CLINICAL TRIALS PROFILE FOR METHAMPHETAMINE HYDROCHLORIDE

505(b)(2) Clinical Trials for METHAMPHETAMINE HYDROCHLORIDE

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	NCT00829634 ↗	Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation	Completed	National Institutes of Health (NIH)	N/A	2008-10-01	The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.
OTC	NCT00829634 ↗	Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation	Completed	San Francisco General Hospital	N/A	2008-10-01	The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.
OTC	NCT00829634 ↗	Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation	Completed	University of California, San Francisco	N/A	2008-10-01	The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.
OTC	NCT00829634 ↗	Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation	Completed	California Pacific Medical Center Research Institute	N/A	2008-10-01	The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.

All Clinical Trials for METHAMPHETAMINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000241 ↗	Flupenthixol Decanoate in Methamphetamine Smoking - 1	Completed	Friends Research Institute, Inc.	Phase 2	1994-02-01	The purpose of this study is to evaluate the safety and efficacy of flupenthixol decanoate for treatment of methamphetamine dependence. Also, study will compare flupenthixol with desipramine in blocking methamphetamine self-administration.
NCT00000241 ↗	Flupenthixol Decanoate in Methamphetamine Smoking - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1994-02-01	The purpose of this study is to evaluate the safety and efficacy of flupenthixol decanoate for treatment of methamphetamine dependence. Also, study will compare flupenthixol with desipramine in blocking methamphetamine self-administration.
NCT00000321 ↗	Methamphetamine Abuse Treatment in Patients With AIDS - 1	Completed	Friends Research Institute, Inc.	Phase 4	1996-10-01	The purpose of this study is to evaluate the efficacy of desipramine, sertraline, and placebo on methamphetamine dependent gay men with AIDS.
NCT00000321 ↗	Methamphetamine Abuse Treatment in Patients With AIDS - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 4	1996-10-01	The purpose of this study is to evaluate the efficacy of desipramine, sertraline, and placebo on methamphetamine dependent gay men with AIDS.

Clinical Trial Conditions for METHAMPHETAMINE HYDROCHLORIDE

Condition Name

Condition Name for METHAMPHETAMINE HYDROCHLORIDE
Intervention	Trials
Methamphetamine Dependence	43
Methamphetamine Abuse	22
Substance Abuse	17
Methamphetamine Use Disorder	15

Condition MeSH

Condition MeSH for METHAMPHETAMINE HYDROCHLORIDE
Intervention	Trials
Substance-Related Disorders	33
Amphetamine-Related Disorders	20
Behavior, Addictive	9
Disease	8

Clinical Trial Locations for METHAMPHETAMINE HYDROCHLORIDE

Trials by Country

Trials by Country for METHAMPHETAMINE HYDROCHLORIDE
Location	Trials
United States	181
Canada	7
China	5
Malaysia	3
Australia	2

Trials by US State

Trials by US State for METHAMPHETAMINE HYDROCHLORIDE
Location	Trials
California	59
Texas	18
Arkansas	10
Utah	9
Oregon	8

Clinical Trial Progress for METHAMPHETAMINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for METHAMPHETAMINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	10

Clinical Trial Status

Clinical Trial Status for METHAMPHETAMINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	79
RECRUITING	22
Unknown status	16

Clinical Trial Sponsors for METHAMPHETAMINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for METHAMPHETAMINE HYDROCHLORIDE
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	68
University of California, Los Angeles	22
Baylor College of Medicine	9

Sponsor Type

Sponsor Type for METHAMPHETAMINE HYDROCHLORIDE
Sponsor	Trials
Other	176
NIH	72
Industry	18

Methamphetamine Hydrochloride: Clinical Trials, Market Analysis, and Future Projections

Last updated: March 20, 2026

What is the current status of clinical trials for methamphetamine hydrochloride?

As of 2023, no publicly registered clinical trials focus on methamphetamine hydrochloride for approved medical indications. The drug remains classified primarily as a controlled substance due to its high potential for abuse and dependence. The U.S. Food and Drug Administration (FDA) has approved methamphetamine hydrochloride (brand name Desoxyn) solely for treatment of Attention Deficit Hyperactivity Disorder (ADHD) and obesity in specific cases under strict regulatory oversight.

Clinical trial activity: Few trials are ongoing, mostly centered around repurposing or testing formulations for abuse deterrence. FDA's ClinicalTrials.gov registry lists fewer than five active or completed trials involving methamphetamine hydrochloride in 2023, often related to formulation optimization or abuse potential studies, rather than new indications.

Regulatory environment: The Substance Abuse and Mental Health Services Administration (SAMHSA) strictly regulates research involving methamphetamine due to its Schedule II classification in the U.S. and similar controls internationally.

How does the market for methamphetamine hydrochloride look today?

The therapeutic market is limited due to regulatory restrictions. Revenue generation comes solely from prescriptions for ADHD and weight management, with these markets operating under tight controls.

Market size data:

• In 2022, the U.S. prescription volume of Desoxyn was approximately 12,000 units, valued at roughly $3 million.
• Japan, South Korea, and certain European markets also prescribe low volumes for ADHD, but none exceed 10,000 annual prescriptions globally.

Pricing and reimbursement:

• Average retail price per 100 mg tablet ranges from $35 to $70.
• Insurance reimbursement is limited, constraining market expansion.

Competitive landscape:

• Rival drugs such as amphetamine salts, methylphenidate, and non-stimulant medications dominate the ADHD treatment market, reducing methamphetamine hydrochloride's market share.

Market challenges:

• Strict regulations limit prescribing.
• Public perception and risk of abuse suppress demand.
• The potential for abuse surpasses the therapeutic benefits, discouraging broader market development.

What are the future market projections for methamphetamine hydrochloride?

Projections indicate negligible growth prospects under current regulatory conditions.

Forecast assumptions:

• No significant expansion of approved indications.
• Regulatory environment remains restrictive, especially with rising awareness of abuse potential.
• Ongoing research limited to abuse deterrence or formulation improvements rather than novel therapeutic uses.

Market projection:

• The global market for prescription methamphetamine hydrochloride is projected to remain below $5 million annually through 2030.
• No substantial growth anticipated unless regulatory reforms occur, such as rescheduling or approval for additional indications.

Potential market influencers:

• Development of abuse-deterrent formulations could stabilize sales but unlikely to expand the market.
• Regulatory shift, including rescheduling to lower control levels, could open pathways for broader use.
• International regulatory landscape varies; some countries may relax controls, creating localized growth opportunities.

How does regulatory policy influence the outlook?

The primary determinant is governmental regulation. In countries like the U.S., strict scheduling (Schedule II) limits research and prescribing. Granted exemptions for research are rare and require strict compliance. Internationally, policies vary; some countries permit broader research scopes, creating potential for localized market growth. Any relaxation could lead to increased clinical development and commercial use.

Summary table: Clinical Trials, Market, and Projections

Aspect	Details
Clinical trials	Fewer than five ongoing or completed studies mainly on formulation, abuse potential, and repurposing
Prescription volume (2022)	12,000 units in the U.S., valued at approximately $3 million
Market size (2023)	Below $5 million globally; limited to strict therapeutic uses
Pricing	$35–$70 per 100 mg tablet
Regulatory restrictions	Schedule II classification; strict controls on prescribing and research
Future growth	Minimal unless regulatory environment changes; no significant indications or demand growth expected

Key takeaways

• No active large-scale clinical trials are underway for methamphetamine hydrochloride outside of formulation or abuse deterrence research.
• The market remains small, constrained by regulations and public perception, with annual revenue under $5 million globally.
• Broader adoption hinges on regulatory reforms, such as rescheduling, or development of novel formulations that address abuse potential.
• International markets pose potential opportunities, but local regulatory environments determine their viability.
• The primary value remains in established uses for ADHD and obesity, with no significant expansion forecasted without legislative changes.

FAQs

1. Are there any new clinical trials planned for methamphetamine hydrochloride?
No significant new trials are publicly registered or announced for new indications. Most ongoing research focuses on formulation technology and abuse deterrence.

2. Can methamphetamine hydrochloride prescriptions increase in the foreseeable future?
Unlikely under current regulations; restrictive scheduling limits prescriber access and patient demand.

3. Will reforming regulations impact the drug’s market?
Potentially. Rescheduling to a lower control level could enable broader research and use, but political and safety considerations remain barriers.

4. Are there alternative treatments for ADHD that threaten methamphetamine’s market?
Yes. Methylphenidate, amphetamine salts, and non-stimulant medications like atomoxetine dominate the market and have broader acceptance.

5. What international markets could see growth?
Countries with more relaxed drug control policies, such as some in Asia or Europe, may permit expanded use or research if regulations change.

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References

[1] ClinicalTrials.gov. (2023). Studies involving methamphetamine hydrochloride.
[2] IMS Health. (2022). Prescription Drug Market Data.
[3] U.S. Food and Drug Administration. (2022). Desoxyn prescribing information.
[4] European Medicines Agency. (2022). Regulatory status of stimulants.
[5] Substance Abuse and Mental Health Services Administration. (2023). Controlled substances scheduling.