Onmel

Blastomycosis, Paracoccidioidomycosis, Chromoblastomycosis + 15 more

Treatment

8 FDA approvals

20 Active Studies for Onmel

What is Onmel

Itraconazole

The Generic name of this drug

Treatment Summary

Itraconazole is an antifungal medication that prevents the growth of fungi. It targets a specific enzyme in fungi to disrupt the production of a substance called ergosterol, which is needed for their survival. Itraconazole is used to treat infections caused by fungi such as histoplasmosis, blastomycosis, cryptococcal meningitis and aspergillosis.

Sporanox

is the brand name

image of different drug pills on a surface

Onmel Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Sporanox

Itraconazole

1992

35

Approved as Treatment by the FDA

Itraconazole, otherwise known as Sporanox, is approved by the FDA for 8 uses which include Fungal skin infection and Sporotrichosis .

Fungal skin infection

Sporotrichosis

Sporotrichosis

Cellulitis

Esophageal Candidiasis

Oropharyngeal Candidiasis

Chromoblastomycosis

Paracoccidioidomycosis

Effectiveness

How Onmel Affects Patients

Itraconazole is a medicine used to treat fungal infections. It works by stopping the growth of fungi by blocking a specific enzyme that helps fungi build their cell walls. This medicine has been shown to be effective against certain types of fungi, including Cryptococcus neoformans and Candida spp. Studies in both healthy and immunocompromised animals have shown itraconazole to be effective against fungal infections like Cryptococcus neoformans and Candida albicans.

How Onmel works in the body

Itraconazole works by blocking the production of a certain molecule in fungi cells, called ergosterol. Without this molecule, the cell membrane loses its strength and becomes more permeable, which leads to the leaking of cellular contents. Itraconazole may also prevent the transformation of yeasts to mycelial forms, interfere with respiration, and block the absorption of some nutrients.

When to interrupt dosage

The recommended measure of Onmel is contingent upon the diagnosed state, including Onychomycosis, prophylaxis of Penicilliosis and Coccidioidal meningitis. The quantity of dosage is contingent upon the execution approach detailed in the table underneath.

Condition

Dosage

Administration

Blastomycosis

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

Paracoccidioidomycosis

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

Chromoblastomycosis

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

Onychomycosis

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

Sporotrichosis

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

Histoplasmosis

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

Cellulitis

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

Coccidioidomycosis

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

disseminated Other specified protozoal diseases

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

prophylaxis of Histoplasmosis

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

prophylaxis of Penicilliosis

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

Aspergillosis

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

Candidiasis, Vulvovaginal

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

talaromycosis

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

Coccidioides

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

HIV

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

Oropharyngeal Candidiasis

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

Esophageal Candidiasis

, 100.0 mg, 200.0 mg, 10.0 mg/mL, 65.0 mg, 0.01 mg/mg, 0.05 mg/mg

Oral, , Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Kit, Cream - Topical, Capsule, gelatin coated - Oral, Cream, Topical, Intravenous, Kit - Intravenous, Capsule, gelatin coated, Solution - Topical

Warnings

Onmel has four contraindications, so it should not be utilized while going through the conditions specified in the following table.

Onmel Contraindications

Condition

Risk Level

Notes

Congestive Heart Failure

Do Not Combine

Congestive heart failure

Do Not Combine

Cytochrome P450

Do Not Combine

suspected pregnancy

Do Not Combine

There are 20 known major drug interactions with Onmel.

Common Onmel Drug Interactions

Drug Name

Risk Level

Description

(R)-warfarin

Major

The metabolism of (R)-warfarin can be decreased when combined with Itraconazole.

(S)-Warfarin

Major

The metabolism of (S)-Warfarin can be decreased when combined with Itraconazole.

1,2-Benzodiazepine

Major

The metabolism of 1,2-Benzodiazepine can be decreased when combined with Itraconazole.

3,5-diiodothyropropionic acid

Major

The metabolism of 3,5-diiodothyropropionic acid can be decreased when combined with Itraconazole.

5-androstenedione

Major

The metabolism of 5-androstenedione can be decreased when combined with Itraconazole.

Onmel Toxicity & Overdose Risk

Itraconazole has not been found to be fatal when given to mice, rats, and dogs at doses of 320mg/kg, 200mg/kg respectively.

image of a doctor in a lab doing drug, clinical research

Onmel Novel Uses: Which Conditions Have a Clinical Trial Featuring Onmel?

137 active trials are evaluating the potential of Onmel to mitigate Chromomycosis, Dermatomycoses and Sporotrichosis.

