drug

revumenib citrate

Marketedupdated 3mo ago

by $SNDX Syndax Pharmaceuticals Inc

Approved

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Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for leukemia and 1 investigational indication.

all catalysts(2)

approval · 2

REVUFORJ (REVUMENIB CITRATE) — FDA approval

REVUFORJ (REVUMENIB CITRATE) — FDA approval

revumenib citrate

→

Patent cliff

source: FDA Orange Book

first barrier falls

Nov 15, 2029

~3.2 years out

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

patents (9)

Dec 18, 2042formulationUS 12564590
Dec 18, 2042formulationUS 12564590
Dec 18, 2042formulationUS 12564590
Jun 8, 2037compositionUS 10683302
Jun 8, 2037compositionUS 10683302
Jun 8, 2037compositionUS 10683302
Jun 8, 2037formulationUS 11479557
Jun 8, 2037formulationUS 11479557
Jun 8, 2037formulationUS 11479557

FDA exclusivities (12)

Nov 15, 2031ODE-505Orphan Drug (7y)
Nov 15, 2031ODE-502Orphan Drug (7y)
Nov 15, 2031ODE-504Orphan Drug (7y)
Nov 15, 2031ODE-505Orphan Drug (7y)
Nov 15, 2031ODE-505Orphan Drug (7y)
Nov 15, 2031ODE-502Orphan Drug (7y)
Nov 15, 2031ODE-504Orphan Drug (7y)
Nov 15, 2031ODE-502Orphan Drug (7y)
Nov 15, 2031ODE-504Orphan Drug (7y)
Nov 15, 2029NCENew Chemical Entity (5y)3.2y
Nov 15, 2029NCENew Chemical Entity (5y)3.2y
Nov 15, 2029NCENew Chemical Entity (5y)3.2y

News(0)

no news has mentioned this drug yet

brand

Revuforj

generic

revumenib citrate

MOA

12.1 Mechanism of Action Revumenib is a menin inhibitor that blocks the interaction of both wild-type lysine methyltransferase 2A (KMT2A) and KMT2A fusion proteins with menin. The binding of wild-type KMT2A or KMT2A fusion proteins with menin is involved in NPM1 mutated acute myeloid leukemias and KMT2A - rearranged acute leukemias, respectively, through activation of a leukemogenic transcriptional pathway. Susceptible NPM1 mutations are defined as those that result in loss of the nucleolar localization signal and the insertion of a new nuclear export signal leading to the accumulation of mutant NPM1 in the cytoplasm of AML cells. The most common of such NPM1 mutations in patients with AML are Types A, B, and D. In nonclinical studies using cells that express KMT2A fusions, inhibition of the menin-KMT2A interaction with revumenib altered the transcription of multiple genes including differentiation markers. In nonclinical in vitro and in vivo studies, revumenib demonstrated antiproliferative and antitumor activity in leukemia cells harboring KMT2A fusion proteins. Revumenib also showed antiproliferative activity in vitro in leukemia cells with an NPM1 mutation.

indication

Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia)

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 28m ago

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revumenib citrate

Marketedupdated 3mo ago

by $SNDX Syndax Pharmaceuticals Inc

Approved

community read0 votes

🐶 often sniffed alongside

top 3

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for leukemia and 1 investigational indication.

all catalysts(2)

approval · 2

REVUFORJ (REVUMENIB CITRATE) — FDA approval

REVUFORJ (REVUMENIB CITRATE) — FDA approval

revumenib citrate

→

Patent cliff

source: FDA Orange Book

first barrier falls

Nov 15, 2029

~3.2 years out

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

patents (9)

Dec 18, 2042formulationUS 12564590
Dec 18, 2042formulationUS 12564590
Dec 18, 2042formulationUS 12564590
Jun 8, 2037compositionUS 10683302
Jun 8, 2037compositionUS 10683302
Jun 8, 2037compositionUS 10683302
Jun 8, 2037formulationUS 11479557
Jun 8, 2037formulationUS 11479557
Jun 8, 2037formulationUS 11479557

FDA exclusivities (12)

Nov 15, 2031ODE-505Orphan Drug (7y)
Nov 15, 2031ODE-502Orphan Drug (7y)
Nov 15, 2031ODE-504Orphan Drug (7y)
Nov 15, 2031ODE-505Orphan Drug (7y)
Nov 15, 2031ODE-505Orphan Drug (7y)
Nov 15, 2031ODE-502Orphan Drug (7y)
Nov 15, 2031ODE-504Orphan Drug (7y)
Nov 15, 2031ODE-502Orphan Drug (7y)
Nov 15, 2031ODE-504Orphan Drug (7y)
Nov 15, 2029NCENew Chemical Entity (5y)3.2y
Nov 15, 2029NCENew Chemical Entity (5y)3.2y
Nov 15, 2029NCENew Chemical Entity (5y)3.2y

News(0)

no news has mentioned this drug yet

brand

Revuforj

generic

revumenib citrate

MOA

indication

Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia)

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 28m ago

Found something off?

comments(0)

5-min edit window · permanent after that

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revumenib citrate

🐶 often sniffed alongside

all catalysts(2)

Patent cliff

patents (9)

FDA exclusivities (12)

News(0)

Report a data issue

comments(0)

revumenib citrate

🐶 often sniffed alongside

all catalysts(2)

Patent cliff

patents (9)

FDA exclusivities (12)

News(0)

Report a data issue

comments(0)