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  1. pharmadog
  2. ›drugs
  3. ›Tolsura
drug · small molecule
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itraconazole

Marketedupdated 3mo ago
by $INTI Inhibitor Therapeutics, Inc.🔗 ChEMBL
Approved
community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 8 approved and 42 investigational indications.

targets

Lanosterol 14-alpha demethylase

all catalysts(0)

nothing on the calendar yet

Trials studying itraconazole

  • phase1A Trial of Lu AH69593 in Healthy Participantsnot yet recruitingn=46
  • phase1A Study in Healthy Men to Find Out How Blocking Certain Transport Proteins Affects the Amount of BI 3000202 in the Bloodnot yet recruitingn=16
  • phase1Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400active not recruitingn=302
  • phase1A Study of LY4515100 in Healthy Participantsrecruitingn=123
  • phase1A Study to Evaluate How Multiple Doses of Itraconazole Interacts With Nacresertib in Healthy Adult Participantsrecruitingn=12
  • phase1A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult Male Participantsterminatedn=22
  • phase1The Study on Effects of CYP3A and P-glycoprotein Inhibitor Itraconazole and CYP Enzyme Inducer Rifampin of HMPL-453 Tartrate Tabletscompletedn=40
  • phase1A Study to Learn if a Medicine Called Itraconazole Changes How the Body Processes the Study Medicine PF-08642534 in Healthy Adults.active not recruitingn=14
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Oct 3, 2028
~2.1 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (6)

  • Jun 21, 2033formulationUS 10463740
  • Jun 21, 2033formulationUS 10806792
  • Jun 21, 2033formulationUS 8921374
  • Jun 21, 2033formulationUS 9272046
  • Jun 21, 2033method-of-use (U-2453)US 9713642
  • Oct 3, 2028formulationUS 84864562.1y

News(1)

  • Opinion: Ten years after WHO recognition, mycetoma remains one of the world’s most neglected diseases
    “The next 10 years of mycetoma care will determine whether it remains a story of neglect or becomes one of collective action,” writes Borna Nyaoke-Anoke.
    stat · 21d ago
brand
Tolsura
trade names
Fungitraxx, Itraconazole, Itraconazole component of suba-, Sporanox, Sporanox i.v., Sporanox-pulse
generic
itraconazole
MOA
Cytochrome P450 51 inhibitor
indication
Gorlin Syndrome (Basal Cell Nevus Syndrome/ Nevoid Basal Cell Carcinoma Syndrome)
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 1m ago
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