Friday, July 10, 2026

Drug profile · INN

baloxavir marboxil

baloxavir marboxil (XOFLUZA) is a polymerase acidic protein inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved PMDA: approved
US status approved
Patents linked 0
Pipeline programs 2
News articles 1
Congress events 1
Drug details — baloxavir marboxil

Quick answer

baloxavir marboxil (XOFLUZA) is a polymerase acidic protein inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN baloxavir marboxil
Brand XOFLUZA
Mechanism Polymerase acidic protein inhibitor
Target Polymerase acidic protein
Route ORAL
Formulation FOR SUSPENSION

Mechanism of action

Polymerase acidic protein inhibitor

Primary target: Polymerase acidic protein

Approval history

Authority Status Date
FDA approved
EMA approved
PMDA approved

Recent coverage

Congress & event coverage

Pipeline programs

  1. Baloxavir Marboxil Phase 3 · HOFFMANN-LA ROCHE · Influenza
  2. NCT02735707 Phase 3 · Disc Medicine · Respiratory tract infection

Related & competitor drugs

  1. baloxavir Polymerase acidic protein inhibitor

Frequently asked questions

What is baloxavir marboxil?

baloxavir marboxil (XOFLUZA) is a polymerase acidic protein inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for baloxavir marboxil?

XOFLUZA is a marketed brand name for baloxavir marboxil. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of baloxavir marboxil?

baloxavir marboxil has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.