Vizimpro

(Dacomitinib)

Phase 2Small molecule

Vizimpro is a small molecule that works as a Epidermal Growth Factor Receptor Erbb1 Inhibitor; Receptor Protein-Tyrosine Kinase Erbb-2 Inhibitor; Receptor Protein-Tyrosine Kinase Erbb-4 Inhibitor.[2] It is being investigated across 6 indications, with its most advanced program in Phase 2.[1]

Vizimpro is one of 90 small molecule programs targeting Neoplasm of the lung. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Neoplasm of the LungActive, not recruiting

Lung NeoplasmActive, not recruiting

Phase 2Active, not recruiting

TrialRecruiting

Rare TumorRecruiting

Advanced Solid TumoursActive, not recruiting

Neoplasm of the LungPreclinical

Active, not recruiting

Lung NeoplasmPreclinical

Active, not recruiting

Phase 2Phase 2

Active, not recruiting

TrialPhase 2

Recruiting

Rare TumorPhase 2

Recruiting

Advanced Solid TumoursPhase 2

Active, not recruiting

Competition

Competitive Landscape

139 competitors in Trial

#DrugCompanyPhaseTrials

Opdivo

Bristol-Myers Squibb

Phase 3

4 2

Yervoy

Bristol-Myers Squibb

Phase 3

3 3

Perjeta

Roche

Phase 3

2 4

Vectibix

Amgen

Phase 3

2 5

Eloxatin

Teva

Phase 3

2 6

Camptosar

Pfizer

Phase 3

2 7

Tarceva

OOSI Pharmaceuticals

Phase 3

5 8

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

5 9

Herceptin

OOrganon and Co

Phase 3

4 10

Adrucil

EElorac, Inc.

Phase 3

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

Timeline

Expected Milestones

Q2 2027

Phase 2Active, not recruiting

Advanced Solid Tumours

NCT04946968

Phase 1/2Recruiting

First-Line Treatment

NCT05271916

Q4 2027

Phase 2Recruiting

Trial

NCT02925234

Phase 2Active, not recruiting

Lung Cancer

NCT04504071

Q3 2028

Phase 2Recruiting

Rare Tumor

NCT04423185

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer

Completed· Pfizer logo

Pfizer·Phase 3·NCT01360554·878 enrolled

A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer

Completed· Pfizer logo

Pfizer·Phase 2·NCT01858389·41 enrolled

A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

Completed· Pfizer logo

Pfizer··NCT05834348·5,279 enrolled

Show 1 more trial

An Open Label, Multicenter, Phase II Study of Dacomitinib for EGFR Mutated Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases

Unknown status·GGuangdong Association of Clinical Trials·Phase 2·NCT04339829·50 enrolled

Advanced NSCLC3 trials

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.

Completed· Pfizer logo

Pfizer·Phase 3·NCT01774721·452 enrolled

Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO

Completed· Pfizer logo

Pfizer·Phase 2·NCT01465802·236 enrolled

Dacomitinib Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced NSCLC

Unknown status·PPeking Union Medical College··NCT04768491·82 enrolled

Lung Cancer3 trials

Dacomitinib in Lung Cancer With Uncommon EGFR Mutations

Active, not recruiting·SShanghai Chest Hospital·Phase 2·NCT04504071·30 enrolled

Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03810807·22 enrolled

A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03755102·17 enrolled

Squamous Cell Carcinoma2 trials

Dacomitinib Plus Radiotherapy, With and Without Cisplatin in Patients With Squamous Cell Carcinoma of the Head and Neck

Completed·UUniversity Health Network, Toronto·Phase 1·NCT01737008·12 enrolled

Dacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis

Completed·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano·Phase 2·NCT01728233·32 enrolled

Trial2 trials

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

18 more indications

Small Cell Lung Cancer2 trials

Real World Utilization and Outcomes With Dacomitinib First Line Treatment for EGFR Mutation-positive Advanced Non Small Cell Lung Cancer Among Asian Patients - A Multi Center Chart Review

Completed· Pfizer logo

Pfizer··NCT04609319·307 enrolled

Dacomitinib for Treatment of Patients in India With Metastatic Non Small Cell Lung Cancer With EGFR Activating Mutations

Completed· Pfizer logo

Pfizer·Phase 4·NCT04511533·101 enrolled

Rare Tumor1 trial

PLATFORM Study of Precision Medicine for Rare Tumors

Recruiting·—·Phase 2·NCT04423185·770 enrolled

Advanced Solid Tumours1 trial

Phase-2 Dacomitinib Study on Patients With EGFR-Driven Advanced Solid Tumours With Low EGFR-AS1 IncRNA Expr or Other Novel Emerging Biomarkers

Active, not recruiting·NNational Cancer Centre, Singapore·Phase 2·NCT04946968·24 enrolled

Intravenous1 trial

A Study To Assess Absorption Of Study Drug Dacomitinib (PF-00299804), Given As An Oral Tablet Compared To An Intravenous Infusion In Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT01796327·14 enrolled

Adenocarcinoma1 trial

Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung

Completed· Pfizer logo

Pfizer·Phase 2·NCT00818441·119 enrolled

Brain Metastases1 trial

A Phase II Study of Dacomitinib in Progressive Brain Metastases

Terminated·—·Phase 2·NCT02047747·4 enrolled

Central Nervous System1 trial

Central Nervous System(CNS) Efficacy of Dacomitinib

Unknown status·SSamsung Medical Center·Phase 2·NCT04675008·30 enrolled

Moderate Hepatic Impairment1 trial

A Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment

Completed· Pfizer logo

Pfizer·Phase 1·NCT01571388·25 enrolled

First-line Treatment1 trial

First-line Treatment With Dacomitinib Plus Anlotinib for Patients With Advanced NSCLC With EGFR 21L858R Mutations

Recruiting·SShanghai Chest Hospital·Phase 1/2·NCT05271916·140 enrolled

Hepatic Impairment1 trial

Evaluate Severe Hepatic Impairment on Dacomitinib PK

Completed· Pfizer logo

Pfizer·Phase 1·NCT03865446·16 enrolled

Squamous Cell Cancer1 trial

Efficacy and Safety of Dacomitinib in the Treatment of Skin Squamous Cell Cancer

Unknown status·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano·Phase 2·NCT02268747·43 enrolled

Breast Cancer1 trial

A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)

Completed· Pfizer logo

Pfizer·Phase 1·NCT01920061·110 enrolled

Advanced1 trial

Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

Completed·TThe Netherlands Cancer Institute·Phase 1/2·NCT02039336·35 enrolled

EGFR Mutation1 trial

Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations

Unknown status·FFondazione Ricerca Traslazionale·Phase 2·NCT04811001·170 enrolled

Tics1 trial

Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT02097433·14 enrolled

Real-world Study1 trial

Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study

Unknown status·GGuangdong Association of Clinical Trials··NCT04575415·272 enrolled

Phase 21 trial

Phase 2 Study of Dacomitinib in NSCLC

Active, not recruiting·NNational Cancer Centre, Singapore·Phase 2·NCT04027647·118 enrolled

Unspecified1 trial

A Rollover Protocol of Dacomitinib For Patients In Japan

Completed· Pfizer logo

Pfizer·Phase 2·NCT02382796·7 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 27, 2018

VIZIMPRO

NDA NDA211288

Sources

References

[1]
ClinicalTrials.gov — 33 trial records for Dacomitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dacomitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dacomitinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211288). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Vizimpro. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Epidermal Growth Factor Receptor Erbb1 Inhibitor; Receptor Protein-Tyrosine Kinase Erbb-2 Inhibitor; Receptor Protein-Tyrosine Kinase Erbb-4 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Pfizer

Patent Landscape[5]

Patent Cliff

Sep 27, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10603314Feb 2, 2026

10596162Feb 2, 2026

7772243Sep 27, 2032

Vizimpro

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Q3 2028

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

Advanced NSCLC3 trials

Lung Cancer3 trials

Squamous Cell Carcinoma2 trials

Trial2 trials

Small Cell Lung Cancer2 trials

Rare Tumor1 trial

Advanced Solid Tumours1 trial

Intravenous1 trial

Adenocarcinoma1 trial

Brain Metastases1 trial

Central Nervous System1 trial

Moderate Hepatic Impairment1 trial

First-line Treatment1 trial

Hepatic Impairment1 trial

Squamous Cell Cancer1 trial

Breast Cancer1 trial

Advanced1 trial

EGFR Mutation1 trial

Tics1 trial

Real-world Study1 trial

Phase 21 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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