Xofluza

(Baloxavir Marboxil)

ApprovedSmall molecule

It is used to treat influenza (the flu) by stopping the virus from spreading in your body. It can be taken as a single dose and works quickly to reduce flu symptoms.[2] Xofluza is currently approved and in use across 3 indications[4].[1]

Xofluza is one of 118 small molecule programs targeting Influenza. It is currently in Approved.

Indications

Total Trials

Active Trials

117

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

InfluenzaRecruiting

Viral DiseaseActive, not recruiting

Hematopoietic and Lymphoid Cell NeoplasmRecruiting

InfluenzaApproved

Recruiting

Viral DiseaseApproved

Active, not recruiting

Hematopoietic and Lymphoid Cell NeoplasmPhase 2

Recruiting

Competition

Competitive Landscape

95 competitors in Influenza

#DrugCompanyPhaseTrials

Influenza Vaccine

Novartis

Phase 3

71 2

Xofluza

Roche

Approved

14 3

FLU Vaccine

GSK

Phase 3

8 4

Inactivated Influenza Vaccine

Sanofi

Phase 3

14 5

Seasonal Influenza Vaccine

Novartis

Phase 3

22 6

Live Attenuated Zoster Vaccine

CChangchun BCHT Biotechnology Co.

Phase 3

12 7

Relenza

GGlaxo Dba Glaxosmithkline

Phase 3

5 8

VAXIGRIP

GSK

Phase 3

8 9

Dexametasone

UUniversity of Malaya

Phase 3

1 10

Baloxavir

IInsight Therapeutics, LLC

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 3Not yet recruiting

Influenza, Human

NCT07827599

Phase 3Recruiting

Influenza

NCT06094010

Q3 2027

Phase 3Recruiting

Influenza

NCT06653569

Q1 2028

Phase 3Recruiting

Pneumonia

NCT02735707

Phase 2Recruiting

Hematopoietic and Lymphoid Cell Neoplasm

NCT04712539

Q2 2036

Phase 3Recruiting

COVID-19

NCT04381936

Clinical

Trials by Indication[1]

Influenza14 trials

Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza

Terminated·WWeill Medical College of Cornell University·Phase 2/3·NCT05170009·2 enrolled

Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households

Completed· Roche logo

Roche·Phase 3·NCT03969212·4,138 enrolled

Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms

Completed· Roche logo

Roche·Phase 3·NCT03629184·173 enrolled

Show 11 more trials

Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle

Completed·UUniversity of Washington·Phase 4·NCT04141930·481 enrolled

A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A

Unknown status·—·N/A·NCT06205641·584 enrolled

Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza

Completed·JJiaxing AnDiCon Biotech Co.,Ltd·Phase 3·NCT06507813·190 enrolled

Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms

Completed· Roche logo

Roche·Phase 3·NCT06774859·100 enrolled

Oseltamivir and Baloxavir Marboxil for Prophylaxis Against Influenza Under a Hospital-based Setting

Not yet recruiting·—·N/A·NCT06762587·372 enrolled

Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms

Completed· Roche logo

Roche·Phase 3·NCT03653364·49 enrolled

Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza

Completed· Roche logo

Roche·Phase 3·NCT03684044·363 enrolled

Evaluation of a Screen and Treat Protocol for Influenza

Terminated·TTricore, Inc··NCT06207058·25 enrolled

A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza

Completed· Shionogi logo

Shionogi·Phase 3·NCT02954354·1,436 enrolled

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

Recruiting· Roche logo

Roche·Phase 3·NCT06094010·750 enrolled

Efficacy of Baloxavir Against Influenza in Hospitalized Patients: the INFLUENT Study (INpatients InFLUENza Treatment)

Recruiting·DDre Pauline Vetter·Phase 3·NCT06653569·484 enrolled

Tics1 trial

Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants

Completed· Roche logo

Roche·N/A·NCT03959332·32 enrolled

COVID-191 trial

Randomised Evaluation of COVID-19 Therapy

Recruiting·UUniversity of Oxford·Phase 3·NCT04381936·70,000 enrolled

Complication1 trial

Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications

Completed· Shionogi logo

Shionogi·Phase 3·NCT02949011·2,184 enrolled

Pneumonia1 trial

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Recruiting·UUMC Utrecht·Phase 3·NCT02735707·20,000 enrolled

3 more indications

Influenza, Human1 trial

A Phase III, Randomized, Double-blinded, Placebo-controlled Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis of Influenza Virus Infection in Chinese Participants

Not yet recruiting· Roche logo

Roche·Phase 3·NCT07827599·325 enrolled

Hematopoietic and Lymphoid Cell Neoplasm1 trial

Efficacy of Combination Baloxovir and Oseltamivir Therapy in Influenza Infected Immunocompromised Hosts

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04712539·60 enrolled

Unspecified1 trial

Xofluza-Wearables Feasibility-Study

Completed·—·Phase 4·NCT06161454·498 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 24, 2018

XOFLUZA

NDA NDA210854

Nov 23, 2020

XOFLUZA

NDA NDA214410

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Baloxavir Marboxil. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Xofluza drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Baloxavir Marboxil compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Baloxavir Marboxil. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214410). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Xofluza. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Polymerase Acidic Protein Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Roche

Patent Landscape[6]

Patent Cliff

Jun 14, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9815835Jun 14, 2030

8927710May 5, 2031

8987441Oct 24, 2032

10633397Apr 27, 2036

10392406Apr 27, 2036

5 more patents

11306106Aug 9, 2037

10759814Aug 9, 2037

11261198Sep 25, 2038

12064438Oct 9, 2039

11925648Apr 21, 2041

Xofluza

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q1 2028

Q2 2036

Trials by Indication[1]

Influenza14 trials

Tics1 trial

COVID-191 trial

Complication1 trial

Pneumonia1 trial

Influenza, Human1 trial

Hematopoietic and Lymphoid Cell Neoplasm1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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