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simmitinib
simmitinib is a Small molecule drug developed by Shanghai Runshi Pharmaceutical Technology Co., Ltd. It is currently in Phase 3 development. Also known as: SOMCL-15-290.
Simmitinib is being studied in clinical trials for various advanced solid tumors, including advanced oesophageal squamous cell carcinoma, localized advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, and HER-2 expressing tumors. The mechanism of simmitinib is not specified in the provided information, but it is being investigated as a potential treatment in a Phase I dose-escalation trial.
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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).
| 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 | simmitinib |
|---|---|
| Also known as | SOMCL-15-290 |
| Sponsor | Shanghai Runshi Pharmaceutical Technology Co., Ltd |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- A Study of Simmitinib Versus Chemotherapy for Participants With Advanced Oesophageal Squamous Cell Carcinoma (PHASE3)
- A PhaseⅠ/Ⅱ Study of Simmitinib or Irinotecan Liposomes Combined With DP303c in Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma (PHASE1, PHASE2)
- A Study of Simmitinib Plus Irinotecan in Advanced Esophageal Squamous Cell Carcinoma (PHASE2)
- A Study of Simmitinib Plus SG001 in Advanced Solid Tumors (PHASE1, PHASE2)
- A Phase I Trial of Simmitinib in Advanced Solid Tumors (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:
- simmitinib CI brief — competitive landscape report
- simmitinib updates RSS · CI watch RSS
- Shanghai Runshi Pharmaceutical Technology Co., Ltd portfolio CI
Frequently asked questions about simmitinib
What is simmitinib?
Who makes simmitinib?
Is simmitinib also known as anything else?
What development phase is simmitinib in?
Related
- Manufacturer: Shanghai Runshi Pharmaceutical Technology Co., Ltd — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: SOMCL-15-290
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing