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Drug

Itraconazole

Established medicine
ClassCytochrome P450 51 inhibitorResearchOngoing clinical research
Also known as Onmel, Sporanox, Tolsura, ITRACONAZOLE COMPONENT OF SUBA-ITRACONAZOLE+5 more

Onmel, Sporanox, Tolsura, ITRACONAZOLE COMPONENT OF SUBA-ITRACONAZOLE, Oriconazole, Itraconazol, (±)-1-SEC-BUTYL-4-(P-(4-(P-(((2R*,4S*)-2-(2,4-DICHLOROPHENYL)-2-(1H-1,2,4-TRIAZOL-1-YLMETHYL)-1,3-DIOXOLAN-4-YL)METHOXY)PHENYL)-1-PIPERAZINYL)PHENYL)-.DELTA.(SUP 2)-1,2,4-TRIAZOLIN-5-ONE, 3H-1,2,4-TRIAZOL-3-ONE, 4-(4-(4-(4-((2-(2,4-DICHLOROPHENYL)-2-(1H-1,2,4-TRIAZOL-1-YLMETHYL)-1,3-DIOXOLAN-4-YL)METHOXY)PHENYL)-1-PIPERAZINYL)PHENYL)-2,4-DIHYDRO-2-(1-METHYLPROPYL)-, Itraconazolum.

RxNorm28031ChEMBLCHEMBL64391ATCJ02AC02UNII304NUG5GF4
1
Research papers
23
Active clinical trials
Lanosterol 14-alpha demethylase
Primary target
80
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: ITRACONAZOLE (ANDA205080)

Regulatory2026-09-14FDA

Label change: ITRACONAZOLE (ANDA206741)

Regulatory2026-09-14FDA

Label change: ITRACONAZOLE (ANDA208481)

Regulatory2026-09-11FDA

An Open-label, Phase 1 Study to Individually Characterize the Food Effect, the Drug-Drug Interaction Effect of OAT Inhibition, and the Drug-Drug Interaction Effect of P-glycoprotein Inhibition on the Pharmacokinetics of MK-8527 in Healthy Adult Participants

Clinical trial2026-09-03Status changed to Active, not recruiting · ClinicalTrials.gov

A Phase 1 Open-Label, Two-Period Study to Evaluate the Impact of Multiple Doses of Itraconazole on the Pharmacokinetics of Nacresertib in Healthy Adult Subjects

Clinical trial2026-09-01Primary completion · ClinicalTrials.gov

A Phase 1 Crossover Design Study to Assess the Effect of CYP3A Moderate and Strong Inhibitors (Fluconazole and Itraconazole) and Strong Inducer (Carbamazepine) on the Single-dose Pharmacokinetics of ASP3082 in Healthy Adults

Clinical trial2026-08-27Status changed to Active, not recruiting · ClinicalTrials.gov

A Phase 1, Open-Label, Fixed-Sequence Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of LY4395089 in Healthy Participants

Clinical trial2026-08-25Status changed to Completed · ClinicalTrials.gov

A Two-Part Clinical Study to Evaluate the Effects of Multiple Doses of Itraconazole on the Single-Dose Pharmacokinetics of MK-2828 (Part 1) and Multiple Doses of MK-2828 on the Single-Dose PK of Midazolam (Part 2) in Healthy Participants

Clinical trial2026-08-06Status changed to Active, not recruiting · ClinicalTrials.gov

A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF 06821497 (MEVROMETOSTAT) IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)

Clinical trial2026-07-29Results expected Q2 2028 · ClinicalTrials.gov

A Phase I/II, Open-label, Adaptive Two-part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies in Participants With Advanced Solid Tumors

Clinical trial2026-07-22Results expected Q1 2028 · ClinicalTrials.gov

Label change: ITRACONAZOLE (NDA020083)

Regulatory2026-07-07FDA

Open-label, exploratory phase II trial of oral itraconazole for the treatment of basal cell carcinoma.

Research2014-02-03Kim DJ · Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Itraconazole
Aliases & brands
OnmelSporanoxTolsuraITRACONAZOLE COMPONENT OF SUBA-ITRACONAZOLEOriconazoleItraconazol(±)-1-SEC-BUTYL-4-(P-(4-(P-(((2R*,4S*)-2-(2,4-DICHLOROPHENYL)-2-(1H-1,2,4-TRIAZOL-1-YLMETHYL)-1,3-DIOXOLAN-4-YL)METHOXY)PHENYL)-1-PIPERAZINYL)PHENYL)-.DELTA.(SUP 2)-1,2,4-TRIAZOLIN-5-ONE3H-1,2,4-TRIAZOL-3-ONE, 4-(4-(4-(4-((2-(2,4-DICHLOROPHENYL)-2-(1H-1,2,4-TRIAZOL-1-YLMETHYL)-1,3-DIOXOLAN-4-YL)METHOXY)PHENYL)-1-PIPERAZINYL)PHENYL)-2,4-DIHYDRO-2-(1-METHYLPROPYL)-Itraconazolum
RxNorm CUI
28031
ChEMBL ID
CHEMBL64391
ATC codes
J02AC02
UNII
304NUG5GF4
Primary mechanism
Cytochrome P450 51 inhibitor
Regulatory jurisdictions
fda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Lanosterol 14-alpha demethylase
ERG11 · P10613
INHIBITORCytochrome P450 51 inhibitor

Regulatory timeline

80 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1992-09-11
Latest approval
2019-08-02
Authorities
FDA
Total events
80
fdaU.S. Food and Drug Administration· 80 events
2026-09-14Label change
Label change: ITRACONAZOLE (ANDA205080)
Evidence ↗
2026-09-14Label change
Label change: ITRACONAZOLE (ANDA206741)
Evidence ↗
2026-09-11Label change
Label change: ITRACONAZOLE (ANDA208481)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

196 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
196
registered trials across all phases
LATEST COMPLETION 2026
23
Active studies
20
Recruiting
27
Late-stage (III+)
154
Completed
19
Discontinued
PHASE DISTRIBUTIONn = 196
Early Phase 14Phase 1148Phase 1 / 26Phase 211Phase 2 / 33Phase 37Phase 410Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Comparison of Itraconazole With Itraconazole and Isotretinoin in the Treatment Duration, Safety, and Cure Rate in Adult Patients With Tinea Corporis/Cruris: A Randomized Controlled Trial.

Not yet recruitingPH IVPak Emirates Military Hospitaln=602027

Comparing the Efficacy of Oral Fluconazole Versus Oral Itraconazole in Treating Resistant Tinea Corporis

RecruitingPH IVUrooj Fatiman=1262026

Comparison of Efficacy of Oral Fluconazole Versus Oral Itraconazole in the Treatment of Pityriasis Versicolor

RecruitingPH IVKhyber Teaching Hospitaln=1062025

A Multicenter, Randomized Trial Comparing The Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Subjects With Hematological Malignancy

TerminatedPH IVXian-Janssen Pharmaceutical Ltd.n=612018

Treatment of Aspergillus Fumigatus in Patients With Cystic Fibrosis: A Randomized, Double-blind, Placebo-Controlled Trial

CompletedPH IVOttawa Hospital Research Instituten=352011

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1, Open-Label Study to Evaluate the Effect of Food on the Single-Dose Pharmacokinetics and a Drug-Drug Interaction Evaluation of Itraconazole and Carbamazepine on INCB123667 When Administered Orally to Healthy Adult Participants

CompletedPH IIncyte Corporationn=512026

Open-label, 2-Part, Fixed-sequence, Crossover Trial Design to Determine the Effect of a Strong CYP3A4 Inducer (Carbamazepine) And a Strong CYP3A4 Inhibitor (Itraconazole) on the Pharmacokinetics of a Single Oral Dose of AP31969 in Healthy Participants

CompletedPH IAcesion Pharman=282026

The Effect of Multiple Doses of Itraconazole on the Single-dose Pharmacokinetics of BI 764198 Following Oral Administration in Healthy Male Trial Participants (an Open-label, Non-randomised, Two-period, Fixed-sequence Design Study)

CompletedPH IBoehringer Ingelheimn=142026

Evaluation of Drug-Drug Interactions Between CS0159 Tablets and Rifampicin/Itraconazole and the Effect of a High-Fat Meal on the Pharmacokinetic Characteristics of CS0159 Tablets in Healthy Adult Participants

CompletedPH ICascade Pharmaceuticals, Incn=322026

An Open-label, Fixed-sequence and Two-part Study to Assess the Impact of Multiple Doses of Itraconazole on the Pharmacokinetics of AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on the Pharmacokinetics of Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants

CompletedPH IAstraZenecan=512026

A Phase 1 First in Human, Single and Multiple Ascending Dose, Food Effect, and Drug-Drug Interaction Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-CLS-616

CompletedPH IAbbVien=1102026

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Open-label, exploratory phase II trial of oral itraconazole for the treatment of basal cell carcinoma.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014 · 194 cites
Recent papers

Open-label, exploratory phase II trial of oral itraconazole for the treatment of basal cell carcinoma.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014 · 194 cites
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
Leading researchers
  • Beachy PA1
  • Chandra K1
  • Fu T1
  • Gilliam A1
  • Khodosh R1
  • Kim DJ1
  • Kim J1
  • Molgo M1
Leading institutions
free-text, unnormalised
  • Stanford University1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.