CLINICAL TRIALS PROFILE FOR AMPHETAMINE

505(b)(2) Clinical Trials for Amphetamine

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
New Indication	NCT01189214 ↗	Psychopharmacotherapy in Multiple Substances Abuse	Completed	National Institutes of Health (NIH)	Phase 3	2009-03-01	Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12 weeks after adjusted methadone dose. During the study, the investigators will evaluate treatment response and adverse effect from multiple dimensions to elucidate the therapeutic effect of add-on memantine on addictive behaviors. It will also explore the possible advantage of this treatment on social re-adaptation and psychopathogenesis of opioid dependence.
New Indication	NCT01189214 ↗	Psychopharmacotherapy in Multiple Substances Abuse	Completed	National Cheng-Kung University Hospital	Phase 3	2009-03-01	Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12 weeks after adjusted methadone dose. During the study, the investigators will evaluate treatment response and adverse effect from multiple dimensions to elucidate the therapeutic effect of add-on memantine on addictive behaviors. It will also explore the possible advantage of this treatment on social re-adaptation and psychopathogenesis of opioid dependence.
OTC	NCT01736332 ↗	Factors Affecting Methamphetamine and Opiates Drug Testing	Completed	National Institute on Drug Abuse (NIDA)	Phase 1	2012-07-19	Background: - Some legal over-the-counter drugs (such as Vicks VapoInhaler ) and some foods (such as poppy seeds) may cause a positive screening drug test. This might look like someone used illegal drugs (such as methamphetamines or opiates) when they did not. Researchers are studying how the body handles chemicals that may test like illegal drugs and for how long they may be detected in the body. Blood, saliva, and urine samples will be collected. This study may help improve the effectiveness and accuracy of drug tests. Objectives: - To see how the body handles chemicals that may produce positive screening tests and how additional testing can eliminate positive drug tests from over-the-counter drugs and food. Eligibility: - Healthy volunteers between 18 and 65 years of age. Design: - Participants are screened with a physical exam, medical history, laboratory tests, and ECG. - This study involves an overnight stay on a secure research unit and 2 days of tests. - On the first day, participants will take Vicks VapoInhaler (two inhalations in each nostril) every 2 hours from 9 a.m. to 7 p.m. They will also take a drink containing poppy seeds twice (at about 9 a.m. and 5 p.m.). - On the morning of the second day, participants will take the Vicks VapoInhaler just once. They will be discharged around 5 p.m. - On both days, participants will provide blood and saliva samples several times throughout the day. All of their urine will be collected during the 2 study days....

All Clinical Trials for Amphetamine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000305 ↗	Amphetamine Cocaine Interaction Study - 2	Terminated	National Institute on Drug Abuse (NIDA)	Phase 1	1969-12-31	The purpose of this study is to evaluate results of d-amphetamine - cocaine (pharmacology) interaction study.
NCT00000305 ↗	Amphetamine Cocaine Interaction Study - 2	Terminated	University of Texas	Phase 1	1969-12-31	The purpose of this study is to evaluate results of d-amphetamine - cocaine (pharmacology) interaction study.
NCT00000305 ↗	Amphetamine Cocaine Interaction Study - 2	Terminated	The University of Texas Health Science Center, Houston	Phase 1	1969-12-31	The purpose of this study is to evaluate results of d-amphetamine - cocaine (pharmacology) interaction study.
NCT00000308 ↗	Dextroamphetamine-Cocaine Behavioral Intervention - 5	Completed	University of Texas	Phase 2	1995-09-01	The purpose of this study is to examine dextroamphetamine-cocaine behavioral intervention in cocaine dependent patients.

Clinical Trial Conditions for Amphetamine

Condition Name

Condition Name for Amphetamine
Intervention	Trials
Healthy	16
Attention Deficit Hyperactivity Disorder	13
ADHD	10
Cocaine Dependence	9

Condition MeSH

Condition MeSH for Amphetamine
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	40
Disease	29
Hyperkinesis	26
Cocaine-Related Disorders	18

Clinical Trial Locations for Amphetamine

Trials by Country

Trials by Country for Amphetamine
Location	Trials
United States	150
Canada	15
Germany	12
Switzerland	8
France	6

Trials by US State

Trials by US State for Amphetamine
Location	Trials
California	20
Texas	16
New York	15
Florida	11
Pennsylvania	9

Clinical Trial Progress for Amphetamine

Clinical Trial Phase

Clinical Trial Phase for Amphetamine
Clinical Trial Phase	Trials
PHASE4	3
PHASE1	2
Phase 4	33

Clinical Trial Status

Clinical Trial Status for Amphetamine
Clinical Trial Phase	Trials
Completed	111
Recruiting	25
Not yet recruiting	10

Clinical Trial Sponsors for Amphetamine

Sponsor Name

Sponsor Name for Amphetamine
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	29
Shire	11
University of California, Los Angeles	9

Sponsor Type

Sponsor Type for Amphetamine
Sponsor	Trials
Other	216
Industry	46
NIH	43

Amphetamine: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

What is the current clinical-trials landscape for amphetamine (therapeutic use)?

Amphetamine is an established central nervous system stimulant used for attention-deficit/hyperactivity disorder (ADHD) and (in many jurisdictions) narcolepsy. Public clinical-trials visibility is fragmented because “amphetamine” also functions as a catch-all for multiple pharmaceutical forms and legacy generics, and because many studies are conducted under specific brand or salt naming rather than “amphetamine” as a single compound label. As a result, the most reliable high-level read-through for current activity comes from trial registries that segment by specific product concepts (immediate-release, extended-release, prodrug or delivery variants).

Net clinical read-through (what market participants act on)

• Active development in amphetamine-related space typically targets duration control (extended-release formulations), abuse-deterrence (where required by payer or regulatory expectations), and patient-friendly dosing (lower pill burden, smoother pharmacokinetic curves).
• Trial activity is usually small-to-mid scale and designed for label expansion or comparative performance against existing stimulant standards rather than for de novo proof of core efficacy in ADHD, because efficacy is already established historically.

Practical implication for investors/R&D

• Treat “amphetamine” trial updates as a portfolio read (formulation and differentiation) rather than as “new mechanism” discovery. Most value creation in recent years concentrates in formulation IP, regulatory exclusivity tactics, and lifecycle management.

Which filings and regulatory dynamics shape amphetamine market continuity?

Amphetamine’s market continuity hinges on three levers:

1. Patent and exclusivity stack for specific formulations/variants (not the base molecule alone).
2. Generic entry timing and bioequivalence pathways for existing IR and ER presentations.
3. Regulatory labeling and controlled-substance compliance that constrains distribution channels and drives payer behavior.

What drives near-term adoption

• Payer preference usually aligns to system-level cost control and clinical predictability of the selected release profile (IR vs ER).
• Clinicians often keep patients on a formulation that matches symptom control and tolerability, which strengthens incumbent hold and makes trial endpoints typically focused on pharmacokinetics and day-to-day symptom coverage.

What is the market size and pricing structure for amphetamine-based ADHD/narcolepsy therapy?

The amphetamine market is best analyzed as part of the stimulant ADHD treatment landscape, where amphetamine formulations compete with:

• methylphenidate-based products,
• lisdexamfetamine-based products (a related but distinct prodrug category in many markets),
• and other stimulant or non-stimulant alternatives depending on local prescribing patterns.

Market structure

• Core demand is patient prevalence in diagnosed ADHD and treated narcolepsy.
• Formulation mix (IR vs ER) influences gross-to-net economics because rebates and pharmacy benefit design target specific product categories and plan formularies.
• Generic penetration typically exerts downward pricing pressure, but differentiation in ER and abuse-deterrent (where applicable) can sustain price premiums relative to pure generic IR.

Pricing reality

• For established stimulant actives, pricing is usually driven by contracting cycles, formulary placement, and rebate structures more than by wholesale list prices.
• Where generics dominate, market growth comes more from share shifts across formulary preference than from unit price expansion.

How should the amphetamine market be projected over the next 5 to 10 years?

A forward projection for “amphetamine” should be modeled as a share-and-formulation story with three scenario drivers:

1) Diagnosis and persistence

• ADHD and narcolepsy remain chronic or long-duration conditions in practice, which supports steady demand growth.
• Persistence rates and dose titration patterns are the key unit drivers, particularly for pediatrics transitioning through school years.

2) Competitive pressure inside stimulants

• Generic competition compresses margins for non-differentiated products.
• Differentiated ER profiles can retain higher pricing versus basic IR generics.

3) Policy and controlled-substance risk controls

• Monitoring, dispensing restrictions, and payer controls can shift market share between brands, controlled-substance packaging formats, and compliant distribution channels.
• Abuse-deterrent or lower-diversion designs (where adopted) can influence payer and pharmacy adoption even if efficacy is similar.

Base-case projection logic (directional)

• Units: modest growth tied to prevalence, increased diagnosis, and continued stimulant use.
• Value: slower growth than units in the presence of ongoing generic penetration, unless a differentiated formulation class captures meaningful share.

What is the likely evolution of amphetamine R&D priorities?

Market winners in amphetamine-adjacent development typically optimize for:

• Extended exposure profiles aligned to school/work schedules.
• Differentiated pharmacokinetics for smoother symptom control and lower “wear-off” variability.
• Compliance and risk mitigation that align with payer and prescriber requirements.

This translates into development programs that look like:

• bioequivalence and formulation studies,
• randomized crossover PK/PD studies for dose timing and duration,
• pragmatic studies focused on endpoints such as functional improvement and tolerability in real-world ADHD dosing schedules.

Where are the investment hotspots in amphetamine-related space?

Given amphetamine’s established core efficacy, “hotspots” concentrate in:

• Formulation IP (IR-to-ER reformulation, release mechanisms, particle engineering).
• Lifecycle management through regulatory strategies that extend exclusivity around specific product presentations.
• Brand or authorized-generic strategies that control channel economics post-LOE.

A practical investment filter:

• Prefer assets with a clear product concept and identifiable label hooks (titration ease, duration alignment, safety messaging).
• Treat “amphetamine” generically as a legacy active unless tied to a specific salt/formulation product with enforceable IP or a distinct regulatory pathway.

Key clinical trial endpoints that matter for amphetamine product launches

Across amphetamine-associated formulation trials, development programs typically anchor on:

• ADHD symptom rating scale improvement (when required for label expansion).
• Pharmacokinetics (Cmax, Tmax, AUC) and day-long exposure profiles for ER performance claims.
• Safety and tolerability (vital signs, appetite/weight effects, sleep impact, and stimulant class AEs).
• Functional outcomes (classroom or work function) when payer or label strategy demands it.

Key Takeaways

• Amphetamine is a mature stimulant active; current clinical activity concentrates on formulation differentiation (especially extended-release and risk-management design), not new mechanism validation.
• Market growth is driven by diagnosis and persistence, while value growth depends on whether a product presentation holds share against generic competition.
• Over 5 to 10 years, the most investable opportunities are tied to enforceable formulation/IP, defensible regulatory claims, and payer-relevant differentiation.

FAQs

1. Is “amphetamine” development mainly new molecular entities?
   No. Most current visible activity around the active class is formulation and lifecycle oriented.

2. Does amphetamine pricing benefit from differentiation?
   Yes, when differentiation supports sustained formulary placement versus generic IR exposure.

3. What endpoints most often determine whether an amphetamine formulation can win share?
   PK exposure for day-long coverage, tolerability, and any symptom control or functional endpoints needed for label or payer requirements.

4. How does generic entry typically affect amphetamine market value?
   It compresses value growth through lower net pricing while unit volumes may keep growing modestly.

5. What is the most defensible R&D angle in amphetamine-related programs?
   Extended-release performance, dosing convenience, and any risk or abuse-deterrence claims that align with regulatory and payer adoption.

References

[1] U.S. FDA. Drugs@FDA: Drug Product databases and labeling information. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] ClinicalTrials.gov. Amphetamine trials search results and study records. https://clinicaltrials.gov/
[3] World Health Organization. Guidelines and background materials on ADHD and stimulant use (general reference set). https://www.who.int/
[4] FDA. Guidance for Industry: Bioequivalence studies and related PK assessment principles. https://www.fda.gov/