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TEW-7197
TEW-7197 is a Small molecule drug developed by Joon Oh Park. It is currently in Phase 1 development. Also known as: TEW-7197, FOLFOX, Vactosertib, vactosetib, vactosertib.
TEW-7197, also known as Vactosertib, is a small molecule inhibitor of the TGF-beta receptor type-1. It is being studied in clinical trials for various conditions, including urothelial carcinoma, gastric cancer, and myeloproliferative neoplasm.
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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 | TEW-7197 |
|---|---|
| Also known as | TEW-7197, FOLFOX, Vactosertib, vactosetib, vactosertib, EW-7197 |
| Sponsor | Joon Oh Park |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer (PHASE1)
- Intra-patient Dose Escalation Study to Investigate Safety and Feasibility of Vactosertib in Treating Anemic MPN Patients (PHASE2)
- Phase 1b/2a, Open-label Study of Vactosertib in Combination With Durvalumab in Advanced NSCLC (PHASE1, PHASE2)
- Study to Assess Safety and Efficacy of Vactosertib in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma (PHASE1, PHASE2)
- Vactosertib in Combination with Pembrolizumab in Metastatic Colorectal or Gastric Cancer (PHASE1, PHASE2)
- Vactosertib with Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition (PHASE2)
- TEW-7197 with Paclitaxel for the Treatment of Metastatic Gastric Cancer (PHASE1, PHASE2)
- Vactosertib in Combination w/ Pomalidomide in Relapsed or Relapsed and Refractory Multiple Myeloma (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:
- TEW-7197 CI brief — competitive landscape report
- TEW-7197 updates RSS · CI watch RSS
- Joon Oh Park portfolio CI
Frequently asked questions about TEW-7197
What is TEW-7197?
Who makes TEW-7197?
Is TEW-7197 also known as anything else?
What development phase is TEW-7197 in?
Related
- Manufacturer: Joon Oh Park — full pipeline
- Also known as: TEW-7197, FOLFOX, Vactosertib, vactosetib, vactosertib, EW-7197
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing