Itraconazole

Overview

One of the triazole antifungal agents that inhibits cytochrome P-450-dependent enzymes resulting in impairment of ergosterol synthesis. It has been used against histoplasmosis, blastomycosis, cryptococcal meningitis & aspergillosis.

Indication

For the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: pulmonary and extrapulmonary blastomycosis, histoplasmosis, aspergillosis, and onychomycosis.

Associated Conditions

Aspergillosis
Blastomycosis
Chromoblastomycosis
Coccidioidal meningitis
Esophageal Candidiasis
Fungal Infections
Fungal skin infection
Histoplasmosis
Onychomycosis
Oropharyngeal Candidiasis
Paracoccidioidomycosis
Penicillium marneffei infection
Pulmonary coccidioides
Sporotrichosis
Vulvovaginal Candidiasis
Disseminated Other specified protozoal diseases

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Assess Adverse Events and How Oral ABBV-932 Moves Through the Body When Given With Oral Itraconazole in Healthy Adult Participants	2025/07/17	NCT07071532	Not Applicable	Recruiting	AbbVie
A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors	2025/07/17	NCT07070232	Not Applicable	Not yet recruiting	BioNTech SE
Efficacy Comparison of Itraconazole Pulse Therapy and Terbinafine Therapy in Treatment of Tinea Capitis in Children.	2025/07/16	NCT07068256	Not Applicable	Recruiting	Muhammad Aamir Latif
A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults	2025/07/15	NCT07066722	Not Applicable	Not yet recruiting	ViiV Healthcare
A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants	2025/06/12	NCT07018635	Phase 1	Recruiting	Incyte Corporation
Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers	2025/04/25	NCT06945276	Phase 1	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)
A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants	2025/04/24	NCT06942936	Phase 1	Recruiting	AstraZeneca
Comparison of Efficacy of Oral Fluconazole Versus Oral Itraconazole in the Treatment of Pityriasis Versicolor	2025/04/10	NCT06922344	Phase 4	Recruiting	Khyber Teaching Hospital
Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29)	2025/04/09	NCT06919991	Phase 1	Recruiting	Arcus Biosciences, Inc.
Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants	2025/04/02	NCT06906809	Phase 1	Recruiting	BeiGene

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Itraconazole	Par Pharmaceutical, Inc.	49884-239	ORAL	100 mg in 1 1	9/12/2023
ITRACONAZOLE	Alembic Pharmaceuticals Inc.	62332-204	ORAL	100 mg in 1 1	2/12/2024
itraconazole	Zydus Pharmaceuticals USA Inc.	68382-697	ORAL	100 mg in 1 1	11/10/2022
Itraconazole	AvPAK	50268-450	ORAL	100 mg in 1 1	1/9/2024
Itraconazole Oral	Natco Pharma USA LLC	69339-159	ORAL	10 mg in 1 mL	4/11/2022
SPORANOX	Janssen Pharmaceuticals, Inc.	50458-295	ORAL	10 mg in 1 mL	3/29/2024
Itraconazole	Amneal Pharmaceuticals LLC	65162-087	ORAL	10 mg in 1 mL	3/22/2024
itraconazole	Patriot Pharmaceuticals	10147-1700	ORAL	100 mg in 1 1	3/25/2024
itraconazole	Patriot Pharmaceuticals, LLC	10147-0150	ORAL	10 mg in 1 mL	11/16/2023
Itraconazole	Accord Healthcare Inc.	16729-271	ORAL	100 mg in 1 1	12/2/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
JAMP ITRACONAZOLE ORAL SOLUTION 10MG/ML	Kleva Pharmaceuticals S.A.	SIN16379P	SOLUTION	10 mg/mL	11/17/2021
SPORANOX CAPSULE 100 mg	JANSSEN CILAG SPA	SIN08206P	CAPSULE	100 mg	6/10/1995
SPORANOX ORAL SOLUTION 10 mg/ml	JANSSEN PHARMACEUTICA NV	SIN09823P	SOLUTION	10 mg/ml	6/12/1998
CANDITRAL CAPSULE 100 mg	GLENMARK PHARMACEUTICALS LTD	SIN11355P	CAPSULE	100 mg	7/27/2000
UNITRAC CAPSULE 100 mg	PT. DANKOS FARMA	SIN12459P	CAPSULE	100 mg	10/30/2003

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
ITRACAN CAP 100MG	N/A	CONTROLLED MEDICATIONS LIMITED	N/A	N/A	5/16/2006
ICOMEIN CAPSULES 100MG	N/A	WELLDONE PHARMACEUTICALS LIMITED	N/A	N/A	8/14/2024

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Tolsura Itraconazole 65mg Capsules	311171	Mayne Pharma International Pty Ltd	Medicine	A	11/5/2018
ITRACAP itraconazole 100 mg capsule blister pack	244472	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/9/2016
Lozanoc 50 mg capsules	216603	Mayne Pharma International Pty Ltd	Medicine	A	10/25/2013
ITRACONAZOLE GXP itraconazole 100 mg capsule blister pack	244332	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/9/2016
LOZANOC itraconazole 50 mg capsule bottle	206360	Mayne Pharma International Pty Ltd	Medicine	A	4/16/2014
ITRACONAZOLE-WGR itraconazole 100 mg capsule blister pack	244334	GM Pharma International Pty Ltd	Medicine	A	8/9/2016
SPINOX itraconazole 100 mg capsule blister pack	244452	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/9/2016
ITRACONAZOLE GPPL itraconazole 100 mg capsule blister pack	244292	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/9/2016
ITRACONAZOLE GENPAR itraconazole 100 mg capsule blister pack	244333	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/9/2016
ITRANOX itraconazole 100 mg capsule blister pack	244432	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/9/2016

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SPORANOX	Janssen Inc	02047454	Capsule - Oral	100 MG	12/31/1993
MINT-ITRACONAZOLE	mint pharmaceuticals inc	02462559	Capsule - Oral	100 MG	5/18/2017
JAMP ITRACONAZOLE ORAL SOLUTION	Jamp Pharma Corporation	02484315	Solution - Oral	10 MG / ML	7/31/2019
SPORANOX	Janssen Inc	02231347	Solution - Oral	10 MG / ML	7/28/1997
ODAN ITRACONAZOLE	odan laboratories ltd	02495988	Solution - Oral	10 MG / ML	7/8/2020

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ITRAGERM 50 MG CAPSULAS DURAS	Isdin S.A.	77459	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
ITRACONAZOL TECNIGEN 100 MG CAPSULAS DURAS EFG	Tecnimede España Industria Farmaceutica S.A.	78838	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
ITRACONAZOL ALTER 100 mg CAPSULAS DURAS EFG	Laboratorios Alter S.A.	65762	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
ITRACONAZOL SANDOZ 100 mg CAPSULAS DURAS EFG	Sandoz Farmaceutica S.A.	65775	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
CANADIOL 10 mg/ml SOLUCION ORAL	Esteve Pharmaceuticals S.A.	61864	SOLUCIÓN ORAL	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ITRACONAZOL VIATRIS 100 MG CAPSULAS EFG	Viatris Pharmaceuticals S.L.U.	65765	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
ITRACONAZOL TARBIS 100 mg CAPSULAS DURAS EFG	Tarbis Farma S.L.	71196	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
ITRACONAZOL NORMON 100 mg CAPSULAS DURAS EFG	Laboratorios Normon S.A.	71234	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
SPORANOX 100 mg CAPSULAS	Janssen Cilag S.A.	59343	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
ITRACONAZOL ALTAN 10 MG/ML CONCENTRADO Y DISOLVENTE PARA SOLUCION PARA PERFUSION EFG	Altan Pharmaceuticals Sa	78446	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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Overview

Indication

Associated Conditions

Clinical Trials

FDA Drug Approvals

EMA Drug Approvals

HSA Drug Approvals

NMPA Drug Approvals

PPB Drug Approvals

TGA Drug Approvals

Health Canada Drug Approvals

CIMA AEMPS Drug Approvals

Philippines FDA Drug Approvals

Saudi SFDA Drug Approvals

Malaysia NPRA Drug Approvals

UK EMC Drug Information

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