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  1. pharmadog
  2. ›drugs
  3. ›Krazati
drug · small molecule
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adagrasib

Marketedupdated 5mo ago
by Bristol-Myers Squibb Co🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 2
  • tagApproval12 co-mentions · 3 sources
  • tagSmall Molecule6 co-mentions · 3 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 4 approved and 1 investigational indication.

indications

investigational
NSCLCBreast CancerColorectal Cancer

targets

GTPase KRas

all catalysts(0)

nothing on the calendar yet

Trials studying adagrasib

  • phase3A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)recruitingn=630
  • phase2A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studiesrecruitingn=170
  • phase3Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7recruitingn=626
  • phase3A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Canceractive not recruitingn=338
  • phase1A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutationterminatedn=6
  • phase1KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumorsrecruitingn=300
  • phase2Genetic Testing in Guiding Treatment for Patients With Brain Metastasesactive not recruitingn=50
  • phase1Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mutated Advanced Solid Tumors, With a Focus on Gynecological, Breast, Pancreatic and KEAP1 Mutated Non-small Cell Lung Cancersterminatedn=1

Patent cliff

source: FDA Orange Book
first barrier falls
Dec 12, 2027
~1.2 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)

  • Aug 21, 2043formulationUS 12383503
  • Sep 10, 2041compositionUS 12281113
  • Feb 5, 2041method-of-use (U-3953)US 12336995
  • May 17, 2037compositionUS 10689377

FDA exclusivities (2)

  • Dec 12, 2029ODE-352Orphan Drug (7y)3.2y
  • Dec 12, 2027NCENew Chemical Entity (5y)1.2y

News(6)

  • Krazati withdrawal completed; Wegovy trial meets endpoint for kids ages 6 to 12
    Plus news about Structure Therapeutics, Cloverleaf Bio and Windward Bio. FDA finalizes Krazati withdrawal: Regulators officially finalized the drug’s withdrawal in second-line colorectal cancer las…
    endpoints · 22d ago
  • GSK pens $1.3B Hutchmed deal for early-stage KRAS-EGFR cancer asset
    GSK is handing over $110 million upfront to Hutchmed in a deal worth up to $1.295 billion to get its hands on a first-in-class oncology candidate.
    fiercebiotech · 27d ago
  • Bristol Myers details Krazati confirmatory study failure in colorectal cancer
    While Americans geared up for the July 4 holiday, Bristol Myers Squibb laid out how a confirmatory trial for its drug Krazati failed in colorectal cancer. Patients taking Krazati plus another drug,…
    endpoints · 2mo ago
  • Roche KRAS drug succeeds in head-to-head lung cancer study
    The Phase 3 trial compared Roche’s divarasib with treatments sold by Amgen and Bristol Myers in patients with non-small cell lung cancer.
    biopharma_dive · 3mo ago
  • ‘Unprecedented’ Revolution data point to paradigm shift in pancreatic cancer
    Highly anticipated data presented at ASCO confirmed what’s been heralded as a medical breakthrough against a historically tough-to-treat tumor.
    biopharma_dive · 4mo ago
  • Krazati fails confirmatory trial in colorectal cancer, putting approval at risk
    Bristol Myers Squibb’s cancer drug Krazati has failed its confirmatory study in second-line colorectal cancer, a company spokesperson confirmed to Endpoints News. Krazati had received accelerated a…
    endpoints · 5mo ago
brand
Krazati
trade names
Krazati
generic
adagrasib
MOA
GTPase KRas inhibitor
indication
Non-Small Cell Lung Cancer
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 3h ago
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