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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.

Background

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
2025/06/12
Phase 1
Not yet 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
2025/03/25
Phase 1
Active, not recruiting
2025/02/26
Phase 1
Completed
2025/02/26
Phase 1
Completed
2025/01/22
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
Itraconazole Injection
H20160558
化学药品
注射剂
11/28/2019
Itraconazole Oral Solution
国药准字H20243039
化学药品
口服溶液剂
1/9/2024
Itraconazole Oral Solution
黄氏制药股份有限公司
国药准字HC20240001
化学药品
口服溶液剂
1/9/2024
Itraconazole Hydrochloride
国药准字H20070141
化学药品
胶囊剂
1/29/2022
Itraconazole Granules
国药准字H20090168
化学药品
颗粒剂
1/24/2024
Itraconazole Capsules
国药准字H20000124
化学药品
胶囊剂
9/23/2020
Itraconazole Capsules
国药准字H20123428
化学药品
胶囊剂
6/28/2022
Itraconazole Capsules
国药准字H20090329
化学药品
胶囊剂
1/10/2024
Itraconazole Capsules
国药准字H20020367
化学药品
胶囊剂
5/28/2020
Itraconazole Capsules
国药准字H20010767
化学药品
胶囊剂
12/2/2019

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
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