Zegfrovy

(sunvozertinib)

Phase 3Small molecule

DDizal Pharmaceuticals

Zegfrovy is one of 177 small molecule programs targeting Non-Small Cell Lung Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

176

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Non-Small Cell Lung CancerActive, not recruiting

TreatmentRecruiting

UnresectableRecruiting

Lung CancerActive, not recruiting

Untreated Advanced NSCLCRecruiting

Advanced NSCLCRecruiting

Treatment FailureRecruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

TreatmentPhase 2

Recruiting

UnresectablePhase 2

Recruiting

Lung CancerPhase 2

Active, not recruiting

Untreated Advanced NSCLCPhase 2

Recruiting

Advanced NSCLCPhase 1

Recruiting

Treatment FailurePhase 2

Recruiting

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Retevmo

Eli Lilly

Phase 3

4 2

Zegfrovy

DDizal Pharmaceuticals

Phase 3

5 3

Navelbine

PPierre Fabre Medicament

Phase 3

24 4

Sacituzumab Tirumotecan

Merck & Co.

Phase 3

5 5

Remeron

OOrganon and Co

Preclinical

1 6

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 7

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—8

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—9

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Active, not recruiting

Non-Small Cell Lung Cancer

NCT03974022

Q2 2027

Phase 2Recruiting

Untreated Advanced NSCLC

NCT07117890

Not yet recruiting

Treatment Failure

NCT06786208

Q4 2027

Phase 3Active, not recruiting

Non-Small Cell Lung Cancer

NCT05668988

Q4 2028

Phase 1Recruiting

Advanced NSCLC

NCT06905197

PreclinicalRecruiting

Non-Small Cell Lung Cancer

NCT07079475

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)

Active, not recruiting·DDizal Pharmaceuticals·Phase 1/2·NCT03974022·315 enrolled

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

Recruiting·DDizal (Jiangsu) Pharmaceutical Co., Ltd.·Phase 3·NCT07182682·360 enrolled

Neoadjuvant Sunvozertinib in Stage II-IIIB Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutation.

Active, not recruiting·SShanghai Pulmonary Hospital, Shanghai, China·Phase 2·NCT07274761·24 enrolled

Show 2 more trials

A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)

Active, not recruiting·DDizal Pharmaceuticals·Phase 3·NCT05668988·324 enrolled

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combined With Sunvozertinib in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN8)

Recruiting·DDizal (Jiangsu) Pharmaceutical Co., Ltd.·Preclinical·NCT07079475·220 enrolled

Treatment Failure2 trials

Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II

Recruiting·SSichuan University·Phase 1/2·NCT06195189·40 enrolled

Real-world Study of Sunvozertinib Treatment in Advanced EGFR-Mutant NSCLC After EGFR-TKI Treatment Failure

Not yet recruiting·HHenan Cancer Hospital··NCT06786208·55 enrolled

Unresectable1 trial

Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

Recruiting·SSun Yat-sen University·Phase 2·NCT06563999·120 enrolled

Untreated Advanced NSCLC1 trial

Sunvozertinib Treatment in Untreated Advanced NSCLC With EGFR Uncommon Mutations

Recruiting·FFudan University·Phase 2·NCT07117890·34 enrolled

Treatment1 trial

Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC

Recruiting·TTang-Du Hospital·Phase 2·NCT06864624·27 enrolled

2 more indications

Lung Cancer1 trial

Sunvozertinib (DZD9008) in Pretreated Lung Cancer Patients with EGFR Exon20 Insertion Mutation (WU-KONG6)

Active, not recruiting·DDizal Pharmaceuticals·Phase 2·NCT05712902·104 enrolled

Advanced NSCLC1 trial

A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)

Recruiting·DDizal Pharmaceuticals·Phase 1·NCT06905197·140 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 2, 2025

ZEGFROVY

NDA NDA219839

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for sunvozertinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — sunvozertinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for sunvozertinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219839). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Zegfrovy. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Dizal Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: DDizal Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Jan 28, 2039

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11504375Jan 28, 2039

11896597Jan 28, 2039

11007198Jan 28, 2039

Zegfrovy

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Q4 2028

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

Treatment Failure2 trials

Unresectable1 trial

Untreated Advanced NSCLC1 trial

Treatment1 trial

Lung Cancer1 trial

Advanced NSCLC1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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