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Label indication XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications . FDA label
Also known as Xofluza
Baloxavir Marboxil · 7 trials · 4 indications
An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability or incapacity, was a congenital anomaly or birth defect.
The virological transmission was determined based on Polymerase Chain Reaction Positive (PCR+) influenza test results. The adjusted incidence (cumulative proportion of events by Day 5) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 5 post IP randomization with virus subtype matching with that of the respective IP, irrespective of being symptomatic or asymptomatic. The adjusted incidence rates presented were estimated using a generalized estimating equations (GEE) approach.
Time to Clinical Improvement (TTCI) is defined as Time to Hospital Discharge OR Time to NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours.
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
| Arm | Type | Description |
|---|---|---|
| Baloxavir Marboxil | EXPERIMENTAL | HHCs will receive baloxavir marboxil according to their body weight as outlined in the protocol. |
| Placebo | PLACEBO_COMPARATOR | HHCs will receive baloxavir marboxil matching placebo according to their body weight as outlined in the protocol. |
| No Intervention | NO_INTERVENTION | Index participants will not receive any study treatment but will continue to receive SOC treatment for influenza, as per the local guidelines. |
| Oseltamivir | ACTIVE_COMPARATOR | Participants will receive oseltamivir twice a day for 5 days based on body weight. |
| Name | Type | Description |
|---|---|---|
| Baloxavir marboxil | DRUG | Baloxavir marboxil will be administered to the HHCs as per the schedule specified in the protocol. |
| Placebo | DRUG | Baloxavir marboxil matching placebo will be administered to the HHCs as per the schedule specified in the protocol. |
| Oseltamivir | DRUG | Oseltamivir will be administered as oral capsule: 30 mg (if weight ≤15 kg), 45 mg (if weight \> 15 kg to ≥ 23 kg), 60 mg (if weight \> 23 kg to ≤ 40 kg) or 75 mg (if weight \> 40 kg), twice daily (BID) for 5 days. |
Inclusion Criteria: Index Participants (Participants With Influenza Virus Infection): * First participant in a household with influenza virus infection in the current influenza season * Fewer than 6 HHCs * Agreement by all household members to participate in the study and comply with the study pro...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
Baloxavir Marboxil is used for the treatment and prevention of influenza, including influenza in humans and post-exposure prophylaxis. It is an infectious disease therapy developed by Roche Holding AG. Clinical development has focused on influenza A and B, including studies in pediatric and adult populations and in household transmission settings.
Baloxavir Marboxil targets the influenza virus PA subunit, a component of the viral polymerase complex. By acting on this target, it interferes with viral replication. This mechanism underlies its activity against influenza A and B viruses and supports its use in treatment and prophylaxis studies.
Baloxavir Marboxil is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating the drug in influenza, including treatment, pediatric, and post-exposure prophylaxis studies.
Baloxavir Marboxil is in Phase 3 clinical development for influenza. It is an investigational small molecule and is not described as approved in the available program information. The Phase 3 program includes completed and ongoing trials across multiple countries and age groups.
Baloxavir Marboxil has been studied in six Phase 3 trials, including NCT03969212, a completed household transmission study, and NCT06094010, a recruiting pediatric surveillance study. Other trials include NCT06774859 in Chinese pediatric participants and NCT07827599, a post-exposure prophylaxis study not yet recruiting.
Across the six Phase 3 trials, total enrollment is 5,923 participants. The largest study, NCT03969212, enrolled 4,138 participants to assess reduction of onward influenza transmission in households. Trials have included randomized, double-blind, placebo-controlled designs and participants from multiple countries.