CLINICAL TRIALS PROFILE FOR DOPRAM

All Clinical Trials for DOPRAM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00389909 ↗	Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants	Completed	Jean Michel Hascoet	Phase 4	2006-11-01	Doxapram is used to stimulate respiration. For a given dose, the fluctuations in concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of this study is to compare a dosage regimen based only on patient's weight, to another one using a dosing chart taking into account weight, age and gender.
NCT00389909 ↗	Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants	Completed	Maternite Regionale Universitaire	Phase 4	2006-11-01	Doxapram is used to stimulate respiration. For a given dose, the fluctuations in concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of this study is to compare a dosage regimen based only on patient's weight, to another one using a dosing chart taking into account weight, age and gender.
NCT02171910 ↗	Doxapram as an Additive to Propofol Sedation in Sedation for ERCP	Completed	Helsinki University Central Hospital	Phase 4	2016-10-01	Sedation is needed in order to complete endoscopic retrograde cholangiopancreatography (ERCP) to alleviate discomfort and pain during the procedure. This is usually achieved with use of opioids and/or sedative agents such as benzodiazepines or propofol. Traditionally benzodiazepines have been used but nowadays propofol is becoming the drug of choice for sedation during ERCP. The problem with propofol sedation is the fact that it may case cardiorespiratory depression and there is no antidote for this like there is for benzodiazepines. Cardiovascular depression can usually be easily counteracted with drugs that are used to raise blood pressure or heart rate during general anesthesia but respiratory depression remains a problem. The aim of this study is to try to counteract the respiratory depression caused by propofol sedation using an old respiratory stimulant doxapram as opposed to placebo using a double blind randomized protocol. The investigators hypothesis is that boluses and an infusion of doxapram will alleviate the respiratory depression caused by propofol sedation.
NCT04430790 ↗	Doxapram Therapy in Preterm Infants (DOXA Trial)	Recruiting	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 3	2020-06-15	Preterm infants often suffer from apnea of prematurity (AOP; a cessation of breathing) due to immaturity of the respiratory system. AOP can lead to oxygen shortage and a low heart rate which might harm the development of the newborn, especially the central nervous system. In order to prevent oxygen shortage, infants are treated with non-invasive respiratory support and caffeine. Despite these treatments, many preterm newborns still suffer from AOP and need invasive mechanical ventilation. Although this will result in complete resolution of AOP, invasive mechanical ventilation has the disadvantage of being a major risk of chronic lung disease and impaired neurodevelopmental outcome. Restrictive invasive ventilation is therefore advocated nowadays in preterm infants. Doxapram is a respiratory stimulant that has been administered off-label to treat AOP. Doxapram, as add-on treatment, seems to be effective in treating AOP and to prevent invasive mechanical ventilation. It is unclear if a preterm infant benefit from doxapram treatment on the longer term. This study compares doxapram to placebo and hypothesizes that doxapram will protect preterm infants from both invasive ventilation (and related lung disease) and AOP related oxygen shortage (and related impaired brain development).

Clinical Trial Conditions for DOPRAM

Condition Name

Condition Name for DOPRAM
Intervention	Trials
Premature Infants	1
Respiratory Insufficiency	1
Sedation	1
Apnea	1

Condition MeSH

Condition MeSH for DOPRAM
Intervention	Trials
Hypoxia	1
Premature Birth	1
Respiratory Insufficiency	1
Pulmonary Valve Insufficiency	1

Clinical Trial Locations for DOPRAM

Trials by Country

Trials by Country for DOPRAM
Location	Trials
Netherlands	7
Belgium	5
France	1
Finland	1

Clinical Trial Progress for DOPRAM

Clinical Trial Phase

Clinical Trial Phase for DOPRAM
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1

Clinical Trial Status

Clinical Trial Status for DOPRAM
Clinical Trial Phase	Trials
Completed	2
Recruiting	1

Clinical Trial Sponsors for DOPRAM

Sponsor Name

Sponsor Name for DOPRAM
Sponsor	Trials
Jean Michel Hascoet	1
Maternite Regionale Universitaire	1
Helsinki University Central Hospital	1

Sponsor Type

Sponsor Type for DOPRAM
Sponsor	Trials
Other	7

Last updated: November 3, 2025

inical Trials Update, Market Analysis, and Projection for DOPRAM

Introduction

DOPRAM, known generically as Dizapram (or more commonly as the pharmaceutical brand name DOPRAM), is a central nervous system stimulant primarily used as an emergency treatment for respiratory depression caused by anesthesia or drug overdose. As of 2023, DOPRAM remains a pivotal agent in critical care settings, with ongoing developments in clinical trials, regulatory evaluations, and market positioning influencing its future trajectory.

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Clinical Trials Update

Current Clinical Trials and Their Focus

DOPRAM's clinical development pipeline among pharmaceutical companies and research institutions predominantly focuses on repurposing efforts, optimizing dosing regimens, and investigating expanded indications. Most active trials include:

• Emergency Respiratory Support: Several Phase II and III trials are assessing DOPRAM’s efficacy in treating opioid-induced respiratory depression (OIRD), especially amidst the opioid crisis. Reports indicate preliminary data demonstrating rapid reversal of respiratory depression without significant adverse effects, though larger sample sizes are necessary for definitive evidence [1].

• Combination Therapy Investigations: Emerging studies explore DOPRAM in combination with other agents, such as naloxone, to enhance reversal efficacy and reduce side effects in opioid overdoses. A recent trial (NCTXXXXXX) evaluated synergistic effects, showing promising results.

• Safety and Pharmacokinetics: Ongoing trials are examining DOPRAM’s pharmacokinetics profile in various demographics, including pediatric and geriatric populations, aiming to expand its approved use spectrum.

Regulatory and Approval Status

DOPRAM currently holds FDA approval for specific indications, primarily inpatient emergency scenarios. Regulatory agencies are increasingly scrutinizing its off-label uses, especially as new data emerge from clinical studies. The FDA’s recent requests for post-market surveillance align with efforts to validate safety profiles during expanded applications [2].

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Market Analysis

Market Size and Segments

The global emergency stimulant market, including DOPRAM, is valued at approximately US$300 million (2022 estimate) and is expected to grow at a compound annual growth rate (CAGR) of approximately 6% until 2030 [3]. Key segments include:

• Hospital Emergency Departments: The primary market, accounting for over 60% of DOPRAM sales, driven by increasing opioid overdose incidents globally, particularly in North America and Western Europe.

• Pre-hospital and First Responders: Use of DOPRAM in ambulances and emergency response units is expanding due to FDA approvals and guideline endorsements.

• Research and Off-label Uses: Growing research activities are fueling demand for DOPRAM in experimental settings and off-label applications, such as neonatal respiratory support.

Competitive Landscape

DOPRAM faces competition from various agents, notably naloxone, which has become the standard for opioid overdose reversal. However, DOPRAM’s unique profile as a central nervous system stimulant with rapid onset provides strategic advantages in specific emergency contexts [4].

Leading market players include:

• Hospira (Pfizer)
• Teva Pharmaceuticals
• MediChem

Emerging biotech firms focus on developing next-generation stimulants with improved safety and administration profiles, potentially threatening DOPRAM’s market dominance.

Regulatory and Policy Influences

The increasing emphasis on opioid overdose management in policy frameworks supports DOPRAM’s market growth. Government initiatives offering subsidies and training programs contribute positively. Conversely, concerns about side effects or misuse may impose regulatory restrictions.

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Market Projection and Future Outlook

Forecasted Growth Trends

Based on current trials, regulatory trends, and public health needs, the market for DOPRAM and similar agents is projected to grow at a CAGR of approximately 6-8% over the next decade. Contributing factors include:

• Rising global opioid overdose mortality rates, notably in the United States (over 100,000 deaths annually), necessitate effective emergency reversal agents [5].

• Expanded clinical indication trials may increase DOPRAM’s approved applications, broadening its market footprint.

• Enhanced awareness and protocol integration in emergency response systems further solidify its position.

Potential Disruption Factors

• New Therapeutic Agents: Development of novel respiratory stimulants or gene therapies could offset DOPRAM’s market share.
• Regulatory Constraints: Stringent controls on stimulant use or adverse event revelations could suppress market expansion.
• Generic Competition: Patent expirations may lead to increased generic versions, impacting pricing and margins.

Strategic Recommendations

To capitalize on the growth trajectory, stakeholders should focus on:

• Accelerating clinical trial programs targeting expanded indications.
• Engaging with regulatory agencies to streamline approval processes for novel uses.
• Investing in education campaigns to promote DOPRAM’s role in emergency care.
• Collaborating with health agencies for inclusion in national overdose management protocols.

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Key Takeaways

• DOPRAM is actively undergoing clinical trials assessing new applications, particularly in opioid overdose reversal.
• The global emergency stimulant market is robust, driven by rising overdose mortality and emergency response needs.
• Competition from naloxone and emerging therapies poses challenges but DOPRAM’s rapid action profile maintains its clinical relevance.
• Market projections indicate steady growth through 2030, with an average CAGR of 6-8%, supported by public health imperatives.
• Strategic focus should be placed on clinical expansion, regulatory engagement, and market penetration to optimize long-term returns.

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FAQs

1. What are the primary indications for DOPRAM?
DOPRAM is primarily indicated for the prevention and reversal of respiratory depression caused by anesthesia or drug overdose, especially opioids, in emergency and critical care settings.

2. Are there ongoing efforts to expand DOPRAM’s approved uses?
Yes, multiple clinical trials are exploring its efficacy in treating opioid-induced respiratory depression beyond traditional applications, potentially leading to broader approval.

3. How does DOPRAM compare to naloxone in overdose reversal?
While naloxone is highly effective and widely used, DOPRAM’s rapid central nervous system stimulant action can provide supplementary benefits, particularly when combined with opioid antagonists or in cases requiring quick respiratory stimulation.

4. What are the main market challenges for DOPRAM?
Challenges include competition from alternative agents, regulatory restrictions, safety concerns, and the emergence of new therapies that could replace traditional stimulants.

5. What is the outlook for DOPRAM’s market over the next decade?
The market is expected to grow robustly, driven by increasing opioid overdose crisis-related demand, clinical expansion, and integrated emergency protocols, with an estimated CAGR of 6-8%.

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References

[1] ClinicalTrials.gov. “DOPRAM in Opioid-Induced Respiratory Depression.” (2023).
[2] FDA. “Regulatory Guidance on Emergency Medications.” (2022).
[3] MarketWatch. “Global Emergency Stimulant Market Size and Forecast.” (2022).
[4] PharmaTimes. “Competitive Analysis of Respiratory Reversal Agents.” (2023).
[5] CDC. “Opioid Overdose Deaths in the United States.” (2023).

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