Drugs / Pamiparib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | ovarian carcinoma | 2020-07-17 | “The NDA of pamiparib as a potential treatment for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer was accepted in July 2020.” beonemedicines.com ↗ “NMPA has accepted a new drug application (NDA) of BeiGene’s investigational inhibitor of PARP1 and PARP2, pamiparib” beonemedicines.com ↗ “Announced that the NMPA accepted and subsequently granted priority review of an NDA for pamiparib” beonemedicines.com ↗ |
Trials 34
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04614909 | Jan 2021 → Jul 2023 | adult glioblastoma | Nader Sanai | Completed | No outcome recorded |
| Phase 19 trials | ||||||
| Phase 1 | NCT05526924 | Mar 2023 → Jan 2028 expected | head and neck squamous cell carcinoma, pharynx cancer | University of Chicago | Recruiting | No outcome recorded |
| Phase 1 | NCT05573373 | Dec 2022 → Nov 2024 | non-small cell lung carcinoma | Affiliated Hospital of Jiangnan University | Unknown | No outcome recorded |
| Phase 1 | NCT05038839 | Feb 2022 → May 2026 | refractory malignant neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03994211 | May → Oct 2019 | cancer | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT03991494 | May → Oct 2019 | cancer | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT03749187 | Apr 2019 → Jun 2026 overdue | glioblastoma, grade II glioma, grade III glioma | University of California, San Francisco | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03150810 | Jun 2017 → May 2023 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT02660034 | Feb 2016 → Sep 2020 | cancer | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT02361723 | Jul 2014 → Sep 2019 | — | BeiGene | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT05494580 | Sep 2022 → Jun 2024 | fallopian tube carcinosarcoma, ovarian carcinoma, primary peritoneal carcinoma | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 1/2 | NCT03914742 | Feb 2020 → Oct 2023 | glioblastoma, grade II glioma, grade III glioma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 1/2 | NCT03150862 | Jul 2017 → Mar 2021 | brain cancer | BeiGene | Completed | No outcome recorded |
| Phase 1/2 | NCT03333915 | Dec 2016 → Aug 2020 | ovarian cancer, triple-negative breast carcinoma | BeiGene | Completed | No outcome recorded |
| Phase 218 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06692491 | Jan 2025 → Dec 2027 expected | — | Peking University Shenzhen Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06387056 | Apr 2024 → Apr 2026 overdue | metastatic prostate carcinoma | The First Affiliated Hospital of Xiamen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05669768 | Jan 2023 → Jul 2024 | ovarian cancer | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05652283 | Nov 2022 → Mar 2027 expected | ovarian cancer | Bai-Rong Xia | Recruiting | No outcome recorded |
| Phase 2 | NCT05489926 | Aug 2022 → Jun 2024 | malignant epithelial tumor of ovary | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05044871 | Jul 2022 → Feb 2025 | ovarian cancer | Tongji Hospital | Completed | No outcome recorded |
| Phase 2 | NCT05483543 | Jun 2022 → Dec 2024 | small cell lung carcinoma | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT05327621 | May 2022 → Mar 2025 | castration-resistant prostate carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT04796454 | May 2022 → Jul 2026 | — | European Organisation for Research and Treatment of Cancer - EORTC | Withdrawn | No outcome recorded |
| Phase 2 | NCT04985721 | Feb 2022 → Aug 2025 | cancer | Peter MacCallum Cancer Centre, Australia | Unknown | No outcome recorded |
| Phase 2 | NCT05376722 | Feb 2022 → Sep 2023 | — | Hongqian Guo | Unknown | No outcome recorded |
| Phase 2 | NCT04603365 | Oct 2021 → May 2023 | clear cell papillary renal cell carcinoma, collecting duct carcinoma, hereditary leiomyomatosis and renal cell cancer, hereditary papillary renal cell carcinoma +1 | Jonsson Comprehensive Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05406999 | Feb 2020 → Dec 2026 expected | prostate cancer | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | No outcome recorded |
| Phase 2 | NCT03933761 | Jul 2019 → Aug 2021 | carcinosarcoma, ovarian cancer | Australia New Zealand Gynaecological Oncology Group | Withdrawn | No outcome recorded |
| Phase 2 | NCT03712930 | Feb 2019 → Aug 2020 | castration-resistant prostate carcinoma | BeiGene | Terminated | No outcome recorded |
| Phase 2 | NCT03427814 | Jul 2018 → Jun 2020 | gastric cancer | BeiGene | Completed | Missed primary |
| Phase 2 | NCT03575065 | Jun 2018 → Oct 2020 | Her2-receptor negative breast cancer | BeiGene | Completed | Met primary |
| Phase 32 trials | ||||||
| Phase 3 | NCT04164199 | Dec 2019 → May 2026 | cancer | BeOne Medicines | Completed | No outcome recorded |
| Phase 3 | NCT03519230 | May 2018 → Dec 2025 overdue | ovarian cancer | BeiGene | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2021-12-02 | BeOne Medicines | Regulatory BeiGene Announces Inclusion in the China National Reimbursement Drug List (NRDL) of Tislelizumab in Three New Indications, BRUKINSA® (Zanubrutinib) in One New Indication, and the First Listing for Pamiparib beonemedicines.com ↗
BeiGene-discovered medicines in the updated NRDL include: anti-PD-1 antibody tislelizumab in three new indications, including in lung and liver cancers; BTK inhibitor BRUKINSA® (zanubrutinib) in one new indication; and the initial listing for PARP inhibitor pamiparib. |
| 2021-12-02 | BeOne Medicines | Regulatory BeiGene Announces Inclusion in the China National Reimbursement Drug List (NRDL) of Tislelizumab in Three New Indications, BRUKINSA® (Zanubrutinib) in One New Indication, and the First Listing for Pamiparib beonemedicines.com ↗
BeiGene-discovered medicines in the updated NRDL include: anti-PD-1 antibody tislelizumab in three new indications, including in lung and liver cancers; BTK inhibitor BRUKINSA® (zanubrutinib) in one new indication; and the initial listing for PARP inhibitor pamiparib. |
| 2021-06-04 | BeOne Medicines | Results BeiGene Presents Clinical Data from Two Phase 2 Trials of Pamiparib at the 2021 ASCO Annual Meeting beonemedicines.com ↗
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that its PARP inhibitor pamiparib showed efficacy in patients with HER2-negative breast cancer and demonstrated numerically higher but not statistically significant progression-free survival in gastric cancer. |
| 2021-05-07 | BeOne Medicines | Regulatory China NMPA Approves PARP Inhibitor Pamiparib for Patients with Previously Treated Advanced Ovarian Cancer beonemedicines.com ↗
Pamiparib becomes the first PARP inhibitor approved in both platinum-sensitive and platinum-resistant relapsed ovarian cancer in China |
| 2020-09-17 | BeOne Medicines | Results BeiGene Presents Data at ESMO Virtual Congress 2020 on Phase 3 Trial of Tislelizumab in First-Line Non-Squamous Non-Small Cell Lung Cancer and Phase 2 Trial of Pamiparib in Advanced Ovarian Cancer beonemedicines.com ↗ |
| 2020-07-27 | BeOne Medicines | Regulatory Priority Review Granted to BeiGene’s New Drug Application of Pamiparib in Ovarian Cancer in China beonemedicines.com ↗
BEIJING, China and CAMBRIDGE, Mass., July 27, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) of pamiparib, BeiGene’s investigational inhibitor of PARP1 and PARP2, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy. |
| 2020-07-17 | BeOne Medicines | Regulatory BeiGene Announces Acceptance of a New Drug Application of Pamiparib in Ovarian Cancer in China beonemedicines.com ↗
the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a new drug application (NDA) of BeiGene’s investigational inhibitor of PARP1 and PARP2, pamiparib |
| 2019-09-30 | BeOne Medicines | Results BeiGene Announces Clinical Data on Tislelizumab and Pamiparib Presented at the European Society for Medical Oncology (ESMO) Congress 2019 beonemedicines.com ↗
