TheraRadar
Data updated: May 26, 2026

ZEGFROVY (sunvozertinib)

Trial Activity: Growth 9 active trials
Breakthrough Therapy Priority Review Accelerated Approval
Oncology Approved 2025-07-02
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Dizal Pharmaceuticals conducting 4 trials (44%)
6 indications explored (Moderate)
→ non-small cell lung cancer (5 trials)
→ non small cell lung cancer (2 trials)
→ potentially resectable egfr exon 20 insertion non-small cell lung cancer (1 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market

Details

Status
Prescription
First Approved
2025-07-02
Patent Cliff
2039

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

DIZAL JIANGSU
Active Ingredient: SUNVOZERTINIB

ZEGFROVY Approval History

2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2025 to 2025
Jul 2025 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What ZEGFROVY Treats

1 FDA approvals

Originally approved for its first indication in 2025 .

  • Other (1)
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Clinical Trial Registry

10 trials
Trial Sponsor ID Phase Status Title
NCT07079475 DZ2025C0001 Ph 1, Ph 2 recruiting Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)
NCT06195189 WU-KONG36 DZ2023EI002 Ph 1, Ph 2 recruiting Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II
NCT06563999 NUMER GASTO-10117 Ph 2 recruiting Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.
NCT06905197 DZ2023C0001 Ph 1 recruiting A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)
NCT05668988 DZ2022E0005 Ph 3 active not recruiting A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
NCT03974022 results posted DZ2019E0001 Ph 1, Ph 2 active not recruiting Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)
NCT07182682 DZ2025E0001 Ph 3 recruiting 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
NCT07274761 LungMate-035 Ph 2 active not recruiting Neoadjuvant Sunvozertinib in Stage II-IIIB Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutation.
NCT06864624 WU-KONG20 K202412-18 Ph 2 recruiting Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC
NCT05712902 DZ2020E0001 Ph 2 active not recruiting Sunvozertinib (DZD9008) in Pretreated Lung Cancer Patients with EGFR Exon20 Insertion Mutation (WU-KONG6)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ZEGFROVY FDA Label Details

View full patent landscape →
3 OB patents · 2 families · 40 international docs across 15 countries

ZEGFROVY Patents & Exclusivity

Latest Patent: Jan 2039
Exclusivity: Jul 2030

Patents (3 active)

US11504375 Expires Jan 28, 2039
US11896597 Expires Jan 28, 2039
US11007198 Expires Jan 28, 2039

Exclusivity

NCE Until Jul 2030
NCE Until Jul 2030
NCE Until Jul 2030
NCE Until Jul 2030
Source: FDA Orange Book

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Deep insights for ZEGFROVY

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2039
  • • 12 active patents

Trial Analysis

  • • 9 total trials
  • • Stage: Growth

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA219839 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment