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  1. pharmadog
  2. ›drugs
  3. ›Ojemda
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tovorafenib

Marketedupdated 3mo ago
by $DAWN Day One Biopharmaceuticals, Inc.
Approved
community read0 votes

all catalysts(0)

nothing on the calendar yet

Trials studying tovorafenib

  • phase1A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumoursrecruitingn=6
  • phase3DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)active not recruitingn=418
  • phase2Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adultsrecruitingn=57
  • phase2Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG)not yet recruitingn=79
  • phase2Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumorsterminatedn=23
  • phase1Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumorsterminatedn=44
  • phase2A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumorsrecruitingn=141
  • —Expanded Access Program (EAP) for Tovorafenib (DAY101) in RAF-Altered, Relapsed or Refractory Low-Grade Gliomaapproved for marketing
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Apr 23, 2029
~2.7 years out

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

patents (4)

  • Jun 23, 2035formulationUS 10426782
  • Jun 23, 2035formulationUS 10426782
  • Aug 4, 2031compositionUS 82937525.0y
  • Aug 4, 2031compositionUS 82937525.0y

FDA exclusivities (4)

  • Apr 23, 2031ODE-478Orphan Drug (7y)4.7y
  • Apr 23, 2031ODE-478Orphan Drug (7y)4.7y
  • Apr 23, 2029NCENew Chemical Entity (5y)2.7y
  • Apr 23, 2029NCENew Chemical Entity (5y)2.7y

News(1)

  • Servier buys into muscular dystrophy with potentially $2.7B deal
    The French drugmaker has agreed to acquire an experimental tablet from Edgewise Therapeutics that some bullish analysts say could eventually hit peak sales of over $2 billion.
    biopharma_dive · 2mo ago
brand
Ojemda
generic
tovorafenib
indication
Low-Grade Glioma
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 35m ago
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