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Binimetinib only treatment (binimetinib-only-treatment)
Binimetinib only treatment (generic name: binimetinib-only-treatment) is a Binimetinib will be administered at the same dose level (15 mg to 45 mg) as that received in the Par drug developed by Pfizer Inc.. It is currently in preclinical development.
Binimetinib will be administered at the same dose level (15 mg to 45 mg) as that received in the Par
Binimetinib is a small molecule inhibitor of the dual specificity mitogen-activated protein kinase kinase 1 (MEK1) enzyme. It has been studied as a treatment for various conditions, including melanoma, gastrointestinal stromal tumor, and metastatic breast cancer, often in combination with other medications.
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Baseline preclinical → approval rate
+5.0pp
Industry-wide preclinical drugs reach approval ~5% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2036–2040 | — |
| EMA | EU | 2037–2041 | +0.7 yr |
| MHRA | GB | 2037–2041 | +0.7 yr |
| Health Canada | CA | 2037–2042 | +0.9 yr |
| TGA | AU | 2037–2042 | +1.2 yr |
| PMDA | JP | 2037–2042 | +1.5 yr |
| NMPA | CN | 2038–2043 | +2.3 yr |
| MFDS | KR | 2037–2042 | +1.4 yr |
| CDSCO | IN | 2037–2043 | +1.8 yr |
| ANVISA | BR | 2038–2043 | +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 | binimetinib-only-treatment |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Binimetinib will be administered at the same dose level (15 mg to 45 mg) as that received in the Par |
| Therapeutic area | Oncology |
| Phase | preclinical |
Mechanism of action
Cancer cells often rely on a chain of molecular signals to grow and divide. One critical link in this chain is a protein called MEK. In certain cancers with specific mutations (like NRAS mutations), this MEK protein becomes overactive, constantly telling cells to multiply. Binimetinib acts as a brake on this system by binding to MEK and preventing it from passing along growth signals. When MEK is blocked, the cascade of commands that normally drives cell division gets interrupted. The cancer cells no longer receive the "grow and divide" message, so they stop proliferating. This is particularly effective in melanomas where NRAS mutations have already activated the growth pathway upstream of MEK, making this protein an ideal target in those specific patients. By using this targeted approach, binimetinib attacks a specific vulnerability in certain cancers while potentially sparing some healthy cells that don't rely as heavily on this same pathway. This is why genetic testing is important—the drug works best in patients whose cancers actually have these MEK-dependent mutations.
Approved indications
Pipeline indications
- Solid Tumors — preclinical
Common side effects
Key clinical trials
- MEK162 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function (Phase 1)
- A Trial of mFOLFIRI With MEK162 in Patients With Advanced RAS (HRAS, NRAS, or KRAS) Positive Metasta (Phase 1)
- The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib fo (Phase 4)
- An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lun (Phase 2)
- A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients (Phase 3)
- MEK162 for Patients With RAS/RAF/MEK Activated Tumors (Phase 2)
- Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patient (Phase 1)
- Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5- (Phase 3)
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:
- Binimetinib only treatment CI brief — competitive landscape report
- Binimetinib only treatment updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Binimetinib only treatment
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Related
- Drug class: All Binimetinib will be administered at the same dose level (15 mg to 45 mg) as that received in the Par drugs
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing