Wednesday, July 8, 2026

Drug profile · INN

niraparib tosylate

niraparib tosylate (ZEJULA) is a poly [adp-ribose] polymerase 2 inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 8
News articles 0
Drug details — niraparib tosylate
US status
approved
Class
Route
ORAL
Patents
0
Programs
8
Data quality
0.84

Quick answer

niraparib tosylate (ZEJULA) is a poly [adp-ribose] polymerase 2 inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN niraparib tosylate
Brand ZEJULA
Mechanism Poly [ADP-ribose] polymerase 2 inhibitor
Target Poly [ADP-ribose] polymerase 2
Route ORAL
Formulation CAPSULE

Mechanism of action

Poly [ADP-ribose] polymerase 2 inhibitor

Primary target: Poly [ADP-ribose] polymerase 2

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. 64091742PCR3001 Phase 3 · Janssen-Cilag International N.V · Metastatic Prostate Cancer
  2. 67652000PCR3002 Phase 3 · Janssen-Cilag International N.V · Deleterious Germline or Somatic Homologous Recombination Rep
  3. Niraparib tosylate monohydrate + abiraterone... for Prostate Cancer Phase 3 · George Institute for · Prostate Cancer
  4. Niraparib Phase 2 · Chinese Academy of · Ovarian Cancer
  5. Niraparib Phase 2 · Takeda · Efficacy
  6. Niraparib Phase 2 · Takeda · Ovarian Cancer
  7. Niraparib Phase 1 · Takeda · Advanced Solid Tumors
  8. Niraparib Approved · Takeda · Epithelial Ovarian Cancer

Related & competitor drugs

  1. talazoparib tosylate Poly [ADP-ribose] polymerase-1 inhibitor
  2. niraparib Antineoplastic and immunomodulating agents (L01)
  3. talazoparib Antineoplastic and immunomodulating agents (L01)
  4. niraparib tosilate hydrate Poly [ADP-ribose] polymerase 2 inhibitor
  5. talazoparib tosilate Poly [ADP-ribose] polymerase 2 inhibitor
  6. imp4297 Poly [ADP-ribose] polymerase 2 inhibitor

Frequently asked questions

What is niraparib tosylate?

niraparib tosylate (ZEJULA) is a poly [adp-ribose] polymerase 2 inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for niraparib tosylate?

ZEJULA is a marketed brand name for niraparib tosylate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of niraparib tosylate?

niraparib tosylate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.