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Five-days oseltamivir
Five-days oseltamivir is a Neuraminidase inhibitor Small molecule drug developed by UMC Utrecht. It is currently in Phase 3 development for Influenza A and B infection treatment, Influenza prophylaxis.
Oseltamivir is a neuraminidase inhibitor that blocks the release of influenza virus particles from infected cells, reducing viral spread.
Oseltamivir is a small molecule medication used to treat conditions such as influenza, pneumonia, and COVID-19. It is administered orally in a dose of 75mg.
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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 | Five-days oseltamivir |
|---|---|
| Sponsor | UMC Utrecht |
| Drug class | Neuraminidase inhibitor |
| Target | Influenza neuraminidase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Oseltamivir inhibits influenza neuraminidase, an enzyme on the viral surface required for the virus to escape from infected host cells. By blocking this enzyme, the drug prevents newly formed viral particles from being released, thereby reducing viral replication and transmission. This 5-day formulation represents a shortened treatment course compared to the standard 5-day regimen.
Approved indications
- Influenza A and B infection treatment
- Influenza prophylaxis
Common side effects
- Nausea
- Vomiting
- Headache
- Abdominal pain
Key clinical trials
- Post-exposure Influenza Prophylaxis (PHASE3)
- Suraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting (PHASE3)
- Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (PHASE3)
- Randomised Evaluation of COVID-19 Therapy (PHASE3)
- Proof-of-Concept: A Pilot, Randomized, Double-Blind Study of Oseltamivir Versus Placebo for Immune Thrombocytopenia (PHASE3)
- Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza (PHASE2)
- Oseltamivir Versus Paracetamol for Influenza-like Illness During the Influenza Season (PHASE4)
- An RCT of Oseltamivir in Outpatients With CPD: A Pilot Study. (PHASE4)
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:
- Five-days oseltamivir CI brief — competitive landscape report
- Five-days oseltamivir updates RSS · CI watch RSS
- UMC Utrecht portfolio CI
Frequently asked questions about Five-days oseltamivir
What is Five-days oseltamivir?
How does Five-days oseltamivir work?
What is Five-days oseltamivir used for?
Who makes Five-days oseltamivir?
What drug class is Five-days oseltamivir in?
What development phase is Five-days oseltamivir in?
What are the side effects of Five-days oseltamivir?
What does Five-days oseltamivir target?
Related
- Drug class: All Neuraminidase inhibitor drugs
- Target: All drugs targeting Influenza neuraminidase
- Manufacturer: UMC Utrecht — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Influenza A and B infection treatment
- Indication: Drugs for Influenza prophylaxis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing