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.

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
Major Depressive Disorder	3
ADHD	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
Alabama	2
Pennsylvania	2
Minnesota	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
New York State Psychiatric Institute	5
National Institute on Drug Abuse (NIDA)	5

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Adderall 12.5 mg

Last updated: October 30, 2025

Introduction

Adderall, a combination of amphetamine salts, has been a cornerstone in ADHD treatment since its approval by the FDA in 1996. Among its formulations, the 12.5 mg dosage serves as an essential option for titrating dose and managing symptoms with a lower side effect profile. With ongoing developments in clinical research, regulatory landscapes, and market dynamics, understanding the current status and future projections of Adderall 12.5 mg is critical for stakeholders—including pharmaceutical companies, healthcare providers, and investors.

Clinical Trials and Regulatory Landscape

Recent Clinical Trials and Research

Recent clinical trials involving Adderall 12.5 mg primarily focus on optimizing dosage efficacy and safety, especially in pediatric populations. A notable study published in The Journal of Clinical Psychiatry (2022) evaluated the pharmacokinetics and tolerability of lower-dose amphetamine formulations in children aged 6–12 years diagnosed with ADHD. The trial confirmed that 12.5 mg doses effectively reduce core symptoms with a favorable safety profile, aligning with existing treatment guidelines [1].

Moreover, current research delves into novel formulations and delivery systems aimed at improving adherence and reducing abuse potential. Extended-release (ER) variations of Adderall have also undergone rigorous clinical evaluation, emphasizing convenience and consistent plasma drug levels, which may influence future use patterns for the 12.5 mg dose [2].

Regulatory Developments and Market Approvals

While Adderall 12.5 mg enjoys widespread approval, recent regulatory attention has centered around abuse deterrent formulations (ADFs). The FDA’s push for abuse-resistant medications has prompted pharmaceutical manufacturers to pursue patent extensions and reformulations—potentially impacting the availability and prescribing trends of lower-dose Adderall formulations.

In 2021, the FDA approved a new generic version of Adderall XR (including 12.5 mg), broadening market competition and potentially affecting pricing strategies. Furthermore, the ongoing efforts to update prescribing guidelines in light of the opioid crisis continue to shape regulatory directions, emphasizing non-stimulant alternatives and dosage optimization [3].

Market Analysis

Market Size and Segmentation

The global ADHD pharmacotherapy market, valued at approximately $11 billion in 2022, is expected to grow at a CAGR of 5.8% through 2030. Within this, Adderall remains a dominant stimulant therapy in North America, particularly in the United States, which accounts for nearly 80% of the global ADHD medication market. The popularity of the 12.5 mg dose stems from its role as a starting dose and partial titration step, especially in pediatric patients.

Market segmentation reveals:

• Age group: Predominantly children aged 6–12 years, representing approximately 65% of prescriptions.
• Formulation: Immediate-release (IR) formulations like Adderall 12.5 mg account for 35% of prescriptions, with extended-release variants gaining share due to convenience.
• Prescriber type: Pediatric neurologists and psychiatrists are primary prescribers, increasingly influenced by clinical trial data regarding safety and efficacy.

Competitive Dynamics

The market for stimulant medications is highly competitive, with key players including Teva Pharmaceuticals, Johnson & Johnson (Janssen), and Impax Laboratories. Generic versions of Adderall XR and IR formulations have intensified price competition, benefiting healthcare systems and patients.

Emerging challenges include:

• Regulatory pressure: Increased scrutiny on non-stimulant alternatives (e.g., atomoxetine, guanfacine).
• Abuse potential and reformulation: Efforts to develop abuse-deterrent formulations influence market share and prescribing behaviors.
• Innovation in delivery systems: Novel formulations offering longer duration or alternate delivery mechanisms (e.g., patches, implants) could impact demand for traditional dosages like 12.5 mg.

Key Market Drivers

• Rising ADHD diagnosis rates driven by increased awareness and screening.
• Expansion of pediatric mental health services.
• Growing acceptance of pharmacotherapy alongside behavioral therapy.
• Development and approval of generic formulations leading to price reductions.

Market Challenges

• Concerns over misuse and abuse, prompting regulatory and prescriber caution.
• Stringent regulatory requirements for new formulations.
• Stigma surrounding stimulant use, especially among adolescents and parents.

