ADHD stimulants.
  • Pharmacy-level substitution norms in many channels.
  • Net price negotiation driven by payer formularies and PBM contracting.

Dose-specific pricing for “15 mg” is therefore mostly a function of overall franchise net pricing and pharmacy mix rather than a unique strength premium.

What supply and channel factors typically swing Adderall tablet demand?

Two factors tend to dominate the short-horizon view:

  • Availability and allocation behavior (when supply tightens, fill completion matters more than list price).
  • Formulary tiering and patient-specific coverage rules (coinsurance and step therapy effects show up quickly in claims).

Market projection: What is the likely demand trajectory for Adderall 15?

Near-term (next 6-18 months): base case

For “Adderall 15,” the base case typically aligns with:

  • Flat-to-moderate unit growth driven by underlying treated prevalence and adult ADHD expansion.
  • Churn between IR and ER products based on convenience and payer preference, with IR retaining share where prescribers need flexible dosing.

Mid-term (2-4 years): scenario framing

Mid-term volume depends on whether the franchise faces:

  • Additional competitive share loss from ER stimulants and newer mechanisms.
  • Offsetting effects from sustained generic accessibility that preserves overall stimulant treatment rates.

For an established therapy like Adderall, absent material label expansion or major formulation disruption, projections usually track the broader ADHD stimulant trend plus mix effects rather than step-function growth.


Investment and R&D implications

What should be watched in clinical development signals?

Even for a dose strength like “Adderall 15,” the key watch items are franchise-level:

  • Any label change that broadens use or clarifies dosing.
  • Any abuse-deterrence or formulation program that affects formulary and patient access.
  • Any data that changes switching behavior between competitors (bioequivalence, tolerability, or administration convenience).

How to translate trial signals into commercial forecasts

Use a funnel framework:

  • Regulatory and label impact (binary for demand change).
  • Payer formulary impact (tiering and PA requirements).
  • Claims mix shift (IR 15 mg share vs other strengths and ER products).
  • Sustained persistence (refill rates by payer and channel).

Key Takeaways

  • “Adderall 15” functions commercially as a dose-strength within the Adderall IR franchise, so most clinical-trial relevance is franchise-level, not strength-specific.
  • Near-term demand is driven primarily by treated prevalence, persistence, and formulary substitution, with supply continuity as the main swing factor.
  • Pricing power for “15 mg” is generally constrained by generic substitution and PBM contracting, so unit growth matters more than strength-specific premium pricing.
  • Market projections for Adderall IR tablets typically run on mix and persistence plus broader ADHD stimulant category growth, unless a label-expanding or access-changing clinical update emerges.

FAQs

1) Is “Adderall 15” a separate drug in clinical trials?

No. It is a strength presentation of the Adderall IR active franchise, so trial activity usually ties to the franchise, not the 15 mg dose specifically.

2) Do new ADHD stimulant trials usually expand Adderall 15’s patient pool?

Only if they trigger label expansion or alter access rules (coverage, PA, or substitution behavior). Otherwise, they tend to shift share rather than expand total treated demand.

3) What is the biggest factor affecting Adderall IR tablet demand in the short run?

Supply continuity and formulary access. These affect whether prescriptions convert into filled scripts.

4) How does generic substitution affect Adderall 15 projections?

It compresses net price and shifts utilization toward the lowest-covered equivalent strengths, so “15 mg” mix depends on pharmacy substitution and payer contracting.

5) What mix metric should be used for Adderall IR forecasting?

Use claims mix by strength and IR vs ER within stimulant-naive and switching cohorts, then apply persistence and refill rates.


References

[1] FDA. “Drug Trials Snapshots.” U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-trials-snapshots
[2] ClinicalTrials.gov. “Adderall” and “amphetamine mixed salts” related study listings. U.S. National Library of Medicine. https://clinicaltrials.gov/
[3] Centers for Disease Control and Prevention (CDC). “Attention-Deficit/Hyperactivity Disorder (ADHD).” https://www.cdc.gov/adhd/
[4] IQVIA Institute. “Medicine Use and Spending” reports (ADHD/stimulants market context). https://www.iqvia.com/insights/the-iqvia-institute/reports

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