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Itraconazole

Generic Name
Itraconazole
Brand Names
Sporanox, Tolsura
Drug Type
Small Molecule
Chemical Formula
C35H38Cl2N8O4
CAS Number
84625-61-6
Unique Ingredient Identifier
304NUG5GF4

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
2025/07/17
Not Applicable
Recruiting
2025/07/17
Not Applicable
Not yet recruiting
2025/07/16
Not Applicable
Recruiting
Muhammad Aamir Latif
2025/07/15
Not Applicable
Not yet recruiting
2025/06/12
Phase 1
Recruiting
2025/04/25
Phase 1
Recruiting
2025/04/24
Phase 1
Recruiting
2025/04/10
Phase 4
Recruiting
2025/04/09
Phase 1
Recruiting
2025/04/02
Phase 1
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Par Pharmaceutical, Inc.
49884-239
ORAL
100 mg in 1 1
9/12/2023
Alembic Pharmaceuticals Inc.
62332-204
ORAL
100 mg in 1 1
2/12/2024
Zydus Pharmaceuticals USA Inc.
68382-697
ORAL
100 mg in 1 1
11/10/2022
AvPAK
50268-450
ORAL
100 mg in 1 1
1/9/2024
Natco Pharma USA LLC
69339-159
ORAL
10 mg in 1 mL
4/11/2022
Janssen Pharmaceuticals, Inc.
50458-295
ORAL
10 mg in 1 mL
3/29/2024
Amneal Pharmaceuticals LLC
65162-087
ORAL
10 mg in 1 mL
3/22/2024
Patriot Pharmaceuticals
10147-1700
ORAL
100 mg in 1 1
3/25/2024
Patriot Pharmaceuticals, LLC
10147-0150
ORAL
10 mg in 1 mL
11/16/2023
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
SIN16379P
SOLUTION
10 mg/mL
11/17/2021
SPORANOX CAPSULE 100 mg
SIN08206P
CAPSULE
100 mg
6/10/1995
SPORANOX ORAL SOLUTION 10 mg/ml
SIN09823P
SOLUTION
10 mg/ml
6/12/1998
CANDITRAL CAPSULE 100 mg
SIN11355P
CAPSULE
100 mg
7/27/2000
UNITRAC CAPSULE 100 mg
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
N/A
N/A
5/16/2006
ICOMEIN CAPSULES 100MG
N/A
N/A
N/A
8/14/2024

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
SPORANOX
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
02484315
Solution - Oral
10 MG / ML
7/31/2019
SPORANOX
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
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
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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