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padeliporfin VTP
padeliporfin VTP is a Photosensitizer Small molecule drug developed by Steba Biotech S.A.. It is currently in Phase 3 development for Treatment of metastatic liver cancer. Also known as: WST11.
Padeliporfin VTP is a photosensitizer that selectively targets and destroys cancer cells upon activation by light.
Padeliporfin VTP is a vascular targeted photodynamic therapy used to treat various cancers, including cholangiocarcinoma, peripheral lung tumor, prostate cancer, non-small cell lung cancer, and localized prostate cancer. Padeliporfin is a small molecule modality.
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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 | padeliporfin VTP |
|---|---|
| Also known as | WST11 |
| Sponsor | Steba Biotech S.A. |
| Drug class | Photosensitizer |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Padeliporfin VTP works by accumulating in cancer cells and becoming activated by light of a specific wavelength, which then generates reactive oxygen species that damage and kill the cancer cells. This mechanism allows for targeted and selective destruction of cancer cells while minimizing damage to surrounding healthy tissue.
Approved indications
- Treatment of metastatic liver cancer
Common side effects
- Photosensitivity
Key clinical trials
- Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma (PHASE1)
- ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study (PHASE3)
- Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer (PHASE1)
- Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer. (PHASE2)
- Evaluation of Efficacy of TOOKAD® (VTP) Versus Active Surveillance for Intermediate Risk Localized Prostate Cancer (PHASE3)
- Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. (PHASE3)
- Safety and Preliminary Efficacy Study of WST11 (Stakel®)-Mediated VTP Therapy in Subjects With CNV Associated With AMD (PHASE2)
- Study of WST11 in Patients With Localized Prostate Cancer (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:
- padeliporfin VTP CI brief — competitive landscape report
- padeliporfin VTP updates RSS · CI watch RSS
- Steba Biotech S.A. portfolio CI
Frequently asked questions about padeliporfin VTP
What is padeliporfin VTP?
How does padeliporfin VTP work?
What is padeliporfin VTP used for?
Who makes padeliporfin VTP?
Is padeliporfin VTP also known as anything else?
What drug class is padeliporfin VTP in?
What development phase is padeliporfin VTP in?
What are the side effects of padeliporfin VTP?
Related
- Drug class: All Photosensitizer drugs
- Manufacturer: Steba Biotech S.A. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Treatment of metastatic liver cancer
- Also known as: WST11
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing