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  2. ›drugs
  3. ›Fyarro
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sirolimus albumin-bound

Marketedupdated 3mo ago
by Kaken Pharmaceutical Co Ltd
Approved
community read0 votes

🐶 often sniffed alongside

top 3
  • drugsirolimus18 co-mentions · 6 sources
  • tagAdCom10 co-mentions · 6 sources
  • tagPMA Approval10 co-mentions · 6 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 19 approved and 113 investigational indications.

all catalysts(0)

nothing on the calendar yet

Trials studying sirolimus albumin-bound

  • N/AMOTIV BTK Randomized Controlled Trialactive not recruitingn=292
  • phase1131I-apamistamab-based Conditioning for Hematopoietic Stem Cell Transplant (HSCT) in Advanced Sickle Cell Disease (SCD)recruitingn=24
  • N/ASafety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesionsrecruitingn=150
  • phase2TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancerrecruitingn=4,200
  • phase3Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumorsrecruitingn=298
  • —S-FLEX Netherlands Registry: Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent Systemrecruitingn=10,000
  • phase4Study to Evaluate the Safety and Effectiveness of ELEVIDYS in Participants With Duchenne Muscular Dystrophy Treated in a Post-Marketing Settingnot yet recruitingn=20
  • N/ANon-inferiority Clinical Trial to Compare the Safety and Performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System Versus Contemporary DES Platforms in Patients With de Novo Coronary Artery Lesionswithdrawn
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Nov 22, 2028
~2.3 years out

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

patents (7)

  • Oct 28, 2040formulationUS 11497737
  • Jun 29, 2036method-of-use (U-3258)US 10973806
  • Jun 29, 2036method-of-use (U-4042)US 12133844
  • Mar 5, 2036formulationUS 10705070
  • Mar 5, 2036formulationUS 12061183
  • Apr 15, 2030formulationUS 102068873.7y
  • Feb 14, 2029formulationUS 89117862.6y

FDA exclusivities (2)

  • Mar 22, 2029ODE-391Orphan Drug (7y)2.7y
  • Nov 22, 2028ODE-386Orphan Drug (7y)2.3y

News(0)

no news has mentioned this drug yet

brand
Fyarro
generic
sirolimus
MOA
FK506-binding protein 1A inhibitor
indication
Mesenchymal Tumor
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 2h ago
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