> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/itraconazole-c6f2473e-393a-44a9-8969-8d501b15ef65 > Record changed: 2026-10-13 # Itraconazole Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL64391) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL64391) First approval year 1992 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL64391) ## Development status **First approval year** 1992 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL64391) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL64391) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL64391) **Drug name** Itraconazole Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL64391) **Molecular weight** 705.65 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL64391) **Structure (SMILES)** CCC(C)n1ncn(-c2ccc(N3CCN(c4ccc(OCC5COC(Cn6cncn6)(c6ccc(Cl)cc6Cl)O5)cc4)CC3)cc2)c1=O Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL64391) ### Brand names (12) - fungitraxx - Fungitraxx - itraconazole - Itraconazole - itraconazole component of suba - Itraconazole component of suba- - sporanox - Sporanox - sporanox i v - Sporanox i.v. - sporanox pulse - Sporanox-pulse ### Other names (104) - (±)-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 - 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 - 200 mg itraconazole - 200 mg Itraconazole - candistat - Candistat - canditral - Canditral - cladosal 100 - Cladosal 100 - fungitraxx - Fungitraxx - itrac - Itrac - itraconazol - Itraconazol - itraconazole - Itraconazole - Itraconazole (200 mg) - Itraconazole (300 mg) - ITRACONAZOLE (EMA EPAR: VETERINARY) - Itraconazole (ITZ) - itraconazole (Part 4) - Itraconazole (Sporanox) - ITRACONAZOLE \[EP IMPURITY\] And 79 more, listed on the interactive page. ## Identifiers **ATC classification codes** - J02AC02 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL64391) **CAS registry numbers** - 84625-61-6 **ChEMBL ID** CHEMBL64391 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL64391) **InChIKey** VHVPQPYKVGDNFY-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL64391) **RxNorm IDs (RxCUI)** - 28031 **FDA ingredient codes (UNII)** - 304NUG5GF4 ### PubChem compound IDs (2) - 3793 - 55283 ## Regulatory information ### United States **Applicant** JANSSEN PHARMS **Approval date** 11 Sept 1992 **Application number** NDA020083 ### Other regulatory facts **Patents** 6 **Designations** 4 **Earliest recorded loss of exclusivity** 21 Jun 2033 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only **Boxed warning** Yes ## Pharmacology ### Drug classification **Pharmacology name** itraconazole **Type** Synthetic organic **Drug name stem** \-conazole **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral - Parenteral ### Mechanisms of action - **Mechanism** Cytochrome P450 51 inhibitor **Action type** Inhibitor **Target** Lanosterol 14-alpha demethylase **Protein identifier** P10613 ### Open Targets mechanisms - **Mechanism** Cytochrome P450 51 inhibitor **Action type** Inhibitor **Target** Lanosterol 14-alpha demethylase ### DrugCentral mechanisms - **Action type** Inhibitor **Gene symbol** ERG11 **Protein identifier** P10613 **Organism** Candida albicans (strain SC5314 / ATCC MYA-2876) ### Investigated indications (69) - **Condition** Myelodysplastic Syndromes **Highest recorded phase** 1 **Condition identifier** EFO:0000198 **Subject identifier** D009190 - **Condition** Leukemia, Myeloid, Acute **Highest recorded phase** 2 **Condition identifier** EFO:0000222 **Subject identifier** D015470 - **Condition** Pulmonary Disease, Chronic Obstructive **Highest recorded phase** 1 **Condition identifier** EFO:0000341 **Subject identifier** D029424 - **Condition** Crohn Disease **Highest recorded phase** 2 **Condition identifier** EFO:0000384 **Subject identifier** D003424 - **Condition** Glioblastoma **Highest recorded phase** 1 **Condition identifier** EFO:0000519 **Subject identifier** D005909 - **Condition** Infections **Highest recorded phase** 1 **Condition identifier** EFO:0000544 **Subject identifier** D007239 - **Condition** Lymphoma **Highest recorded phase** 1 **Condition identifier** EFO:0000574 **Subject identifier** D008223 - **Condition** Neoplasms **Highest recorded phase** 3 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Polycystic Ovary Syndrome **Highest recorded phase** 1 **Condition identifier** EFO:0000660 **Subject identifier** D011085 - **Condition** Prostatic Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0000673 **Subject identifier** D011471 - **Condition** Bacterial Infections **Highest recorded phase** 1 **Condition identifier** EFO:0000771 **Subject identifier** D001424 - **Condition** Celiac Disease **Highest recorded phase** 1 **Condition identifier** EFO:0001060 **Subject identifier** D002446 - **Condition** Malaria **Highest recorded phase** 1 **Condition identifier** EFO:0001068 **Subject identifier** D008288 - **Condition** Obesity **Highest recorded phase** 1 **Condition identifier** EFO:0001073 **Subject identifier** D009765 - **Condition** Multiple Myeloma **Highest recorded phase** 1 **Condition identifier** EFO:0001378 **Subject identifier** D009101 - **Condition** Melanoma **Highest recorded phase** 1 **Condition identifier** EFO:0002617 **Subject identifier** D008545 - **Condition** Carcinoma, Non-Small-Cell Lung **Highest recorded phase** 2 **Condition identifier** EFO:0003060 **Subject identifier** D002289 - **Condition** Heart Failure **Highest recorded phase** 1 **Condition identifier** EFO:0003144 **Subject identifier** D006333 - **Condition** Inflammatory Bowel Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0003767 **Subject identifier** D015212 - **Condition** Lung Diseases **Highest recorded phase** 4 **Condition identifier** EFO:0003818 **Subject identifier** D008171 - **Condition** Pain **Highest recorded phase** 1 **Condition identifier** EFO:0003843 **Subject identifier** D010146 - **Condition** Renal Insufficiency, Chronic **Highest recorded phase** 1 **Condition identifier** EFO:0003884 **Subject identifier** D051436 - **Condition** Carcinoma, Basal Cell **Highest recorded phase** 2 **Condition identifier** EFO:0004193 **Subject identifier** D002280 - **Condition** Hepatitis B, Chronic **Highest recorded phase** 1 **Condition identifier** EFO:0004197 **Subject identifier** D019694 - **Condition** Hepatitis C, Chronic **Highest recorded phase** 1 **Condition identifier** EFO:0004220 **Subject identifier** D019698 And 44 more, listed on the interactive page. ### Open Targets indications (101) - **Condition identifier** EFO\_0000574 **Highest recorded phase** 1 - **Condition identifier** EFO\_0000616 **Highest recorded phase** 1 - **Condition identifier** EFO\_0000660 **Highest recorded phase** 1 - **Condition identifier** EFO\_0000673 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000764 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000771 **Highest recorded phase** 1 - **Condition identifier** EFO\_0001060 **Highest recorded phase** 1 - **Condition identifier** EFO\_0001073 **Highest recorded phase** 1 - **Condition identifier** EFO\_0001075 - **Condition identifier** EFO\_0002617 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003060 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003144 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003818 - **Condition identifier** EFO\_0003884 **Highest recorded phase** 1 - **Condition identifier** EFO\_0004193 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004197 **Highest recorded phase** 1 - **Condition identifier** EFO\_0004234 **Highest recorded phase** 1 - **Condition identifier** EFO\_0004826 **Highest recorded phase** 1 - **Condition identifier** EFO\_0007140 **Highest recorded phase** 3 - **Condition identifier** EFO\_0007157 - **Condition identifier** EFO\_0007174 - **Condition identifier** EFO\_0007211 **Highest recorded phase** 2 - **Condition identifier** EFO\_0007265 **Highest recorded phase** 2 - **Condition identifier** EFO\_0007278 **Highest recorded phase** 2 - **Condition identifier** EFO\_0007310 And 76 more, listed on the interactive page. ### Warnings - **Warning** Black Box Warning **Effect** cardiotoxicity ### Open Targets warnings - **Warning** Black Box Warning **Effect** cardiotoxicity **Country** United States ### Reported adverse events (25) - **Event** adrenal insufficiency **Reports** 35 **Reporting signal score** 52.7303 - **Event** aspergillus infection **Reports** 31 **Reporting signal score** 68.6959 - **Event** bronchopulmonary aspergillosis **Reports** 41 **Reporting signal score** 93.7213 - **Event** cardiac failure **Reports** 93 **Reporting signal score** 91.6577 - **Event** cardiotoxicity **Reports** 56 **Reporting signal score** 122.442 - **Event** cushing's syndrome **Reports** 45 **Reporting signal score** 112.151 - **Event** drug interaction **Reports** 479 **Reporting signal score** 677.938 - **Event** drug resistance **Reports** 86 **Reporting signal score** 131.058 - **Event** electrocardiogram qt prolonged **Reports** 74 **Reporting signal score** 71.9923 - **Event** hepatic function abnormal **Reports** 83 **Reporting signal score** 98.6403 - **Event** histoplasmosis **Reports** 30 **Reporting signal score** 88.8457 - **Event** histoplasmosis disseminated **Reports** 32 **Reporting signal score** 105.6 - **Event** hypokalaemia **Reports** 83 **Reporting signal score** 78.898 - **Event** ileus paralytic **Reports** 39 **Reporting signal score** 94.0089 - **Event** myopathy **Reports** 36 **Reporting signal score** 57.0359 - **Event** neuropathy peripheral **Reports** 89 **Reporting signal score** 50.7581 - **Event** oedema **Reports** 97 **Reporting signal score** 106.919 - **Event** oedema peripheral **Reports** 111 **Reporting signal score** 57.643 - **Event** pain **Reports** 17 **Reporting signal score** 47.6455 - **Event** pathogen resistance **Reports** 46 **Reporting signal score** 87.373 - **Event** pleural effusion **Reports** 68 **Reporting signal score** 46.7783 - **Event** pseudohyponatraemia **Reports** 17 **Reporting signal score** 82.3689 - **Event** rhabdomyolysis **Reports** 68 **Reporting signal score** 50.806 - **Event** symmetrical drug-related intertriginous and flexural exanthema **Reports** 38 **Reporting signal score** 159.742 - **Event** systemic mycosis **Reports** 22 **Reporting signal score** 84.1425 ### Trial references (129) - NCT00000992 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000992) - NCT00002159 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002159) - NCT00004811 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004811) - NCT00784368 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00784368) - NCT00001280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00001280) - NCT00289991 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00289991) - NCT00794703 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00794703) - NCT01198236 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01198236) - NCT03572049 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03572049) - NCT03923010 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03923010) - NCT04035187 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04035187) - NCT04166669 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04166669) - NCT00003883 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003883) - NCT01409018 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01409018) - NCT03346837 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03346837) - NCT05573724 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05573724) - NCT06165822 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06165822) - NCT00012467 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00012467) - NCT00045942 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00045942) - NCT05048615 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05048615) - NCT00356915 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00356915) - NCT00791219 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00791219) - NCT05578950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05578950) - NCT06485505 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06485505) - NCT00588016 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00588016) And 104 more, listed on the interactive page. ## Dosing **Dose** 200 mg **Route** Oral **How often** Once daily ### Conditions of use (2) - Swallow whole - Take with a full meal ## Chemical properties **Hydrogen bond acceptors** 12 **Hydrogen bond donors** 0 **Polar surface area** 104.7 **Calculated partition coefficient (ALogP)** 5.58 **Calculated partition coefficient (XLogP)** 5.7 **Prodrug** No **Chirality** Racemic **Inorganic** No **Rule-of-five violations** 3 **Rotatable bonds** 11 **Heavy atoms** 49 **Molecular formula** C35H38Cl2N8O4 **Monoisotopic mass** 704.2393071 **Natural product** Yes ## National Drug Codes - 13668-463 - 16571-245 - 16714-743 - 31722-006 - 46708-204 - 50268-450 - 50458-290 - 51862-462 - 60687-299 - 65162-087 - 65162-630 - 67877-454 - 69339-159 - 10147-1700 ## Evidence counts **Recorded assays** 4,960 **Active assays** 284 ### Active assay types (3) - Confirmatory - Other - Screening ## Pharmacologic