This section highlights FDA-related milestones and regulatory updates for drugs developed by Zentalis Pharmaceuticals (ZNTL).
Over the past two years, Zentalis Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
azenosertib and DENALI. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Azenosertib FDA Regulatory Timeline and Events
Azenosertib is a drug developed by Zentalis Pharmaceuticals for the following indication: Wee1 inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- azenosertib
- Announced Date:
- October 18, 2026
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals, Inc. announced that overall survival (OS) data from an interim analysis of the DENALI Part 1b study (GOG-3066) have been published in the abstract for the upcoming rapid oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026.
Read Announcement- Drug:
- azenosertib
- Announced Date:
- May 21, 2026
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals, Inc. announced that data from Part 1 of the Phase 1b MUIR trial will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 29 – June 2, 2026, in Chicago, Illinois.
AI Summary
Zentalis Pharmaceuticals said data from Part 1 of its Phase 1b MUIR trial will be presented at the 2026 ASCO Annual Meeting in Chicago from May 29 to June 2, 2026. The study tested azenosertib, the company’s WEE1 inhibitor, in combination with chemotherapy in patients with platinum-resistant ovarian cancer.
In 46 patients across four dose groups, the trial showed encouraging activity compared with historical paclitaxel alone. In the all-comer group, the overall response rate was about 30% and median progression-free survival was about 4 months. Results were also similar in Cyclin E1-positive and Cyclin E1-negative patients, suggesting the biomarker may not be required for benefit when azenosertib is combined with chemotherapy.
At the 250 mg intermittent dose cohort, the company said the treatment appeared to have a manageable safety profile and a possible favorable balance of benefit and tolerability. The poster will be posted on Zentalis’ website after ASCO.
Read Announcement- Drug:
- azenosertib
- Announced Date:
- May 5, 2026
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals, Inc. nnounced that the first patient has been dosed in the Phase 3 ASPENOVA clinical trial (NCT07546500, GOG-3147, ENGOT-ov109, APGOT-OV27) evaluating azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC).
AI Summary
Zentalis Pharmaceuticals announced that the first patient has been dosed in the Phase 3 ASPENOVA trial (NCT07546500, GOG-3147, ENGOT-ov109, APGOT-OV27). ASPENOVA is a global, randomized, controlled study comparing azenosertib to standard-of-care chemotherapy in patients with Cyclin E1–positive platinum-resistant ovarian cancer (PROC).
The trial is intended as a confirmatory study to support the company’s DENALI Phase 2 accelerated approval pathway, subject to FDA feedback. ASPENOVA aims to provide definitive evidence of azenosertib’s benefit over existing treatments in this hard-to-treat patient group.
The study is being run in collaboration with The GOG Foundation, ENGOT and APGOT, reflecting international support for addressing the unmet needs of PROC patients. Enrollment is underway, marking a key step toward potential regulatory submission if results are positive.
Read Announcement- Drug:
- azenosertib
- Announced Date:
- March 17, 2026
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals, Inc announced two poster presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting, taking place April 17-22, 2026, in San Diego, CA.
AI Summary
Zentalis Pharmaceuticals announced two poster presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting, April 17–22 in San Diego. The company will share preclinical and real‑world data addressing targeted therapy approaches for difficult‑to‑treat cancers, highlighting a WEE1 inhibitor program and clinical patterns in ovarian cancer.
The first poster, “WEE1 Inhibition as a Therapeutic Strategy in Triple‑Negative Breast Cancer: Evaluating Single Agent and Combination Activity of Azenosertib in Preclinical Models” (Abstract 2012), will be presented by Alexandra Levy, MS, on Monday, April 20, 2026, from 2:00 p.m. to 5:00 p.m. PDT. It reports laboratory studies of azenosertib’s activity alone and in combinations against triple‑negative breast cancer models.
The second poster, “Real‑World Treatment Patterns and Outcomes Reveal Distinct Clinical Trajectories of Patients with Cyclin E1‑Positive Ovarian Cancer” (Abstract 1708), will be presented by Jinkil Jeong, PhD, on Sunday, April 19, 2026, from 2:00 p.m. to 5:00 p.m. PDT. This analysis examines treatment patterns and outcomes in patients with cyclin E1‑positive ovarian cancer.
Read Announcement- Drug:
- azenosertib
- Announced Date:
- January 6, 2026
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals, Inc. today provided a corporate update and highlighted key milestones and expected momentum in the azenosertib development program for 2026.
AI Summary
Zentalis Pharmaceuticals provided a 2026 update for azenosertib, its investigational oral WEE1 inhibitor. The company completed enrollment in DENALI Part 2a and expects dose confirmation in the first half of 2026. They plan to start ASPENOVA, a randomized Phase 3 confirmatory trial versus standard chemotherapy, also in the first half of 2026. DENALI Part 2 topline results are expected by year-end 2026 and, if positive, could support an accelerated approval pathway.
