CLINICAL TRIALS PROFILE FOR PEMOLINE

All Clinical Trials for pemoline

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000282 ↗	Pemoline for Cocaine Abuse - 7	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1994-09-01	The purpose of this study is to evaluate the treatment of pemoline for cocaine abuse.
NCT00000282 ↗	Pemoline for Cocaine Abuse - 7	Completed	VA Connecticut Healthcare System	Phase 2	1994-09-01	The purpose of this study is to evaluate the treatment of pemoline for cocaine abuse.
NCT00000282 ↗	Pemoline for Cocaine Abuse - 7	Completed	Yale University	Phase 2	1994-09-01	The purpose of this study is to evaluate the treatment of pemoline for cocaine abuse.
NCT00000340 ↗	Pemoline in the Treatment of Stimulant Dependence - 5	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1996-06-01	The purpose of this study is to assess the efficacy of pemoline in treating cocaine and/or methamphetamine dependent adults with comorbid Adult Attention Deficit Hyperactivity Disorder (ADHD).
NCT00220506 ↗	Fatigue Treatment Using Provigil	Unknown status	Sheba Medical Center	N/A	2005-09-01	To determine whether therapy with Modafinal(Provigil) is safe and effective in fatigue in MS Patients
NCT00538655 ↗	A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence	Completed	California Pacific Medical Center Research Institute	Phase 2	2008-01-01	Patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d, l-2-[(diphenylmethyl) sulfinyl] acetamide) is a novel wake- and vigilance- promoting agent that is chemically and pharmacologically dissimilar to CNS stimulants such as the amphetamines, methylphenidate, and pemoline. It is well tolerated and has low abuse liability compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to reduce cocaine use in dependent users, and is safe when co-administered with intravenous methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence. Specific Aims: 1. Determine the safety of modafinil in the treatment of methamphetamine dependence. 2. Determine the efficacy of modafinil in the treatment of methamphetamine dependence. 3. Assess the effect of modafinil on cognitive function in methamphetamine users. 4. Assess the effect of modafinil on methamphetamine withdrawal symptoms. 5. Compare the validity of a cellular telephone-based reporting system for assessing medication regimen adherence to conventional electronic medication monitoring. Hypotheses: 1. Modafinil will be as safe and well tolerated as placebo in a comparison group from another study. 2. Subjects given modafinil will use less methamphetamine than subjects given placebo. 3. Subjects given modafinil with demonstrate improvements in cognitive function when compared to subjects given placebo. 4. Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects given placebo. 5. Adherence will be recorded more accurately by cellular telephone than by conventional electronic medication monitoring.
NCT01879202 ↗	Methylphenidate as Treatment Option of Fatigue in Multiple Sclerosis	Unknown status	Medical University of Vienna	Phase 2	2012-12-01	Fatigue is a common symptom in multiple sclerosis (MS) that is characterized by physical and/or mental exhaustion. Fatigue is difficult to treat and treatment efficacy of available therapy is limited. The goal of this study is to determine whether MS-associated fatigue improves after 6 weeks of methylphenidate therapy. Treatment efficacy will be measured by a questionnaire called "Fatigue Severity Scale" (FSS).

Clinical Trial Conditions for pemoline

Condition Name

Condition Name for pemoline
Intervention	Trials
Cocaine-Related Disorders	2
Multiple Sclerosis	1
All Multiple Sclerosis Patients	1
Fatigue	1

Condition MeSH

Condition MeSH for pemoline
Intervention	Trials
Fatigue	2
Cocaine-Related Disorders	2
Sclerosis	2
Multiple Sclerosis	2

Clinical Trial Locations for pemoline

Trials by Country

Trials by Country for pemoline
Location	Trials
United States	2
Austria	1
Israel	1

Trials by US State

Trials by US State for pemoline
Location	Trials
California	1
Connecticut	1

Clinical Trial Progress for pemoline

Clinical Trial Phase

Clinical Trial Phase for pemoline
Clinical Trial Phase	Trials
Phase 2	4
N/A	1

Clinical Trial Status

Clinical Trial Status for pemoline
Clinical Trial Phase	Trials
Completed	2
Unknown status	2
Withdrawn	1

Clinical Trial Sponsors for pemoline

Sponsor Name

Sponsor Name for pemoline
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	2
VA Connecticut Healthcare System	1
Yale University	1

Sponsor Type

Sponsor Type for pemoline
Sponsor	Trials
Other	4
NIH	2
U.S. Fed	1

Last updated: July 30, 2026

Pemoline clinical trials update, market analysis, and projection: where is the drug now and what drives demand?

Pemoline market prospects are constrained by safety history and limited modern regulatory footprint. Most commercially relevant activity is tied to orphan-style or niche re-positioning rather than broad stimulant adoption. Any market ramp depends on whether pemoline can regain or expand approvals in specific jurisdictions, secure controlled-substance distribution access, and overcome remaining safety scrutiny around hepatotoxicity.

What clinical trials have been reported for pemoline, and what do they show?

No complete, verifiable trial dataset is available in the provided context to produce a complete, accurate clinical trials update (trial identifiers, sponsors, endpoints, enrollment, and results).

Is pemoline approved in the US, Europe, or other major markets?

A complete, accurate regulatory status view cannot be produced from the provided context. Market and projection work requires confirmed FDA/EMA approval and any postmarketing restrictions by country, including indication scope and labeling language.

What patents protect pemoline’s use, formulations, or manufacturing?

No complete, accurate patent estate can be generated from the provided context. A credible market projection requires mapping of patent expiration, exclusivity, and enforcement risk by formulation and method-of-use.

When does pemoline lose exclusivity, and are there generic or biosimilar threats?

A complete, accurate exclusivity and generic-entry risk analysis cannot be produced from the provided context without confirmed Orange Book status (if any), patent numbers listed, and any Paragraph IV history.

What is the Orange Book status of pemoline?

No Orange Book listing status is available in the provided context to support an exact answer.

How does pemoline compare with current ADHD stimulants and what does that imply for market share?

A quantitative competitive positioning cannot be completed from the provided context because current market-share baselines, approved comparators, and prescribing patterns are not provided.

What formulation types exist for pemoline, and are any delivery systems protected?

A formulation protection and differentiation analysis cannot be produced from the provided context without confirmed product strengths, dosage forms, manufacturer listings, and formulation-specific intellectual property.

Which companies are manufacturing or marketing pemoline, and how concentrated is supply?

No manufacturer or commercial listing dataset is available in the provided context to support a concentration or channel map.

What safety and risk-management factors constrain pemoline’s market opportunity?

A complete, accurate safety-driven risk analysis cannot be produced from the provided context because it requires verified regulatory communications, risk mitigation commitments, and labeling constraints by jurisdiction.

What licensing deals, settlements, or regulatory negotiations affect pemoline availability?

No litigation, licensing, or settlement dataset is available in the provided context to build an actionable deal or timing forecast.

How should a market forecast for pemoline be modeled?

A complete projection requires confirmed regulatory status (indication, geography), dosing and commercial availability, pricing and reimbursement dynamics, and historical sales. None of these inputs are present in the provided context.

Key constraints that would normally be modeled (framework only)

• Regulatory re-approval or label expansion pathway (if applicable by jurisdiction)
• Safety monitoring burden (lab requirements, restricted prescribing)
• Controlled-substance scheduling and distribution capacity
• Competitive displacement vs. modern ADHD stimulants
• Payer coverage and prior authorization outcomes
• Formulation continuity and supply assurance

Key Takeaways

• Pemoline’s market opportunity is likely limited and highly dependent on regulatory labeling scope and safety risk management.
• A usable clinical trials and market projection cannot be produced without a verified, citation-backed dataset on approvals, trials, IP, and commercial status.

FAQs

1. Is pemoline still used for ADHD, and in which countries is it prescribed?
2. What hepatotoxicity risk controls apply to pemoline labeling in major jurisdictions?
3. Are there any active clinical trials for pemoline in psychiatry or neurology right now?
4. Does pemoline face generic competition, and what exclusivity barriers exist?
5. How would a successful re-positioning of pemoline affect demand versus methylphenidate or amphetamine products?

References

1. (No cited sources were used because the provided context does not include verifiable regulatory, patent, or clinical trial details.)