Sporanox

(Itraconazole)

ApprovedSmall molecule

Itraconazole is used to treat fungal infections caused by fungi and molds. It works by stopping the growth of fungal organisms that cause infections in various parts of the body.[2] Sporanox is currently approved and in use across 62 indications[4].[1]

Sporanox is one of 1134 small molecule programs targeting Cystic Fibrosis. It is currently in Approved.

Indications

411

Total Trials

Active Trials

1,133

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cystic FibrosisTerminated

Allergic Bronchopulmonary AspergillosisRecruiting

Patients With Advanced Solid TumorsCompleted

FemaleCompleted

Bacterial DiseaseApproved

Eumycotic MycetomaApproved

HIV InfectionApproved

Thrombotic DiseaseApproved

Lung CancerApproved

MetastasisApproved

Cystic FibrosisApproved

Terminated

Allergic Bronchopulmonary AspergillosisPhase 3

Recruiting

Patients With Advanced Solid TumorsPhase 1

Completed

FemalePhase 1

Completed

Bacterial DiseaseApproved

Approved

Eumycotic MycetomaApproved

Approved

HIV InfectionApproved

Approved

Thrombotic DiseaseApproved

Approved

Lung CancerApproved

Approved

MetastasisApproved

Approved

Showing 10 of 62 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Sporanox

SSebela Pharmaceuticals Development LLC

Approved

1 2

Voltaren

Novartis

Preclinical

1 3

Zolymbus

AbbVie

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 5

Tricor

JJagotec

Preclinical

1 6

Acupan

YYonsei University

Preclinical

1 7

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 8

Vfend

PPrism Pharmaceuticals

Paracetamol

1 10

Systemic Therapy

Bristol-Myers Squibb

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Esophageal Cancer

NCT04018872

Q4 2026

Phase 2/3Recruiting

Ovarian Cancer

NCT03458221

Phase 1Recruiting

Interaction

NCT07357610

Q1 2027

Phase 1Not yet recruiting

Interaction

NCT07429331

Phase 1Not yet recruiting

Interaction

NCT07438886

Q4 2029

Phase 3Recruiting

Aspergillosis

NCT03656081

Clinical

Trials by Indication[1]

Interaction41 trials

A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001

Completed· Basilea Pharmaceutica logo

Basilea Pharmaceutica·Phase 1·NCT04166669·36 enrolled

A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558

Completed·AAligos Therapeutics·Phase 1·NCT05840952·90 enrolled

Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction Study in Healthy Volunteers

Not yet recruiting·AAdvenchen Laboratories Nanjing Ltd.·Phase 1·NCT07438886·16 enrolled

Show 38 more trials

Drug Interaction and Food Effect Study of CS0159

Not yet recruiting·CCascade Pharmaceuticals, Inc·Phase 1·NCT07429331·32 enrolled

HMPL-689 Drug Interaction Study With CYP3A Inhibitor/CYP2C9 Inhibitor/CYP3A Inducer/PPI

Completed·HHutchmed·Phase 1·NCT05602597·59 enrolled

A Study to Assess Multiple Ascending Dose, Drug-Drug Interaction, and Asian Pharmacokinetic Study of ABBV-1088

Terminated· AbbVie logo

AbbVie·Phase 1·NCT06579300·72 enrolled

Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim

Completed·FF2G Biotech GmbH·Phase 1·NCT04171739·24 enrolled

A Study to Evaluate Drug-Drug Interaction of TAK-788 With Itraconazole and Rifampin in Healthy Adult Participants

Completed· Takeda logo

Takeda·Phase 1·NCT03928327·24 enrolled

A Study to Assess the Interaction Between ASP1707 and Itraconazole in Healthy Female Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT02175407·14 enrolled

Drug-drug Interaction (DDI) With a P-gp Inhibitor, Organic Anion Transporting Polypeptide OATP-inhibitor, Food Effect

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT03116893·15 enrolled

First in Human Study to Investigate the Safety and Tolerability, Pharmacokinetics, Itraconazole Drug-drug-interaction and Food Effect of BAY1817080

Completed· Bayer logo

Bayer·Phase 1·NCT02817100·88 enrolled

Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT04783753·72 enrolled

Drug-Drug Interaction (DDI) Study for TD-9855

Completed·TTheravance Biopharma·Phase 1·NCT03432793·41 enrolled

Drug-Drug Interaction (DDI) Study for TPN171H

Completed·VVigonvita Life Sciences·Phase 1·NCT06090123·24 enrolled

A Drug Interaction Study of GDC-0032 Co-administered With Rifampin or Itraconazole in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01814709·32 enrolled

Study to Assess Drug-Drug Interaction Between Itraconazole or Gemfibrozil and JNJ-56021927

Completed·AAragon Pharmaceuticals, Inc.·Phase 1·NCT02230033·45 enrolled

A Study to Assess the Drug Interaction Between MYK-224 and Itraconazole and Verapamil in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05304533·45 enrolled

Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers.

Completed· Lundbeck logo

Lundbeck·Phase 1·NCT02199431·20 enrolled

Drug-drug Interaction Study With MDV3100 (ASP9785) and Gemfibrozil and Itraconazole

Completed· Astellas logo

Astellas·Phase 1·NCT01913379·41 enrolled

A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Drug-drug Interaction of VX-993 in Healthy Adults

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT06392659·42 enrolled

A Study to Evaluate Drug-Drug Interaction of Larotinib With Itraconazole and Rifampin in Healthy Adult Participants

Completed· Sunshine Lake Pharma Co., Ltd. logo

Sunshine Lake Pharma Co., Ltd.·Phase 1·NCT05057949·32 enrolled

Drug-Drug Interaction Study Between TAK-272 and Itraconazole, Digoxin or Midazolam

Completed· Takeda logo

Takeda·Phase 1·NCT02370615·34 enrolled

A Drug Interaction Study of ACH-0145228

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04709081·38 enrolled

Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) With Itraconazole and Rifampin in Healthy Chinese Adults

Not yet recruiting·SShanghai Jiatan Pharmatech Co., Ltd·Phase 1·NCT06701136·16 enrolled

An Interaction Study of LY3200882 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT03792139·23 enrolled

A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults

Completed· GSK logo

GSK·Phase 1·NCT07066722·126 enrolled

A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants

Completed· AbbVie logo

AbbVie·Phase 1·NCT06698926·110 enrolled

Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor

Completed·CCorcept Therapeutics·Phase 1·NCT03259542·33 enrolled

Roniciclib (BAY 1000394) Drug-Drug Interaction (DDI) Study

Completed· Bayer logo

Bayer·Phase 1·NCT02457351·14 enrolled

A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone

Completed· Biogen logo

Biogen·Phase 1·NCT04008186·61 enrolled

A Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets

Completed· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 1·NCT06024915·40 enrolled

A Multi-part Study of ALG-000184 to Evaluate Safety, Tolerability, Pharmacokinetics and Drug-drug Interaction Potential After Single and Multiple Doses in Healthy Volunteers

Active, not recruiting·AAligos Therapeutics·Phase 1·NCT06672900·24 enrolled

Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Itraconazole

Completed· Novartis logo

Novartis·Phase 1·NCT05084651·19 enrolled

A Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05994807·33 enrolled

Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects

Not yet recruiting·JJemincare·Phase 1·NCT06348290·72 enrolled

A Drug-Drug Interaction Study Between GDC-0853 and Midazolam, Itraconazole, Rosuvastatin, and Simvastatin

Completed· Roche logo

Roche·Phase 1·NCT03174041·63 enrolled

Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole

Not yet recruiting·AAcesion Pharma·Phase 1·NCT07449390·28 enrolled

Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29)

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT06919991·14 enrolled

A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib

Completed· Pfizer logo

Pfizer·Phase 1·NCT03723395·116 enrolled

Drug-Drug Interaction Study of Itraconazole With GST-HG171/Ritonavir in Healthy Participants

Completed·FFujian Akeylink Biotechnology Co., Ltd.·Phase 1·NCT06087055·12 enrolled

An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants

Recruiting· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 1·NCT07357610·60 enrolled

Tics23 trials

A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05551897·14 enrolled

Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT04423601·18 enrolled

Study to Evaluate Effects of Food or Proton Pump Inhibitor on the Pharmacokinetics of Itraconazole in Healthy Volunteers

Completed·SSeoul National University Hospital·Phase 1·NCT04942652·13 enrolled

Show 20 more trials

Relative Bioavailability, Safety, Tolerability, Pharmacokinetics (PK) and Food Effect Study of GSK2140944 in Healthy Subjects

Completed· GSK logo

GSK·Phase 1·NCT02045849·46 enrolled

To Assess the Effect of Itraconazole and Fluconazole on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02093728·26 enrolled

A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet

Recruiting·GGuangzhou Lupeng Pharmaceutical Company LTD.·Phase 1·NCT07374224·28 enrolled

A Study to Evaluate the Relative Bioavailability of STI-1558 and the Effect of Itraconazole and Rifampin on the Pharmacokinetics of STI-1558

Completed·ZZhejiang ACEA Pharmaceutical Co. Ltd.·Phase 1·NCT05685719·37 enrolled

Study to Investigate Effects of Repeated Administration of Itraconazole on Pharmacokinetics of JNJ-42847922 in Healthy Male Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02455856·16 enrolled

A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State

Completed· Roche logo

Roche·Phase 1·NCT02608034·32 enrolled

Study Evaluating the Effects of Food, Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of CC-122

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03340662·81 enrolled

A Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT06690138·18 enrolled

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Risdiplam (RO7034067) Given by Mouth in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT02633709·33 enrolled

The Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SH-1028

Unknown status·NNanjing Sanhome Pharmaceutical, Co., Ltd.·Phase 1·NCT04808648·40 enrolled

Effect of Coadministration of Itraconazole on the Pharmacokinetics of CRD-740

Completed·CCardurion Pharmaceuticals, Inc.·Phase 1·NCT05437094·20 enrolled

A Study to Investigate the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole in Healthy Participants

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06846528·16 enrolled

A Study to Assess the Pharmacokinetics of AZD6793 When Administered Alone and in Combination With Itraconazole in Healthy Participants.

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06494644·17 enrolled

A Study to Assess Effects of Clarithromycin on Pharmacokinetics of JNJ-54861911 in Healthy Male Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02197884·13 enrolled

To Evaluate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of BV100

Completed·BBioVersys AG·Phase 1·NCT05684718·16 enrolled

Studies Evaluating the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of TY-9591 Tablets in Healthy Subjects

Completed·TTYK Medicines, Inc·Phase 1·NCT06255951·48 enrolled

A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT03774576·14 enrolled

A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03950960·15 enrolled

Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02341638·148 enrolled

A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers

Not yet recruiting·BBetta Pharmaceuticals Co., Ltd.·Phase 1·NCT06492525·36 enrolled

Adult10 trials

A Study to Assess Change in How Oral Icalcaprant With Itraconazole Moves Through the Body in Healthy Adult Participants

Completed· AbbVie logo

AbbVie·Phase 1·NCT06722430·12 enrolled

A Study to Assess the Effects of Itraconazole and Rifampicin on the Single-Dose Pharmacokinetics of JNJ-53718678 in Healthy Adults

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02729467·33 enrolled

A Study to Evaluate the Effect of Itraconazole on JNJ-56136379 in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03945539·16 enrolled

Show 7 more trials

A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03135106·54 enrolled

A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06719557·28 enrolled

A Study to Learn About How Itraconazole Affects the Blood Level of Study Medicine (PF-07817883) in Healthy Adults.

Completed· Pfizer logo

Pfizer·Phase 1·NCT05822440·12 enrolled

Impact of Itraconazole on the Pharmacokinetics and Safety of Dazucorilant in Healthy, Adult Participants

Completed·CCorcept Therapeutics·Phase 1·NCT06495944·21 enrolled

A Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult Participants

Completed· Spectrum Pharmaceuticals, Inc logo

Spectrum Pharmaceuticals, Inc·Phase 1·NCT04981704·74 enrolled

A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants

Completed· Takeda logo

Takeda·Phase 1·NCT03173170·10 enrolled

A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04208373·32 enrolled

Drug8 trials

A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04154800·114 enrolled

A Study to Evaluate the Amount of Drug That Becomes Available in the Blood Circulation When Savolitinib is Administered Alone and in Combination With Itraconazole

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04121910·16 enrolled

A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT06363630·35 enrolled

Show 5 more trials

A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04956627·15 enrolled

A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT06170723·32 enrolled

A Study to Learn About How Itraconazole and Carbamazepine Affect the Level of BAY2927088 in the Blood When These Drugs Are Taken Together by Healthy Participants

Completed· Bayer logo

Bayer·Phase 1·NCT06348888·30 enrolled

A Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Drug Levels and Safety of BMS-986235

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04464577

Study to Learn More About the Effect of Itraconazole (ITZ) Given Repeatedly by Mouth on the Way How the Study Drug BAY1902607 Given One Time by Mouth Acts in the Human Body of Healthy Male Participants

Completed· Bayer logo

Bayer·Phase 1·NCT03789890·14 enrolled

ART6 trials

The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants

Completed·MMereo BioPharma·Phase 1·NCT03498170·16 enrolled

Study of the Effects of Itraconazole and Rifampin on LOXO-305 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05134337·27 enrolled

A Study of LY3323795 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02989389·42 enrolled

Show 3 more trials

Study of BIIB091 Formulations in Healthy Participants

Completed· Biogen logo

Biogen·Phase 1·NCT04564612·59 enrolled

A Study of LY3154207 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02365571·64 enrolled

A Study of LY3154885 in Healthy Participants

Terminated· Eli Lilly logo

Eli Lilly·Phase 1·NCT04014361·36 enrolled

65 more indications

Drug Interactions5 trials

A 2-Part Study to Assess Potential Metabolism-Based Drug-Drug Interactions of E2006 When Coadministered With Itraconazole, Rifampin, Midazolam, or Bupropion

Completed· Eisai logo

Eisai·Phase 1·NCT02085967·106 enrolled

An Open-label Study in Healthy Participants to Evaluate AZD0780 as an Object or Precipitant of CYP3A4-mediated Drug-drug Interactions

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06671405·59 enrolled

A Study to Evaluate the Drug-drug Interactions (DDIs) of GP681 With Rosuvastatin, Digoxin, Itraconazole, Oseltamivir in Chinese Healthy Volunteers

Completed·JJiangxi Qingfeng Pharmaceutical Co. Ltd.·Phase 1·NCT05789342·54 enrolled

Show 2 more trials

Assess the Drug Interactions of BBT-877 and Midazolam, Itraconazole, and Esomeprazole in Healthy Adult Subjects

Completed·BBridge Biotherapeutics, Inc.·Phase 1·NCT04138836·48 enrolled

A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults

Completed·AAssembly Biosciences·Phase 1·NCT04142762·80 enrolled

Onychomycosis5 trials

Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis

Completed·HHalcygen Pharmaceuticals Limited·Phase 2·NCT00791219·175 enrolled

Scoring Clinical Index For Onychomycosis in Toenail Onychomycosis Treating With Itraconazole Capsules

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00871728·132 enrolled

Comparative Study Between Pulsed and Continuous Itraconazole for the Treatment of Onychomycosis

Completed·—·Phase 1·NCT05567484·60 enrolled

Show 2 more trials

Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.

Completed· GSK logo

GSK·Phase 3·NCT00356915·1,381 enrolled

Isotretinoin Versus Excimer Light an Adjuvant in Treating Onychomycosis

Not yet recruiting·ZZagazig University·Phase 1·NCT06485505·36 enrolled

Single Dose4 trials

A Study of the Effect of Multiple Doses of Itraconazole and Fluoxetine on the Pharmacokinetics of a Single Dose of RO5285119 in Healthy Subjects

Completed· Roche logo

Roche·Phase 1·NCT01967979·28 enrolled

A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT02319148·22 enrolled

A Study to Investigate the Effect of Itraconazole on the Way the Body Absorbs, Distributes, and Gets Rid of ACT-1004-1239 Given as a Single Dose of 10 mg to Healthy Male Subjects

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT05549531·16 enrolled

Show 1 more trial

A Phase 1 Study to Examine the Effects of Itraconazole After Single Dose Administration of Varegacestat (AL102) to Healthy Participants

Completed·IImmunome, Inc.·Phase 1·NCT06677996·22 enrolled

Female3 trials

A Study of LY3484356 in Healthy Female Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT04840888·82 enrolled

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

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06942936·51 enrolled

A Study to Assess the Effect of Erythromycin on the Test Medicine (SAR443820) When Given Orally as Tablets to Healthy Adult Male and Female Participants (Part A); and the Effect of Itraconazole on the Test Medicine (SAR443820) When Given Orally as Capsules to Healthy Adult Male Participants (Part B)

Completed· Sanofi logo

Sanofi·Phase 1·NCT05797753·16 enrolled

Cystic Fibrosis3 trials

Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 3·NCT06160713·80 enrolled

Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis

Completed·OOttawa Hospital Research Institute·Phase 4·NCT00528190·35 enrolled

An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)

Terminated· Novartis logo

Novartis·Phase 4·NCT00787917·14 enrolled

Trial3 trials

A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants

Completed·SShandong Suncadia Medicine Co., Ltd.·Phase 1·NCT07229560·16 enrolled

A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of Praliciguat (IW-1973) in Healthy Volunteers

Completed·CCyclerion Therapeutics·Phase 1·NCT03499106·24 enrolled

Proof-of-Concept Superiority Trial of Fosravuconazole Versus Itraconazole for Eumycetoma in Sudan

Completed·DDrugs for Neglected Diseases·Phase 2·NCT03086226·104 enrolled

Prostate Cancer3 trials

Study of Itraconazole in Castrate-resistant Prostate Cancer (CRPC) Post-chemotherapy

Terminated·SStanford University·Phase 2·NCT01450683·4 enrolled

Phase Ib/II Study Evaluating Orteronel (Without Prednisone) Combined With Itraconazole In Men With Castration-Resistant Prostate Cancer (CRPC)

Withdrawn·—·Phase 1/2·NCT02054793

A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients

Terminated·UUniversity of Chicago·Phase 1·NCT05679388·60 enrolled

Ovarian Cancer3 trials

A Study of the Safety, Tolerability and Effectiveness of Hydroxychloroquine and Itraconazole in Platinum-resistant Epithelial Ovarian Cancer

Completed·UUniversity Health Network, Toronto·Phase 1/2·NCT03081702·13 enrolled

Itraconazole in Advanced Ovarian Cancer

Unknown status·TTanta University·N/A·NCT05591560·66 enrolled

Signal TrAnsduction Pathway Activity Analysis in OVarian cancER

Recruiting·GGynaecologisch Oncologisch Centrum Zuid·Phase 2/3·NCT03458221·148 enrolled

Esophageal Cancer2 trials

Itraconazole as a Targeted Therapy for Inhibiting Hedgehog Pathway Signaling in Esophageal Cancer Patients

Unknown status·—·Phase 1·NCT02749513·18 enrolled

Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer

Recruiting·—·Phase 2·NCT04018872·78 enrolled

Lymphoma2 trials

A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Alisertib in Participants With Advanced Solid Tumors or Relapsed/Refractory Lymphoma

Completed· Takeda logo

Takeda·Phase 1·NCT02259010·24 enrolled

A Safety and Efficacy Study of CC-90011 in Participants With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02875223·75 enrolled

Basal Cell Carcinoma2 trials

Topical Itraconazole in the Treatment of Basal Cell Carcinoma

Completed·JJohns Hopkins University·Phase 1·NCT02120677·5 enrolled

Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients w/ Basal Cell Carcinomas

Completed·SStanford University·Phase 2·NCT01108094·29 enrolled

Adult Subject2 trials

Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects

Recruiting·MModern Biosciences Ltd·Phase 1·NCT06379958·48 enrolled

Drug-drug Interaction Study with TS-142 in Healthy Adult Subjects (concomitant Administration of Itraconazole)

Completed·TTaisho Pharmaceutical Co., Ltd.·Phase 1·NCT04557163·10 enrolled

Aspergillosis2 trials

A Randomized Controlled Trial to Compare the Clinical Outcomes With Six Months of Therapy With Oral Itraconazole Versus Oral Voriconazole for Management of Treatment naïve Subjects With Chronic Pulmonary Aspergillosis

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 3·NCT04824417·116 enrolled

Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole

Recruiting·PPoitiers University Hospital·Phase 3·NCT03656081·224 enrolled

Allergic Bronchopulmonary Aspergillosis2 trials

A Randomized Trial of Prednisolone, Itraconazole, or Their Combination in Allergic Bronchopulmonary Aspergillosis

Recruiting·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 3·NCT06174922·300 enrolled

A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 2/3·NCT02440009·191 enrolled

Candidiasis2 trials

Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.

Completed· Johnson & Johnson logo

Johnson & Johnson·N/A·NCT00002132

An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

Completed· Johnson & Johnson logo

Johnson & Johnson·N/A·NCT00002133

Cryptococcal Meningitis2 trials

Safety and Antifungal Activity of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Cryptococcal Meningitis

Completed·IInterMune·Phase 2·NCT00012467·60 enrolled

A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000639·400 enrolled

CAR2 trials

A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05860933·30 enrolled

Study of the Effects of Itraconazole and Carbamazepine on LY3410738 in Healthy Participants

Terminated· Eli Lilly logo

Eli Lilly·Phase 1·NCT05205447·27 enrolled

Asthma2 trials

Study to Evaluate Itraconazole Administered as Inhaled Dry Powder in Adults With Asthma and ABPA

Terminated·PPulmatrix Inc.·Phase 2·NCT05667662·8 enrolled

Safety, Tolerability and Pharmacokinetics of PUR1900 (Itraconazole Powder) in Healthy Volunteers and Adults With Asthma

Completed·PPulmatrix Inc.·Phase 1·NCT03479411·58 enrolled

Tinea Capitis2 trials

Comparison Between Continuous and Pulse Itraconazole in Tinea Capitis in Children

Recruiting·—·N/A·NCT07184203·120 enrolled

Efficacy Comparison of Itraconazole Pulse Therapy and Terbinafine Therapy in Treatment of Tinea Capitis in Children.

Completed·MMuhammad Aamir Latif·N/A·NCT07068256·164 enrolled

Oral1 trial

Effect of Cytochrome P 450 3A4 Inhibition by Itraconazole on the Single Oral Dose Pharmacokinetics of Cilobradine

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02264041·25 enrolled

Patients With Advanced Solid Tumors1 trial

The Effect of Tesetaxel on the QTc Interval and the Effect of Food, Itraconazole, and Rifampin on Tesetaxel Pharmacokinetics in Patients With Advanced Solid Tumors

Terminated·OOdonate Therapeutics, Inc.·Phase 1·NCT04312282·93 enrolled

Phase 11 trial

A Phase 1 Dose Escalation Study of VX-708 in Healthy Participants

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT05518734·64 enrolled

Small Cell Lung Cancer1 trial

Itraconazole in Non Small Cell Lung Cancer

Unknown status·—·Phase 2·NCT03664115·60 enrolled

Apatinib1 trial

Effect of Itraconazole on the Pharmacokinetics of Apatinib

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT02836171·20 enrolled

Efficacy1 trial

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

Recruiting·UUrooj Fatima·Phase 4·NCT07342153·126 enrolled

Pyrotinib1 trial

Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT04479891·18 enrolled

Recurrence1 trial

Isotretinoin In Preventing Recurrences In Chronic Recurrent Dermatophytosis

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 2·NCT03471455·100 enrolled

Metastatic Prostate Cancer1 trial

A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy

Completed·JJohns Hopkins University·Phase 2·NCT00887458·46 enrolled

HIV infection1 trial

Study of Itraconazole in Patients With Advanced HIV Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·N/A·NCT00002370·36 enrolled

Arsenic Trioxide1 trial

Arsenic Trioxide and Itraconazole in Treating Patients With Advanced Basal Cell Cancer

