Itraconazole

Sold as Sporanox, Onmel, Tolsura. Every FDA application for this active ingredient: 6 branded and 14 generic.

As of Nov 15, 2026, FDA lists 20 applications for Itraconazole (sold as Sporanox, Onmel, Tolsura), first approved Sep 11, 1992, with 3 new uses approved and 0 published complete response letters.

First approved: Sep 11, 1992
Applications: 20
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $7.8M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Itraconazole	Part D	$7.1M	+1%	17,327
Tolsura	Part D	$619K	+11%	47
Sporanox	Part D	$83K	-32%	11

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

ITRACONAZOLE 10 MG/ML SOLUTION: $1.10 per MLGeneric · +4% in a year
ITRACONAZOLE 100 MG CAPSULE: $0.849 per unitGeneric · -10% in a year
SPORANOX 100 MG CAPSULE: $28.36 per unitBrand · +3% in a year

Orphan Designations (FDA)

2 designations, 0 approved for the designated use; see all orphan designations

Treatment of coccidioidomycosisMayne Pharma International Pty Ltd. c/o Mayne Pharma Inc. · designated Nov 17, 2020
Treatment of basal cell carcinoma nevus syndrome.Mayne Pharma LLC · designated May 19, 2016

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

ItrizoleA drug with new indications for (1) the treatment of fungal infection, (2) the treatment of febrile neutropenia with suspected fungal infection, and (3) the… · Janssen Pharmaceutical K.K. · Sep 26, 2011

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Itraconazole Capsule	To Be Discontinued	Feb 27, 2026	Feb 27, 2026

Clinical Trials

72 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Comparative Efficacy of Luliconazole and Bifonazole Combined With Itraconazole in DermatophytosisTinea Corporis, Tinea Cruris · University of Faisalabad	Phase 4	Not yet recruiting	Nov 5, 2026
LTG-321 - Itraconazole Drug-drug Interaction (DDI) StudyPK Drug-drug Interaction Study · Latigo Biotherapeutics	Phase 1	Not yet recruiting	Nov 4, 2026
A Study to Assess the Effect of Itraconazole on the Pharmacokinetics of HRS-4642 Following Intravenous Infusion in Healthy ParticipantsPancreatic Cancer · Shanghai Hengrui Pharmaceutical Co., Ltd.	Phase 1	Not yet recruiting	Oct 30, 2026
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, PakistanDermatophytosis, Tinea Corporis · Dr. Amara Safdar	—	Recruiting	Oct 27, 2026
Effect of Itraconazole on the Pharmacokinetics of Intravenous HRS-4642 in Healthy ParticipantsDrug Interactions · The Third Xiangya Hospital of Central South University	Phase 1	Not yet recruiting	Oct 26, 2026
A Study to Evaluate the Effect of Carbamazepine or Itraconazole on Radiprodil in Healthy Adult ParticipantsHealthy Adult Participants · GRIN Therapeutics, Inc.	Phase 1	Active, not recruiting	Oct 21, 2026
A Phase 1 Multiple Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, Drug-Drug Interactions, and Pharmacokinetics of TBD11Healthy Adult Participants · Gates Medical Research Institute	Phase 1	Recruiting	Oct 20, 2026
A Phase I Study of the Interaction of D-2570 With Other Drugs in Healthy AdultsHealthy Subjects · InventisBio Co., Ltd	Phase 1	Not yet recruiting	Oct 15, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 11, 1992	SporanoxNDA 20083 · New molecular entity	Janssen Pharms	52	Marketed
Dec 6, 1996	SporanoxNDA 20694 · TYPE 6	Janssen Pharma	0	Marketed
Feb 21, 1997	SporanoxNDA 20657 · New dosage form	Janssen Pharms	32	Discontinued
Mar 30, 1999	SporanoxNDA 20966 · New dosage form	Janssen Pharms	15	Discontinued
May 28, 2004	ItraconazoleANDA 76104	Sandoz	13	Marketed
Apr 29, 2010	OnmelNDA 22484 · New formulation or manufacturer	Sebela Ireland Ltd	0	Discontinued
Jul 20, 2012	ItraconazoleANDA 200463	Mylan Pharms Inc	6	Discontinued
Oct 30, 2015	ItraconazoleANDA 205573	Amneal Pharms	3	Marketed
May 26, 2016	ItraconazoleANDA 205991	Accord Hlthcare	0	Discontinued
Sep 26, 2016	ItraconazoleANDA 205080	Amneal Pharms	9	Marketed
Dec 13, 2016	ItraconazoleANDA 205724	Rising	7	Marketed
Dec 13, 2016	ItraconazoleANDA 206741	Alembic	10	Marketed
Feb 23, 2017	ItraconazoleANDA 203445	Jubilant Generics	3	Discontinued
Jun 12, 2017	ItraconazoleANDA 208591	Alkem Labs Ltd	7	Marketed
Sep 19, 2017	ItraconazoleANDA 204672	Zydus Pharms	4	Marketed
Aug 24, 2018	ItraconazoleANDA 209460	Torrent	4	Marketed
Dec 11, 2018	TolsuraNDA 208901 · New formulation or manufacturer	Mayne Pharma	1	Marketed
Jul 2, 2019	ItraconazoleANDA 206410	Strides Pharma	0	Discontinued
Aug 2, 2019	ItraconazoleANDA 208481	Apotex	5	Discontinued
Sep 1, 2020	ItraconazoleANDA 212239	Annora Pharma	4	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA