Lamisil

(Terbinafine)

ApprovedSmall molecule

Terbinafine is used to treat fungal infections of the nails and skin, such as toenail fungus and athlete's foot. It works by stopping the growth of the fungus.[2] Lamisil is currently approved and in use across 9 indications[4].[1]

Lamisil is one of 134 small molecule programs targeting Tinea Pedis. It is currently in Approved.

Indications

Total Trials

Active Trials

133

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Tinea PedisActive, not recruiting

Chronic HepatitisActive, not recruiting

Fungal Infectious DiseaseActive, not recruiting

Prostate CancerActive, not recruiting

Ulcerative ColitisActive, not recruiting

Dermatophytosis of Scalp or BeardActive, not recruiting

SpondyloarthropathyActive, not recruiting

TineaActive, not recruiting

Tinea UnguiumApproved

Tinea PedisPhase 3

Active, not recruiting

Chronic HepatitisPhase 1/Phase 2

Active, not recruiting

Fungal Infectious DiseaseApproved

Active, not recruiting

Prostate CancerPhase 2

Active, not recruiting

Ulcerative ColitisPhase 2

Active, not recruiting

Dermatophytosis of Scalp or BeardPreclinical

Active, not recruiting

SpondyloarthropathyPhase 1

Active, not recruiting

TineaApproved

Active, not recruiting

Tinea UnguiumApproved

Approved

Competition

Competitive Landscape

1399 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Lamisil

Novartis

Approved

1 2

Novantrone

Pfizer

Preclinical

5 3

Mekinist

Novartis

Preclinical

3 4

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 5

Viagra

VViatris Specialty LLC

Preclinical

1 6

Duragesic

CCephalon

Preclinical

1 7

Prednisone/prednisolone

Roche

Preclinical

3 8

Triptorelin Pamoate

Ipsen

Preclinical

2 9

Osmitrol

BB. Braun Medical Inc.

Preclinical

—10

Xylocaine

CCitius Pharmaceuticals, Inc.

Preclinical

—

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

Timeline

Expected Milestones

Q4 2030

Phase 2Not yet recruiting

Prostate Cancer

NCT07365423

Clinical

Trials by Indication[1]

Onychomycosis5 trials

Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis

Completed·HHelsinki University Central Hospital·Phase 4·NCT01851590·129 enrolled

Efficacy of Intralesional PRP in Treatment of Onychomycosis

Unknown status·SSohag University·Phase 3·NCT05128916·75 enrolled

Comparative Study Between Pulse Therapy With Oral Itraconazole Versus Continuous Oral Terbinafine Therapy for Treatment of Onychomycosis

Completed·—·Phase 1·NCT05578950·100 enrolled

Show 2 more trials

Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis

Completed·NNexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)·Phase 1·NCT00691184·56 enrolled

Antifungal Drugs in Treatment of Onychomycosis

Unknown status·—·Phase 3·NCT03171584·60 enrolled

Tinea Capitis2 trials

Efficacy Comparison of Itraconazole Pulse Therapy and Terbinafine Therapy in Treatment of Tinea Capitis in Children.

Completed·MMuhammad Aamir Latif·N/A·NCT07068256·164 enrolled

Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis

Recruiting·SShandong University··NCT07046988·60 enrolled

Efficacy and Safety2 trials

A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00491764·218 enrolled

Efficacy and Safety of Terbinafine and Itraconazole

Unknown status·—·Phase 2/3·NCT05881980·150 enrolled

Efficacy2 trials

Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail

Completed· Novartis logo

Novartis·Phase 3·NCT00443898·518 enrolled

Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail

Completed· Novartis logo

Novartis·Phase 3·NCT00443820·526 enrolled

Fungal Resistance1 trial

Clinical and Laboratory Evaluation of Antifungal Resistance in Tinea Capitis

Not yet recruiting·—·Phase 1·NCT06400056·30 enrolled

10 more indications

Recurrence1 trial

Isotretinoin In Preventing Recurrences In Chronic Recurrent Dermatophytosis

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 2·NCT03471455·100 enrolled

Chronic Hepatitis1 trial

From Fungus to Virus, Investigating the Safety and Efficacy of Terbinafine in Chronic Hepatitis B Patients

Recruiting·—·Phase 1/2·NCT06295328·36 enrolled

Fed1 trial

Bioequivalency Study of Terbinafine Tablets Under Fed Conditions

Completed·RRoxane Laboratories·N/A·NCT00602251·30 enrolled

Tinea Pedis1 trial

Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis

Completed· Novartis logo

Novartis·Phase 3·NCT01433107·290 enrolled

Ulcerative Colitis1 trial

Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis

Completed·HHamilton Health Sciences Corporation·Phase 2·NCT02606032·75 enrolled

Fasting Conditions1 trial

Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00602342·30 enrolled

TED1 trial

Mycosis Culture Collection From Dermatological Isolated

Active, not recruiting·UUniversity of Rome Tor Vergata··NCT05482763·200 enrolled

Spondyloarthropathy1 trial

Terbinafine Treatment of Axial Spondyloarthropathy

Withdrawn·OOregon Health and Science University·Phase 1·NCT05119712

Prostate Cancer1 trial

Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)

Not yet recruiting·SSwiss Cancer Institute·Phase 2·NCT07365423·42 enrolled

Unspecified1 trial

Bioequivalence Study for Terbinafine 250 mg

Completed· GSK logo

GSK·Phase 1·NCT01772212·30 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 30, 1992

LAMISIL

NDA NDA020192

May 10, 1996

LAMISIL

NDA NDA020539

Oct 17, 1997

LAMISIL

NDA NDA020749

Apr 29, 1998

LAMISIL

NDA NDA020846

Mar 9, 1999

LAMISIL

NDA NDA020980

Mar 17, 2000

LAMISIL AT

NDA NDA021124

Jul 24, 2006

LAMISIL AT

NDA NDA021958

Sep 28, 2007

LAMISIL

NDA NDA022071

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for Terbinafine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lamisil drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Terbinafine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Terbinafine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022071). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Squalene Monooxygenase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Lamisil

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2030

Trials by Indication[1]

Onychomycosis5 trials

Tinea Capitis2 trials

Efficacy and Safety2 trials

Efficacy2 trials

Fungal Resistance1 trial

Recurrence1 trial

Chronic Hepatitis1 trial

Fed1 trial

Tinea Pedis1 trial

Ulcerative Colitis1 trial

Fasting Conditions1 trial

TED1 trial

Spondyloarthropathy1 trial

Prostate Cancer1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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