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Fluzoparib Monotherapy
Fluzoparib Monotherapy is a PARP inhibitor Small molecule drug developed by Tianjin Medical University Cancer Institute and Hospital. It is currently in Phase 3 development for BRCA-mutated ovarian cancer, BRCA-mutated breast cancer, Homologous recombination deficient tumors.
Fluzoparib is a PARP inhibitor that blocks poly(ADP-ribose) polymerase enzymes, preventing DNA repair and inducing cell death in cancer cells.
Fluzoparib is a small molecule PARP inhibitor used in various clinical trials for conditions such as platinum-sensitive advanced triple-negative breast cancer, ovarian cancer, and esophageal squamous cell carcinoma. It has been studied as a monotherapy in a single-arm phase II study for platinum-sensitive advanced triple-negative breast cancer.
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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 | Fluzoparib Monotherapy |
|---|---|
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Drug class | PARP inhibitor |
| Target | PARP1/PARP2 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
PARP inhibitors like fluzoparib trap PARP proteins on damaged DNA, preventing single-strand break repair and leading to double-strand breaks and apoptosis. This mechanism is particularly effective in tumors with BRCA mutations or homologous recombination deficiency, where alternative DNA repair pathways are compromised. Fluzoparib is being evaluated as monotherapy in various cancer types.
Approved indications
- BRCA-mutated ovarian cancer
- BRCA-mutated breast cancer
- Homologous recombination deficient tumors
Common side effects
- Anemia
- Thrombocytopenia
- Nausea
- Fatigue
- Leukopenia
Key clinical trials
- A Single-Arm Phase Ⅱ Study of Fluzoparib Maintenance in Platinum-sensitive Advanced Triple-Negative Breast Cance (PHASE2)
- Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (PHASE2)
- Fluzoparib+Bevacizumab/Dietary Intervention vs Fluzoparib Monotherapy as First-line Maintenance in HRD+/- Advanced Ovarian Cancer (PHASE3)
- A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients (PHASE2)
- A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer (PHASE2)
- Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer (PHASE2)
- Fluzoparib Neoadjuvant Therapy for Ovarian Cancer (PHASE2)
- A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Advanced Pancreatic Cancer (PHASE1, PHASE2)
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:
- Fluzoparib Monotherapy CI brief — competitive landscape report
- Fluzoparib Monotherapy updates RSS · CI watch RSS
- Tianjin Medical University Cancer Institute and Hospital portfolio CI
Frequently asked questions about Fluzoparib Monotherapy
What is Fluzoparib Monotherapy?
How does Fluzoparib Monotherapy work?
What is Fluzoparib Monotherapy used for?
Who makes Fluzoparib Monotherapy?
What drug class is Fluzoparib Monotherapy in?
What development phase is Fluzoparib Monotherapy in?
What are the side effects of Fluzoparib Monotherapy?
What does Fluzoparib Monotherapy target?
Related
- Drug class: All PARP inhibitor drugs
- Target: All drugs targeting PARP1/PARP2
- Manufacturer: Tianjin Medical University Cancer Institute and Hospital — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for BRCA-mutated ovarian cancer
- Indication: Drugs for BRCA-mutated breast cancer
- Indication: Drugs for Homologous recombination deficient tumors
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing