CLINICAL TRIALS PROFILE FOR ZEJULA

All Clinical Trials for Zejula

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03207347 ↗	A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)	Suspended	GlaxoSmithKline	Phase 2	2018-08-13	This open-label, non-randomized study will investigate the use of niraparib in patients with tumors known to have mutations in BAP1 and other select DNA damage response pathway genes.
NCT03207347 ↗	A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)	Suspended	Tesaro, Inc.	Phase 2	2018-08-13	This open-label, non-randomized study will investigate the use of niraparib in patients with tumors known to have mutations in BAP1 and other select DNA damage response pathway genes.
NCT03207347 ↗	A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)	Suspended	University of Florida	Phase 2	2018-08-13	This open-label, non-randomized study will investigate the use of niraparib in patients with tumors known to have mutations in BAP1 and other select DNA damage response pathway genes.
NCT03221400 ↗	PEN-866 in Patients With Advanced Solid Malignancies	Recruiting	Tarveda Therapeutics	Phase 1/Phase 2	2017-08-29	Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.
NCT03307785 ↗	Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042	Active, not recruiting	Tesaro, Inc.	Phase 1	2017-10-12	Part A: To test the safety and tolerability of combination therapy with Niraparib and TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part B: To test the safety and tolerability of combination therapy with Carboplatin-Paclitaxel and TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part C: To test the safety and tolerability of combination therapy with Niraparib, TSR-042 and Bevacizumab and to establish a safe dose that will be used in a Phase 2 study. Part D: To test the safety and tolerability of combination therapy with Carboplatin-Paclitaxel, TSR-042 and Bevacizumab and to establish a safe dose that will be used in a Phase 2 study. Part E: To test the safety and tolerability of combination therapy with Carboplatin-Pemetrexed and TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part F: To test the safety and tolerability of combination therapy with Carboplatin-Pemetrexed, TSR-022 and TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part G: To test the safety and tolerability of combination therapy with Carboplatin-nab-Paclitaxel, TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part H: To test the safety and tolerability of combination therapy with Carboplatin-nab-Paclitaxel, TSR-022 and TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part I: To test the safety and tolerability of combination therapy with Carboplatin-Paclitaxel, TSR-022 and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
NCT03308942 ↗	Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants	Completed	Covance	Phase 2	2017-09-29	This is a multicenter, open-label, phase 2 study to evaluate the efficacy and safety of niraparib alone and in combination with PD-1 inhibitors in participants with locally advanced and metastatic non-small cell lung cancer (NSCLC). The study will consist of 2 stages. In stage 1, participants from Cohorts 1 and 2 will receive niraparib plus PD-1 inhibitor; pembrolizumab and participants from Cohort 3 will receive niraparib alone. In Stage 2, participants from Cohorts 1A and 2A will receive niraparib plus the PD-1 inhibitor, TSR-042 (Dostarlimab).

Clinical Trial Conditions for Zejula

Condition Name

Condition Name for Zejula
Intervention	Trials
Ovarian Cancer	12
Neoplasms	6
Ovarian Neoplasms	6
Solid Tumor	5

Condition MeSH

Condition MeSH for Zejula
Intervention	Trials
Ovarian Neoplasms	18
Carcinoma, Ovarian Epithelial	16
Carcinoma	8
Breast Neoplasms	8

Clinical Trial Locations for Zejula

Trials by Country

Trials by Country for Zejula
Location	Trials
United States	153
Germany	8
China	8
United Kingdom	8
Italy	7

Trials by US State

Trials by US State for Zejula
Location	Trials
Massachusetts	13
California	12
Florida	10
North Carolina	8
Tennessee	7

Clinical Trial Progress for Zejula

Clinical Trial Phase

Clinical Trial Phase for Zejula
Clinical Trial Phase	Trials
PHASE2	1
Phase 3	4
Phase 2	39

Clinical Trial Status

Clinical Trial Status for Zejula
Clinical Trial Phase	Trials
Recruiting	26
Not yet recruiting	19
Active, not recruiting	8

Clinical Trial Sponsors for Zejula

Sponsor Name

Sponsor Name for Zejula
Sponsor	Trials
GlaxoSmithKline	22
Tesaro, Inc.	21
Massachusetts General Hospital	5

Sponsor Type

Sponsor Type for Zejula
Sponsor	Trials
Other	87
Industry	67
NIH	2

ZEJULA (niraparib): Clinical Trials Update, Market Analysis, and 2025–2030 Projection

Last updated: May 1, 2026

What is ZEJULA’s current clinical development posture?

ZEJULA (niraparib) is a PARP inhibitor with an established label in ovarian cancer and expanded studies in earlier lines and broader oncology settings. Public clinical-trial activity remains concentrated in (1) front-line or maintenance regimens in ovarian cancer and (2) combination trials with immunotherapy, anti-angiogenics, and other targeted agents. The most commercially relevant clinical endpoints for market modeling are: progression-free survival (PFS) in maintenance/first-line settings, overall survival (OS) evidence where available, and durability of benefit in biomarker-defined subgroups (BRCA-mutated and HRD-positive).

Commercially material clinical areas for ZEJULA (as modeled for projection):

• Front-line ovarian cancer maintenance: studies designed to support broader positioning versus earlier PARP use patterns.
• Combination oncology: trials testing niraparib with agents likely to win additional indications by improving response rates and depth.
• Biomarker stratification: trials that explicitly target BRCA-mutated and HRD-positive populations with clear selection rules.

Which trials most impact near-term label and uptake?

Clinical trial updates for ZEJULA affect market trajectory primarily through the likelihood of label expansion and competitive differentiation in maintenance and first-line settings. The following trial categories are the highest-leverage for uptake:

• Confirmatory studies for broadened maintenance use in ovarian cancer (especially earlier lines).
• Combination regimens that can move niraparib into settings where uptake is currently dominated by other PARP inhibitors.
• Real-world deployability influenced by trial eligibility criteria, dosing practicality, and toxicity management profiles (notably thrombocytopenia and neutropenia risk monitoring).

What is the competitive context for niraparib in ovarian cancer?

ZEJULA faces competition from other PARP inhibitors with strong penetration in ovarian cancer maintenance. Competitive pressure is strongest in:

• First-line maintenance where payer adoption follows evidence depth and duration of benefit.
• Biomarker-defined maintenance where differentiation relies on PFS/OS and subgroup consistency.
• Combination strategies where standard-of-care evolves quickly, and the “best-in-class” PARP depends on regimen-level efficacy.

Market modeling inputs used for projection:

• Share-of-prescription dynamics driven by guideline alignment and payer coverage.
• Uptake sensitivity to safety-management requirements (dose interruptions, monitoring burden).
• Evidence cadence: each new or clarified indication has a probability-weighted effect on penetration.

What does the market data say about ZEJULA performance and pricing power?

ZEJULA has a large incumbent footprint across major markets. Revenue trajectories historically depend on:

• Strength of position in maintenance ovarian cancer
• Expansion from BRCA/HRD-defined populations into broader groups
• Competitive substitution dynamics as other PARP inhibitors gain or consolidate positions

Public market-monitoring sources indicate PARP inhibitors as a high-growth oncology category, with ovarian cancer as the core use-case. Niraparib competes within that category and typically grows when it captures new indication coverage or sustains strong guideline and formulary placement.

How big is the PARP inhibitor opportunity relevant to ZEJULA?

PARP inhibitors collectively represent one of the fastest-growing segments in oncology due to expanded maintenance use and growth in earlier-line therapy. Industry reporting consistently frames the PARP inhibitor market as driven by:

• Maintenance therapy in ovarian cancer
• Rapid adoption in HRD/BRCA biomarker settings
• Ongoing expansion of combination regimens

For ZEJULA-specific modeling, the relevant TAM is the subset of PARP-eligible ovarian cancer maintenance and related lines in which niraparib has evidence and guideline fit.

How do we project ZEJULA revenue through 2030?

This projection uses a label-and-uptake framework:

• Base penetration: incumbent maintenance share in ovarian cancer.
• Incremental lift: probability-weighted effects of new indications or regimen approvals.
• Erosion: substitution by competitors where evidence is stronger or where payer preference shifts.

Market projection summary (nominal USD, company-level ZEJULA revenue)

No projection can be made accurately to numeric values without a defined baseline revenue dataset and trial/approval probability map tied to specific geographies and net pricing. Under the operating constraint, no complete and accurate quantified forecast is provided.

What are the key drivers and risks to ZEJULA uptake?

Drivers

• Evidence depth in ovarian cancer maintenance that supports guideline and payer uptake.
• Biomarker strategy clarity (BRCA/HRD) that improves patient selection and outcomes.
• Combination regimens that may expand the treatment window beyond current standard patterns.

Risks

• Loss of share if competitors achieve superior PFS/OS in earlier-line maintenance or broader populations.
• Competition intensification as more PARP-based combinations become standard.
• Safety-management burden that affects real-world adherence and formulary preference.

What monitoring and safety considerations influence market access?

PARP inhibitors have a manageable but consequential safety profile that influences:

• Dose modifications and treatment continuity
• Real-world persistence
• Institutional prescribing habits and prior authorization processes

For ZEJULA, safety monitoring requirements and dose-adjustment protocols shape clinician adoption and payer comfort, particularly in broader first-line use where real-world patient mix increases.

What to watch next in clinical and regulatory timing?

Near-term market impact is most sensitive to:

• Any regulatory label expansions tied to front-line maintenance in ovarian cancer
• Any approvals enabling niraparib combinations that demonstrate regimen-level benefit
• Ongoing evidence updates that strengthen OS or reinforce durability of PFS benefits

Key Takeaways

• ZEJULA’s market trajectory is primarily driven by ovarian cancer maintenance uptake and the probability of label expansion into earlier-line or combination regimens.
• Competitive substitution risk is highest in first-line maintenance, where payer and guideline adoption track regimen-level evidence.
• Clinical updates most likely to move commercial outcomes are those that confirm improved durability (PFS and, where available, OS) and enable broader eligibility.
• A numeric 2025–2030 revenue projection cannot be produced accurately without a complete baseline revenue dataset and a trial-to-approval probability map tied to specific geographies and net pricing.

FAQs

1) What is ZEJULA’s therapy class and core indication area?

ZEJULA (niraparib) is a PARP inhibitor used primarily in ovarian cancer, with commercial focus on maintenance settings.

2) Which clinical outcomes drive payer adoption for niraparib?

PFS durability and subgroup consistency (BRCA-mutated and HRD-positive populations) are the main adoption levers; OS adds incremental value when supported.

3) How does safety monitoring influence uptake?

Safety-management protocols that govern dose interruption and modification affect real-world treatment continuity and payer confidence.

4) What is the biggest competitive threat to ZEJULA?

Other PARP inhibitors with stronger or more consistent evidence in first-line maintenance and broader eligibility windows.

5) What type of new data would most change ZEJULA’s market outlook?

Regulatory-relevant evidence from front-line or combination trials that show regimen-level benefit and translate into label expansions.

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References

[1] FDA. (2017). ZEJULA (niraparib) prescribing information. U.S. Food and Drug Administration.
[2] EMA. (2017). Zejula (niraparib): Summary of Product Characteristics. European Medicines Agency.
[3] National Cancer Institute (NCI). (n.d.). PARP inhibitors in cancer treatment (review pages and evidence summaries).
[4] ClinicalTrials.gov. (n.d.). ZEJULA (niraparib) clinical trials registry entries.