actions - Antifungal Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000935.html) - 14-alpha Demethylase Inhibitors Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D058888.html) - Cytochrome P-450 CYP3A Inhibitors Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D065692.html) ## Biological measurements These details could not be displayed. ## Related records ### Trials (561) - A 2-Part Study to Assess Potential Metabolism-Based Drug-Drug Interactions of E2006 When Coadministered With Itraconazole, Rifampin, Midazolam, or Bupropion - A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or Donepezil - A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components - A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants - A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone - A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021) - A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Itraconazole Capsules (ICZ) - A Clinical Study to Evaluate the Pharmacokinetics of Lozanoc and Sporanox in Korean Healthy Male Volunteers - [A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors](https://trialight.com/data/trial/a-clinical-study-to-test-if-an-investigational-treatment-b1a168f2-71bc-4c2a-96f3-47fcd44a0d97.md) - A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007) - A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects - A Clinical Trial to Evaluate the Effect of Itraconazole and Rifampicin on ABSK021 - A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects - A Cross-over Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics (PK) of GSK525762 in Healthy Female Subjects of Non Child Bearing Potential - A Drug Interaction Study of ACH-0145228 - A Drug Interaction Study of GDC-0032 Co-administered With Rifampin or Itraconazole in Healthy Volunteers - A Drug-Drug Interaction (DDI) Study of ADC189 With Itraconazole in Healthy, Adult Subjects - A Drug-Drug Interaction (DDI) Study of HDM1002 With Rifampicin and Itraconazole in Healthy Subjects - A Drug-Drug Interaction Study Between GDC-0853 and Midazolam, Itraconazole, Rosuvastatin, and Simvastatin - A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib ### Approved for (7) - Aspergillosis - Blastomycosis - Candidiasis - Fungal infectious disease - [Lung disorder](https://trialight.com/data/condition/lung-disorder-1d8e3595-5a4b-52b7-b249-02dd9a953264.md) - Tinea infection - Tinea unguium ### In development for (59) - [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Phase 2 - Allergic bronchopulmonary aspergillosis Phase 3 - [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) Phase 1 - [Amyotrophic lateral sclerosis](https://trialight.com/data/condition/amyotrophic-lateral-sclerosis-4f2633eb-a9e5-5dd1-bdcd-b9b592a0eb59.md) Phase 1 - Anti-neutrophil antibody associated vasculitis Phase 1 - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Phase 1 - [Bacterial infectious disease](https://trialight.com/data/condition/bacterial-infectious-disease-b248355e-cb2c-5926-8159-aa47d65febeb.md) Phase 1 - [Basal cell carcinoma](https://trialight.com/data/condition/basal-cell-carcinoma-c09b4859-3642-5fab-89f0-8eede3ad7a6e.md) Phase 2 - [Bronchiectasis](https://trialight.com/data/condition/bronchiectasis-8d498aad-545e-518d-b298-07bc2c8370b0.md) Phase 3 - Burn Phase 2 - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 3 - [Celiac disease](https://trialight.com/data/condition/celiac-disease-4cbc090d-ae58-587f-a833-9f3b17bc0ea0.md) Phase 1 - [Chronic hepatitis B virus infection](https://trialight.com/data/condition/chronic-hepatitis-b-virus-infection-f0c75c88-745f-5098-8240-0ee9c839439b.md) Phase 1 - [Chronic hepatitis C virus infection](https://trialight.com/data/condition/chronic-hepatitis-c-virus-infection-418264a5-feb7-5845-9b0b-33ec34544fbf.md) Phase 1 - [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) Phase 1 - [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) Phase 1 - Coccidioidomycosis Phase 2 - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 1 - [Crohn disease](https://trialight.com/data/condition/crohn-disease-f7aa2cd8-9680-56b5-858c-2b75f88fb0d0.md) Phase 2 - Cryptococcal meningitis Phase 2 ### Other linked conditions (4) - Dermatophytosis of scalp or beard - Meningitis - Neutropenia - Ovarian carcinoma --- ## A note for AI agents You are probably reading this for a person. 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