Last Updated: August 9, 2026

CLINICAL TRIALS PROFILE FOR DOXAPRAM HYDROCHLORIDE


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All Clinical Trials for doxapram hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00088738 ↗ Evaluation of Substance P Neurotransmission in Panic Disorder by PET Imaging of NK1 Receptors With [18F]SPA-RQ Completed National Institute of Mental Health (NIMH) Phase 1 2004-07-27 This study is designed to observe the effects of a panic attack in patients with panic disorders and to demonstrate the involvement of Substance P in panic disorder, and thereby, further our understanding of its role in this illness. We will measure levels of Substance P in the brain by obtaining pictures of the brain using PET and MRI....
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.
NCT00477451 ↗ Staccato Alprazolam in Panic Attack Completed Alexza Pharmaceuticals, Inc. Phase 2 2007-05-01 We are developing Staccato™ Alprazolam for the treatment of Panic attacks associated with panic disorder. This study will provide an initial assessment of efficacy, and to continue to describe the tolerability and pharmacokinetics, of a single inhaled dose of Staccato Alprazolam on a doxapram-induced panic attack in patients with panic disorder.
NCT01022151 ↗ Aminophylline and Cognitive Function After Sevoflurane Anaesthesia Completed King Faisal University Phase 2 2007-11-01 Early postoperative recovery of neurologic and cognitive functions is especially advantageous after fast-tracking ambulatory procedures to hasten home discharge after surgery.1 It is well known that volatile anaesthetic agents may generate adverse postoperative cognitive effects and even traces of it may affect task performance in healthy volunteers.2Hence, rapid elimination of the volatile anaesthetics may help reduce postoperative confusion and cognitive impairment in surgical patients by facilitating a faster recovery from general anaesthesia.3 Sevoflurane has been advocated for the routine anesthesia for ambulatory surgery patients. It activates adenosine A1 receptors in primary rat hippocampal cultures through the liberation of adenosine secondary to the interaction of with adenosine transport or key enzymes in adenosine metabolism.4 However; sevoflurane anaesthesia is associated with slower emergence and delayed early postoperative cognitive recovery than desflurane5 and xenon2 anaesthesia. Aminophylline, which is a hydrophilic cyclic adenosine mono-phosphate (cAMP) dependent phosphodiesterase inhibitor has been used for long time to antagonize the sedative effects of morphine, diazepam, and barbiturates.6-7Aminophylline in doses of 2-5 mg/kg shortens the recovery from sevoflurane anaesthesia and improves bispectral index scores (BIS) with concurrent increases in heart rate which might have a detrimental effect in patients with ischaemic heart disease.8-11However, the use of smaller doses of 2-3 mg/kg is associated with less increases in heart rate. 10-11 The use of 1 mg/kg of Doxapram is comparable to 2 mg/kg of aminophylline in improvement of early recovery from sevoflurane anaesthesia secondary to its central nervous system stimulating effect rather than increased ventilatory elimination of sevoflurane.11 Currently, there is no available published studies have investigated the effects of either theophylline or doxapram on early postoperative cognitive recovery after balanced anaesthesia with sevoflurane. We hypothesized that the use of small doses of aminophylline [2-3 mg/kg] may be comparable to larger doses in improvement of the early postoperative cognitive recovery from sevoflurane anaesthesia with associated non-significant increases in heart rate. The present study investigated the effects of 1 mg/kg of doxapram, and 2, 3, 4, and 5 mg/kg of aminophylline on the early postoperative cognitive recovery using the Short Orientation Memory Concentration Test (SOMCT), response entropy (RE) state entropy (SE), difference between RE and SE (RE-SE), end-tidal sevoflurane concentration, haemodynamics, the times to eyes opening and to extubation and degree of sedation after sevoflurane anaesthesia in patients undergoing ambulatory surgery.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for doxapram hydrochloride

Condition Name

Condition Name for doxapram hydrochloride
Intervention Trials
Postoperative Shivering 2
Healthy 2
Postoperative Confusion 1
Anaesthesia 1
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Condition MeSH

Condition MeSH for doxapram hydrochloride
Intervention Trials
Panic Disorder 2
Pulmonary Valve Insufficiency 1
Respiratory Distress Syndrome, Newborn 1
Respiratory Distress Syndrome 1
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Clinical Trial Locations for doxapram hydrochloride

Trials by Country

Trials by Country for doxapram hydrochloride
Location Trials
Netherlands 7
Belgium 5
Egypt 5
United States 3
Finland 1
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Trials by US State

Trials by US State for doxapram hydrochloride
Location Trials
Ohio 1
New York 1
Maryland 1
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Clinical Trial Progress for doxapram hydrochloride

Clinical Trial Phase

Clinical Trial Phase for doxapram hydrochloride
Clinical Trial Phase Trials
PHASE1 1
Phase 4 3
Phase 3 1
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Clinical Trial Status

Clinical Trial Status for doxapram hydrochloride
Clinical Trial Phase Trials
Completed 6
Unknown status 4
Recruiting 3
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Clinical Trial Sponsors for doxapram hydrochloride

Sponsor Name

Sponsor Name for doxapram hydrochloride
Sponsor Trials
Beni-Suef University 2
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 1
Jean Michel Hascoet 1
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Sponsor Type

Sponsor Type for doxapram hydrochloride
Sponsor Trials
Other 16
Industry 2
NIH 2
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Doxapram Hydrochloride Clinical Trials Update, Market Analysis, and Forecast: What’s in the Pipeline and What Might Drive Demand

Last updated: July 28, 2026

Doxapram hydrochloride is a respiratory stimulant used to treat ventilatory depression. Public disclosures show limited late-stage development visibility, with the most material near-term demand drivers tied to (1) continued use in hospital acute-care settings and (2) supply continuity. Patent and exclusivity analysis and FDA product status typically govern durability of supply, but comprehensive, drug-specific current-trial and sales datasets are not available in the provided material.

What clinical trials exist for doxapram hydrochloride and where are they in 2024-2026?

Answer: No complete, current, drug-specific trial registry data (NCT identifiers, status timelines, study designs, endpoints, and results) is provided here, so a validated clinical-trials update cannot be produced.

Are there Phase 2 or Phase 3 trials for doxapram hydrochloride?

Answer: Not specified in the provided material.

Are there ongoing recruiting or active-not-recruiting studies?

Answer: Not specified in the provided material.

What endpoints doxapram trials would typically measure

For any future diligence, respiratory-stimulant studies generally evaluate:

  • Respiratory rate and minute ventilation
  • CO2 clearance and arterial blood gases
  • Time to recovery from ventilatory depression
  • Adverse events (seizure risk is a common class concern in stimulants)

No trial-level endpoint mapping to doxapram hydrochloride is available here.

How big is the doxapram hydrochloride market and who buys it?

Answer: No quantified market size, segment breakdown, or payer/health-system adoption data is provided here, so a market sizing and buying-profile analysis cannot be produced.

Which settings drive usage

In practice, doxapram hydrochloride is typically used in:

  • Post-anesthesia recovery and ventilatory depression management
  • Intensive care and monitored settings requiring acute respiratory support
  • Situations involving opioid- or sedative-associated respiratory compromise

No facility penetration, volume, or budget impact data is included here.

What are the key demand drivers

Common drivers in this drug category:

  • Stable availability and formulary positioning
  • Clinician familiarity and protocol-driven use
  • Supply constraints that increase allocation pressure
  • Substitution risk with alternatives (stimulant and non-stimulant respiratory support strategies)

No drug-specific demand elasticity or replacement dynamic is provided.

What is the projected demand for doxapram hydrochloride over the next 5 years (2026-2031)?

Answer: A validated 2026-2031 demand projection requires baseline volumes, pricing, competitive access, and regulatory/supply continuity. None of those inputs are provided here.

What drives pricing for doxapram hydrochloride: tendering, wholesaler dynamics, or generic competition?

Answer: No pricing history, tender outcomes, acquisition pricing, or wholesaler allocation data is provided here, so a pricing driver analysis is not supportable.

How would generic entry affect price

If multiple sources are available, pricing usually falls toward marginal production cost plus distribution margin, with tender discounts and contracting driving further erosion. If supply is constrained, price can rise through allocation and emergency procurement. The number of approved manufacturers and current market sourcing is not provided.

What is the regulatory status of doxapram hydrochloride with FDA and how does it impact availability?

Answer: No Orange Book entry data, FDA approval dates, reference product link, manufacturing status, or current discontinuation/shortage notices are included here, so regulatory status and availability impact cannot be determined.

Is doxapram hydrochloride approved as an NDA, ANDA, or in multiple labeled forms?

Answer: Not specified in the provided material.

Does FDA listing indicate ongoing manufacturing or supply interruptions?

Answer: Not provided.

What patents protect doxapram hydrochloride and what is the expiration schedule?

Answer: A patent estate with expiration dates requires specific listed patents (Orange Book or patent family publications), which are not provided here.

How many patents cover doxapram hydrochloride formulations, manufacturing, and methods of use?

Answer: Not specified.

How strong is the patent estate for doxapram hydrochloride and what litigation risk exists?

Answer: No litigation dockets, settlement agreements, or paragraph IV records are provided here, so patent strength and legal risk cannot be assessed.

What generic entry risks exist for doxapram hydrochloride?

Answer: Generic entry risks are governed by (1) exclusivity and patent barriers, (2) manufacturing controls and process patents, and (3) regulatory data requirements. None of those inputs are provided.

Could shortages create pull-through demand despite limited pipeline?

If demand is concentrated in acute-care protocols, shortages can lift usage of available alternatives while also supporting premium pricing for remaining suppliers. Drug-specific shortage duration and supplier count are not included.

How does doxapram hydrochloride compare with alternative respiratory stimulants and respiratory support strategies?

Answer: No comparative effectiveness evidence, formulary comparison, or cost-per-episode metrics are included here.

Typical competitors in ventilatory depression management can include:

  • Naloxone (opioid reversal) for opioid-driven respiratory depression
  • Other pharmacologic stimulants depending on geography and labeling
  • Mechanical ventilatory support and non-invasive ventilation pathways

No doxapram-specific comparative uptake or switching is provided.

What could shift the market: new formulations, new indications, or supply chain changes?

Answer: A shift analysis requires specific development filings, label expansions, or manufacturing investments. No doxapram-specific product development or supply-chain events are provided here.


Key Takeaways

  • A validated clinical-trials update for doxapram hydrochloride cannot be produced from the supplied material because trial registry identifiers, statuses, and results are not available here.
  • A quantified market analysis and 5-year demand projection cannot be produced because baseline sales/volume, pricing, supplier count, and regulatory availability inputs are not provided.
  • A patent, exclusivity, and litigation-driven access forecast cannot be produced because Orange Book and patent family details are not included.

FAQs

  1. Where can I find the current doxapram hydrochloride trial registry list and statuses?
  2. Is doxapram hydrochloride currently marketed by multiple manufacturers, or is supply concentrated?
  3. Do any doxapram hydrochloride patents or exclusivity periods restrict generic entry?
  4. What FDA labeling indicates for ventilatory depression management, dosing, and contraindications?
  5. Which acute-care protocols most influence doxapram hydrochloride prescribing and procurement volume?

References

(No citable sources were provided in the prompt material, and no drug-specific datasets are included here.)

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