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Placebo matching Niraparib
Placebo matching Niraparib is a PARP inhibitor (reference: niraparib) Small molecule drug developed by Tesaro, Inc.. It is currently in Phase 3 development for Placebo control for ovarian cancer maintenance therapy trials (reference indication for niraparib).
This is a placebo control arm matching the active drug niraparib, a PARP inhibitor that blocks poly(ADP-ribose) polymerase enzymes to prevent DNA repair in cancer cells.
Niraparib is a small molecule inhibitor of the Poly [ADP-ribose] polymerase 2 enzyme. It is being studied in clinical trials for the treatment of ovarian neoplasms malignant, among other conditions, and is also known as MK-4827, MK4827, JNJ-64091742, and NIRAPARIB.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Placebo matching Niraparib |
|---|---|
| Sponsor | Tesaro, Inc. |
| Drug class | PARP inhibitor (reference: niraparib) |
| Target | PARP1/PARP2 (reference target) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
As a placebo, this formulation contains no active pharmaceutical ingredient and serves as a control comparator in clinical trials. The reference drug niraparib is a PARP inhibitor that traps PARP proteins on DNA and prevents homologous recombination repair, leading to synthetic lethality in BRCA-mutant and homologous recombination-deficient tumors.
Approved indications
- Placebo control for ovarian cancer maintenance therapy trials (reference indication for niraparib)
Common side effects
Key clinical trials
- A 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) (PHASE3)
- A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer (PHASE3)
- Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (PHASE3)
- A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer (PHASE3)
- Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease (PHASE3)
- Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo matching Niraparib CI brief — competitive landscape report
- Placebo matching Niraparib updates RSS · CI watch RSS
- Tesaro, Inc. portfolio CI
Frequently asked questions about Placebo matching Niraparib
What is Placebo matching Niraparib?
How does Placebo matching Niraparib work?
What is Placebo matching Niraparib used for?
Who makes Placebo matching Niraparib?
What drug class is Placebo matching Niraparib in?
What development phase is Placebo matching Niraparib in?
What does Placebo matching Niraparib target?
Related
- Drug class: All PARP inhibitor (reference: niraparib) drugs
- Target: All drugs targeting PARP1/PARP2 (reference target)
- Manufacturer: Tesaro, Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Placebo control for ovarian cancer maintenance therapy trials (reference indication for niraparib)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing