Last Updated: May 7, 2026

CLINICAL TRIALS PROFILE FOR ADDERALL 20


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505(b)(2) Clinical Trials for ADDERALL 20

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 20

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

Clinical Trial Conditions for ADDERALL 20

Condition Name

Condition Name for ADDERALL 20
Intervention Trials
Attention Deficit Hyperactivity Disorder 10
Attention Deficit Disorder With Hyperactivity 6
Cocaine Dependence 3
Attention Deficit Hyperactivity Disorder (ADHD) 3
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Condition MeSH

Condition MeSH for ADDERALL 20
Intervention Trials
Attention Deficit Disorder with Hyperactivity 23
Hyperkinesis 16
Disease 8
Depressive Disorder 4
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Clinical Trial Locations for ADDERALL 20

Trials by Country

Trials by Country for ADDERALL 20
Location Trials
United States 39
Canada 6
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Trials by US State

Trials by US State for ADDERALL 20
Location Trials
New York 9
Massachusetts 7
Pennsylvania 2
Minnesota 2
Illinois 2
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Clinical Trial Progress for ADDERALL 20

Clinical Trial Phase

Clinical Trial Phase for ADDERALL 20
Clinical Trial Phase Trials
PHASE4 1
Phase 4 13
Phase 3 3
[disabled in preview] 14
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Clinical Trial Status

Clinical Trial Status for ADDERALL 20
Clinical Trial Phase Trials
Completed 21
Recruiting 7
Terminated 4
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Clinical Trial Sponsors for ADDERALL 20

Sponsor Name

Sponsor Name for ADDERALL 20
Sponsor Trials
Shire 7
National Institute on Drug Abuse (NIDA) 5
New York State Psychiatric Institute 5
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Sponsor Type

Sponsor Type for ADDERALL 20
Sponsor Trials
Other 45
Industry 13
NIH 8
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ADDERALL 20: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 26, 2026

What is Adderall 20 and what is the labeled commercial product scope?

Adderall 20 typically refers to Adderall tablets in a 20 mg strength of an amphetamine mixed salts product. The active ingredients are the mixed salts of dextroamphetamine and levoamphetamine, delivered as an oral formulation in strength-specific tablets used for ADHD and (depending on labeling and market) narcolepsy. Adderall’s commercial footprint is tied to its oral immediate-release tablet line and its generic competitive landscape in the US.

Key commercial framing for “Adderall 20” is that it is a strength within a branded molecule/product family, not a separate active ingredient. Market dynamics therefore follow the same forces as branded Adderall in the US: generic penetration, payer contracting, demand for stimulant therapy, and supply continuity.

What is the clinical trials status for amphetamine mixed salts (Adderall) relevant to “20 mg” tablets?

No public clinical-trial evidence supports a claim that 20 mg-specific trials drive innovation distinct from the broader amphetamine mixed salts development program. In practice, “Adderall 20” strength is used within existing formulations, while clinical activity in the therapeutic class is more commonly directed at:

  • New stimulant delivery systems (extended-release profiles, abuse-deterrent approaches)
  • Non-stimulant adjunct or alternative ADHD therapies
  • Combination regimens and sequence studies
  • Real-world effectiveness and safety outcomes
  • Formulation bioequivalence/optimization for generics (not typically branded “Adderall” innovation)

Because “Adderall 20” is a market strength within a legacy branded product, the most consequential “clinical trials update” for business decisions usually comes from: 1) Competitive class trials that may shift prescriber preference, and
2) Regulatory/labeling changes affecting stimulant prescribing patterns, persistence, and managed-care coverage.

What is the likely near-term clinical pipeline impact on Adderall 20 demand?

The near-term demand outlook for Adderall 20 is less about new branded trials and more about competitive substitution pressure. In US ADHD pharmacotherapy, prescribers and payers face increasing options beyond branded stimulants, including:

  • Extended-release stimulant formulations (branded and generic)
  • Non-stimulant ADHD agents
  • Wear-off mitigation strategies (dose scheduling, titration, and formulation switching)

Net effect on Adderall 20: brand-level demand can remain stable even when total ADHD script volume grows, but share can compress under generic and alternative therapies depending on payer formularies and patient persistence.

What is the Adderall 20 market setup and why generic competition matters most?

US amphetamine mixed salts tablets operate in a market where generic versions are widely available, and payers price through:

  • Formulary tiering
  • Mandatory step edits or prior authorization in some plans
  • Net price erosion of branded products over time
  • Switching to generics when patient-specific stability allows

In that structure, Adderall 20’s commercial performance is best analyzed as a function of:

  • Total stimulant demand for ADHD and narcolepsy
  • Share of “amphetamine mixed salts” vs methylphenidate products
  • Branded Adderall net price versus closest generics
  • Script persistence (patients who remain on the same mixed salts product)

Market analysis: Where does Adderall fit in ADHD prescribing economics?

ADHD prescribing in the US is dominated by stimulants. Economic outcomes for the branded Adderall line typically hinge on:

  • Branded-to-generic substitution rates after plan negotiations
  • Switching friction (titration schedules, tolerance, and patient response)
  • Availability and supply continuity (supply shocks can temporarily shift demand)
  • Controlled substance risk management (monitoring rules affect prescribing flow)

Because “Adderall 20” is a tablet strength rather than a new product line, its standalone market is not separately tracked as a unit in standard reporting. The realistic analytic unit is Adderall overall and how much of volume can be allocated to the 20 mg strength through prescribing distribution.

How to project Adderall 20 revenue and volume without separate public strength reporting

Strength-level forecasts are typically derived from:

  • Total Adderall branded volume and prescriptions (product family)
  • Prescribing mix by tablet strength (observed titration patterns)
  • Persistence rates on comparable dose bands
  • Switching rates under payer changes

Under normal market behavior, 20 mg tablets tend to map to a mid-to-upper titration range for adults and some pediatric subsets, which can make its growth rate sensitive to:

  • Adult ADHD treatment growth
  • Provider preference for amphetamine mixed salts
  • Short-acting rebound dynamics that affect dose frequency and strength selection

What is the market projection direction for Adderall (and thus Adderall 20)?

For a branded legacy stimulant facing extensive generics, baseline projection commonly follows one of two tracks:

1) Low growth / flat branded volume with margin pressure, if payer contracting continues to incentivize generics; or
2) Moderate branded stability if supply continuity, prescriber loyalty, and patient stability limit switching.

The more aggressive upside scenarios for Adderall 20 typically require one or more of:

  • Favorable contracting outcomes (better net pricing)
  • Reduced competitive substitution due to supply or policy constraints
  • A shift toward mixed amphetamine salts over alternatives

The more adverse downside typically follows:

  • Intensified formulary narrowing to specific generics
  • Supply disruptions that shift volume away and then do not fully revert
  • Competitive uptake of non-stimulant or alternate stimulant profiles

Business projection model (scenario framework)

The following projection framework is designed for investment and R&D planning when strength-level reporting is not separately available.

Base case

  • Adderall branded demand tracks overall ADHD stimulant demand growth, with share compression to generics
  • Adderall 20 strength mix stays consistent with titration patterns within the branded base

Bull case

  • Branded persistence improves (patient stability, prescriber preference)
  • Net pricing stabilizes due to managed-care agreements
  • Adult ADHD volume growth supports higher mid-dose use

Bear case

  • Formularies favor lower-cost alternatives more aggressively
  • Switching accelerates as new patients are initiated on generics first-line
  • Branded net pricing compresses faster than volume gains

What regulatory or access factors could move Adderall 20 demand?

ADHD stimulant access can move quickly with:

  • Formulary and prior authorization changes
  • Controlled substance prescribing practices
  • Supply availability that changes patient continuity
  • Policy-driven changes in how stimulant therapy is monitored and continued

For business planning, these factors usually matter more than new trial results for a legacy strength, since they directly change:

  • Who gets treated
  • Which product is covered
  • Whether patients stay on therapy

Competitive landscape: what is most relevant to Adderall 20?

The competitive set includes:

  • Generic amphetamine mixed salts immediate-release tablets (direct substitution)
  • Branded and generic extended-release stimulant products (indirect substitution)
  • Non-stimulant ADHD therapies (secondary alternative)

Adderall 20’s market risk profile is dominated by direct generic substitution because it is the same active ingredient class and similar therapeutic effect for many patients when switching is tolerable.

Key takeaways for clinical strategy

For branded legacy products, clinical strategy that moves the needle usually targets one of:

  • Label expansion or new dosing evidence (rare for an established stimulant)
  • Evidence supporting real-world persistence and tolerability under payer constraints
  • Evidence generation to reduce friction in switching back and forth

Without new branded clinical development that is specific to 20 mg, the pragmatic clinical decision horizon is:

  • Monitor pipeline shifts in ADHD alternatives that could shift prescriber patterns
  • Track payer policy that can change initiation and persistence

Key takeaways for market strategy

  • Adderall 20 is not marketed as an innovation; it is a strength within a legacy branded family
  • The revenue outlook tracks Adderall branded performance, which is primarily driven by generic competition and payer contracting
  • Projection should be built from branded family totals and strength mix assumptions rather than expecting strength-specific trial catalysts

Key Takeaways

  • Adderall 20 is best treated as a tablet strength within branded amphetamine mixed salts, so its market fate follows broader Adderall branded economics.
  • The most material “clinical trials update” for Adderall 20 is indirect: class-level innovations and real-world evidence that shift ADHD prescribing and persistence.
  • Generic substitution and payer coverage dominate near-term volume and net price outcomes more than any 20 mg-specific clinical development.
  • A robust forecast uses Adderall family volume plus strength mix and models persistence and formulary dynamics under base, bull, and bear scenarios.

FAQs

1) Is Adderall 20 a distinct drug or a separate clinical program?
No. “Adderall 20” refers to the 20 mg tablet strength within the branded amphetamine mixed salts product family.

2) Do clinical trials specifically for 20 mg drive the commercial outlook?
Not typically. Market drivers usually come from payer policy, generic substitution, and therapeutic class developments, not strength-specific trials for a legacy formulation.

3) What is the biggest market risk for Adderall 20?
Direct generic substitution of amphetamine mixed salts tablets and payer contracting that favors generics over the branded product.

4) What is the biggest upside lever for branded Adderall strength demand?
Improved branded persistence and net pricing stability through formulary and contracting outcomes, supported by stable prescriber and patient behavior.

5) How should projection be structured without strength-level reporting?
Forecast Adderall branded totals and apply an assumed strength mix for 20 mg based on typical titration and dosing distribution.


References

[1] FDA. Drug Approval Package: Adderall (amphetamine-dextroamphetamine). US Food and Drug Administration.
[2] FDA. Drug Trials Snapshots. US Food and Drug Administration.
[3] NIH ClinicalTrials.gov. ClinicalTrials.gov search results for amphetamine mixed salts and ADHD (trial listings). National Library of Medicine.
[4] IMS/DRUG pipeline and market references are not used here because no strength-level or branded net-price dataset was cited in the prompt-provided materials.

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