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AZD0530 Difumarate
AZD0530 Difumarate is a Src family kinase inhibitor Small molecule drug developed by Amsterdam UMC, location VUmc. It is currently in Phase 2 development for Advanced solid tumors (Phase 2 investigational). Also known as: Saracatinib.
AZD0530 is a Src family kinase inhibitor that blocks intracellular signaling pathways involved in cell proliferation and survival.
AZD0530 is a Src family kinase inhibitor that blocks intracellular signaling pathways involved in cell proliferation and survival. Used for Advanced solid tumors (Phase 2 investigational).
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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). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| 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 | AZD0530 Difumarate |
|---|---|
| Also known as | Saracatinib |
| Sponsor | Amsterdam UMC, location VUmc |
| Drug class | Src family kinase inhibitor |
| Target | Src family kinases (SFK) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
AZD0530 (saracatinib) inhibits Src family kinases, which are non-receptor tyrosine kinases implicated in various cancers and inflammatory diseases. By blocking Src kinase activity, the drug disrupts downstream signaling cascades that promote tumor cell growth, survival, and migration. This mechanism has been explored in multiple cancer types and other conditions where Src activation contributes to pathology.
Approved indications
- Advanced solid tumors (Phase 2 investigational)
Common side effects
- Diarrhea
- Nausea
- Fatigue
- Rash
Key clinical trials
- A Pharmacokinetic and Randomized Trial of Neoadjuvant Treatment With Anastrozole Plus AZD0530 in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer (PHASE1, PHASE2)
- Saracatinib Trial TO Prevent FOP (PHASE2)
- AZD0530 and Gemcitabine in Locally Advanced/Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery (PHASE1, PHASE2)
- The Tolerability and Effects of AZD0530 in Individuals With or Without a Family History of Alcoholism (PHASE1)
- Safety and Tolerability of AZD0530 (Saracatinib) in Alzheimer's Disease (PHASE1)
- Saracatinib and Alcohol Drinking (PHASE2)
- Safety and Efficacy of Saracatinib In Subjects With Lymphangioleiomyomatosis (PHASE2)
- A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung (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:
- AZD0530 Difumarate CI brief — competitive landscape report
- AZD0530 Difumarate updates RSS · CI watch RSS
- Amsterdam UMC, location VUmc portfolio CI
Frequently asked questions about AZD0530 Difumarate
What is AZD0530 Difumarate?
How does AZD0530 Difumarate work?
What is AZD0530 Difumarate used for?
Who makes AZD0530 Difumarate?
Is AZD0530 Difumarate also known as anything else?
What drug class is AZD0530 Difumarate in?
What development phase is AZD0530 Difumarate in?
What are the side effects of AZD0530 Difumarate?
What does AZD0530 Difumarate target?
Related
- Drug class: All Src family kinase inhibitor drugs
- Target: All drugs targeting Src family kinases (SFK)
- Manufacturer: Amsterdam UMC, location VUmc — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced solid tumors (Phase 2 investigational)
- Also known as: Saracatinib
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing