CLINICAL TRIALS PROFILE FOR ADDERALL 12.5

505(b)(2) Clinical Trials for Adderall 12.5

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 12.5

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 12.5

Condition Name

Condition Name for Adderall 12.5
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 12.5
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	23
Hyperkinesis	16
Disease	8
Depressive Disorder	4

Clinical Trial Locations for Adderall 12.5

Trials by Country

Trials by Country for Adderall 12.5
Location	Trials
United States	39
Canada	6

Trials by US State

Trials by US State for Adderall 12.5
Location	Trials
New York	9
Massachusetts	7
Maryland	2
Georgia	2
Florida	2

Clinical Trial Progress for Adderall 12.5

Clinical Trial Phase

Clinical Trial Phase for Adderall 12.5
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	13
Phase 3	3

Clinical Trial Status

Clinical Trial Status for Adderall 12.5
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Terminated	4

Clinical Trial Sponsors for Adderall 12.5

Sponsor Name

Sponsor Name for Adderall 12.5
Sponsor	Trials
Shire	7
National Institute on Drug Abuse (NIDA)	5
New York State Psychiatric Institute	5

Sponsor Type

Sponsor Type for Adderall 12.5
Sponsor	Trials
Other	45
Industry	13
NIH	8

Last updated: May 3, 2026

ADDERALL 12.5: Clinical-trial and Market Outlook for Immediate-Release Amphetamine Salts

What is “ADDERALL 12.5” from a regulatory and product-definition standpoint?

“ADDERALL 12.5” refers to Adderall immediate-release (IR) tablets at a 12.5 mg strength. Adderall IR is a fixed-dose combination of dextroamphetamine and amphetamine used to treat ADHD and narcolepsy in the US. The product line is typically discussed as “Adderall” with strength-based SKUs (e.g., 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, 25 mg), rather than a separate molecule or development program.

Core commercial drivers for a strength-specific SKU

• Prescriber demand for IR dosing schedules that fit titration and individualized dosing.
• Pharmacy substitution constraints are usually SKU/strength-driven, not molecule-driven; payor policy and stock availability determine which strengths move most.

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Are there new clinical trials specifically for “Adderall 12.5”?

No actionable, strength-specific clinical program exists in public registries in a way that can be reliably attributed to “Adderall 12.5” as a distinct development target. Clinical trial reporting is generally by drug product name (Adderall) and formulation (IR vs XR) and does not stratify by a single tablet strength such as 12.5 mg.

What is observable at the program level (formulation and molecule) Public trial activity in stimulant therapeutics tends to cluster around:

• ADHD efficacy comparisons vs other stimulants
• Controlled-release vs immediate-release comparisons
• Pediatric/adolescent enrollment updates
• Switching studies between branded and generic amphetamine combinations
• Abuse-deterrence, pharmacokinetics, and formulation optimization

Those programs, where they exist, apply to the Adderall IR product class as a whole rather than one strength SKU.

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What does the current clinical pipeline imply for near-term adoption of Adderall IR (including 12.5 mg)?

Near-term adoption is driven by:

1. Formulation continuity: Adderall IR is an established therapy with stable prescribing patterns.
2. Switching and titration realities: Strength-level choice (including 12.5 mg) is often a bridge for titration. That supports ongoing demand even when the overall molecule has limited pipeline novelty.
3. Competition intensity: Market share swings in ADHD stimulants often reflect payer step edits, prior authorization, and pharmacy network substitution, not clinical trial breakthroughs unique to 12.5 mg.

Net effect for 12.5 mg
If Adderall IR remains the prescribed IR option, 12.5 mg demand follows as a dosing step. If payors push toward a different branded or generic IR/ER alternative, the 12.5 mg SKU loses volume with the broader IR category.

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Market Analysis: What is the addressable revenue pool for Adderall IR 12.5 mg?

How big is the ADHD stimulant category, and where does Adderall IR fit?

The ADHD population and stimulant demand create a large, recurring addressable market. Adderall IR competes within a stimulant landscape that includes:

• Other amphetamine-based regimens (brand and generic)
• Methylphenidate-based regimens (brand and generic)
• Extended-release and prodrug alternatives
• Non-stimulant options (atomoxetine, guanfacine, clonidine, etc.) that can shift patient mix

Adderall IR generally competes on:

• Clinical familiarity
• Dosing flexibility
• Supply and pharmacy accessibility
• Coverage and formulary placement relative to alternatives

What drives 12.5 mg specifically?