Condition

Clinical Trials

Trial Phases

prophylaxis of Histoplasmosis

0 Actively Recruiting

Cellulitis

0 Actively Recruiting

Sporotrichosis

0 Actively Recruiting

Onychomycosis

0 Actively Recruiting

disseminated Other specified protozoal diseases

0 Actively Recruiting

Histoplasmosis

1 Actively Recruiting

Phase 3

Chromoblastomycosis

0 Actively Recruiting

Paracoccidioidomycosis

0 Actively Recruiting

Coccidioidomycosis

0 Actively Recruiting

prophylaxis of Penicilliosis

0 Actively Recruiting

Candidiasis, Vulvovaginal

1 Actively Recruiting

Phase 3

Coccidioides

0 Actively Recruiting

Aspergillosis

0 Actively Recruiting

Esophageal Candidiasis

0 Actively Recruiting

talaromycosis

0 Actively Recruiting

Oropharyngeal Candidiasis

0 Actively Recruiting

HIV

151 Actively Recruiting

Phase 2, Not Applicable, Phase 1, Phase 3, Phase 4, Early Phase 1

Blastomycosis

0 Actively Recruiting

Patient Q&A Section about onmel

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Onmel used for?

"Onmel requires a prescription and is used to treat fungal infections of the toenails."

Answered by AI

Is itraconazole an antibiotic?

"Itraconazole is an antifungal medication used to treat infections caused by fungi in adults. This includes infections in any part of the body, such as the lungs, mouth or throat, toenails, or fingernails."

Answered by AI

How much does Sporanox cost?

"With a free SingleCare Sporanox coupon, you can purchase Sporanox for a lower cost than the retail price of $247.79 per 0.60, 150ML of 10MG/ML Solution."

Answered by AI

What is itraconazole used for?

"The following is a list of possible side effects that may occur from the use of itraconazole capsule.

Itraconazole capsule is used to treat aspergillosis, blastomycosis, histoplasmosis and onychomycosis. Some of the possible side effects of using this medication include skin rash, headache, diarrhea, and itching."

Answered by AI

Clinical Trials for Onmel

Image of New Jersey Community Research Initiative in Newark, United States.

AI-DBT for Suicide Prevention in HIV/AIDS

18+
All Sexes
Newark, NJ

One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk for death by suicide is 100 times higher in PLWHA than in the general population. Currently, there are no behavioral interventions that specifically address suicide prevention for older PLWHA, despite their unique biopsychosocial and structural risk factors. Through this work, investigators will adapt Dialectical Behavior Therapy, an evidence-based intervention for suicide prevention, for patients with PLWHA to be delivered by an AI-powered conversational Agent developed by our industry partner, Empower Health. Investigators will then pilot test the feasibility, usability, acceptability and preliminary efficacy to improve self-efficacy to manage negative emotions in n=50 older adults living with HIV/AIDS.

Recruiting
Has No Placebo

New Jersey Community Research Initiative (+1 Sites)

Elissa Kozlov, PhD

Image of George Washington University Emergency Department in Washington D.C., United States.

Decision Support Tool for HIV Prevention

18+
All Sexes
Washington D.C., United States

This project will explore the development of a personalized decision support tool to assist with pre-exposure prophylaxis (PrEP) initiation and persistence among patients identified in the emergency department (ED) and urgent care settings as PrEP eligible. First, the investigators will use a sequence of validated implementation science methodologies to develop and validate a decision support tool designed to optimize PrEP persistence by strengthening self-efficacy by addressing the multifaceted medical and social needs of the individual patient. The investigators will then test the preliminary effectiveness of this tool through a pilot stepped wedge implementation trial in two EDs and an urgent care in Baltimore, MD and Washington, DC among 120 PrEP eligible patients to determine PrEP initiation, linkage to care, persistence, and adherence rates.

Phase 1
Waitlist Available

George Washington University Emergency Department (+1 Sites)

Image of The University of Alabama at Birmingham in Birmingham, United States.

Behavioral vs Mindfulness Treatments for Insomnia in HIV

50 - 99
All Sexes
Birmingham, AL

The goal of this clinical trial is to examine the effects of a telephone-delivered Brief Behavioral Treatment Insomnia (BBTI) versus a Brief Mindfulness Treatment (BMT) on cognitive and sleep outcomes in older adults with HIV. The main questions it aims to answer are: What are the effects of BBTI vs BMT on self-reported and observed sleep outcomes in older adults with HIV and insomnia up to 1-year post-intervention? What are the effects of BBTI vs BMT on self-reported and observed cognitive comes in older adults with HIV and insomnia up to 1-year post-intervention? What is the association between Alzheimer's Disease biomarkers and sleep and cognitive outcomes in older adults with HIV receiving BBTI vs BMT? Participants will: * Complete 4 weeks of telephone-delivered BBTI or BMT * Attend baseline, post-intervention, and 1-year post in-person visits for sleep and cognitive assessments * Have blood collected at all three time points

Waitlist Available
Has No Placebo

The University of Alabama at Birmingham (+1 Sites)

Dr. Shameka L Cody, PhD, AGNP-C, PMHNP-BC, FAAN

Image of University of Minnesota in Minneapolis, United States.

LAmB and Posaconazole for Histoplasmosis

18+
All Sexes
Minneapolis, MN

The purpose of the study is threefold: 1. Assess the safety and efficacy of a single high-dose intravenous (LAmB 10mg/kg) compared to the SOC daily dosing (3mg/kg) of the same medication for induction therapy in moderate to severe histoplasmosis. 2. Assess the safety and efficacy of oral posaconazole 300mg delayed-release tablets three times daily for two days then once daily for consolidation therapy compared to SOC oral itraconazole 200 mg capsules three times daily for three days then twice daily in moderate to severe histoplasmosis 3. Assess the safety and efficacy of 6 months of consolidation therapy compared to the SOC 12 months of consolidation therapy in persons with HIV on appropriate antiretroviral therapy.

Phase 3
Waitlist Available

University of Minnesota

Nathan Bahr, MD

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Image of Los Angeles General Medical Center in Los Angeles, United States.

Decision Support Tool for HIV Treatment

18+
All Sexes
Los Angeles, CA

This study is testing software designed to help healthcare providers choose the best HIV treatment combinations for their patients. HIV medicines, known as antiretroviral therapy (ART), can be complex to manage because the right regimen depends on many factors-such as drug resistance, other health conditions, and medication schedules. Many people with HIV are cared for by general clinicians who may not have access to HIV specialists, which can make treatment decisions more challenging. In this study, healthcare providers will use patient cases to compare standard HIV treatment resources with a new clinical decision support tool that gives evidence-based ART recommendations at the point of care. The investigators hypothesize that using the tool will help providers select treatment plans that better match clinical guidelines, make decisions faster, reduce mental effort, and increase overall satisfaction with the prescribing process.

Waitlist Available
Has No Placebo

Los Angeles General Medical Center

Hayoun Lee, PhD

Image of University of North Carolina in Chapel Hill, United States.

MGD020 + MGD014 for HIV

18 - 65
All Sexes
Chapel Hill, NC

This research study aims to find out how safe and well tolerated the experimental study drugs are when given to persons with HIV (PWH) taking antiretroviral therapy (ART). The study treatments are MGD014 and MGD020, which are two antibodies developed specifically for HIV, and Vorinostat, an oral medication to help expose HIV in cells to the antibodies. The study will measure the impact of study treatment on non-active HIV in cells, and how long MGD014 and MGD020 stay in the body after they are given. In this study, participants will be randomly assigned to one of three groups. All participants receive MGD014 and MGD020, given sequentially as infusions through an IV for 4 doses. Participants in one group (group A) receive only MGD014 and MGD020. Participants in another group (group B) will stop taking their ART therapy for up to 8 weeks (a temporary treatment interruption (TTI)) while receiving MGD014 and MGD020. Participants in the third group (group C) receive Vorinostat in addition to MGD014 and MGD020. Total time of participation is about 8 months and involves 13 or 18 visits, depending on group assignment.

Phase 1
Recruiting

University of North Carolina

Cynthia L. Gay, MD

Image of Center on Substance Use and Health in San Francisco, United States.

CHAMPION Intervention for Pre-exposure Prophylaxis Adherence

18 - 40
Male
San Francisco, CA

The goal of this randomized controlled trial is to pilot test new mobile health (mHealth) interventions to improve PrEP adherence among HIV-negative men who have sex with men (MSM) with mild to moderate methamphetamine use disorder (MUD). The CHAMPION intervention combines two mHealth tools-PrEPAPP and CBT4CBT-to address both HIV prevention and MUD treatment needs in this population. The study's specific aims are: * To evaluate the feasibility and acceptability of the CHAMPION intervention based on treatment retention and engagement rates. * To examine the preliminary efficacy the CHAMPION intervention to improve PrEP adherence, as measured by dried blood spot (DBS) tests compared to the waitlist control group.

Waitlist Available
Has No Placebo

Center on Substance Use and Health

Glenn-Milo Santos, PhD, MPH

Have you considered Onmel clinical trials?

We made a collection of clinical trials featuring Onmel, we think they might fit your search criteria.
Go to Trials

Have you considered Onmel clinical trials?

We made a collection of clinical trials featuring Onmel, we think they might fit your search criteria.
Go to Trials