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Virulizin®
Virulizin® is a Oncolytic virus Small molecule drug developed by Aptose Biosciences Inc.. It is currently in Phase 3 development for Ovarian cancer (in combination with chemotherapy), Other solid tumors (investigational).
Virulizin is an oncolytic virus therapy that selectively infects and destroys cancer cells while sparing normal tissue.
Virulizin is a treatment that has been studied in combination with standard chemotherapy for pancreatic cancer. A clinical trial (NCT00040092) that tested the effectiveness of Virulizin in combination with standard chemotherapy for pancreatic cancer has been completed.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | Virulizin® |
|---|---|
| Sponsor | Aptose Biosciences Inc. |
| Drug class | Oncolytic virus |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Virulizin is based on a modified vaccinia virus engineered to replicate preferentially in tumor cells with defective interferon signaling. The virus directly lyses cancer cells and triggers anti-tumor immune responses. It is designed to work synergistically with chemotherapy and other cancer treatments.
Approved indications
- Ovarian cancer (in combination with chemotherapy)
- Other solid tumors (investigational)
Common side effects
- Flu-like symptoms
- Fever
- Fatigue
- Injection site reactions
Key clinical trials
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:
- Virulizin® CI brief — competitive landscape report
- Virulizin® updates RSS · CI watch RSS
- Aptose Biosciences Inc. portfolio CI
Frequently asked questions about Virulizin®
What is Virulizin®?
How does Virulizin® work?
What is Virulizin® used for?
Who makes Virulizin®?
What drug class is Virulizin® in?
What development phase is Virulizin® in?
What are the side effects of Virulizin®?
Related
- Drug class: All Oncolytic virus drugs
- Manufacturer: Aptose Biosciences Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Ovarian cancer (in combination with chemotherapy)
- Indication: Drugs for Other solid tumors (investigational)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing