Luzu

(Luliconazole Cream 1%)

ApprovedSmall molecule

BBausch Health Americas, Inc.

Luzu is one of 21 small molecule programs targeting Tinea Pedis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Tinea PedisActive, not recruiting

Pityriasis VersicolorActive, not recruiting

Tinea PedisApproved

Active, not recruiting

Pityriasis VersicolorApproved

Active, not recruiting

Competition

Competitive Landscape

56 competitors in Tinea Pedis

#DrugCompanyPhaseTrials

Lotrimin

Bayer

Approved

—2

Diflucan

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

Lamisil

1 4

Nizoral

WWim Janssens

Phase 3

2 5

Luzu

BBausch Health Americas, Inc.

Approved

1 6

Inomax

MMallinckrodt

Phase 2

1 7

Ciclopirox Olamine

AAtlas Molecular Pharma

Phase 3

2 8

Terbinafine Hydrochloride

Novartis

Phase 2

2 9

NAFT-500

MMerz North America, Inc.

Phase 3

1 10

VT-1161

VViamet

Phase 2

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Pityriasis Versicolor

NCT07333170

Clinical

Trials by Indication[1]

Pityriasis Versicolor1 trial

Comparison of the Efficacy of Topical Luliconazole 2% Cream vs Topical Ketoconazole 1% Cream in the Treatment of Pityriasis Versicolor.

Not yet recruiting·PPAEC General Hospital, Islamabad·Phase 4·NCT07333170·86 enrolled

Tinea Pedis1 trial

Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris

Completed·BBausch Health Americas, Inc.·Phase 4·NCT02767271·30 enrolled

Interaction1 trial

Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris

Completed·BBausch & Lomb Incorporated·Phase 4·NCT02394340·20 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis

Completed·BBausch Health Americas, Inc.·Phase 4·NCT02767947·75 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 14, 2013

LUZU

NDA NDA204153

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Luliconazole Cream 1%. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Luliconazole Cream 1% compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Luliconazole Cream 1%. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA204153). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Luzu. U.S. Food & Drug Administration.
[6]
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: Approved[1]
Company: BBausch Health Americas, Inc.

Patent Landscape[5]

Patent Cliff

Sep 6, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9012484Sep 6, 2033

9453006Sep 6, 2033

9199977Sep 6, 2033

8980931Apr 28, 2034

Luzu

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Pityriasis Versicolor1 trial

Tinea Pedis1 trial

Interaction1 trial

Safety and Efficacy1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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