Wednesday, July 8, 2026

Drug profile · INN

itraconazole

itraconazole (ITRACAP) is a cytochrome p450 51 inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved TGA: approved NMPA: clinical trials
US status approved
Patents linked 2
Pipeline programs 20
News articles 0
Drug details — itraconazole
US status
approved
Class
Route
INJECTION
Patents
2
Programs
20
Data quality
0.89

Quick answer

itraconazole (ITRACAP) is a cytochrome p450 51 inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN itraconazole
Brand ITRACAP
Mechanism Cytochrome P450 51 inhibitor
Target Lanosterol 14-alpha demethylase
Route INJECTION
Formulation CAPSULE

Mechanism of action

Cytochrome P450 51 inhibitor

Primary target: Lanosterol 14-alpha demethylase

Approval history

Authority Status Date
FDA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. itraconazole Phase 2 · Ultragenyx UK · Histoplasmosis
  2. 1434-0021 Phase 1 · Boehringer Ingelheim · Healthy volunteer trial
  3. 1516-0004 Phase 1 · Boehringer Ingelheim · Healthy volunteer trial
  4. 22537 Phase 1 · Bayer · Soil-transmitted helminth infection, Onchocerciasis (river b
  5. AZD5462-D9090C00012 Phase 1 · AstraZeneca · Chronic Heart Failure
  6. BP45228 Phase 1 · HOFFMANN-LA ROCHE · Not applicable, healthy volunteers
  7. BP45248 Phase 1 · HOFFMANN-LA ROCHE · Not applicable
  8. C3421063 Phase 1 · First Biotech (Australia) · Type 2 Diabetes Mellitus, Obesity, Overweight management

Related & competitor drugs

  1. clotrimazole Cytochrome P450 51 inhibitor
  2. efinaconazole Lanosterol 14-alpha demethylase inhibitor
  3. fluconazole Cytochrome P450 51 inhibitor
  4. ketoconazole Antiinfectives for systemic use (J02)
  5. miconazole nitrate Cytochrome P450 51 inhibitor
  6. posaconazole Antiinfectives for systemic use (J02)
  1. US 9839636

    Itraconazole analogues and methods of use thereof

    Expires Mon Dec 07 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 9650365

    Itraconazole analogues and methods of use thereof

    Expires Mon May 11 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is itraconazole?

itraconazole (ITRACAP) is a cytochrome p450 51 inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for itraconazole?

ITRACAP is a marketed brand name for itraconazole. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of itraconazole?

itraconazole has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.