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 96 small molecule programs targeting Dermatophytosis of Scalp or Beard. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Dermatophytosis of Scalp or BeardActive, not recruiting

TineaActive, not recruiting

Fungal Infectious DiseaseActive, not recruiting

Tinea UnguiumApproved

FedCompleted

Fasting ConditionsCompleted

Recurrent Prostate CancerRecruiting

Acute Kidney InjuryNot yet recruiting

Fungal ResistanceNot yet recruiting

Dermatophytosis of Scalp or BeardPreclinical

Active, not recruiting

TineaApproved

Active, not recruiting

Fungal Infectious DiseaseApproved

Active, not recruiting

Tinea UnguiumApproved

Approved

FedPreclinical

Completed

Fasting ConditionsPreclinical

Completed

Recurrent Prostate CancerPhase 2

Recruiting

Acute Kidney InjuryPhase 2

Not yet recruiting

Fungal ResistancePhase 1

Not yet recruiting

Competition

Competitive Landscape

92 competitors in Acute Kidney Injury

#DrugCompanyPhaseTrials

Maxipime

Pfizer

Approved

1 2

Glypressin

MMallinckrodt

Approved

2 3

Lamisil

Novartis

Approved

1 4

Giapreza

LLa Jolla Pharmaceutical Company

Phase 3

2 5

Oraverse

LLife Extension Foundation Inc.

Phase 3

1 6

Northera

Lundbeck

Phase 2

1 7

Desferal

Jazz Pharmaceuticals

Phase 2

1 8

Pitressin

AAultman Health Foundation

Phase 2

1 9

Arginine Vasopressin

SStanford University

Phase 3

1 10

Jardiance

Boehringer Ingelheim

Phase 1

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

Timeline

Expected Milestones

Q2 2028

Phase 2Not yet recruiting

Acute Kidney Injury

NCT07738328

Q4 2030

Phase 2Recruiting

Recurrent Prostate Cancer

NCT07365423

Clinical

Trials by Indication[1]

Onychomycosis5 trials

Efficacy of Intralesional PRP in Treatment of Onychomycosis

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

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

Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis

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

Show 2 more trials

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

Completed·—·Phase 1·NCT05578950·100 enrolled

Antifungal Drugs in Treatment of Onychomycosis

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

Efficacy and Safety2 trials

Efficacy and Safety of Terbinafine and Itraconazole

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

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

Tinea Capitis2 trials

Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis

Recruiting·SShandong University··NCT07046988·60 enrolled

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

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

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

11 more indications

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

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

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

Fasting Conditions1 trial

Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions

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

Fungal Resistance1 trial

Clinical and Laboratory Evaluation of Antifungal Resistance in Tinea Capitis

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

Fed1 trial

Bioequivalency Study of Terbinafine Tablets Under Fed Conditions

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

Acute Kidney Injury1 trial

Terbinafine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury: A Randomized Controlled Trial

Not yet recruiting·GGuangdong Provincial People's Hospital·Phase 2·NCT07738328·208 enrolled

Recurrent Prostate Cancer1 trial

Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro) - A Phase II Drug-repurposing Study

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 9, 1999

LAMISIL

NDA NDA020980

Sep 3, 1999

LAMISIL

NDA NDA020980

Mar 17, 2000

LAMISIL AT

NDA NDA021124

May 9, 2001

LAMISIL

NDA NDA020980

May 9, 2001

LAMISIL AT

NDA NDA021124

Mar 11, 2002

LAMISIL AT

NDA NDA021124

Apr 8, 2002

LAMISIL AT

NDA NDA021124

Jul 25, 2002

LAMISIL AT

NDA NDA021124

Jul 24, 2006

LAMISIL AT

NDA NDA021958

Jul 25, 2007

LAMISIL

NDA NDA020980

Sep 28, 2007

LAMISIL

NDA NDA022071

Jul 25, 2008

LAMISIL AT

NDA NDA021124

Jun 15, 2009

LAMISIL AT

NDA NDA021124

Nov 19, 2009

LAMISIL

NDA NDA020980

Feb 12, 2010

LAMISIL AT

NDA NDA021124

Mar 20, 2012

LAMISIL

NDA NDA020980

Mar 20, 2012

LAMISIL AT

NDA NDA021124

Sep 10, 2013

LAMISIL

NDA NDA020980

Nov 13, 2013

LAMISIL AT

NDA NDA021124

Nov 24, 2014

LAMISIL

NDA NDA020980

Oct 18, 2018

LAMISIL AT

NDA NDA021124

Jul 17, 2019

LAMISIL

NDA NDA020980

Jul 18, 2019

LAMISIL AT

NDA NDA021124

Sources

References

[1]
ClinicalTrials.gov — 23 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 NDA021124). 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

Q2 2028

Q4 2030

Trials by Indication[1]

Onychomycosis5 trials

Efficacy and Safety2 trials

Tinea Capitis2 trials

Efficacy2 trials

Ulcerative Colitis1 trial

TED1 trial

Spondyloarthropathy1 trial

Tinea Pedis1 trial

Recurrence1 trial

Chronic Hepatitis1 trial

Fasting Conditions1 trial

Fungal Resistance1 trial

Fed1 trial

Acute Kidney Injury1 trial

Recurrent Prostate Cancer1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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