Bepreve

(Bepotastine Besilate)

Phase 3Small molecule

BBausch Health Americas, Inc.

Bepreve is one of 93 small molecule programs targeting Allergic Conjunctivitis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Allergic ConjunctivitisActive, not recruiting

Allergic RhinitisActive, not recruiting

Atopic DermatitisActive, not recruiting

Seasonal Allergic RhinitisActive, not recruiting

Allergic ConjunctivitisPhase 2

Active, not recruiting

Allergic RhinitisPhase 3

Active, not recruiting

Atopic DermatitisPhase 3

Active, not recruiting

Seasonal Allergic RhinitisPhase 2

Active, not recruiting

Competition

Competitive Landscape

508 competitors in Atopic Dermatitis

#DrugCompanyPhaseTrials

Olumiant

Eli Lilly

Phase 3

11 2

Eucrisa

AAnacor

Phase 3

4 3

Flovent

PParatek Pharmaceuticals Inc

Phase 3

1 4

Tagamet

DDT MedTech, LLC

Phase 3

1 5

Bepreve

BBausch Health Americas, Inc.

Phase 3

1 6

Rocatinlimab

Amgen

Phase 3

8 7

GR1802

GGenrix (Shanghai) Biopharmaceutical Co., Ltd.

Phase 3

1 8

VC005

JJiangsu vcare pharmaceutical technology co., LTD

Phase 3

6 9

EBGLYSS

Cibinqo

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

Clinical

Trials by Indication[1]

Allergic Conjunctivitis3 trials

Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis

Completed·BBausch & Lomb Incorporated·Phase 2/3·NCT00424398·107 enrolled

Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis

Completed·BBausch & Lomb Incorporated·Phase 3·NCT00586664·130 enrolled

Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients

Completed·BBausch & Lomb Incorporated·Phase 2·NCT01174823·245 enrolled

Seasonal Allergic Rhinitis2 trials

Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis

Completed·BBausch & Lomb Incorporated·Phase 2·NCT01578278·606 enrolled

Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)

Completed·BBausch & Lomb Incorporated·Phase 2·NCT01753739·617 enrolled

Allergic Rhinitis2 trials

The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 3·NCT01861522·473 enrolled

A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 3·NCT01900054·58 enrolled

Efficacy1 trial

Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber

Completed·BBausch & Lomb Incorporated·Phase 1/2·NCT01222299·89 enrolled

Atopic Dermatitis1 trial

A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 3·NCT01840605·303 enrolled

1 more indication

Unspecified1 trial

Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+

Completed·LLaboratorios Sophia S.A de C.V.·Phase 1·NCT04693429·22 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 8, 2009

BEPREVE

NDA NDA022288

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Bepotastine Besilate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Bepotastine Besilate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Bepotastine Besilate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022288). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bausch Health Americas, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: BBausch Health Americas, Inc.

Bepreve

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Allergic Conjunctivitis3 trials

Seasonal Allergic Rhinitis2 trials

Allergic Rhinitis2 trials

Efficacy1 trial

Atopic Dermatitis1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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