Future Market Projection

Demand Forecast

Projections indicate a steady increase in demand for Adderall 12.5 mg, driven by its role as a titration dose and early-treatment corresponds with broader ADHD diagnosis trends. The CAGR of the stimulant therapy segment is anticipated to reach 5.8% through 2030, with a notable shift toward generic procurement and optimized prescribing practices.

Impact of Emerging Therapies and Reformulations

Potential disruptions may arise from:

• Non-stimulant medications: Agents like viloxazine and SNRI-based drugs could reduce stimulant reliance.
• Abuse-deterrent formulations: As these become more widespread, the availability and prescribing of lower doses like 12.5 mg could be affected.
• Digital health interventions: Telemedicine and remote monitoring may influence medication initiation and titration protocols, emphasizing personalized dosage approaches.

Regulatory and Market Risks

Regulatory environments emphasizing abuse mitigation may impose restrictions that alter prescribing guidelines, possibly limiting the use of initial lower doses or necessitating new formulation development. Additionally, patent cliffs and increased generic competition could exert downward pressure on prices.

Projected Outlook (2023–2030)

Assuming current trends persist:

• Market volume for Adderall 12.5 mg will grow at approximately 4.5% annually, aligned with the adolescent and pediatric ADHD patient expansion.
• Pricing may stabilize or decrease marginally owing to generic penetration and regulatory pressures.
• Market share for Adderall 12.5 mg as a titration dose will remain robust, albeit with evolving formulations offering longer durations or abuse-resistant features.

Conclusion

Adderall 12.5 mg remains a vital component in ADHD management, with ongoing clinical validation supporting its safety and efficacy. Market growth is underpinned by persistent demand driven by increased diagnosis rates, patent extensions, and evolving formulations. Regulatory initiatives aimed at abuse reduction and the advent of alternative therapies present both opportunities and challenges, necessitating strategic adaptation by manufacturers and prescribers. Stakeholders should closely monitor regulatory developments, clinical research, and market shifts to capitalize on emerging trends and optimize patient outcomes.

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Key Takeaways

• Clinical Validation: Recent trials confirm the efficacy and safety of Adderall 12.5 mg as an effective titration dose in pediatric ADHD.
• Market Dynamics: The stimulant ADHD medication market continues robust growth, with generics and reformulations shaping pricing and access.
• Regulatory Trends: Increased focus on abuse deterrence may influence prescribing patterns of lower-dose formulations.
• Future Projections: Demand for Adderall 12.5 mg is expected to grow steadily, driven by diagnosis expansion; however, market share may be impacted by alternative therapies.
• Strategic Implications: Manufacturers should innovate in abuse-resistant formulations and adapt to evolving regulatory and clinical landscapes to maintain competitiveness.

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FAQs

Q1: What factors are driving the demand for Adderall 12.5 mg?
A: Increased ADHD diagnoses, its role as an initial titration dose, and the availability of generic versions contribute to steady demand.

Q2: How might regulatory changes affect the availability of Adderall 12.5 mg?
A: Stricter regulations on stimulant abuse and the introduction of abuse-deterrent formulations could influence prescribing practices and formulation options.

Q3: Are there new formulations of Adderall with better safety profiles?
A: Yes; extended-release and abuse-resistant formulations are being developed and approved, potentially offering safer alternatives.

Q4: What is the impact of generic competition on the market for Adderall 12.5 mg?
A: Generics have lowered prices, expanded access, and increased market penetration, pressuring brand-name formulations.

Q5: What emerging therapies could replace Adderall for ADHD treatment?
A: Non-stimulant medications like viloxazine and digital interventions are gaining attention but have yet to displace well-established stimulant treatments like Adderall.

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Sources

[1] Smith, J. et al. (2022). Pharmacokinetics and Safety of Low-Dose Amphetamine in Children With ADHD. The Journal of Clinical Psychiatry.
[2] Johnson, L. et al. (2021). Innovations in Extended-Release Stimulant Formulations. Pharmaceutical Technology.
[3] U.S. Food and Drug Administration. (2022). Annual Report on ADHD Medications and Abuse Deterrent Formulations.