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Last Updated: February 3, 2023

CLINICAL TRIALS PROFILE FOR BALOXAVIR MARBOXIL


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All Clinical Trials for Baloxavir Marboxil

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02949011 ↗ Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications Completed Shionogi Phase 3 2017-01-11 The primary objective of this study is to evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo by measuring the time to improvement of influenza symptoms in patients with influenza presenting within 48 hours of symptom onset.
NCT02954354 ↗ A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza Completed Shionogi Phase 3 2016-12-08 The primary objective of this study is to evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo by measuring the time to alleviation of symptoms in patients with uncomplicated influenza virus infection.
NCT03629184 ↗ Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms Completed Hoffmann-La Roche Phase 3 2018-11-20 This study will evaluate the safety, pharmacokinetics, and efficacy of baloxavir marboxil compared with oseltamivir in a single influenza episode in otherwise healthy pediatric participants (i.e., 1 to <12 years of age) with influenza-like symptoms.
NCT03653364 ↗ Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms Recruiting Hoffmann-La Roche Phase 3 2019-01-23 This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in healthy pediatric participants from birth to <1 year with influenza like symptoms
NCT03684044 ↗ Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza Completed Hoffmann-La Roche Phase 3 2019-01-08 This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients with influenza.
NCT03959332 ↗ Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants Completed Shionogi N/A 2019-06-19 This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
NCT03959332 ↗ Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants Completed Hoffmann-La Roche N/A 2019-06-19 This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Baloxavir Marboxil

Condition Name

Condition Name for Baloxavir Marboxil
Intervention Trials
Influenza 9
Respiratory Viral Infection 1
Healthy Volunteer 1
Hematopoietic and Lymphoid Cell Neoplasm 1
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Condition MeSH

Condition MeSH for Baloxavir Marboxil
Intervention Trials
Influenza, Human 9
Virus Diseases 1
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Clinical Trial Locations for Baloxavir Marboxil

Trials by Country

Trials by Country for Baloxavir Marboxil
Location Trials
United States 83
India 9
Spain 9
Mexico 8
Brazil 7
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Trials by US State

Trials by US State for Baloxavir Marboxil
Location Trials
Texas 5
Colorado 4
California 4
North Carolina 4
New York 4
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Clinical Trial Progress for Baloxavir Marboxil

Clinical Trial Phase

Clinical Trial Phase for Baloxavir Marboxil
Clinical Trial Phase Trials
Phase 4 2
Phase 3 6
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Baloxavir Marboxil
Clinical Trial Phase Trials
Completed 6
Not yet recruiting 2
Recruiting 2
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Clinical Trial Sponsors for Baloxavir Marboxil

Sponsor Name

Sponsor Name for Baloxavir Marboxil
Sponsor Trials
Hoffmann-La Roche 5
Shionogi 3
Genentech, Inc. 2
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Sponsor Type

Sponsor Type for Baloxavir Marboxil
Sponsor Trials
Industry 10
Other 3
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Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
AstraZeneca
Baxter
Dow
Express Scripts

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