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Brivudin (BRIVUDINE)
Brivudin (generic name: BRIVUDINE) is a brivudine drug. It is currently in Phase 2 development.
Brivudin works by mimicking the structure of a nucleoside, which is then incorporated into viral DNA, causing chain termination and preventing viral replication.
Brivudin, also known as brivudine phosphoramidate, is a medication used to treat Herpes Zoster and has been studied in clinical trials for its potential use in treating Colorectal Cancer.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | BRIVUDINE |
|---|---|
| Drug class | brivudine |
| Target | Thymidine kinase, cytosolic, Thymidine kinase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
Imagine your body's cells are like factories that build new parts. Brivudin is like a faulty part that gets inserted into the viral DNA, causing the factory to stop working properly and preventing the virus from making more copies of itself.
Approved indications
Common side effects
- Labelled drug-drug interaction medication error
- Mucosal inflammation
- Pharyngeal inflammation
- Pancytopenia
- Oesophagitis
- Rash maculovesicular
Key clinical trials
- Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster (PHASE4)
- NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer (PHASE1,PHASE2)
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:
- Brivudin CI brief — competitive landscape report
- Brivudin updates RSS · CI watch RSS
Frequently asked questions about Brivudin
What is Brivudin?
How does Brivudin work?
What is the generic name of Brivudin?
What drug class is Brivudin in?
What development phase is Brivudin in?
What are the side effects of Brivudin?
What does Brivudin target?
Related
- Drug class: All brivudine drugs
- Target: All drugs targeting Thymidine kinase, cytosolic, Thymidine kinase
- Therapeutic area: All drugs in Infectious Disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing