Back to discover
Drug

Itraconazole

Approved · FDA
Emerging researchLate-stage development
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.

RxNorm28031UNII304NUG5GF4
1
Research papers
23
Active clinical trials
53
Regulatory events
Latest activity
beta

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

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 trial2026-07-31Primary completion · 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 trial2026-07-09Results expected Q2 2028 · ClinicalTrials.gov

An Open-label, Fixed Sequence Phase I Study to Evaluate the Effect of Itraconazole (a Strong CYP3A Inhibitor) on the Pharmacokinetics of AZ14170132, the TOP1 Inhibitor Payload of the Antibody Drug Conjugate AZD5335, in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Clinical trial2026-07-07Results expected Q4 2027 · ClinicalTrials.gov

Label change: ITRACONAZOLE (NDA020083)

Regulatory2026-07-07FDA

A Phase 1 Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics, Safety, and Tolerability of ABBV-722 in Healthy Adult Subjects

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Efficacy of Low Dose Isotretinoin Versus Excimer Light as an Adjuvant for Itraconazole in Treatment of Onychomycosis: a Randomized Controlled Trial.

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

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.

Clinical trial2026-06-30Results expected Q1 2027 · ClinicalTrials.gov

A Phase II Trial Evaluating the Effectiveness of Itraconazole in Improving Pathologic Complete Response Rates in Patients With Esophageal Cancer Through Inhibition of the Hedgehog and AKT Signaling Pathways

Clinical trial2026-06-24Primary completion · ClinicalTrials.gov

Label change: ITRACONAZOLE (NDA020083)

Regulatory2024-12-19FDA

Label change: ITRACONAZOLE (NDA020083)

Regulatory2024-10-25FDA

Label change: ITRACONAZOLE (NDA020083)

Regulatory2024-02-05FDA

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

Research2014-02-03Journal 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
UNII
304NUG5GF4
Regulatory jurisdictions
fda

Regulatory timeline

53 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
2014-06-13
Authorities
FDA
Total events
53
fdaU.S. Food and Drug Administration· 53 events
2026-07-07Label change
Label change: ITRACONAZOLE (NDA020083)
Evidence ↗
2024-12-19Label change
Label change: ITRACONAZOLE (NDA020083)
Evidence ↗
2024-10-25Label change
Label change: ITRACONAZOLE (NDA020083)
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
22
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
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.