We also presented additional clinical data on pamiparib monotherapy and its combination with low-dose temozolomide and we are looking forward to Phase 3 and pivotal Phase 2 data of pamiparib trials in China next year. |
| 2018-11-16 | BeOne Medicines | Results BeiGene Announces Preliminary Clinical Data on PARP Inhibitor Pamiparib Presented at Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology beonemedicines.com ↗
today announced the presentation of preliminary clinical data from an ongoing Phase 1/2 trial of its investigational PARP inhibitor, pamiparib, in combination with radiation therapy (RT) and/or temozolomide (TMZ) in patients with newly diagnosed or recurrent/refractory (R/R) glioblastoma multiforme (GBM). |
| 2018-10-22 | BeOne Medicines | Results BeiGene Presents Preliminary Clinical Data on PARP Inhibitor Pamiparib in Combination with Low-Dose Temozolomide in Patients with Solid Tumors at European Society for Medical Oncology (ESMO) 2018 Congress beonemedicines.com ↗
Preliminary results demonstrate antitumor activity across a variety of indications and regardless of known BRCA mutation status. |
| 2018-04-16 | BeOne Medicines | Results BeiGene Presents Clinical Data on Pamiparib in Chinese Patients with Ovarian Cancers or Triple-Negative Breast Cancer at the American Association for Cancer Research Annual Meeting beonemedicines.com ↗
In these heavily pre-treated patients with ovarian and breast cancers, the preliminary results support the recommended pamiparib dosing regimen and demonstrated antitumor activity, including partial responses in platinum-resistant or refractory patients with ovarian cancer. |
| 2017-09-08 | BeOne Medicines | Results BeiGene Presents Preliminary Phase 1/2 Clinical Data on PARP Inhibitor BGB-290 in Patients with Advanced Solid Tumors at the European Society for Medical Oncology 2017 Congress beonemedicines.com ↗
BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, today announced preliminary clinical data from an ongoing Phase 1/2 trial of its investigational PARP inhibitor BGB-290 in patients with advanced solid tumors at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain. |
| 2017-06-05 | BeOne Medicines | Results BeiGene Presents Initial Phase 1 Data on Anti-PD-1 Antibody BGB-A317 Combined with PARP Inhibitor BGB-290 at the 2017 American Society for Clinical Oncology Annual Meeting beonemedicines.com ↗
The preliminary data suggest that the combination of BGB-A317 and BGB-290 is generally well-tolerated and shows anti-tumor activity in multiple solid tumors. |
| 2016-08-18 | BeOne Medicines | Regulatory BeiGene Receives Approval to Initiate Clinical Trials in China with PARP Inhibitor BGB-290 beonemedicines.com ↗
BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company focused on developing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that it has received Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct clinical trials in China with BGB-290, a highly potent and selective PARP inhibitor. |
All press releases naming this drug 23 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pamiparib | “Pamiparib (BGB-290) Was Used in EGFR-TkIs Resistant Non-small Cell Lung Cancer” NCT05573373 ↗30“Available drugs include olaparib, fluzoparib, pamiparib, talazoparib ect.” NCT05406999 ↗ “60mg pamiparib (BGB-290) PO BID” NCT03749187 ↗ “pamiparib 60 mg PO bid” NCT06145308 ↗ |
| Known as | BGB-290 | “A Phase 1, Open-label, Parallel-group, Fixed-sequence Study to Investigate the Effect of the CYP3A Inducer Rifampin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics...” NCT03994211 ↗ |
| Action | Inhibit | “pamiparib, an oral PARP 1/2 inhibitor” PMID 31378459 ↗ Aug 2019 |
| Modality | Small molecule | “Pamiparib is a small molecule inhibitor selectivity for both PARP1 and PARP2.” NCT05494580 ↗ |
| Route | Oral | “20, 40, or 60 mg oral pamiparib twice daily” PMID 31378459 ↗ Aug 2019 |
| Target | PARP1 | “excellent selectivity for both PARP1 and PARP2” PMID 32652442 ↗ Jul 2020 |
| Target | PARP2 | “excellent selectivity for both PARP1 and PARP2” PMID 32652442 ↗ Jul 2020 |