CLINICAL TRIALS PROFILE FOR DESOXYN

All Clinical Trials for DESOXYN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01967381 ↗	Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse	Completed	National Institute on Drug Abuse (NIDA)	Early Phase 1	2013-10-01	The research proposed in this application will determine the initial efficacy, safety and tolerability of a novel drug combination, oxazepam (Serax®) and naltrexone (Revia®), as a pharmacotherapy for methamphetamine (Desoxyn®) dependence. A rigorous, inpatient human laboratory study will be conducted. The proposed study is innovative and important because it will provide the impetus for the conduct of double blind, placebo-controlled trials to further demonstrate the efficacy of combined oxazepam and naltrexone for managing methamphetamine dependence.
NCT01967381 ↗	Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse	Completed	University of Kentucky	Early Phase 1	2013-10-01	The research proposed in this application will determine the initial efficacy, safety and tolerability of a novel drug combination, oxazepam (Serax®) and naltrexone (Revia®), as a pharmacotherapy for methamphetamine (Desoxyn®) dependence. A rigorous, inpatient human laboratory study will be conducted. The proposed study is innovative and important because it will provide the impetus for the conduct of double blind, placebo-controlled trials to further demonstrate the efficacy of combined oxazepam and naltrexone for managing methamphetamine dependence.
NCT02058966 ↗	Pilot Study of Entacapone for Methamphetamine Abuse	Completed	Portland VA Medical Center	Early Phase 1	2014-06-01	Addiction to methamphetamine is a serious health problem. There are no medications that a doctor can give someone to help them stop using methamphetamine. Entacapone (Comtan©) is a medication that could help people addicted to methamphetamine. This study will see how entacapone works in healthy people who are given methamphetamine. We think that the study drug will be well tolerated, and that it will prevent some of the effects of methamphetamine that make it so addictive. We also want to see how differences in people's genes may cause differences in the ways the study drug and methamphetamine work for them. The study has six total visits. The first visit is for screening. Tests and procedures will make sure it is safe for subjects to participate. The second visit is a familiarization day. Subjects will receive methamphetamine, but no entacapone. This is done to make sure they can tolerate the drug and recognize its effects before being given a second drug on the same day. Subjects will take surveys and computer tests to see how the medications change mood, thinking, and liking the drug. The final four visits are the actual study days. Subjects will be randomly assigned (like the flip of a coin) to the different ways to get either 1) study medication or placebo (placebo contains no active study medication) and then 2) methamphetamine or placebo. Subjects will be in all four groups during the study, which means that each day a subject will get a different group.
NCT02058966 ↗	Pilot Study of Entacapone for Methamphetamine Abuse	Completed	Oregon Health and Science University	Early Phase 1	2014-06-01	Addiction to methamphetamine is a serious health problem. There are no medications that a doctor can give someone to help them stop using methamphetamine. Entacapone (Comtan©) is a medication that could help people addicted to methamphetamine. This study will see how entacapone works in healthy people who are given methamphetamine. We think that the study drug will be well tolerated, and that it will prevent some of the effects of methamphetamine that make it so addictive. We also want to see how differences in people's genes may cause differences in the ways the study drug and methamphetamine work for them. The study has six total visits. The first visit is for screening. Tests and procedures will make sure it is safe for subjects to participate. The second visit is a familiarization day. Subjects will receive methamphetamine, but no entacapone. This is done to make sure they can tolerate the drug and recognize its effects before being given a second drug on the same day. Subjects will take surveys and computer tests to see how the medications change mood, thinking, and liking the drug. The final four visits are the actual study days. Subjects will be randomly assigned (like the flip of a coin) to the different ways to get either 1) study medication or placebo (placebo contains no active study medication) and then 2) methamphetamine or placebo. Subjects will be in all four groups during the study, which means that each day a subject will get a different group.

Clinical Trial Conditions for DESOXYN

Condition Name

Condition Name for DESOXYN
Intervention	Trials
Methamphetamine Dependence	2
Methamphetamine-dependence	2
HIV-1-infection	1
Methamphetamine Abuse	1

Condition MeSH

Condition MeSH for DESOXYN
Intervention	Trials
Substance-Related Disorders	1
HIV Infections	1
Acquired Immunodeficiency Syndrome	1

Clinical Trial Locations for DESOXYN

Trials by Country

Trials by Country for DESOXYN
Location	Trials
United States	4

Trials by US State

Trials by US State for DESOXYN
Location	Trials
Oregon	2
Kentucky	1
California	1

Clinical Trial Progress for DESOXYN

Clinical Trial Phase

Clinical Trial Phase for DESOXYN
Clinical Trial Phase	Trials
Phase 4	2
N/A	1
Early Phase 1	2

Clinical Trial Status

Clinical Trial Status for DESOXYN
Clinical Trial Phase	Trials
Completed	3
Recruiting	2

Clinical Trial Sponsors for DESOXYN

Sponsor Name

Sponsor Name for DESOXYN
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	2
Portland VA Medical Center	2
Oregon Health and Science University	2

Sponsor Type

Sponsor Type for DESOXYN
Sponsor	Trials
Other	5
NIH	2
U.S. Fed	2

Desoxyn (methamphetamine hydrochloride): Clinical-trial status, market snapshot, and sales projection framework

Last updated: April 29, 2026

What is Desoxyn and who sells it?

Desoxyn is the U.S. brand of methamphetamine hydrochloride, an FDA-approved central nervous system stimulant indicated for ADHD and for short-term management of exogenous obesity in selected patients.

What is the current clinical-trials landscape for Desoxyn?

A clinical-trials update for “Desoxyn” requires trial records that explicitly name the brand drug. Public registries generally list the active ingredient (methamphetamine) rather than the brand (Desoxyn), and most records involving methamphetamine focus on different indications, formulations, or investigational products. Under the operating constraints here, a complete, accurate “Desoxyn-specific” clinical-trials update cannot be produced without verified brand-level trial identity.

What does the market look like for prescription methamphetamine brands?

U.S. prescribing demand

Methamphetamine prescriptions in the U.S. are driven by:

• Stimulant use patterns for ADHD and
• Access to alternatives (methylphenidate and amphetamine salts)

Brand-level revenue for Desoxyn typically behaves like a small, niche controlled-substance asset:

• steady but limited demand
• strong payer and prescriber gatekeeping
• sensitivity to generic availability in adjacent categories (not necessarily for Desoxyn itself)

Price and reimbursement

For niche CNS stimulants, U.S. net price is usually shaped by:

• WAC-to-net discounts (PBM rebates and contracting)
• patient mix (commercial vs Medicare vs Medicaid)
• prior authorization and formulary placement

A reliable market model for Desoxyn requires brand-level pricing, script volume, and net sales history. Without those verified inputs, a numeric projection cannot be stated under the accuracy constraint.

How should you project Desoxyn sales? (Framework)

A defensible projection model for Desoxyn uses a script-volume approach rather than a broad market-size approach.

Core model components

1. Total addressable scripts (ADHD + obesity)
2. Market share of Desoxyn among methamphetamine prescriptions
3. Net price per prescription (blended by payer)
4. Formulary friction (prior auth rates, step edits, coverage)
5. Controlled-substance regulatory environment (supply and prescribing constraints)

Projection equations

• Annual prescriptions = Addressable prescriptions × Desoxyn share
• Annual revenue = Annual prescriptions × Net price
• Growth = (change in addressable prescriptions) + (change in share) + (change in net price)

Sensitivity drivers

• Shift in ADHD prescribing toward or away from methamphetamine-based therapy
• Changes in formulary placement or step therapy outcomes
• Availability and distribution stability

What can be concluded from a brand-level positioning view?

Even without a numeric projection, the business mechanics for a small, controlled-substance brand are clear:

• Revenue is dominated by maintenance of a narrow prescriber base
• Upside comes from coverage expansion, not label expansion
• Downside is mostly access loss (formulary tightening, PA friction, supply constraints)

Key Takeaways

• Desoxyn is a U.S. brand of methamphetamine hydrochloride for ADHD and short-term exogenous obesity.
• A complete Desoxyn-specific clinical-trials update cannot be produced here because public trial records commonly index by active ingredient and do not consistently identify Desoxyn as the enrolled product.
• A reliable sales projection requires brand-level historical net sales or script and price inputs; absent verified brand data, any numeric projection would not meet the accuracy constraint.
• The correct projection method is a scripts times net price model driven by formulary access and prescribing share, not a generic “market growth” estimate.

FAQs

1) Is Desoxyn still FDA-approved?
Yes. Desoxyn remains an FDA-approved prescription product containing methamphetamine hydrochloride for its labeled indications.

2) Are Desoxyn clinical trials listed under the brand name in registries?
Often not. Many registries list trials under the active ingredient or an investigational formulation rather than the marketed brand, which complicates brand-specific updates.

3) What drives Desoxyn revenue more: price or volume?
For niche CNS stimulants, revenue is typically more sensitive to script volume and access (coverage and PA friction) than to small net price changes.

4) Can label expansion materially change Desoxyn sales?
Yes in theory, but in practice, Desoxyn’s commercial profile is usually constrained by access and controlled-substance prescribing dynamics; most near-term movement comes from formulary access rather than expansion.

5) What are the main risks in projecting Desoxyn demand?
Coverage changes (formulary/PA), prescribing shifts within ADHD stimulant choices, and supply chain stability for a controlled-substance product.

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References

[1] U.S. Food and Drug Administration. Desoxyn (methamphetamine hydrochloride) prescribing information. FDA Drug Label information.