ZEGFROVY
LaunchSMsunvozertinib
NDAORALTABLETPriority Review
Approved
Jul 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 10h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEGFROVY (sunvozertinib) is an oral small-molecule tablet approved in July 2025 for an undisclosed indication. Specific mechanism of action and clinical indications are not detailed in available data, limiting assessment of therapeutic positioning.
Growth12.6 years to LOE
Early-stage launch product with no established market share; commercial team building and field expansion likely underway.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery
Started Dec 2025
360 enrolled
Non-Small Cell Lung Cancer
Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)
Started Jul 2025
160 enrolled
Non-Small Cell Lung Cancer
Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC
Started Feb 2025
27 enrolled
NSCLC
Sunvozertinib (DZD9008) in Pretreated Lung Cancer Patients with EGFR Exon20 Insertion Mutation (WU-KONG6)
Started Jul 2021
104 enrolled
Non-Small Cell Lung Cancer
Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)
Started Jul 2019
315 enrolled
Non-Small Cell Lung Cancer
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.