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  1. pharmadog
  2. ›drugs
  3. ›Xdemvy
drug
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lotilaner

Marketedupdated 3mo ago
by $TARS Tarsus Pharmaceuticals, Inc.
Approved
community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for nasopharyngeal carcinoma and eye infection and 2 investigational indications.

all catalysts(0)

nothing on the calendar yet

Trials studying lotilaner

  • phase2A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposureactive not recruitingn=722
  • phase2Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE)enrolling by invitationn=155
  • phase4Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearerscompletedn=145
  • phase3Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Studycompletedn=163
  • phase1A Six Week Pharmacokinetic Study of TP-03 in Healthy Subjectscompletedn=24
  • phase2Study of TP-04 in Participants With Papulopustular Rosaceacompletedn=37
  • phase1Study to Evaluate the Food Effect of TP-05 in Healthy Participantscompletedn=42

Patent cliff

source: FDA Orange Book
first barrier falls
Jul 24, 2028
~1.9 years out

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

patents (9)

  • Dec 14, 2038method-of-use (U-3674)US 10835517
  • Dec 14, 2038method-of-use (U-3674)US 11197847
  • Dec 14, 2038method-of-use (U-3674)US 11690826
  • Dec 14, 2038method-of-use (U-3674)US 11690827
  • Dec 14, 2038formulationUS 11752137
  • Dec 14, 2038method-of-use (U-3674)US 12171750
  • Dec 14, 2038formulationUS 12213964
  • Dec 14, 2038formulationUS 12364685
  • Jan 17, 2030compositionUS 83836593.4y

FDA exclusivities (1)

  • Jul 24, 2028NCENew Chemical Entity (5y)1.9y

News(1)

  • Tarsus pays $450M for Alkeus and its phase 3-stage retinal disease drug
    Tarsus Pharmaceuticals is fronting $450 million to acquire Alkeus Pharmaceuticals for its phase 3-stage retinal disease therapy that's being touted as a potential blockbuster.
    fiercebiotech · 9d ago
brand
Xdemvy
generic
lotilaner
indication
Demodex Blepharitis
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 15m ago
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