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Zejula (niraparib)

GSK · FDA-approved active Quality 69/100

Zejula works by blocking the action of an enzyme called PARP, which helps repair damaged DNA in cancer cells.

At a glance

Generic nameniraparib
SponsorGSK
Drug classPoly(ADP-Ribose) Polymerase Inhibitor
TargetPoly [ADP-ribose] polymerase 2
Therapeutic areaOncology
PhaseFDA-approved
First approval2017
Annual revenue600

Mechanism of action

Niraparib is an inhibitor of PARP enzymes, including PARP-1 and PARP-2, that play role in DNA repair. In vitro studies have shown that niraparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis, and cell death. Increased niraparib-induced cytotoxicity was observed in tumor cell lines with or without deficiencies in BRCA1/2. Niraparib decreased tumor growth in mouse xenograft models of human cancer cell lines with deficiencies in BRCA1/2 and in human patient-derived xenograft tumor models with HRD that had either mutated or wild-type BRCA1/2.

Approved indications

Common side effects

Key clinical trials

Patents

PatentExpiryType

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results
FDA Orange BookPatents + exclusivity
SEC EDGARRevenue + earnings