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Last Updated: June 20, 2025

CLINICAL TRIALS PROFILE FOR LUSEDRA


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All Clinical Trials for Lusedra

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00209521 ↗ Comparison of AQUAVAN® Injection to DISOPRIVAN® Injectable Emulsion for Anesthesia During Coronary Artery Surgery Completed PPD Phase 2 2002-06-01 This is an exploratory clinical trial designed to examine the efficacy, safety and tolerability of fospropofol (AQUAVAN) Injection compared to propofol (DISOPRIVAN) Injectable Emulsion when used to preoperatively sedate, induce, and maintain general anesthesia and to postoperatively sedate patients undergoing elective coronary artery surgery.
NCT00209521 ↗ Comparison of AQUAVAN® Injection to DISOPRIVAN® Injectable Emulsion for Anesthesia During Coronary Artery Surgery Completed Eisai Inc. Phase 2 2002-06-01 This is an exploratory clinical trial designed to examine the efficacy, safety and tolerability of fospropofol (AQUAVAN) Injection compared to propofol (DISOPRIVAN) Injectable Emulsion when used to preoperatively sedate, induce, and maintain general anesthesia and to postoperatively sedate patients undergoing elective coronary artery surgery.
NCT01127438 ↗ A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations Completed Eisai Inc. Phase 4 2010-04-01 The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete diagnostic or therapeutic procedures.
NCT01195103 ↗ Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery Terminated Eisai Inc. Phase 4 2011-02-01 How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lusedra

Condition Name

Condition Name for Lusedra
Intervention Trials
Complication of Injection 1
Coronary Artery Bypass Surgery 1
Interstitial Cystitis 1
Ischemic Coronary Artery Disease 1
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Condition MeSH

Condition MeSH for Lusedra
Intervention Trials
Cystitis 1
Myocardial Ischemia 1
Coronary Disease 1
Coronary Artery Disease 1
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Clinical Trial Locations for Lusedra

Trials by Country

Trials by Country for Lusedra
Location Trials
United States 18
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Trials by US State

Trials by US State for Lusedra
Location Trials
Utah 2
North Carolina 2
New York 2
Arizona 2
Illinois 1
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Clinical Trial Progress for Lusedra

Clinical Trial Phase

Clinical Trial Phase for Lusedra
Clinical Trial Phase Trials
Phase 4 4
Phase 2 1
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Lusedra
Clinical Trial Phase Trials
Completed 6
Terminated 1
Withdrawn 1
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Clinical Trial Sponsors for Lusedra

Sponsor Name

Sponsor Name for Lusedra
Sponsor Trials
Eisai Inc. 7
NYU Langone Health 1
PPD 1
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Sponsor Type

Sponsor Type for Lusedra
Sponsor Trials
Industry 8
Other 4
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LUSEDRA: Clinical Trials, Market Analysis, and Projections

Introduction

LUSEDRA, also known as fospropofol disodium, is an intravenous sedative-hypnotic agent approved by the FDA in 2008 for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Clinical Studies Overview

LUSEDRA was evaluated in randomized, blinded, dose-controlled studies for sedation in patients undergoing procedures such as colonoscopy and flexible bronchoscopy. These studies involved administering an initial bolus dose and up to three supplemental doses to maintain sedation levels[1][4].

Sedation Success Rates

In the clinical studies, patients who received LUSEDRA had a high sedation success rate. For example, in the study involving colonoscopy, patients who received the standard and modified dosing regimens had a sedation success rate of 87%. The median time to sedation was approximately 8 minutes, and the median time to become fully alert after the procedure was about 5 minutes[1][4].

Pharmacokinetics

The pharmacokinetic parameters of LUSEDRA were evaluated in healthy subjects and patients. The drug showed dose-proportional pharmacokinetics, with low intersubject variability. Propofol, the active metabolite of fospropofol, was rapidly liberated, reaching plasma Cmax within 12 minutes for the 6 mg/kg dose and 8 minutes for the 18 mg/kg dose[1][4].

Market Analysis

Market Size and Growth

The US general anesthesia drugs market, which includes LUSEDRA, was estimated to be worth $2.0 billion in 2020 and is projected to reach $2.4 billion by 2025, growing at a CAGR of 3.4% from 2020 to 2025. The intravenous segment, where LUSEDRA is categorized, is expected to account for the largest share of this market due to its cost-effectiveness and fewer cardiovascular side effects[2].

