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

Marketedupdated 5mo 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 Study to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participantsrecruitingn=30
  • phase1A Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participantsrecruitingn=30
  • phase1Phase I Study of QLC5508 in Advanced Solid Tumors: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interactionrecruitingn=48
  • phase1A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021)active not recruitingn=44
  • phase1A Study of RO7890597 in Healthy Adult Volunteersrecruitingn=139
  • phase1A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adultsactive not recruitingn=54
  • phase1A Study of the Effects of Itraconazole on LY4395089 in Healthy Participantscompletedn=14
  • phase1Investigating the Effect of Itraconazole on the Pharmacokinetics of AZD4144 in Healthy Participantsrecruitingn=32

Patent cliff

source: FDA Orange Book
first barrier falls
Oct 3, 2028
~2.0 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 84864562.0y

News(3)

  • Boehringer Ingelheim suspends early study for pill candidate after ‘safety event’
    Not much is known about Boehringer Ingelheim’s drug candidate, dubbed BI 3031185, though the asset has completed at least two other Phase 1 studies this year.
    biospace · 1mo ago
  • Boehringer places phase 1 study of investigational drug on hold to examine ‘safety event’
    Boehringer Ingelheim has suspended a phase 1 trial of an investigational small molecule drug while it seeks to understand a “safety event,” although the German pharma isn't shedding light on the na…
    fiercebiotech · 1mo ago
  • 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 · 2mo 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 11m ago
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