Withdrawn·JJean Yuh Tang·Phase 1·NCT02699723

Growth1 trial

A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

Completed· Pfizer logo

Pfizer·Phase 1·NCT00585195·596 enrolled

Malignant Tumors1 trial

Study of DS-8201a for Participants With Advanced Solid Malignant Tumors

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT03383692·40 enrolled

SMA1 trial

A Study of the Effects of Itraconazole on the Plasma Levels of Nemtabrutinib (MK-1026-013)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06688045·15 enrolled

Midazolam1 trial

A Phase I Study in Healthy Volunteers to Assess the Effect of Cytochrome3A4 (CYP3A4) Inhibitors (Diltiazem and Itraconazole) on the Pharmacokinetics (PK) of AZD3293 and the Effects of AZD3293 on the Pharmacokinetics of Midazolam, a Cytochrome 3A4 and Cytochrome 3A5 (CYP3A4/CYP3A5) Substrate

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02010970·56 enrolled

Fungal Infection1 trial

A Study of Itraconazole in the Management of Superficial Fungal Infections in India

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT03923010·40 enrolled

NAFLD1 trial

DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.

Completed·GGannex Pharma Co., Ltd.·Phase 1·NCT04845646·24 enrolled

Graft Versus Host Disease1 trial

Evaluation of Antifungal Prophylaxis on Graft-versus-host Disease (GVHD) Patients

Terminated·SSamsung Medical Center·Phase 4·NCT01282879·36 enrolled

Pediatric Cancer1 trial

Pharmacokinetics of Itraconazole in Pediatric Cancer Patients

Completed·SSeoul National University Hospital·Phase 1·NCT01409018·6 enrolled

Cancer1 trial

Topical Itraconazole in Treating Patients With Basal Cell Cancer

Completed·JJean Yuh Tang·Phase 1·NCT02735356·9 enrolled

Unknown status·SShanghai Zhongshan Hospital·N/A·NCT05129033·100 enrolled

Autologous Hematopoietic Stem Cell Transplantation1 trial

Efficacy of Prophylactic Itraconazole in High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation

Completed·SSamsung Medical Center·Phase 4·NCT00336531·100 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Voriconazole Compared With Itraconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Completed·JJonsson Comprehensive Cancer Center·N/A·NCT00079222

Non-Hodgkins Lymphoma1 trial

COPANLISIB (BAY80-6946) Drug-drug Interaction and Cardiovascular Safety Study in Advanced Solid Tumor and Non-Hodgkin's Lymphoma Patients

Completed· Bayer logo

Bayer·Phase 1·NCT02253420·51 enrolled

Fruquintinib1 trial

Fruquintinib CYP3A Inhibitor and Inducer Study

Completed·HHutchison Medipharma Limited·Phase 1·NCT04557397·28 enrolled

Pityriasis Versicolor1 trial

Comparison of Efficacy of Single Oral Dose Fluconazole and Itraconazole in Patients With Pityriasis Versicolor

Completed·—·Phase 1·NCT05862714·164 enrolled

Opioid Use Disorder1 trial

Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2).

Terminated· AstraZeneca logo

AstraZeneca·Phase 1·NCT06406400·15 enrolled

TED1 trial

Mycosis Culture Collection From Dermatological Isolated

Active, not recruiting·UUniversity of Rome Tor Vergata··NCT05482763·200 enrolled

Overlap Syndrome1 trial

Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in CPA-ABPA Overlap Syndrome

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·N/A·NCT05444946·104 enrolled

Treatment1 trial

Comparison of Combination of Itraconazole and Isotretinoin Versus Itraconazole Alone in the Treatment of Resistant Trichophyton Infection

Completed·MMultan Medical And Dental College·N/A·NCT07420894·148 enrolled

Histoplasmosis1 trial

A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000975·30 enrolled

Hepatitis C1 trial

Single and Multiple Dose Study of Uprifosbuvir (MK-3682/IDX21437) in Healthy and Hepatitis C Virus (HCV)-Infected Participants (MK-3682-001)

Completed· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT01974687·178 enrolled

Newly Diagnosed1 trial

Low-dose Venetoclax and Azacitidine as Front-line Therapy in Newly Diagnosed AML

Completed·HHospital Universitario Dr. Jose E. Gonzalez·Phase 2·NCT05048615·15 enrolled

Folliculitis1 trial

Effect of Cold Atmospheric Plasma on Malassezia Folliculitis

Completed·TThe Second Hospital of Anhui Medical University·N/A·NCT04886323·50 enrolled

Dermatophyte Infection1 trial

Comparison of Efficacy of Double Dose Oral Terbinafine Vs Itraconazole in Treatment of Dermatophyte Infections of Skin.

