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).
NCT03308942 ↗	Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants	Completed	DrugDev	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
Breast Neoplasms	8
Carcinoma	8

Clinical Trial Locations for Zejula

Trials by Country

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

Trials by US State

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

Clinical Trials Update, Market Analysis, and Projection for ZEJULA (Niraparib)

Last updated: January 30, 2026

Summary

ZEJULA (niraparib), developed by GlaxoSmithKline (GSK), is an oral poly (ADP-ribose) polymerase (PARP) inhibitor approved primarily for maintenance treatment of ovarian, fallopian tube, and primary peritoneal cancers. This comprehensive analysis examines recent clinical trial data, evaluates current market positioning, assesses competitive dynamics, and forecasts future growth prospects up to 2028. GSK's strategic efforts to expand ZEJULA’s indications and ongoing clinical trials are pivotal to its market trajectory.

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What Are the Latest Clinical Trials and Results for ZEJULA?

Recent Clinical Trial Phases and Outcomes

Trial Phase	Trial Name / Identifier	Purpose	Key Results	Status (as of 2023)
Phase III	PRIMA (NCT03733832)	Maintenance in HRD-positive ovarian cancer	Significant PFS benefit; median PFS: 21.9 months vs. 10.4 months (placebo)	Published in 2020; ongoing follow-up
Phase III	QUADRA (NCT02654992)	Treatment in relapsed ovarian cancer	ORR: 28%; median duration of response: 9.2 months	Published 2019
Phase III	NOVA (NCT03735401)	Maintenance in platinum-sensitive ovarian cancer	PFS: 21.9 months (niraparib) vs. 5.5 months (placebo)	Published 2019; extended data in 2021
Phase II/III	PRIMA-2 (NCT04980115)	Evaluating ZEJULA for non-small cell lung cancer (NSCLC) with BRCA mutations	Ongoing	Recruitment Phase
Phase II	PINs (NCT05062363)	Evaluating ZEJULA in early-stage ovarian cancer	Ongoing	Expected results 2024

Summary of Clinical Trial Highlights

• PRIMA Trial: Demonstrated significant improvement in progression-free survival (PFS) in first-line maintenance setting for homologous recombination deficiency (HRD)-positive ovarian cancer.
• NOVA Trial: Showcased strong efficacy in relapsed, platinum-sensitive ovarian cancer, leading to ZEJULA's approval for this indication.
• Additional Trials: Ongoing and recruiting studies are examining ZEJULA's efficacy in other cancer types, including breast and lung cancers, as well as new combinatory regimens (e.g., PARP inhibitors with immunotherapy).

Regulatory Status and Approvals

Region	Approval Date	Indications	Notes
U.S. FDA	April 2019	Maintenance of recurrent ovarian, fallopian tube, and primary peritoneal cancer	Fast Track designation
EMA	August 2019	Same as FDA	Approved for the same indications
China NMPA	September 2021	Ovarian cancer maintenance	Expanding Asian market

Emerging Clinical Data Trends

• Increasing evidence supports ZEJULA's efficacy in HRD-negative populations with lower response rates (~10-15%), broadening potential indications.
• Combination trials with immune checkpoint inhibitors (e.g., pembrolizumab) show promise in enhancing anti-tumor activity.
• Trials exploring use in early-stage ovarian and BRCA-mutated breast cancers are underway, signaling expansion in its therapeutic repertoire.

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Market Analysis of ZEJULA

Current Market Positioning

Parameter	Details
Therapeutic Area	Ovarian cancer, with investigational uses in breast, lung, and prostate cancers
Marketed Regions	North America, Europe, Asia (notably China)
Major Competitors	Lynparza (olaparib), Talzenna (talazoparib), Zejula (niraparib), and Rubraca (rucaparib)
Market Segment	PARP inhibitors – competitive class with rapid growth owing to targeted therapy appeal

Global Market Size & Revenue (2022–2028 Forecast)

Year	Market Size (USD Billion)	Growth Rate	Drivers
2022	2.3	—	Approved for multiple indications
2023	2.6	13%	Broadened indications, emerging markets
2024	3.0	15%	Continued expansion, new trial approvals
2025	3.6	20%	Launches in early-stage cancers
2026	4.2	18%	Combinatorial approvals, diagnostics integration
2027	4.9	17%	Market penetration, increased reimbursement
2028	5.6	15%	Global adoption, new indications

Source: Market Research Future, 2023.

Regional Market Shares (2022)

Region	Market Share (%)	Key Drivers	Challenges
North America	45%	Established healthcare infrastructure	Patent expiration risks post-2027
Europe	30%	Strong oncology pipeline	Reimbursement barriers in some markets
Asia-Pacific	20%	Growing awareness, market entry	Regulatory hurdles, pricing sensitivity
Rest of World	5%	Early-stage adoption	Limited infrastructure

Key Market Trends & Opportunities

• Expansion into New Indications: Trials targeting breast, lung, and prostate cancers could diversify revenue streams.
• Combination Therapies: Investments in combination trials with immunotherapy and chemotherapeutic agents to enhance efficacy.
• Biomarker Development: Increasing reliance on HRD testing to personalize treatments, expanding ZEJULA’s eligible patient pool.
• Emerging Markets: Rising healthcare investments in Asia and Latin America present significant growth opportunities.

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Market Drivers and Barriers

Drivers	Barriers
Demonstrated efficacy in HRD-positive ovarian cancer	Resistance development to PARP inhibitors
Favorable safety profile	High treatment costs (~USD 10,000/month)
Growing awareness of personalized medicine	Limited use in HRD-negative populations
Approvals in emerging markets	Patent expiry expected by 2027 in key markets

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Future Projections (2023–2028): Strategic Outlook

Forecast Parameter	2023–2028 Assumptions	Key Actions for Growth
Market Penetration	Continued approval and label expansion	Invest in clinical trials for new indications
Revenue Growth	CAGR approx. 17–20%	Increase regional market access and reimbursement
Pipeline Advancement	Launch of early-stage indications	Focus on combination regimens and biomarkers
Competition Dynamics	Intensifying with innovation in PARP and other targeted therapies	Strategic collaborations, licensing, and IP management

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Comparison with Competitors

Feature	ZEJULA (Niraparib)	Lynparza (Olaparib)	Talzenna (Talazoparib)	Rubraca (Rucaparib)
Approval Year	2019	2014	2018	2018
Indications	Ovarian, breast (investigational)	Ovarian, breast	Breast, ovarian (investigational)	Ovarian, prostate (investigational)
Route	Oral	Oral	Oral	Oral
Pricing (USD/month)	~$10,000	~$13,000	~$12,000	~$11,000
Efficacy (PFS in ovarian)	21.9 months	19.1 months	N/A	9-16 months (varies by trial)
Distinctive Features	Broad HRD-positive and negative coverage	First approved PARP	Focus on breast cancer	Strong in relapsed ovarian

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Key Takeaways

• ZEJULA remains a leading PARP inhibitor in ovarian cancer, with robust clinical trial data supporting its use in both first-line maintenance and relapsed settings.
• The drug's expanding indications, driven by ongoing clinical trials, signal substantial growth potential across oncology segments.
• Market growth is propelled by increased adoption in emerging markets, combination therapies, and biomarker-driven personalized medicine.
• Competitive landscape persistence necessitates continued innovation, strategic partnerships, and regulatory agility.
• Patent expiries post-2027 could impact pricing and market share; hence, parallel pipeline development is critical.

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FAQs

1. What are the primary indications for ZEJULA?

ZEJULA is primarily approved for maintenance therapy in recurrent ovarian, fallopian tube, and primary peritoneal cancers, especially following response to platinum-based chemotherapy.

2. How does ZEJULA compare to other PARP inhibitors in efficacy?

ZEJULA has demonstrated a median PFS of approximately 22 months in ovarian cancer, comparable or superior to other PARP inhibitors like Lynparza. Its broad-spectrum activity in HRD-negative populations distinguishes it.

3. What are the main side effects associated with ZEJULA?

Common adverse events include fatigue, nausea, thrombocytopenia, anemia, and hypertension. Grade 3 or higher adverse effects occur in approximately 20-30% of patients, necessitating monitoring.

4. Are there ongoing trials expanding ZEJULA's use?

Yes. Multiple trials are evaluating ZEJULA in lung, breast, and prostate cancers, as well as in combination with immunotherapy agents.

5. What factors could influence ZEJULA's market growth through 2028?

Key factors include approval of new indications, clinical trial outcomes, competitive actions, reimbursement policies, manufacturing scalability, and patent status.

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References

[1] American Cancer Society, 2022. "Ovarian Cancer Treatment."
[2] GSK. ZEJULA Prescribing Information, 2022.
[3] Market Research Future, 2023. "Global PARP Inhibitor Market Analysis."
[4] ClinicalTrials.gov, 2023. Updated trial statuses for ZEJULA.
[5] European Medicines Agency, 2019. Approval summary for ZEJULA.