drug · small molecule
niraparib
Marketedupdated 3mo agoby $JNJ JOHNSON & JOHNSON🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 3Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for neoplasm and 26 investigational indications.
indications
investigational
NSCLC
targets
Poly [ADP-ribose] polymerase 2Poly [ADP-ribose] polymerase 1
all catalysts(5)
approval · 5
Apr 26, 2023
approval
ZEJULA (NIRAPARIB TOSYLATE) — FDA approval
niraparib
→
Jun 18, 2025
approval
ZEJULA (NIRAPARIB TOSYLATE) — FDA approval
niraparib
→
Jun 18, 2025
approval
ZEJULA (NIRAPARIB TOSYLATE) — FDA approval
niraparib
→
Jul 18, 2025
approval
ZEJULA (NIRAPARIB TOSYLATE) — FDA approval
niraparib
→
Mar 27, 2026
approval
ZEJULA (NIRAPARIB TOSYLATE) — FDA approval
niraparib
→
Trials studying niraparib
- phase3A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
- phase2Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer
- phase1Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)
- phase4Study Evaluating Safety, Tolerability, and Metabolism of Niraparib
- phase3Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer
- phase3A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study
- EP1Niraparib In Recurrent IDH 1/2 Gliomas
- phase1A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
Patent cliff
source: FDA Orange Bookfirst barrier falls
Oct 23, 2026
63 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (31)
- Jan 25, 2039formulationUS 11730725
- Jan 25, 2039formulationUS 11730725
- Jan 25, 2039formulationUS 11730725
- Mar 27, 2038formulationUS 11091459
- Mar 27, 2038formulationUS 11091459
- Mar 27, 2038formulationUS 11091459
- Mar 27, 2038formulationUS 11091459
- Mar 27, 2038formulationUS 11673877
- Mar 27, 2038formulationUS 11673877
- Mar 27, 2038formulationUS 11673877
- Mar 27, 2038formulationUS 11673877
- Aug 4, 2031method-of-use (U-2655)US 88595625.0y
- Aug 4, 2031method-of-use (U-2655)US 88595625.0y
- Aug 4, 2031method-of-use (U-2655)US 88595625.0y
- Aug 4, 2031method-of-use (U-2655)US 88595625.0y
- Mar 27, 2031compositionUS 80716234.6y
- Mar 27, 2031compositionUS 80716234.6y
- Mar 27, 2031compositionUS 80716234.6y
- Mar 27, 2031compositionUS 80716234.6y
- Apr 24, 2029compositionUS 84361852.7y
- Apr 24, 2029compositionUS 84361852.7y
- Apr 24, 2029compositionUS 84361852.7y
- Apr 24, 2029compositionUS 84361852.7y
- Aug 12, 2027method-of-use (U-2655)US 8071579356d
- Aug 12, 2027method-of-use (U-2655)US 8071579356d
- Aug 12, 2027method-of-use (U-2655)US 8071579356d
- Aug 12, 2027method-of-use (U-2655)US 8071579356d
- Aug 12, 2027method-of-use (U-2655)US 8143241356d
- Aug 12, 2027method-of-use (U-2655)US 8143241356d
- Aug 12, 2027method-of-use (U-2655)US 8143241356d
- Aug 12, 2027method-of-use (U-2655)US 8143241356d
FDA exclusivities (2)
- Apr 29, 2027ODE-295Orphan Drug (7y)251d
- Oct 23, 2026ODE-277Orphan Drug (7y)63d
News(5)
- Earnings roundup: Biogen’s ‘resiliency,’ AstraZeneca’s growth pitch and GSK’s oncology pushBetter-than-expected sales helped Biogen regain the support of investors, while AstraZeneca and GSK worked to convince Wall Street that they can hit ambitious revenue targets.biopharma_dive · 22d ago
- GSK lung cancer drug gets speedy approval following $10.6B dealThe clearance is GSK’s first for a lung cancer medicine and the latest step forward in a yearslong push by the British drugmaker into oncology.biopharma_dive · 29d ago
- GSK, Hansoh ADC extends survival in lung cancer studyGSK claimed the result was a first for an ADC aimed at the “B7-H3” protein, an increasingly popular target of late among cancer drugmakers.biopharma_dive · 1mo ago
- GSK boosts cancer pipeline with $11B Nuvalent buyoutThe British drugmaker's third acquisition this year gives it two experimental lung cancer drugs under FDA review that it hopes will support a franchise.biopharma_dive · 2mo ago
- GU Cancer Experts Highlight Top Abstracts to Watch During ASCO 2026We spoke with leading voices in GU oncology to see which presentations they are most looking forward to during the 2026 ASCO Annual Meeting.onclive · 3mo ago
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