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Baloxavir Marboxil tablets
Baloxavir Marboxil tablets is a Cap-dependent endonuclease inhibitor Small molecule drug developed by Jiaxing AnDiCon Biotech Co.,Ltd. It is currently in Phase 3 development for Acute uncomplicated influenza (treatment), Influenza prophylaxis.
Baloxavir marboxil inhibits the influenza virus endonuclease, blocking viral cap-dependent transcription and preventing viral replication.
Baloxavir Marboxil tablets are a small molecule inhibitor of the polymerase acidic protein, classified as an INHIBITOR drug class. They are indicated for the treatment of influenza and have been studied in clinical trials for various conditions including infection, coronavirus, and transplant-related infections.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Baloxavir Marboxil tablets |
|---|---|
| Sponsor | Jiaxing AnDiCon Biotech Co.,Ltd |
| Drug class | Cap-dependent endonuclease inhibitor |
| Target | Influenza PA endonuclease |
| Modality | Small molecule |
| Therapeutic area | Virology/Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Baloxavir marboxil is a prodrug that is converted to its active form, baloxavir, which selectively inhibits the polymerase acidic (PA) protein endonuclease of influenza viruses. This enzyme is essential for viral mRNA synthesis, as it cleaves host pre-mRNA to generate primers for viral transcription. By blocking this mechanism, the drug prevents the virus from synthesizing its own mRNA and replicating.
Approved indications
- Acute uncomplicated influenza (treatment)
- Influenza prophylaxis
Common side effects
- Headache
- Diarrhea
- Nausea
- Nasopharyngitis
Key clinical trials
- Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza (PHASE3)
- Xofluza-Wearables Feasibility-Study (PHASE4)
- Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households (PHASE3)
- A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A (NA)
- Randomised Evaluation of COVID-19 Therapy (PHASE3)
- Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle (PHASE4)
- Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications (PHASE3)
- A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Baloxavir Marboxil tablets CI brief — competitive landscape report
- Baloxavir Marboxil tablets updates RSS · CI watch RSS
- Jiaxing AnDiCon Biotech Co.,Ltd portfolio CI
Frequently asked questions about Baloxavir Marboxil tablets
What is Baloxavir Marboxil tablets?
How does Baloxavir Marboxil tablets work?
What is Baloxavir Marboxil tablets used for?
Who makes Baloxavir Marboxil tablets?
What drug class is Baloxavir Marboxil tablets in?
What development phase is Baloxavir Marboxil tablets in?
What are the side effects of Baloxavir Marboxil tablets?
What does Baloxavir Marboxil tablets target?
Related
- Drug class: All Cap-dependent endonuclease inhibitor drugs
- Target: All drugs targeting Influenza PA endonuclease
- Manufacturer: Jiaxing AnDiCon Biotech Co.,Ltd — full pipeline
- Therapeutic area: All drugs in Virology/Infectious Disease
- Indication: Drugs for Acute uncomplicated influenza (treatment)
- Indication: Drugs for Influenza prophylaxis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing