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Zymar

(gatifloxacin)

ApprovedSmall molecule

Zymar is one of 51 small molecule programs targeting Cataract. It is currently in Approved.

2

Indications

11

Total Trials

0

Active Trials

50

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

CataractActive, not recruiting

FluoroquinoloneCompleted

CataractApproved

Active, not recruiting

FluoroquinolonePreclinical

Completed

Competition

Competitive Landscape

63 competitors in Cataract

#DrugCompanyPhaseTrials

Avelox

Eylea

Decadron

AAspen Global Incorporated

Bromday

BBausch Health Americas, Inc.

Precedex

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

Lovenox

Toradol

Cipro

Voltaren

Deltasone

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

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

Clinical

Trials by Indication[1]

Cataract2 trials

Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery

Withdrawn·QQueen's University·N/A·NCT00335231

Therapeutic Variables in Cataract Surgery

Completed·IInnovative Medical·Phase 4·NCT00407017

Concentration2 trials

Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects

Completed·BBausch & Lomb Incorporated·Phase 1·NCT00824070·105 enrolled

Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation

Completed·BBausch & Lomb Incorporated·Phase 1·NCT00905762·119 enrolled

Bacterial Conjunctivitis2 trials

Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis

Terminated·BBausch & Lomb Incorporated·Phase 3·NCT01330355·33 enrolled

A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis

Completed· AbbVie logo

AbbVie·Phase 4·NCT00464438·171 enrolled

Antibiotics1 trial

Topical Antibiotics and Intravitreous Injections

Completed·SStanford University·Phase 4·NCT00410891·129 enrolled

Pulmonary Tuberculosis1 trial

Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00396084·70 enrolled

3 more indications

Fluoroquinolone1 trial

Comparison of the Effect of 4th Generation Fluoroquinolones, Gatifloxacin and Moxifloxacin, on Epithelial Healing Following Photorefractive Keratectomy (PRK), A Substudy of: Initial Evaluation of Excimer Laser Keratorefractive Surgery in U.S. Army Personnel (WU # 2335-99)

Completed·WWalter Reed Army Medical Center·N/A·NCT00414011·40 enrolled

Treatment1 trial

Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen

Completed·CCarolina Eyecare Physicians, LLC·Phase 4·NCT03578276·35 enrolled

Enteric Fever1 trial

Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

Completed·OOxford University Clinical Research Unit, Vietnam·Phase 4·NCT01421693·300 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 28, 2003

ZYMAR

NDA NDA021493

May 18, 2010

ZYMAXID

NDA NDA022548

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for gatifloxacin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — gatifloxacin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for gatifloxacin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022548). U.S. Food & Drug Administration.
[5]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

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

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