Monistat 1 Combination Pack

(miconazole)

ApprovedSmall molecule

JJohnson & Johnson Consumer and Personal Products Worldwide

Monistat 1 Combination Pack is one of 54 small molecule programs targeting Lichen Planus. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Lichen PlanusActive, not recruiting

Diabetes MellitusUnknown status

Lichen PlanusPreclinical

Active, not recruiting

Diabetes MellitusApproved

Unknown status

Competition

Competitive Landscape

111 competitors in Diabetes Mellitus

#DrugCompanyPhaseTrials

Victoza

Novo Nordisk

Approved

7 2

Farxiga

AstraZeneca

Approved

5 3

Jardiance

Boehringer Ingelheim

Approved

13 4

Geodon

Pfizer

Approved

1 5

Januvia

ZZydus Therapeutics Inc.

Approved

5 6

Tradjenta

Boehringer Ingelheim

Approved

5 7

Precose

Bayer

Approved

—8

Tekturna

Tibotec Pharmaceuticals, Ireland

Approved

3 9

Pletal

Otsuka

Approved

1 10

Brevibloc

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

Phase 3

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

Clinical

Trials by Indication[1]

TIA1 trial

DDI Potential: Dapivirine Vaginal Ring and Miconazole Nitrate

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1·NCT01731574·36 enrolled

Efficacy1 trial

Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic

Completed·UUniversity of Sao Paulo·Phase 3·NCT02818803·40 enrolled

Clinical Trial1 trial

Clinical Trial of Hydroquinone Versus Miconazol in Melasma

Unknown status·UUniversidad Autonoma de San Luis Potosí·Phase 4·NCT01661556·60 enrolled

Chemotherapy-Induced Oral Mucositis1 trial

Topical Chamomile in Preventing Chemotherapy-induced Oral Mucositis

Unknown status·HHams Hamed Abdelrahman·Phase 2·NCT04317183·45 enrolled

Oral Mucositis1 trial

Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis

Unknown status·HHams Hamed Abdelrahman·Phase 2·NCT04308161·45 enrolled

2 more indications

Lichen Planus1 trial

Glutamine With Topical Corticosteroids for Lichen Planus Treatment

Completed·HHams Hamed Abdelrahman·N/A·NCT04442633·30 enrolled

Diabetes Mellitus1 trial

Use of Maqui Berry Extract in Treating Oral Candidiasis in Diabetes Mellitus Patients and Systemically Healthy Persons

Unknown status·UUniversity of Belgrade·Phase 4·NCT05916729·90 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

MONISTAT-DERM

NDA NDA017739

Jan 1, 1982

MONISTAT-DERM

NDA NDA017494

Jan 1, 1982

MONISTAT

NDA NDA018040

Aug 15, 1984

MONISTAT 3

NDA NDA018888

Oct 27, 1989

MONISTAT 5

NDA NDA018592

Feb 15, 1991

MONISTAT 7

NDA NDA017450

Feb 15, 1991

MONISTAT 7

NDA NDA018520

Apr 26, 1993

MONISTAT 7 COMBINATION PACK

NDA NDA020288

Apr 16, 1996

MONISTAT 3 COMBINATION PACK

NDA NDA020670

Mar 30, 1998

MONISTAT 3

NDA NDA020827

Jun 29, 2001

MONISTAT 1 COMBINATION PACK

NDA NDA021308

Jun 17, 2003

MONISTAT 3 COMBINATION PACK

NDA NDA021261

Apr 16, 2010

ORAVIG

NDA NDA022404

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for miconazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — miconazole compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for miconazole. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022404). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Johnson & Johnson Consumer and Personal Products Worldwide company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: JJohnson & Johnson Consumer and Personal Products Worldwide

Monistat 1 Combination Pack

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

TIA1 trial

Efficacy1 trial

Clinical Trial1 trial

Chemotherapy-Induced Oral Mucositis1 trial

Oral Mucositis1 trial

Lichen Planus1 trial

Diabetes Mellitus1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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