Drugs / Azenosertib

Trials 17

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT05368506 Jul 2023 → Sep 2024 fallopian tube carcinoma, female breast carcinoma, ovarian carcinoma, primary peritoneal carcinoma +1 OHSU Knight Cancer Institute Withdrawn No outcome recorded
Phase 0 NCT04005690 Aug 2019 → Jun 2027 expected pancreatic ductal adenocarcinoma OHSU Knight Cancer Institute Recruiting No outcome recorded
Phase 18 trials
Phase 1 NCT06364410 Feb 2025 → Jul 2027 expected gastric carcinoma, gastroesophageal junction adenocarcinoma, metastatic malignant neoplasm National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 1 NCT06351332 May 2024 → Feb 2026 female breast carcinoma, triple-negative breast carcinoma Filipa Lynce, MD Terminated No outcome recorded
Phase 1 NCT05743036 Feb 2023 → Jul 2024 colorectal cancer K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Terminated No outcome recorded
Phase 1 NCT05431582 Dec 2022 breast cancer, lung cancer, malignant pancreatic neoplasm, ovarian cancer M.D. Anderson Cancer Center Withdrawn No outcome recorded Stop: Enrollment
Phase 1 NCT04833582 Aug 2021 → Aug 2023 osteosarcoma K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT04972422 Jul 2021 → Jun 2022 cancer Zentera Therapeutics HK Limited Unknown No outcome recorded
Phase 1 NCT04516447 Oct 2020 → Jun 2028 expected fallopian tube cancer, malignant epithelial tumor of ovary, peritoneum cancer K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Recruiting No outcome recorded
Phase 1 NCT04158336 Nov 2019 → May 2025 cancer K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT05682170 Dec 2022 → Jul 2024 acute myeloid leukemia Zentalis Pharmaceuticals, Inc. Terminated No outcome recorded Stop: Business
Phase 1/2 NCT05198804 Jan 2022 → Oct 2025 fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Completed No outcome recorded
Phase 24 trials
Phase 2 NCT06369155 Mar 2025 → Jan 2027 expected endometrial serous adenocarcinoma Joyce Liu, MD Recruiting No outcome recorded
Phase 2 NCT06015659 Nov 2023 → Aug 2025 overdue pancreatic ductal adenocarcinoma Brandon Huffman, MD Active not recruiting No outcome recorded
Phase 2 NCT05128825 Feb 2022 → Dec 2026 expected serous adenocarcinoma K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Recruiting No outcome recorded
Phase 2 NCT04814108 Jul 2021 → Oct 2025 uterine cancer K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Completed No outcome recorded
Phase 31 trial
Phase 3 NCT07546500 Apr 2026 → May 2028 expected ovarian cancer K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 16

DateIssuerRelease
2026-05-21 K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Results Zentalis Pharmaceuticals to Present Phase 1b MUIR Trial Data Showing Encouraging Clinical Activity and Manageable Safety Profile of Azenosertib Plus Paclitaxel in Platinum-Resistant Ovarian Cancer at ASCO 2026 zentalis.com ↗
Activity of the combined regimen across all dose cohorts achieved 39% ORR and 7.3-month median PFS
2026-04-17 K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Results Zentalis Pharmaceuticals To Present Azenosertib Preclinical Data in Triple-Negative Breast Cancer and Real-World Analysis of Unmet Need in Cyclin E1-Positive Ovarian Cancer at AACR 2026 zentalis.com ↗
The data show encouraging preclinical activity of azenosertib in triple-negative breast cancer (TNBC) and highlight the poor prognosis of Cyclin E1-positive ovarian cancer patients with currently available treatments in a real-world data analysis.
2026-04-09 K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Results Zentalis Pharmaceuticals Announces 400mg QD 5:2 Azenosertib Monotherapy as the Pivotal Study Dose in Cyclin E1-Positive Platinum-Resistant Ovarian Cancer zentalis.com ↗
Planned interim analysis from DENALI Part 2a showed a clearly differentiated response rate at 400mg QD 5:2 over 300mg QD 5:2 and comparable safety profiles between the two dose groups
2025-03-15 K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Results Zentalis Pharmaceuticals Presents Updated Clinical Data At The Society Of Gynecologic Oncology 2025 Annual Meeting On Women’s Cancer zentalis.com ↗
In the intent-to-treat patients with Cyclin E1+ PROC (patients who received at least one dose of azenosertib), the ORR was 31.3% (15/48; 95% CI: 18.7 - 46.3), and an mDOR of 6.3 months (95% CI: 2.7 – not estimable).
2025-01-29 K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Results Zentalis Pharmaceuticals Shares Updated Clinical Data Demonstrating Meaningful Azenosertib Activity In Cyclin E1+, Platinum-Resistant Ovarian Cancer zentalis.com ↗
2025-01-09 K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Regulatory Zentalis Pharmaceuticals Announces Azenosertib Fast Track Designation And Virtual Corporate Event To Present Updated Data From Azenosertib Clinical Studies zentalis.com ↗
2024-09-16 K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Regulatory Zentalis Pharmaceuticals Announces Fda Has Lifted Partial Clinical Hold On Azenosertib Studies zentalis.com ↗
The FDA has cleared the Company to resume enrollment in all ongoing azenosertib clinical studies with no changes in the clinical development plan.
2024-09-09 K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Results Zentalis Pharmaceuticals To Present Preclinical Azenosertib Data At ESMO 2024 zentalis.com ↗
Data in the abstract showed that the combination of azenosertib with TOP1 inhibitors demonstrated significant synergistic effects in all cell lines tested.
2024-06-18 K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Regulatory Zentalis Pharmaceuticals Provides Update On Azenosertib Clinical Development Program zentalis.com ↗
2024-05-23 K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Results Zentalis Pharmaceuticals To Present Promising Results From Phase 1 Trial Of Azenosertib And Gemcitabine In Relapsed Or Refractory Osteosarcoma At 2024 American Society Of Clinical Oncology Annual Meeting zentalis.com ↗
today announced the presentation of final results from a Phase 1 trial of azenosertib and gemcitabine in relapsed or refractory (R/R) osteosarcoma at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
2024-04-02 K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Results Zentalis Pharmaceuticals To Highlight Preclinical Data Demonstrating That Wee1 Inhibitor Azenosertib Exerts Synergistic Anti-Tumor Activity With Kras(G12C) Inhibitors At AACR Annual Meeting 2024 zentalis.com ↗
Research demonstrated that the Company’s WEE1 inhibitor, azenosertib, exerts synergistic anti-tumor activity when combined with KRAS G12C inhibitors.
2023-11-06 K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Results Zentalis Pharmaceuticals Reports Third Quarter 2023 Financial Results And Operational Updates zentalis.com ↗
Updated data from azenosertib monotherapy study with longer follow up shows 37% ORR and mPFS of 6.5 months in heavily pretreated ovarian and uterine serous carcinoma patients

All press releases naming this drug 32 releases

DateIssuerRelease

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

FieldValueCited text
Known as Azenosertib ClinicalTrials.gov intervention name — accepted as the source's own label NCT04814108 ↗
10

NCT04833582 ↗

NCT07546500 ↗

NCT04158336 ↗

NCT06351332 ↗

NCT06369155 ↗

NCT05128825 ↗

NCT04005690 ↗

NCT06364410 ↗

NCT05198804 ↗

NCT04516447 ↗

Known as KP-2638 “This is a Phase 2 open-label, multicenter study to evaluate the clinical activity and safety of ZN-c3 (also known as azenosertib; KP-2638) in adult women with recurrent or...” NCT04814108 ↗
Known as ZN-c3 “ZN-c3 (a small molecule inhibitor of the WEE1 tyrosine kinase)” NCT06015659 ↗
5

NCT04972422 ↗

NCT05743036 ↗

NCT05368506 ↗

NCT05431582 ↗

NCT05682170 ↗

Action Inhibit “inhibitor of WEE1” NCT05128825 ↗
Modality Small molecule “a small molecule inhibitor of the WEE1 tyrosine kinase” NCT06015659 ↗
1

CHEMBL5095036 ↗

Route Oral “Azenosertib (ZN-c3) taken orally with food” NCT04814108 ↗
Target WEE1 “inhibitor of WEE1” NCT05128825 ↗