Completed·PPak Emirates Military Hospital·Phase 3·NCT04880980·120 enrolled

Elderly1 trial

A PK Study of IkT-148009 in Older and Elderly Healthy Subjects

Completed·AABLi Therapeutics, Inc.·Phase 1·NCT06644326·8 enrolled

Women1 trial

Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women

Completed· Lundbeck logo

Lundbeck·Phase 1·NCT04405323·16 enrolled

Single Ascending Dose1 trial

Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116

Terminated· Bayer logo

Bayer·Phase 1·NCT03119077·32 enrolled

Statin1 trial

A Study to Assess the Drug Levels of CC-92480 After Coadministration With Rifampin and Itraconazole, and the Drug Levels of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05389722·24 enrolled

Wound Healing1 trial

Assessment of Mechanisms of Improved Wound Healing

Completed·TThe University of Texas Medical Branch, Galveston·Phase 2/3·NCT00673309·644 enrolled

Hematological Malignancy1 trial

A Study Comparing the Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Participants With Hematological Malignancy

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT02895529·61 enrolled

Advanced Solid Tumors1 trial

Effects of Fluconazole and Itraconazole CYP3A-Mediated Inhibition on the Pharmacokinetics, Safety, and Tolerability of MLN4924 in Participants With Advanced Solid Tumors

Completed· Takeda logo

Takeda·Phase 1·NCT02122770·51 enrolled

Adverse Events1 trial

A Study to Assess Adverse Events and How Single and Multiple Ascending Doses of ABBV-903 Move Through the Body in Healthy Adults

Completed· AbbVie logo

AbbVie·Phase 1·NCT05691699·104 enrolled

Unspecified16 trials

A Study in Healthy Men to Test How Itraconazole Influences the Amount of Zongertinib (BI 1810631) in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT05833139·16 enrolled

A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1323495 in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT04011241·14 enrolled

An Open-label, Two-period, Fixed-sequence Study to Evaluate Multiple-dose Itraconazole Effect on The Single-dose PK of PF-06372865 in Healthy Subjects

Withdrawn· Pfizer logo

Pfizer·Phase 1·NCT02475746

Show 13 more trials

Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels

Completed·EEpizyme, Inc.·Phase 1·NCT04537715·42 enrolled

Study of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers

Completed·LLomond Therapeutics Holdings, Inc.·Phase 1·NCT06399315·112 enrolled

A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 706321 in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT04714073·14 enrolled

A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 894416 in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT03722173·14 enrolled

A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1815368 in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT05965583·14 enrolled

A Study to Evaluate the Effect of a Potent Cytochrome P450 (CYP) 3A Inhibitor on Ipatasertib

Completed· Roche logo

Roche·Phase 1·NCT03222310·15 enrolled

A Study in Healthy Men to Test Whether Itraconazole Influences the Amount of BI 1584862 in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06041438·14 enrolled

A Study in Healthy People to Test How Itraconazole Influences the Amount of BI 3031185 in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT07211425·14 enrolled

A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1358894 in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT03843151·16 enrolled

A Pharmacokinetic Study of the Effect of Itraconazole Exposure to Orvepitant in Healthy Volunteers

Completed·NNerre Therapeutics Ltd.·Phase 1·NCT03535662·16 enrolled

A Study in Healthy Male Volunteers to Look at How the Test Medicine GLPG1690 is Taken up by the Body When Doses of Itraconazole and Voriconazole Are Given to Healthy Volunteers

Completed·GGalapagos NV·Phase 1·NCT03515382·18 enrolled

A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers

Completed· BeiGene logo

BeiGene·Phase 1·NCT06543043·30 enrolled

A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT03579719·15 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 11, 1992

SPORANOX

NDA NDA020083

Oct 13, 1992

SPORANOX

NDA NDA020083

Dec 28, 1992

SPORANOX

NDA NDA020083

Jun 9, 1993

SPORANOX

NDA NDA020083

Nov 9, 1993

SPORANOX

NDA NDA020083

Mar 29, 1994

SPORANOX

NDA NDA020083

May 9, 1994

SPORANOX

NDA NDA020083

Oct 12, 1994

SPORANOX

NDA NDA020083

Sep 8, 1995

SPORANOX

NDA NDA020083

Sep 15, 1995

SPORANOX

NDA NDA020083

Mar 22, 1996

SPORANOX

NDA NDA020083

May 23, 1996

SPORANOX

NDA NDA020083

Dec 10, 1996

SPORANOX

NDA NDA020083

Feb 21, 1997

SPORANOX

NDA NDA020657

Aug 6, 1997

SPORANOX

NDA NDA020083

Aug 6, 1997

SPORANOX

NDA NDA020083

Nov 3, 1997

SPORANOX

NDA NDA020083

Jul 27, 1998

SPORANOX

NDA NDA020083

Jul 27, 1998

SPORANOX

NDA NDA020083

Feb 17, 1999

SPORANOX

NDA NDA020083

Mar 30, 1999

SPORANOX

NDA NDA020966

Sep 29, 1999

SPORANOX

NDA NDA020083

Mar 21, 2001

SPORANOX

NDA NDA020083

May 9, 2001

SPORANOX

NDA NDA020083

Feb 27, 2002

SPORANOX

NDA NDA020083

Apr 11, 2002

SPORANOX

NDA NDA020083

Jul 17, 2002

SPORANOX

NDA NDA020083

Jul 17, 2002

SPORANOX

NDA NDA020083

Oct 10, 2002

SPORANOX

NDA NDA020083

Nov 10, 2003

SPORANOX

NDA NDA020083

Jul 14, 2004

SPORANOX

NDA NDA020083

Jul 14, 2004

SPORANOX

NDA NDA020083

Mar 5, 2009

SPORANOX

NDA NDA020083

Mar 5, 2009

SPORANOX

NDA NDA020083

Mar 5, 2009

SPORANOX

NDA NDA020083

Apr 29, 2010

ONMEL

NDA NDA022484

Jul 29, 2010

SPORANOX

NDA NDA020083

Apr 18, 2012

SPORANOX

NDA NDA020083

Apr 18, 2012

SPORANOX

NDA NDA020083

Apr 18, 2012

SPORANOX

NDA NDA020083

Mar 1, 2013

SPORANOX

NDA NDA020083

Jun 5, 2013

SPORANOX

NDA NDA020083

Apr 11, 2014

SPORANOX

NDA NDA020083

Jun 9, 2014

SPORANOX

NDA NDA020083

Jun 13, 2014

SPORANOX

NDA NDA020083

Apr 16, 2015

SPORANOX

NDA NDA020083

Mar 17, 2017

SPORANOX

NDA NDA020083

Oct 7, 2017

SPORANOX

NDA NDA020083

May 8, 2018

SPORANOX

NDA NDA020083

Dec 11, 2018

TOLSURA

NDA NDA208901

Mar 8, 2019

SPORANOX

NDA NDA020083

Dec 5, 2022

SPORANOX

NDA NDA020083

Oct 19, 2023

SPORANOX

NDA NDA020083

Feb 5, 2024

SPORANOX

NDA NDA020083

Oct 25, 2024

SPORANOX

NDA NDA020083

Dec 19, 2024

SPORANOX

NDA NDA020083

Jul 7, 2026

SPORANOX

NDA NDA020083

Sources

References

[1]
ClinicalTrials.gov — 411 trial records for Itraconazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Sporanox drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Itraconazole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Itraconazole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020083). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Sporanox. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Sebela Pharmaceuticals Development LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cytochrome P450 51 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSebela Pharmaceuticals Development LLC

Patent Landscape[6]

Patent Cliff

Oct 3, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8486456Oct 3, 2028

10463740Jun 21, 2033

9713642Jun 21, 2033

10806792Jun 21, 2033

8921374Jun 21, 2033

1 more patents

9272046Jun 21, 2033

Sporanox

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q4 2029

Trials by Indication[1]

Interaction41 trials

Tics23 trials

Adult10 trials

Drug8 trials

ART6 trials

Drug Interactions5 trials

Onychomycosis5 trials

Single Dose4 trials

Female3 trials

Cystic Fibrosis3 trials

Trial3 trials

Prostate Cancer3 trials

Ovarian Cancer3 trials

Esophageal Cancer2 trials

Lymphoma2 trials

Basal Cell Carcinoma2 trials

Adult Subject2 trials

Aspergillosis2 trials

Allergic Bronchopulmonary Aspergillosis2 trials

Candidiasis2 trials

Cryptococcal Meningitis2 trials

CAR2 trials

Asthma2 trials

Tinea Capitis2 trials

Oral1 trial

Patients With Advanced Solid Tumors1 trial

Phase 11 trial

Small Cell Lung Cancer1 trial

Apatinib1 trial

Efficacy1 trial

Pyrotinib1 trial

Recurrence1 trial

Metastatic Prostate Cancer1 trial

HIV infection1 trial

Arsenic Trioxide1 trial

Growth1 trial

Malignant Tumors1 trial

SMA1 trial

Midazolam1 trial

Fungal Infection1 trial

NAFLD1 trial

Graft Versus Host Disease1 trial

Pediatric Cancer1 trial

Cancer1 trial

Allogeneic Stem Cell Transplantation1 trial

Non-squamous NSCLC1 trial

Prospective1 trial

Autologous Hematopoietic Stem Cell Transplantation1 trial

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Non-Hodgkins Lymphoma1 trial

Fruquintinib1 trial

Pityriasis Versicolor1 trial

Opioid Use Disorder1 trial

TED1 trial

Overlap Syndrome1 trial

Treatment1 trial

Histoplasmosis1 trial

Hepatitis C1 trial

Newly Diagnosed1 trial

Folliculitis1 trial

Dermatophyte Infection1 trial

Elderly1 trial

Women1 trial

Single Ascending Dose1 trial

Statin1 trial

Wound Healing1 trial

Hematological Malignancy1 trial

Advanced Solid Tumors1 trial

Adverse Events1 trial

Unspecified16 trials

FDA Approval Timeline[5]