Acuvue Theravision With Ketotifen

(Ketotifen)

ApprovedSmall molecule

Acuvue Theravision With Ketotifen is one of 220 small molecule programs targeting Dyspepsia. It is currently in Approved.

Indications

Total Trials

Active Trials

219

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

DyspepsiaActive, not recruiting

Allergic ConjunctivitisActive, not recruiting

Non-Alcoholic Fatty Liver DiseaseActive, not recruiting

Peripheral NeuropathyActive, not recruiting

ContractureActive, not recruiting

Allergic RhinitisActive, not recruiting

Breast CancerActive, not recruiting

FibromyalgiaActive, not recruiting

DyspepsiaPhase 3

Active, not recruiting

Allergic ConjunctivitisPhase 3

Active, not recruiting

Non-Alcoholic Fatty Liver DiseaseApproved

Active, not recruiting

Peripheral NeuropathyPhase 3

Active, not recruiting

ContracturePhase 2

Active, not recruiting

Allergic RhinitisPhase 3

Active, not recruiting

Breast CancerPreclinical

Active, not recruiting

FibromyalgiaPhase 3

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Acuvue Theravision With Ketotifen

AAlcon Research

Approved

1 2

Gemzar

GGynecologic Oncology Group

Preclinical

22 3

Chirocaine

PPurdue Pharma LP

Preclinical

1 4

Tricor

JJagotec

Preclinical

1 5

Conventional Chemotherapy

SShanghai Jiao Tong University School of Medicine

Preclinical

1 6

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 7

Tianeptine

Pfizer

Preclinical

1 8

Iniparib

Sanofi

Preclinical

6 9

Citalopram Hydrobromide

TTorrent Pharmaceuticals Limited

Preclinical

1 10

Lapatinib Plus Capecitabine

GSK

Preclinical

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

Timeline

Expected Milestones

Q2 2027

Phase 3Recruiting

Dyspepsia

NCT02484248

Clinical

Trials by Indication[1]

Allergic Conjunctivitis3 trials

Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.

Completed·BBausch & Lomb Incorporated·Phase 3·NCT00769886·144 enrolled

Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

Completed· Novartis logo

Novartis·Phase 4·NCT00133627·229 enrolled

Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.

Completed·BBausch & Lomb Incorporated·Phase 3·NCT00770133·141 enrolled

Desensitization1 trial

Pilot Study to Evaluate the Effect of Ketotifen on the Adverse Events Associated With Peanut Desensitization

Unknown status·GGordon Sussman Clinical Research·Phase 2·NCT01625715·6 enrolled

Dyspepsia1 trial

Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia

Recruiting·—·Phase 3·NCT02484248·40 enrolled

Dengue Fever1 trial

Ketotifen as a Treatment for Vascular Leakage During Dengue Fever

Unknown status·NNational University Hospital, Singapore·Phase 4·NCT02673840·110 enrolled

Non-Alcoholic Fatty Liver Disease1 trial

Ketotifen in Non-Alcoholic Fatty Liver Disease Patients

Completed·TTanta University·Phase 4·NCT05616442·60 enrolled

6 more indications

Breast Cancer1 trial

Ketotifen: as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy

Completed·HHorus University··NCT04435028·111 enrolled

Peripheral Neuropathy1 trial

The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy

Recruiting·TTanta University·Phase 3·NCT05624138·64 enrolled

Tics1 trial

Influence of Antipruritics on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin.

Completed·UUniversitaire Ziekenhuizen KU Leuven·N/A·NCT04399148·13 enrolled

Contracture1 trial

Investigations of Mechanisms and Treatment in Post-traumatic Joint Contractures

Completed·UUniversity of Calgary·Phase 2·NCT01902017·152 enrolled

Fibromyalgia1 trial

Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study

Completed·IIndiana University·Phase 3·NCT01553318·51 enrolled

Allergic Rhinitis1 trial

Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial Allergic Rhinitis

Completed· UCB logo

UCB·Phase 3·NCT00639587·149 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 19, 2006

ZADITOR

NDA NDA021066

Dec 1, 2006

ALAWAY

NDA NDA021996

Feb 25, 2022

ACUVUE THERAVISION WITH KETOTIFEN

NDA NDA022388

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Ketotifen. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ketotifen compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ketotifen. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022388). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Acuvue Theravision With Ketotifen. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Alcon Research company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAlcon Research

Patent Landscape[5]

Patent Cliff

Mar 27, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9474746Mar 27, 2028

9962376Jun 27, 2030

Acuvue Theravision With Ketotifen

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Trials by Indication[1]

Allergic Conjunctivitis3 trials

Desensitization1 trial

Dyspepsia1 trial

Dengue Fever1 trial

Non-Alcoholic Fatty Liver Disease1 trial

Breast Cancer1 trial

Peripheral Neuropathy1 trial

Tics1 trial

Contracture1 trial

Fibromyalgia1 trial

Allergic Rhinitis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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