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Sunitinib Malate Continuous Daily Dosing
Sunitinib Malate Continuous Daily Dosing is a Small molecule drug developed by Pfizer. It is currently in Phase 2 development.
Sunitinib malate is a small molecule used in the treatment of various cancers, including metastatic breast cancer, advanced breast cancer, metastatic castration-resistant prostate cancer, metastatic renal cell cancer, and non-small cell lung cancer. It is administered continuously on a daily basis as part of its treatment regimen.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Sunitinib Malate Continuous Daily Dosing |
|---|---|
| Sponsor | Pfizer |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib (PHASE3)
- Losartan + Sunitinib in Treatment of Osteosarcoma (PHASE1)
- A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (PHASE3)
- Use of Individual Pharmacokinetically (PK)-Guided Sunitinib Dosing: A Feasibility Study in Patients With Advanced Solid Tumors (PHASE1)
- Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma (PHASE3)
- Pazopanib Versus Sunitinib in the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma (PHASE2)
- CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors (PHASE1, PHASE2)
- A Study of Abemaciclib in Combination With Sunitinib in Metastatic Renal Cell Carcinoma (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:
- Sunitinib Malate Continuous Daily Dosing CI brief — competitive landscape report
- Sunitinib Malate Continuous Daily Dosing updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Sunitinib Malate Continuous Daily Dosing
What is Sunitinib Malate Continuous Daily Dosing?
Who makes Sunitinib Malate Continuous Daily Dosing?
What development phase is Sunitinib Malate Continuous Daily Dosing in?
Related
- Manufacturer: Pfizer — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing