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
Apnea of Prematurity	1
Hypoxia	1
Premature Infants	1
Respiratory Insufficiency	1

Condition MeSH

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

Clinical Trial Locations for DOPRAM

Trials by Country

Trials by Country for DOPRAM
Location	Trials
Netherlands	7
Belgium	5
Finland	1
France	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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	1
Nederlands Neonataal Netwerk (N3), the Netherlands	1
Universitaire Ziekenhuizen Leuven	1

Sponsor Type

Sponsor Type for DOPRAM
Sponsor	Trials
Other	7

DOPRAM Market Analysis and Financial Projection

Last updated: February 4, 2026

What Is the Current Status of DOPRAM Clinical Trials?

DOPRAM (doxapram hydrochloride) is an CNS stimulant used primarily to treat respiratory depression. Its current clinical development efforts mainly focus on repurposing for various indications, including neonatal depression, opioid overdose, and anesthesia recovery.

Clinical Trial Landscape (as of early 2023)

• No ongoing Phase III trials registered in ClinicalTrials.gov specifically for DOPRAM.
• Phase II studies have explored its efficacy in neonatal respiratory depression with mixed outcomes.
• An investigator-initiated trial examined DOPRAM as an adjunct in opioid overdose but faced recruitment challenges.

Regulatory Status

• Approved in the United States for respiratory depression under specific indications.
• No recent comprehensive filings for additional indications or label extensions to the FDA (Federal Drug Administration).
• No new drug application (NDA) submissions for expanded uses recorded in recent years.

What Is the Market Size and Segment for DOPRAM?

DOPRAM's market is small compared to the broader respiratory management space but remains relevant in niche applications.

Market Segments

Segment	Description	Estimated Market Size (2023)
Neonatal respiratory depression	Use in NICUs for infants with respiratory depression.	USD 100 million
Opioid overdose management	Adjunct in emergency settings for opioid overdose reversal.	Estimated USD 50 million^1
Anesthesia recovery	Short-term use post-surgery to enhance respiratory drive.	USD 25 million

Market Trends and Drivers

• Rising number of opioid overdose deaths drives demand for respiratory stimulants.
• Growing neonatal care needs in developed countries increases target patient populations.
• Increased adoption of emergency medical protocols may sustain demand, despite competition from broad-spectrum antidotes like naloxone.

What Are the Competitive Dynamics and Challenges?

Key Competitors

• Naloxone: Dominates opioid overdose reversal market.
• Mechanical ventilation devices: Alternative for respiratory support.
• Emerging agents under investigation offer broader indications and improved safety/new mechanisms.

Challenges

• Limited patent protection: DOPRAM is off-patent, reducing incentives for R&D investment.
• Safety concerns: Potential adverse cardiovascular effects restrict broader use.
• Regulatory hurdles: Additional clinical trials needed to expand indications.

Market Projection and Growth Opportunities

Short-term Outlook (Next 3-5 Years)

• Stable niche demand, mainly in neonatal units and emergency settings.
• No significant growth in North America and Europe due to limited R&D activity.
• Potential for modest expansion if new clinical data support broader applications.

Long-term Outlook (Beyond 5 Years)

• Prospects depend on emerging data for repurposing in opioid-related respiratory failure.
• R&D limitations and off-label use trends likely constrain large-scale growth.
• Innovative formulations (e.g., inhaled DOPRAM) could open new administration pathways.

Investment and Commercialization Potential

Factor	Impact
Patents	None, high generic exposure
Regulatory Environment	Stable but cautious for new indications
Clinical Evidence	Limited, needed for wider approval
Market Demand	Growing in niche segments

Final Considerations

DOPRAM retains a restricted presence in respiratory care, mainly serving neonatal and emergency contexts. The absence of active clinical trials and patent protections diminishes incentives for R&D investment. Market growth prospects are limited unless new indications are validated through robust clinical data or novel delivery systems emerge.

Key Takeaways

• No ongoing Phase III trials for DOPRAM as of early 2023; current use remains niche.
• The market is small, with estimated value around USD 175-175 million across key segments.
• Competitive landscape favors broad-spectrum antidotes, limiting DOPRAM’s growth.
• R&D barriers include off-patent status and safety profile concerns.
• Opportunities hinge on clinical validation for new indications or advanced delivery mechanisms.

FAQs

1. Is DOPRAM approved for any indications outside the U.S.?
DOPRAM has limited approval mainly in the U.S. for respiratory depression. Its regulatory status outside the U.S. varies and often lacks comprehensive approvals for broader uses.

2. What are the main safety concerns associated with DOPRAM?
Risks include hypertension, tachycardia, and arrhythmias, particularly at higher doses or with prolonged use.

3. Could future clinical trials revive DOPRAM’s market potential?
Yes, provided studies demonstrate safety and efficacy for expanded uses—particularly in opioid overdose or neonatal care. Currently, the lack of active trials limits this potential.

4. How does DOPRAM compare to other respiratory stimulants?
It is less favored due to safety concerns and limited patent life. Alternatives like naloxone are more widely used, especially in overdose situations.

5. Are there innovations that could enhance DOPRAM’s clinical utility?
Formulation developments such as inhaled delivery and combination therapies may improve efficacy and safety, opening new avenues for its application.

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References

[1] ClinicalTrials.gov. "Doxapram Trials," access early 2023.