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Onureg · pharmadog

pharmadog
drugs
Onureg

drug

patient view →

Onureg

Marketedupdated 2mo ago

by Bristol-Myers Squibb Co

Approved

community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 5 approved and 49 investigational indications.

all catalysts(2)

phase 1 2 initiation · 2

phase 1 2 initiation

National Institutes of Health Clinical Center — azacitidine (Phase I/II Trial Initiation)

phase 1 2 initiation

Institute of Hematology & Blood Diseases Hospital — azacitidine (Phase I/II Trial Initiation)

News(0)

no news has mentioned this drug yet

brand

Onureg

generic

azacitidine

MOA

DNA (cytosine-5)-methyltransferase 1 inhibitor; DNA (cytosine-5)-methyltransferase 3A inhibitor

indication

Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia)

phase

marketed

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Patent cliff

source: FDA Orange Book

first barrier falls

Sep 1, 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 (6)

Jun 3, 2030formulationUS 88466283.9y
Jun 3, 2030formulationUS 88466283.9y
May 14, 2029formulationUS 115714362.9y
May 14, 2029formulationUS 115714362.9y
May 14, 2029method-of-use (U-2950)US 120534822.9y
May 14, 2029method-of-use (U-2950)US 120534822.9y

FDA exclusivities (3)

May 20, 2029ODE-399Orphan Drug (7y)2.9y
Sep 1, 2027ODE-320Orphan Drug (7y)1.2y
Sep 1, 2027ODE-320Orphan Drug (7y)1.2y

Data sources

ClinicalTrials.gov

last refreshed 55m ago

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🐶 often sniffed alongside

top 8

drugazacitidine21 co-mentions · 9 sources
tagApproval12 co-mentions · 3 sources
tagSmall Molecule8 co-mentions · 4 sources
tagAML7 co-mentions · 2 sources
tagOncology3 co-mentions · 2 sources
tagDrug Shortage3 co-mentions · 3 sources
tagPulmonology2 co-mentions · 1 sources
drugivosidenib2 co-mentions · 1 sources

Trials studying Onureg

phase1Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutationsactive not recruitingn=260
phase2Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemiacompletedn=36
phase2Pacritinib With Aza for Upfront Myelodysplastic Syndromenot yet recruitingn=25
phase2Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndromeactive not recruitingn=249
phase1Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemiaactive not recruitingn=17
phase3A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapycompletedn=443
phase4Study to Assess Adverse Events and Change in Disease Activity of Oral Venetoclax in Combination With Subcutaneous (SC) or Intravenous (IV) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Standard Induction Therapy in Indiarecruitingn=100
phase3Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AMLrecruitingn=1,300

more trials →