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Lotrimin

(Clotrimazole)

ApprovedSmall molecule

Clotrimazole is used to treat fungal infections of the skin, nails, and mucous membranes, such as athlete's foot, jock itch, ringworm, and yeast infections. It works by stopping the growth of fungi.[2] Lotrimin is currently approved and in use across 18 indications[4].[1]

Lotrimin is one of 267 small molecule programs targeting HIV infection. It is currently in Approved.

18

Indications

25

Total Trials

1

Active Trials

266

Competitors

18

FDA Applications

NDA/BLA/ANDA regulatory filings

1

Patents

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionApproved

Tinea PedisActive, not recruiting

Vulvovaginal CandidiasisApproved

VaginitisActive, not recruiting

OtomycosisActive, not recruiting

Skin InfectionActive, not recruiting

FolliculitisApproved

CandidiasisActive, not recruiting

Kidney TransplantActive, not recruiting

Fungal Infectious DiseaseActive, not recruiting

HIV InfectionApproved

Approved

Tinea PedisApproved

Active, not recruiting

Vulvovaginal CandidiasisApproved

Approved

VaginitisPhase 2/Phase 3

Active, not recruiting

OtomycosisPhase 3

Active, not recruiting

Skin InfectionApproved

Active, not recruiting

FolliculitisApproved

Approved

CandidiasisPhase 3

Active, not recruiting

Kidney TransplantPhase 1/Phase 2

Active, not recruiting

Fungal Infectious DiseaseApproved

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

476 competitors in Kidney Transplant

#DrugCompanyPhaseTrials

Lotrimin

Simulect

Zinbryta

Zemplar

Cysteine Hydrochloride

Sensipar

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Precedex

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

Jardiance

Boehringer Ingelheim

Nydrazid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

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

Timeline

Expected Milestones

Q1 2028

Post-ApprovalNot yet recruiting

Pregnant Women

NCT06349122

Clinical

Trials by Indication[1]

Vulvovaginal Candidiasis4 trials

A Protocol for the Role of Fractional CO2 Laser in Consolidation Treatment of Recurrent Vulvovaginal Candidiasis

Unknown status·SSecond Affiliated Hospital of Wenzhou Medical University·N/A·NCT04292704·205 enrolled

Patients With Vulvovaginal Candidiasis

Unknown status·UUniversity of Sao Paulo·Phase 1/2·NCT03024502·90 enrolled

Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

Completed·PPeking University Shenzhen Hospital·Phase 4·NCT02180828·240 enrolled

Show 1 more trial

Efficacy, Safety LactiSal 1% Gel, LactSal 50 mg, Clotrimazole 100 mg Tablet in Treatment Vulvovaginal Candidiasis

Withdrawn·MMedinova AG·Phase 3·NCT02907307

Otomycosis3 trials

Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis

Completed·SSalvat·Phase 3·NCT01993823·190 enrolled

Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Otomycosis Treatment

Completed·RRawalpindi Medical College·Phase 1·NCT06339294·90 enrolled

Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients

Completed·KKhon Kaen Hospital·N/A·NCT01547221·120 enrolled

Fungal Infection2 trials

A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDS

Completed· Pfizer logo

Pfizer·N/A·NCT00002282

Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000676·500 enrolled

Vaginal Discharge1 trial

Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies.

Withdrawn·AAche Laboratorios Farmaceuticos S.A.·Phase 3·NCT02713139

Efficacy and Safety1 trial

Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections

Unknown status·LLaboratório Teuto Brasileiro S/A·Phase 3·NCT01105013·90 enrolled

14 more indications

Pouchitis1 trial

Clotrimazole Enemas for Pouchitis in Children and Adults

Terminated·WWeb·Phase 1/2·NCT00061282·11 enrolled

Candidiasis1 trial

Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients

Completed·VValerio Therapeutics·Phase 3·NCT00390780·578 enrolled

Phase II1 trial

ProF-001_Phase IIa

Completed·PProFem GmbH·Phase 2/3·NCT03115073·84 enrolled

Interaction1 trial

To Assess the Drug-drug Interaction Potential Between Dapivirine Vaginal Ring-004, Containing 25 mg of Dapivirine, and Clotrimazole 10 mg/g (1%)

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1·NCT02847286·36 enrolled

Efficacy1 trial

Comparative Efficacy of Ovule vs Tablet

Completed· Bayer logo

Bayer·Phase 3·NCT00755053·466 enrolled

Pregnant Women1 trial

Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth

Not yet recruiting·AAssistance Publique Hopitaux De Marseille·Phase 4·NCT06349122·1,292 enrolled

Treatment1 trial

Comparative Efficacy of Topical Oxiconazole Cream (1%) Versus Topical Clotrimazole Cream (1%) in the Treatment of Tinea CrurisAbstract

Completed·HHayat Abad Medical Complex, Peshawar·Phase 1·NCT07441005·386 enrolled

Adjuvant Treatment1 trial

Study of Lactobacillus in Adjuvant Treatment of RVVC

Completed·PPeking University Shenzhen Hospital·Phase 4·NCT04699240·140 enrolled

Keratosis1 trial

Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis

Unknown status·—·Phase 2·NCT03632733·30 enrolled

Kidney Transplant1 trial

Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults

Completed·UUniversity of Wisconsin, Madison·Phase 1/2·NCT00078559·10 enrolled

Vaginitis1 trial

Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.

Completed·—·Phase 2/3·NCT03005353·100 enrolled

Islet Transplantation1 trial

B-Lymphocyte Immunotherapy in Islet Transplantation for Initial Islet Graft Failure

No longer available·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT01049633

Anemia1 trial

Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia

Completed·UUniversity of North Carolina·Phase 1/2·NCT00004492·20 enrolled

Unspecified1 trial

Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes

Completed·—·N/A·NCT00004404·20 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

MYCELEX

NDA NDA018181

Jan 1, 1982

LOTRIMIN

NDA NDA017613

Jan 1, 1982

MYCELEX

NDA NDA018183

Jan 1, 1982

LOTRIMIN

NDA NDA017619

Jun 17, 1983

MYCELEX

NDA NDA018713

Feb 17, 1984

LOTRIMIN

NDA NDA018813

Apr 19, 1985

MYCELEX-G

NDA NDA019069

Nov 30, 1990

GYNE-LOTRIMIN

NDA NDA018052

Nov 30, 1990

GYNE-LOTRIMIN

NDA NDA017717

Dec 26, 1991

MYCELEX-7

NDA NDA018230

Dec 26, 1991

MYCELEX-7

NDA NDA018182

Apr 26, 1993

GYNE-LOTRIMIN COMBINATION PACK

NDA NDA020289

Jun 23, 1994

MYCELEX-7 COMBINATION PACK

NDA NDA020389

Jul 29, 1996

GYNE-LOTRIMIN 3

NDA NDA020525

Jul 29, 1996

GYNE-LOTRIMIN 3 COMBINATION PACK

NDA NDA020526

Nov 24, 1998

GYNE-LOTRIMIN 3

NDA NDA020574

Apr 12, 2000

TRIVAGIZOLE 3

NDA NDA021143

Sep 26, 2025

CLOTIC

NDA NDA217628

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for Clotrimazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lotrimin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Clotrimazole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Clotrimazole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA217628). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Lotrimin. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cytochrome P450 51 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Bayer

Patent Landscape[6]

Patent Cliff

May 26, 2042

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12246006May 26, 2042

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