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SS1(DSFV)-PE38
SS1(DSFV)-PE38 is a drug. It is currently in Phase 1 development.
Mesothelin binding agent
SS1(DSFV)-PE38 is a mesothelin binding agent used in cancer treatment. It has been studied in combination with pemetrexed and cisplatin to treat malignant pleural mesothelioma, as well as other conditions such as non-small cell lung cancer and pancreatic neoplasms.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | SS1(DSFV)-PE38 |
|---|---|
| Target | CHEMBL3712878 |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma (PHASE1, PHASE2)
- SS1(dsFV)PE38 Plus Pemetrexed and Cisplatin to Treat Malignant Pleural Mesothelioma (PHASE1)
- A Phase I Trial of SS1 (dsFv) PE38 With Paclitaxel, Carboplatin, and Bevacizumab in Subjects With Unresectable Non-Small Cell Lung Adenocarcinoma (PHASE1)
- Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors (PHASE1)
- Immunotoxin Therapy in Treating Patients With Advanced Cancer (PHASE1)
- Study of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion for 10 Days (PHASE1)
- Study of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: IV Infusion QOD x Six Doses (PHASE1)
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:
- SS1(DSFV)-PE38 CI brief — competitive landscape report
- SS1(DSFV)-PE38 updates RSS · CI watch RSS
Frequently asked questions about SS1(DSFV)-PE38
What is SS1(DSFV)-PE38?
How does SS1(DSFV)-PE38 work?
What development phase is SS1(DSFV)-PE38 in?
What does SS1(DSFV)-PE38 target?
Related
- Target: All drugs targeting CHEMBL3712878
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing