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Glumetinib
Glumetinib is a Small molecule drug developed by Haihe Biopharma Co., Ltd.. It is currently in Phase 3 development. Also known as: SCC244.
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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 | Glumetinib |
|---|---|
| Also known as | SCC244 |
| Sponsor | Haihe Biopharma Co., Ltd. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors (PHASE2)
- Glumetinib Combined With Fruquintinib in the Treatment of MET Amplification or Protein Overexpression in Third-Line Unresectable Metastatic Colorectal Cancer (PHASE1, PHASE2)
- A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients After Resistance to EGFR-TKIs (PHASE3)
- Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients (PHASE2, PHASE3)
- A Phase I Study of SCC244 in Patients with Advanced MET Alterations Solid Tumors (PHASE1)
- Study to Evaluate the Safety and Anti-tumor Activity of SCC244 (PHASE1)
- A Real-World Study of Treatment Patterns and Effectiveness in MET Mutation-Positive Advanced Lung Cancer
- A Study to Evaluate the Efficacy and Safety of the Combination of Glumetinib and Docetaxel（Albumin Bound）Verse Docetaxel for the Treatment of MET-overexpressed Non-small Cell Lung 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:
- Glumetinib CI brief — competitive landscape report
- Glumetinib updates RSS · CI watch RSS
- Haihe Biopharma Co., Ltd. portfolio CI
Frequently asked questions about Glumetinib
What is Glumetinib?
Who makes Glumetinib?
Is Glumetinib also known as anything else?
What development phase is Glumetinib in?
Related
- Manufacturer: Haihe Biopharma Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: SCC244
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing