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Details:
Jemperli (dostarlimab) in combination with Zejula (niraparib) is being evaluated in phase 3 ciical trials for the treatment of primary advanced or recurrent endometrial cancer.
Lead Product(s): Dostarlimab,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Jemperli
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2024
Details:
Jemperli (dostarlimab) in combination with Zejula (niraparib) is being evaluated in phase 3 ciical trials for the treatment of primary advanced or recurrent endometrial cancer.
Lead Product(s): Dostarlimab,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Jemperli
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 18, 2023
Details:
JNJ-64091742 (niraparib) is an orally administered, highly selective poly (ADP-ribose) polymerase (PARP) inhibitor that is currently being studied for the treatment of metastatic castrationresistant prostate cancer with BRCA alterations.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: JNJ-64091742
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2023
Details:
GSK101 (IDE705), a small molecule inhibitor of Pol Theta Helicase, in combination with niraparib, the GSK small molecule inhibitor of PARP for the treatment of patients having tumors with BRCA or other homologous recombination mutations.
Lead Product(s): IDE705,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: GSK101
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: GSK
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 21, 2023
Details:
USFDA approves FoundationOne®CDx to be used as a companion diagnostic for AKEEGA (niraparib and abiraterone acetate), the first-and-only dual action tablet, which was approved for deleterious BRCA-mutated metastatic castration-resistant prostate cancer in adults.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Akeega
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 14, 2023
Details:
KEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, for the treatment of adult patients with BRCA-positive mCRPC.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Akeega
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2023
Details:
Successful enrollment completion of a Phase 2 study of Oregovomab, a murine monoclonal antibody against CA 125, in combination with niraparib, GSK's poly (ADP-ribose) polymerase (PARP) inhibitor, for treatment of patients with platinum-sensitive recurrent ovarian cancer.
Lead Product(s): Oregovomab,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: MAb-B43.13
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: GSK
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2023
Details:
ZN-c3 (azenosertib) is a potentially first-in-class and best-in-class small molecule WEE1 inhibitor in development for the treatment of ovarian cancer and uterine serous carcinoma.
Lead Product(s): ZN-C3,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: ZN-c3
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2023
Details:
Akeega is a combination of niraparib, a highly selective poly (ADP ribose) polymerase (PARP) inhibitor and abiraterone acetate, an androgen biosynthesis inhibitor is being studied for adult patients with BRCA1/2 gene mutated metastatic castration resistant prostate cancer.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Akeega
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2023
Details:
JNJ-64091742 is a combination of niraparib, an orally administered, highly selective poly (ADP-ribose) polymerase (PARP) inhibitor and abiraterone acetate, an androgen biosynthesis inhibitor, is currently being studied for the treatment of prostate cancer.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: JNJ-64091742
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2023
Details:
Akeega is a combination of niraparib, a highly selective poly (ADP ribose) polymerase (PARP) inhibitor and abiraterone acetate, an androgen biosynthesis inhibitor is being studied for adult patients with BRCA1/2 gene mutated metastatic castration resistant prostate cancer.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate
Therapeutic Area: Oncology Product Name: Akeega
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2023
Details:
Zejula (niraparib) is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor used for the maintenance treatment of women with platinum-sensitive recurrent ovarian cancer.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2022
Details:
Phase III NOVA trial met primary endpoint of PFS in both gBRCAm and non-gBRCAm cohorts, demonstrating a statistically significant and clinically meaningful treatment effect of Zejula (niraparib) in this patient population, regardless of biomarker status.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2022
Details:
ZEJULA having niraparib, is the only once-daily oral first-line maintenance treatment for women with advanced ovarian cancer after responding to platinum-based chemotherapy.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: DRI Healthcare Trust
Deal Size: $45.0 million Upfront Cash: $35.0 million
Deal Type: Divestment September 12, 2022
Details:
Zejula (niraparib) maintained a durable PFS benefit in the overall population (HR 0.66; 95% CI, (0.56–0.79); p<0.0001).The estimated probability of no progressive disease or death at four years in the overall population was 24% for Zejula vs 14% for placebo, respectively.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2022
Details:
ZEJULA (Niraparib) is indicated as monotherapy for maintenance treatment of adult patients with advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response following completion of first-line platinum-based chemotherapy.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2022
Details:
IDEAYA is collaborating with GSK on IND-enabling studies to support the evaluation of Pol Theta Helicase DC in combination with niraparib, GSK's PARP inhibitor, for patients having tumors with BRCA or other homologous recombination mutations or recombination deficiency.
Lead Product(s): Undisclosed,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: GSK
Deal Size: $960.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration June 28, 2022
Details:
The submission to the European Medicines Agency is based on results from the Phase 3 MAGNITUDE study evaluating niraparib in combination with abiraterone acetate plus prednisone for the treatment of patients with mCRPC who are positive for HRR gene alterations.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Details:
ZN-c3 showed robust clinical activity in an advanced, sicker patient population (57% had prior pembrolizumab/lenvatinib use), specifically demonstrating a deepening of tumor response, which included one patient who achieved an unconfirmed complete response.
Lead Product(s): ZN-C3,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: ZN-c3
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 11, 2022
Details:
ZN-c3 in combination with chemotherapy demonstrated strong anti-tumor activity in a heavily pretreated population, with an ORR of 30.2% across all chemotherapy cohorts, also exhibit a better hematologic and gastrointestinal tolerability profile within Wee1 inhibitor class.
Lead Product(s): ZN-C3,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: ZN-c3
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2022
Details:
PRIME study demonstrates that Zejula (niraparib) treatment had a statistically significant and clinically meaningful improvement in progression-free survival in the overall study population regardless of biomarker status when compared to placebo.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2022
Details:
Zejula (niraparib) is a once-daily oral monotherapy maintenance treatment approved for women with first-line platinum-responsive (complete or partial response) advanced ovarian cancer regardless of biomarker status in the US and the EU.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 15, 2022
Details:
Niraparib is an orally administered, selective poly-ADP ribose polymerase (PARP) inhibitor, that is currently being studied by Janssen for the treatment of patients with prostate cancer.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: JNJ-64091742
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2022
Details:
Niraparib is an orally administered, poly-ADP ribose polymerase inhibitor that is currently studied for the treatment of prostate cancer. ERLEADA (apalutamide), an androgen receptor inhibitor indicated for the treatment of non-metastatic castration-resistant prostate cancer.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2022
Details:
Initial results from Phase 3 MAGNITUDE study of niraparib in combination with abiraterone acetate plus prednisone as a first-line therapy in patients with metastatic castration-resistant prostate cancer featured as an oral presentation.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2022
Details:
IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T-cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia.
Lead Product(s): Gamma Delta T-Cell Therapy,Temozolomide,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: INB-100
Highest Development Status: PreclinicalProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2021
Details:
The launch of the Phase 0 clinical trial with niraparib will begin by enrolling six Arm A participants to determine the Optimal Time Interval (OTI) and the tumor resection that can detect maximum unbound drug concentration in the gadolinium nonenhancing region of the tumor.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: GSK
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 22, 2021
Details:
RP-3500, a potential leading ATR inhibitor demonstrated a manageable safety profile and promising early antitumor efficacy in patients with tumors, and alone or in combination with talazoparib, a PARP inhibitor, in patients with advanced solid tumors.
Lead Product(s): Niraparib Tosylate,Olaparib
Therapeutic Area: Oncology Product Name: RP-3500
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2021
Details:
RP-3500 is a potent and selective oral small molecule inhibitor of ATR being developed for the treatment of solid tumors with specific genome instability related genomic alterations including those in the ATM (ataxia-telangiectasia mutated) gene.
Lead Product(s): Niraparib Tosylate,Olaparib
Therapeutic Area: Oncology Product Name: RP-3500
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2021
Details:
Zai Lab's lead product Zejula (Niraparib) is a highly potent and oral, once-daily small molecule poly (ADP-ribose) polymerase 1/2, or PARP 1/2, inhibitor for treatment across multiple solid tumor types.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: J.P. Morgan Securities LLC
Deal Size: $750.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 19, 2021
Details:
Under the terms of the non-exclusive collaboration, Zentalis is responsible for conducting the study with GSK providing all required doses of niraparib. Zentalis maintains full ownership of ZN-c3.
Lead Product(s): ZN-C3,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: ZN-c3
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Zentalis Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 12, 2021
Details:
Zejula is the first PARP inhibitor approved as monotherapy in the European Union for patients with platinum-responsive advanced ovarian cancer, regardless of biomarker status.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2020
Details:
This patent will provide a term of protection until 2036. It completes the already robust set of patent families protecting AsiDNA™ and its related compounds, alone or in combination.
Lead Product(s): AsiDNA,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: AsiDNA
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
Revocan phase 1b/2 study is designed to evaluate the effect of AsiDNA™, Onxeo’s first-in-class DDR inhibitor, on the acquired resistance to PARP inhibitor (PARPi) niraparib for second line maintenance treatment of relapsed ovarian cancer.
Lead Product(s): AsiDNA,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: AsiDNA
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2020
Details:
ZEJULA (niraparib) is now approved in Canada for the monotherapy maintenance treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2020
Details:
The Company plans to use the net proceeds for R&D efforts in respect to, and commercialization for, its core products which includes lead drug Zejula, fund its ongoing and planned clinical trials and preparation for registration filings of other drug candidates.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: J.P. Morgan Securities
Deal Size: $766.4 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 22, 2020
Details:
The Type II variation application is based on data from the phase 3 PRIMA study (ENGOT-OV26/GOG-3012), which demonstrated a clinically meaningful progression-free survival benefit of Zejula treatment in the first-line maintenance setting.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2020
Details:
ZEJULA was recommended as a monotherapy first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer in the Ovarian Cancer PARP Inhibitor Clinical Guidelines published by Gynecological Oncology, Chinese Medical Association.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2020
Details:
First patients have started treatment in a Phase I study of its investigational antibody-drug conjugate (ADC) [vic-]trastuzumab duocarmazine (SYD985) in combination with niraparib in patients with a HER2-expressing locally advanced or metastatic solid tumor.
Lead Product(s): Trastuzumab duocarmazine,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: SYD985
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2020
Details:
The REVocan study aims to evaluate the abrogation by AsiDNA™ of tumor resistance to a PARP inhibitor in relapsed ovarian cancer.
Lead Product(s): AsiDNA,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 29, 2020
Details:
The NORA study randomized 265 patients at 2:1 to receive ZEJULA or placebo until disease progression. The study meets all primary and secondary endpoints.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 28, 2020
Details:
Preclinical data supports the differentiated ability of AsiDNA™, its first-in-class DNA Damage Response (DDR) inhibitor, to reverse resistance to PARP inhibitors (PARPi) by preventing death-tolerant cells (DTC) regrowth.
Lead Product(s): AsiDNA,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2020
Details:
Presentation showcases data on final analysis of overall survival (OS) from the Phase III ARAMIS trial investigating darolutamide in men with non-metastatic castration-resistant prostate cancer.
Lead Product(s): Radium-223,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2020
Details:
Zejula (niraparib) is the only once-daily PARP inhibitor approved by FDA in first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer regardless of biomarker status.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 03, 2020
Details:
Zejula (niraparib) is the only once daily PARP inhibitor approved in the US as monotherapy treatment for women with advanced ovarian cancer beyond those with BRCAm ovarian cancer in the first-line and recurrent maintenance treatment, as well as late-line treatment settings.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2020
Details:
ZEJULA treatment resulted in a 38% reduction in the risk of disease progression or death in the overall study population when compared to placebo.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2020
Details:
Zejula (niraparib) is an oral, once-daily PARP inhibitor that is currently being evaluated in first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2020
Details:
Submission based on data from the Phase III PRIMA clinical study that demonstrated clinically-meaningful outcomes of niraparib maintenance treatment in the first-line setting.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2020
Details:
Phase 1b study of Niraparib in combination with MGD013 in advanced or metastatic gastric cancer in China.
Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 04, 2020
Details:
The REVOCAN ph 1b/2 study, will evaluate the effect of AsiDNA™ on the acquired resistance to PARP inhibitor niraparib in 2nd line maintenance treatment of relapsed ovarian cancer.
Lead Product(s): AsiDNA,Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 29, 2020
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