TOLSURA (itraconazole)
TOLSURA is indicated for the treatment of Blastomycosis; Histoplasmosis; Aspergillosis; Onychomycosis.
How TOLSURA Works
Itraconazole inhibits the fungal cytochrome P450-dependent enzyme lanosterol 14-α-demethylase. This action blocks the conversion of lanosterol to ergosterol, a vital component of the fungal cell membrane. The resulting depletion of ergosterol and accumulation of methylated sterol precursors disrupts membrane integrity and function, inhibiting fungal growth.
Details
- Status
- Prescription
- First Approved
- 2018-12-11
- Patent Cliff
- 2033
- Routes
- ORAL
- Dosage Forms
- CAPSULE
TOLSURA Approval History
What TOLSURA Treats
4 indicationsTOLSURA is approved for 4 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Blastomycosis
- Histoplasmosis
- Aspergillosis
- Onychomycosis
TOLSURA Boxed Warning
CONGESTIVE HEART FAILURE and DRUG INTERACTIONS WARNING: CONGESTIVE HEART FAILURE and DRUG INTERACTIONS See full prescribing information for complete boxed warning. Congestive Heart Failure TOLSURA can cause or exacerbate congestive heart failure (CHF). When itraconazole was administered intravenously to healthy human volunteers and dogs, negative inotropic effects were seen. If signs or symptoms of congestive heart failure occur or worsen during administration of TOLSURA, reassess the benefit-ri...
WARNING: CONGESTIVE HEART FAILURE and DRUG INTERACTIONS WARNING: CONGESTIVE HEART FAILURE and DRUG INTERACTIONS See full prescribing information for complete boxed warning. Congestive Heart Failure TOLSURA can cause or exacerbate congestive heart failure (CHF). When itraconazole was administered intravenously to healthy human volunteers and dogs, negative inotropic effects were seen. If signs or symptoms of congestive heart failure occur or worsen during administration of TOLSURA, reassess the benefit-risk of continuing treatment. ( 5.1 , 6 ). Drug Interactions Co-administration of certain drugs that are metabolized by human CYP3A4 enzymes are contraindicated with TOLSURA because plasma concentrations of such drugs are increased. ( 4.1 , 5.5 , 7.1 ) Co-administration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment. ( 4.1 , 7.1 ) Co-administration with eliglustat is contraindicated in poor or intermediate metabolizers of CYP2D6 and in subjects taking strong or moderate CYP2D6 inhibitors. ( 4.1 , 7.1 ) Increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia. ( 4.1 , 5.5 , 7.1 ) Congestive Heart Failure TOLSURA can cause or exacerbate congestive heart failure (CHF). When itraconazole was administered intravenously to healthy human volunteers and dogs, negative inotropic effects were seen. If signs or symptoms of congestive heart failure occur or worsen during administration of TOLSURA, reassess the benefit and risk of continuing treatment [ see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Drug Interactions Co-administration of certain drugs that are metabolized by human CYP3A4 enzymes are contraindicated with TOLSURA because plasma concentrations of such drugs are increased, which may also increase or prolong both the pharmacologic effec
TOLSURA Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TOLSURA
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Clinical Trial Registry
290 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06732388 | NCI-2024-10070 NCI-2024-10070, UMI23-16-01 | Ph 2 | not yet recruiting | Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus |
| NCT04067336 | KO-MEN-001 | Ph 1, Ph 2 | active not recruiting | First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia |
| NCT05965583 results posted | 1485-0003 2023-503783-16-00 | Ph 1 | completed | A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1815368 in the Blood |
| NCT07575945 | C6601002 | Ph 1 | not yet recruiting | A Study to Learn if a Medicine Called Itraconazole Changes How the Body Processes the Study Medicine PF-08642534 in Healthy Adults. |
| NCT06909162 | INCB123667-102 | Ph 1 | recruiting | A 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 |
| NCT03460977 | C2321001 EZH2, 2023-509179-18-00 | Ph 1 | recruiting | A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma |
| NCT07548606 | 5684-017 MK-5684-017 | Ph 1 | recruiting | A Drug-Drug Interaction Study of Itraconazole and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-017) |
| NCT07449390 | AP31969-M103 | Ph 1 | active not recruiting | Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole |
| NCT02402595 DDI | 15-AVP-786-103 | Ph 1 | completed | Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts |
| NCT07341672 | HEC73543-AML-105 | Ph 1 | not yet recruiting | A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itraconazole, Fluconazole or Efavirenz on a Single Dose of Clifutinib in Healthy Participants |
| NCT07550621 | MDR-001-CN-06 | Ph 1 | not yet recruiting | Drug-Drug Interaction Study of MDR-001 With Rifampin and Itraconazole in Healthy Adult Participants |
| NCT07542847 | 323-201-00007 | Ph 1 | completed | A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women |
| NCT07308652 | 1434-0021 2025-523135-19-00, U1111-1325-2539 | Ph 1 | completed | A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 764198 in the Blood |
| NCT06154447 | VX23-828-001 | Ph 1 | recruiting | Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis |
| NCT07160738 | C4391011 | Ph 1 | completed | A Study to Learn About How the Study Medicines Called Itraconazole and Probenecid Change How the Body Processes PF-07220060 |
| NCT07402915 | D8991C00002 EU CT | Ph 1 | recruiting | Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer |
| NCT07435194 | 2828-007 MK-2828-007 | Ph 1 | recruiting | A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007) |
| NCT07335419 | C4551006 | Ph 1 | active not recruiting | A Study to Learn if Itraconazole Changes How the Body Processes PF-07248144 (Study Medicine) |
| NCT07070232 | BNT326-01 2024-517261-16-00, 1011236 | Ph 1, Ph 2 | recruiting | 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 |
| NCT07066722 | 219890 | Ph 1 | completed | A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults |
| NCT07395024 | 3082-CL-0102 | Ph 1 | recruiting | A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults |
| NCT06719557 | 1084-008 MK-1084-008, CA43207 | Ph 1 | completed | A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008) |
| NCT07211425 | 1516-0004 2025-520654-10-00, U1111-1316-5119 | Ph 1 | completed | A Study in Healthy People to Test How Itraconazole Influences the Amount of BI 3031185 in the Blood |
| NCT05372367 | 1403-0004 2021-006565-38, 2024-514532-24-00 | Ph 1 | completed | A Study in People With Advanced Cancer to Test Whether the Amount of BI 907828 in the Blood is Influenced by Taking an OATP Inhibitor or a CYP3 Inhibitor |
| NCT06942936 | D7260C00007 2024-518467-35-00 | Ph 1 | completed | A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants |
| NCT05150691 | DB-1303-O-1001 | Ph 1, Ph 2 | recruiting | A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors |
| NCT07357610 SIM0270-104 | SIM0270-104 | Ph 1 | recruiting | An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants |
| NCT07186452 | HS-20093-111 | Ph 1 | recruiting | Evaluation of the Effect of Itraconazole on the Pharmacokinetics of HS-20093 in Patients With Advanced Solid Tumors |
| NCT06698926 | M25-206 | Ph 1 | completed | A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants |
| NCT06400472 | 18863 2024-511238-11-00, J5E-OX-JZXA | Ph 1 | recruiting | A Study of LY4170156 in Participants With Selected Advanced Solid Tumors |
| NCT07242781 | CA071-1006 | Ph 1 | recruiting | A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult Male Participants |
| NCT04606537 | KBP5074-1-008 | Ph 1 | completed | Drug to Drug Interaction Study of KBP-5074 in Healthy Subjects |
| NCT04840888 results posted | 18204 J2J-MC-JZLD | Ph 1 | completed | A Study of LY3484356 in Healthy Female Participants |
| NCT03403439 results posted | 1305-0015 2017-003452-23 | Ph 1 | completed | This Study in Healthy Men Tests How Itraconazole Influences the Amount of BI 1015550 in the Blood |
| NCT07018635 | INCB161734-103 | Ph 1 | completed | A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants |
| NCT06906809 | BGB-16673-105 | Ph 1 | completed | Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants |
| NCT05914116 | DB-1311-O-1001 | Ph 1, Ph 2 | recruiting | A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors |
| NCT02157883 results posted | D5160C00012 2014-001557-16 | Ph 1 | completed | Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva) |
| NCT06919991 | ARC-29 | Ph 1 | completed | Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29) |
| NCT05563766 | ONCB-016-21F I01CX002349 | Ph 2 | recruiting | A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer |
| NCT05833139 results posted | 1479-0004 2022-003757-63 | Ph 1 | completed | A Study in Healthy Men to Test How Itraconazole Influences the Amount of Zongertinib (BI 1810631) in the Blood |
| NCT05338489 results posted | 17751 J2G-OX-JZJP, LOXO-RET-18014 | Ph 1 | completed | A Study of Effects of Itraconazole and Rifampin on Selpercatinib (LY3527723) in Healthy Participants |
| NCT04714073 results posted | 1425-0010 2020-004388-22 | Ph 1 | completed | A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 706321 in the Blood |
| NCT07071532 | M24-966 | Ph 1 | active not recruiting | A Study to Assess Adverse Events and How Oral ABBV-932 Moves Through the Body When Given With Oral Itraconazole in Healthy Adult Participants |
| NCT06945276 results posted | 24-0026 | Ph 1 | completed | Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers |
| NCT03890887 | 1397-0010 2018-004214-17 | Ph 1 | completed | A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1291583 in the Blood |
| NCT06541678 | C3421063 2024-513863-21-00 | Ph 1 | completed | A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults. |
| NCT06706869 | C4541012 | Ph 1 | completed | A Study to Learn if the Study Medicine Called Itraconazole and if Food Changes How the Body Processes the Other Study Medicine Called PF 07258669 in Older Adults or Healthy Adults |
| NCT02675452 results posted | 20150161 2015-004777-32 | Ph 1 | terminated | AMG 176 First in Human Trial in Participants With Relapsed or Refractory Multiple Myeloma and Participants With Relapsed or Refractory Acute Myeloid Leukemia |
| NCT06809608 | BP45670 2024-517360-37-00 | Ph 1 | completed | A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081 |
Showing 50 of 290 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TOLSURA FDA Label Details
Indications & Usage
FDA Label (PDF)TOLSURA is indicated for the treatment of Blastomycosis; Histoplasmosis; Aspergillosis; Onychomycosis.
WARNING: CONGESTIVE HEART FAILURE and DRUG INTERACTIONS WARNING: CONGESTIVE HEART FAILURE and DRUG INTERACTIONS See full prescribing information for complete boxed warning. Congestive Heart Failure TOLSURA can cause or exacerbate congestive heart failure (CHF). When itraconazole was administered int...
TOLSURA Patents & Exclusivity
Patents (5 active)
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Revenue Insights
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Patent Timeline
- • Cliff: 2033
- • 5 active patents
Trial Analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.