Strength-level SKU demand typically correlates with:

• Titration pathways (moving from lower to mid-dose)
• Patient-specific dose rounding to clinically workable tablet strengths
• Pediatric and adolescent dosing patterns, where smaller incremental steps are more common
• Formulary constraints that favor certain strengths due to stocking or pharmacy ordering efficiency

Commercial implication: 12.5 mg is usually not a “hero strength” compared with top sellers at other doses, but it often acts as a volume support strength through titration and adherence.

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Projection: Revenue and volume direction for Adderall IR (including 12.5 mg)

What is the direction of market share pressure for Adderall IR?

For branded stimulant products, market share and revenue usually move with:

• Generic erosion risk (where generic competition expands)
• Formulary restrictions and payer policy changes
• Supply chain stability and DEA-controlled substance allocation dynamics
• Switching behavior tied to shortages and substitution rules
• Ongoing competition from extended-release alternatives

Because “Adderall 12.5” is a strength within a mature product, the projection is usually category-share dependent, not pipeline dependent. The near-term path for 12.5 mg is therefore best modeled as:

• Adderall IR net share trend × strength mix within Adderall IR

Near-term projection framework (actionable model)

A practical projection for “Adderall 12.5” should track:

• Total Adderall IR demand trend (prescriptions and days supply)
• Adderall IR mix shift vs ER and vs non-stimulants
• Patient retention on IR schedules (stability vs switching)
• 12.5 mg mix within Adderall IR dosing patterns

Base-case expectation for 12.5 mg
In a mature therapy with ongoing prescribing, 12.5 mg demand tends to be:

• Stable-to-down under competitive pressure
• Cushioned by titration use and pharmacy-level substitution dynamics
• More sensitive to payer policies than to clinical novelty

Upside scenario typically requires:

• Favorable payer reinstatement or formulary lift for Adderall IR
• Reduced competitive access to alternative IR strengths
• Supply smoothing that reduces forced substitutions

Downside scenario typically requires:

• Increased substitution away from Adderall IR
• Tightened step edits favoring alternatives or ER regimens
• Supply disruptions that shift patients to other available strengths or products

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Competitive positioning: where Adderall IR 12.5 mg wins and loses

What levers decide whether prescribers choose Adderall IR 12.5 mg?

Wins

• Fits titration for patients needing mid-step dosing
• Supports IR schedule flexibility for school and work timing
• Holds a prescriber comfort level and entrenched prescribing routines

Losses

• Payer restrictions that prefer a different branded product, a specific generic, or ER
• Stockouts forcing replacement with different strength SKUs or formulations
• Shortage-driven switching that can persist beyond supply normalization

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Key Takeaways

• “ADDERALL 12.5” is Adderall immediate-release at 12.5 mg, not a separate drug-development entity.
• Public clinical trial visibility is generally at the Adderall IR level, not a distinct “12.5 mg” program; strength-specific trials are not a reliable basis for forecasting.
• Near-term demand for 12.5 mg is primarily driven by Adderall IR category share, payer/formulary decisions, and 12.5 mg mix within titration patterns.
• Market projections for 12.5 mg should be modeled as (Adderall IR overall trend) × (12.5 mg dosing mix), not as pipeline-led growth.

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FAQs

1) Is “Adderall 12.5” part of a separate clinical development program?

No. It is a strength SKU within Adderall immediate-release and is typically represented clinically at the product level rather than as a standalone trial target.

2) Do clinical trial results for ADHD stimulants transfer to “Adderall 12.5”?

They transfer at most to Adderall IR overall prescribing and patient mix. They do not usually isolate outcomes for a single tablet strength.

3) What most strongly affects short-term performance of the 12.5 mg SKU?

Payer coverage, formulary placement, pharmacy substitution, and supply stability that change which product and strength patients actually receive.

4) Does the market shift toward extended-release hurt 12.5 mg?

Usually yes, because moving patients from IR to ER reduces IR days supply, and 12.5 mg loses volume along with IR.

5) What would be a realistic upside catalyst for 12.5 mg?

A formulary or access improvement that increases Adderall IR share, plus a stable supply that lets prescribers execute titration using 12.5 mg when clinically appropriate.

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References

[1] US Food and Drug Administration. Adderall (amphetamine mixed salts) immediate-release prescribing information (product label). FDA.
[2] US Food and Drug Administration. Drug Trials Snapshots: Adderall. FDA.
[3] ClinicalTrials.gov. Adderall and amphetamine mixed salts trial search results. National Library of Medicine (NIH).
[4] Drug Enforcement Administration. Controlled substances and DEA regulatory framework for schedule II stimulants. DEA.