Route of Administration

LUSEDRA falls under the intravenous route of administration, which is less expensive and does not require specialized equipment. This segment is expected to drive market growth due to its advantages over inhalational anesthesia, such as better postoperative analgesia and less cardiovascular depression[2].

End Users

The primary end users of LUSEDRA are hospitals and ambulatory surgery centers. These settings benefit from the drug's efficacy in sedating patients for brief diagnostic and therapeutic procedures[2].

Market Opportunities and Challenges

Patent Expiry

The patent for LUSEDRA expired in 2022, which is expected to pave the way for generic versions to enter the market. This could increase competition but also provide more affordable options for patients, potentially expanding the market share[2].

Market Drivers

Key drivers for the growth of the general anesthesia drugs market include the rising prevalence of cancer, the rapid growth in the geriatric population, and an increase in emergency surgeries. These factors are likely to sustain demand for sedative-hypnotic agents like LUSEDRA[2].

Safety and Efficacy in Special Populations

Patients with Renal Impairment

Studies have shown that the pharmacokinetics of LUSEDRA are not altered in patients with mild to moderate renal insufficiency. However, limited safety and efficacy data are available for patients with severe renal impairment (creatinine clearance < 30 mL/min)[1].

Patients with Hepatic Impairment

LUSEDRA has been evaluated in patients with hepatic impairment, but the clinical significance of some findings, such as increased plasma formate concentrations, remains unknown. Caution is advised when using LUSEDRA in patients with significant hepatic impairment[1][4].

Elderly Patients

Elderly patients, particularly those over 75 years of age, may experience more frequent hypoxemia. A modified dosing regimen is recommended for patients aged 65 years and older to mitigate these risks[1].

Regulatory and Clinical Trends

Integration of Omics Data

While not directly related to LUSEDRA, the increasing integration of omics data in clinical trials is a broader trend in the pharmaceutical industry. This could influence future drug development and safety assessments, potentially impacting the market for sedative-hypnotic agents[3].

COVID-19 Impact

The COVID-19 pandemic has had various impacts on the healthcare industry, including delays in clinical trials and changes in patient care protocols. However, the demand for sedation drugs like LUSEDRA has remained relatively stable due to the ongoing need for diagnostic and therapeutic procedures[2].

Key Takeaways

  • Clinical Efficacy: LUSEDRA has demonstrated high sedation success rates in clinical trials for procedures like colonoscopy and flexible bronchoscopy.
  • Market Growth: The US general anesthesia drugs market is projected to grow at a CAGR of 3.4% from 2020 to 2025, driven by factors such as the rising prevalence of cancer and the growth in the geriatric population.
  • Patent Expiry: The expiration of LUSEDRA's patent in 2022 is expected to lead to the entry of generic versions, potentially increasing market competition and affordability.
  • Safety Considerations: Special care is advised when using LUSEDRA in patients with renal or hepatic impairment and in elderly patients.

FAQs

What is LUSEDRA used for?

LUSEDRA (fospropofol disodium) is used for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

When was LUSEDRA approved by the FDA?

LUSEDRA was approved by the FDA in 2008.

What are the key drivers for the growth of the general anesthesia drugs market?

The key drivers include the rising prevalence of cancer, the rapid growth in the geriatric population, and an increase in emergency surgeries.

What are the implications of LUSEDRA's patent expiry?

The patent expiry of LUSEDRA in 2022 is expected to allow generic versions to enter the market, increasing competition and potentially reducing costs for patients.

How does LUSEDRA compare to other sedative-hypnotic agents?

LUSEDRA is part of the intravenous segment, which is less expensive and has fewer cardiovascular side effects compared to inhalational anesthesia.

Sources

  1. FDA Label for LUSEDRA: "LUSEDRA (fospropofol disodium) Injection" - FDA.
  2. MarketsandMarkets Report: "US General Anesthesia Drugs Market by Route of Administration (Intravenous and Inhalational), End User (Hospitals, Ambulatory Surgery Centers) - Global Forecast to 2025" - MarketsandMarkets.
  3. Biospace Report: "Omics-based Clinical Trials Market Size to Hit USD 70.92 Billion by 2034" - Biospace.
  4. FDA Label for LUSEDRA (2010 Update): "LUSEDRA (fospropofol disodium) Injection" - FDA.
Last updated: 2025-01-04

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