Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Zejula
ZL-2306 Niraparib） · 1 trial · 1 indication
The ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) (version1.1).
| Arm | Type | Description |
|---|---|---|
| ZL-2306(Niraparib) | EXPERIMENTAL | The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count |
| Name | Type | Description |
|---|---|---|
| ZL-2306(Niraparib） | DRUG | The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count |
Inclusion Criteria: * 1\. Patients must be female and at least 18 years of age * 2\. Patients must provide written informed consent * 3\. Patients must be gBRCA mutation or HRD positive * 4\. Patients must have histologically diagnosed high-grade (Grade 2 or 3)serous epithelial ovarian, fallopian t...
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ZL-2306 (Niraparib) is being studied for the treatment of ovarian cancer. Zai Lab Limited is developing it as a Phase 2 small molecule therapy, and the clinical work has focused on patients with relapsed ovarian cancer. It is an investigational agent in this program rather than an approved product.
ZL-2306 (Niraparib) is being developed by Zai Lab Limited, which trades under the ticker ZLAB. The company is running the ovarian cancer program for this small molecule candidate, including the Phase 2 study conducted in China.
ZL-2306 (Niraparib) is in Phase 2 development for ovarian cancer. The program includes one completed Phase 2 trial, and there are currently no active trials listed for this asset. It is an investigational therapy and has not been established as approved for this use.
The ZL-2306 (Niraparib) program includes the completed Phase 2 trial NCT04392102, titled A Study of Niraparib in Patients With Relapsed Ovarian Cancer. That study enrolled 15 female patients aged 18 years and older in China and was an uncontrolled, non-randomized trial.
Yes, ZL-2306 is the same compound as niraparib. Zai Lab Limited uses ZL-2306 as its designation for niraparib in its ovarian cancer development program, so searches for either name refer to the same small molecule agent.
ZL-2306 (Niraparib) is an investigational therapy in Zai Lab's ovarian cancer program and remains in clinical development at Phase 2. The completed trial NCT04392102 evaluated the agent in relapsed ovarian cancer patients in China, and no approval for this program is reflected in the development record.