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Drugs in development · updated 30 October 2026

Baloxavir Marboxil: clinical trials and development status

Other names and codes: Xofluza

FDA verified identityApproved in the US (FDA)Authorised in the EU (EMA) since 7 January 2021

As of 30 October 2026 Baloxavir Marboxil is in 6 active clinical trials (recruiting or ongoing, phases I–III) for 8 diseases. The most advanced phase is III.

6Active trials
IIIMost advanced phase
8Diseases studied

Summary updated every week · data as of 30 October 2026. In Phuturdex you can follow Baloxavir Marboxil and get an email at every change or safety alert.

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Diseases studied

For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.

DiseaseMost advanced phaseActive trialsReference trial
InfluenzaIII5NCT06094010
Community-acquired pneumoniaIII2NCT04381936
COVID-19III2NCT04381936
PneumoniaIII2NCT04381936
Respiratory tract infectionIII2NCT07827599
Lung diseaseIII1NCT02735707
Respiratory diseaseIII1NCT02735707
Hematologic neoplasmII1NCT04712539

Everything on Baloxavir Marboxil

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Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 30 October 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, is a Phuturdex calculation described on the Method page, not official data.

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