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  1. pharmadog
  2. ›drugs
  3. ›Komzifti
drug · small molecule
save

ziftomenib

Marketedupdated 5mo ago
by $KURA Kura Oncology, Inc.🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 2
  • tagApproval4 co-mentions · 1 sources
  • tagSmall Molecule2 co-mentions · 1 sources

Small molecule drug with a maximum clinical stage of Phase 1 2 (across all indications), with 2 investigational indications.

all catalysts(0)

nothing on the calendar yet

Trials studying ziftomenib

  • phase3Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AMLrecruitingn=1,300
  • phase2First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemiarecruitingn=263
  • phase2TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia IIrecruitingn=90
  • phase1Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemiarecruitingn=171
  • phase1A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AMLrecruitingn=420
  • phase2Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard Therapynot yet recruitingn=70
  • phase1A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)recruitingn=157
  • phase1A Phase I Study Investigating the Combination of the Ziftomenib, Venetoclax and Azacitidine in Pediatric Relapsed and Refractory Acute Leukemiasrecruitingn=22

Patent cliff

source: FDA Orange Book
first barrier falls
Nov 13, 2030
~4.1 years out

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

patents (8)

  • Jul 16, 2044compositionUS 12410184
  • Jul 16, 2044formulationUS 12521396
  • Sep 6, 2038method-of-use (U-4349)US 11944627
  • Mar 15, 2037compositionUS 10781218
  • Mar 15, 2037method-of-use (U-4351)US 11673898
  • Jan 26, 2037method-of-use (U-4353)US 10869868
  • Mar 16, 2036compositionUS 10077271
  • Mar 16, 2036method-of-use (U-4354)US 10174041

FDA exclusivities (1)

  • Nov 13, 2030NCENew Chemical Entity (5y)4.1y

News(3)

  • Kura spins diabetes work into a Lilly-backed biotech startup
    Caspian Therapeutics aims to develop menin inhibitors, which have proven effective against leukemia, for diabetes and other cardiometabolic conditions.
    biopharma_dive · 24d ago
  • Kura Oncology spins out diabetes pipeline with $50M and Lilly's help
    Kura Oncology, the maker of the menin inhibitor Komzifti, is spinning out its diabetes R&D to a new company that has attracted the attention of the leading pharma in the metabolic field. ...
    endpoints · 24d ago
  • Kura creates Lilly-backed spinout armed with $50M to advance next-gen diabetes therapy
    Kura Oncology has spun out a biotech armed with $50 million in fresh funding to take forward a next-generation diabetes treatment.
    fiercebiotech · 24d ago
brand
Komzifti
generic
ziftomenib
indication
Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia)
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 2h ago
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