Azenosertib is being developed as a targeted, non‑chemo option for Cyclin E1–positive platinum‑resistant ovarian cancer, a group Zentalis estimates comprises roughly 50% of PROC patients. The company reported encouraging earlier DENALI data and a manageable safety profile at the 400 mg 5:2 dose schedule. Zentalis also said it has financial resources expected to provide runway into late 2027 to support these development plans.
Read Announcement- Drug:
- azenosertib
- Announced Date:
- April 28, 2025
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals, Inc. announced that the first patient has been dosed in Part 2 of the Phase 2 DENALI clinical trial (NCT05128825) of azenosertib in patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC).
AI Summary
Zentalis® Pharmaceuticals, Inc. announced a significant milestone in its clinical study for ovarian cancer treatment. The first patient has been dosed in Part 2 of the Phase 2 DENALI clinical trial (NCT05128825), which is testing azenosertib in patients with Cyclin E1+ platinum-resistant ovarian cancer. In close cooperation with the FDA, the trial design allows seamless enrollment into two parts. Part 2a is confirming the primary dose with about 30 patients planned for each of the two dosing levels, while Part 2b will enroll an additional 70 patients at the dose selected based on early results and FDA feedback. Topline data are anticipated by the end of 2026. If successful, the trial may support an accelerated approval, potentially offering a new treatment option for women suffering from this challenging form of ovarian cancer.
Read Announcement- Drug:
- azenosertib
- Announced Date:
- April 28, 2025
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals, Inc. announced that Topline data from DENALI Part 2 anticipated by year end 2026 with the potential to support an accelerated approval, subject to FDA feedback
AI Summary
Zentalis® Pharmaceuticals, Inc. announced that topline data from the Phase 2 DENALI trial is expected by the end of 2026. The results from this study could support accelerated approval of their novel cancer treatment, azenosertib, pending favorable FDA feedback. The DENALI trial, aimed at patients with Cyclin E1+ platinum-resistant ovarian cancer, is designed in two parts. Part 2 will first confirm the most promising dose levels, and then further evaluate safety and effectiveness at the chosen dose. This approach is expected to streamline the study and provide clear insights into the treatment’s potential benefits. If the upcoming data shows positive results, it could lead to faster regulatory approval, making azenosertib available sooner to patients who face limited treatment options for advanced ovarian cancer.
Read Announcement- Drug:
- azenosertib
- Announced Date:
- March 15, 2025
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals, announced updated clinical data from Part 1b of the ongoing DENALI clinical trial of azenosertib in patients with PROC in an oral presentation at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women's Cancer.
AI Summary
Zentalis Pharmaceuticals recently presented updated data from Part 1b of its ongoing DENALI clinical trial at the SGO 2025 Annual Meeting on Women’s Cancer. The study focused on azenosertib in patients with platinum-resistant ovarian cancer, specifically analyzing those with Cyclin E1 overexpression. Updated results showed a median duration of response of 6.3 months and an objective response rate of approximately 35% in response-evaluable patients. These promising findings highlight the potential of azenosertib as a treatment option for this hard-to-treat patient group. The trial used a 400mg dose administered on an intermittent schedule, and the data also supports Cyclin E1 as a useful biomarker to identify patients who may benefit most from this therapy. Encouraged by the results, the company is on track to initiate Part 2 of the trial in early 2025, with topline data anticipated by the end of 2026.
Read Announcement- Drug:
- azenosertib
- Announced Date:
- March 3, 2025
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals announced multiple presentations, including an oral presentation with updated clinical data from the ongoing Phase 2 DENALI clinical trial of azenosertib in patients with platinum-resistant ovarian cancer (PROC), at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women's Cancer, to be held on March 14-17 in Seattle, Washington.,
AI Summary
Zentalis® Pharmaceuticals announced that it will present updated clinical data from its ongoing Phase 2 DENALI clinical trial of azenosertib in patients with platinum-resistant ovarian cancer (PROC) at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women’s Cancer in Seattle, Washington, from March 14–17, 2025. Dr. Fiona Simpkins will deliver an oral presentation on March 15 at 8:25 am PST, discussing how Cyclin E1 can serve as a predictive biomarker for azenosertib benefit in PROC patients, based on outcomes from Part 1b of the DENALI Study.
Additionally, the company will share preclinical evidence of azenosertib’s enhanced antitumor effects when combined with microtubule inhibitor-based antibody drug conjugates. This session further highlights the potential of azenosertib as a promising treatment option for patients with platinum-resistant ovarian cancer.
Read Announcement- Drug:
- azenosertib
- Announced Date:
- January 29, 2025
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals, Inc. announced that Company aligned with FDA on seamless study design for DENALI Part 2 in patients with Cyclin E1+ PROC; study expected to begin 1H 2025
AI Summary
Zentalis Pharmaceuticals announced that it has aligned with the FDA on a seamless design for its upcoming DENALI Part 2 study in patients with Cyclin E1+ platinum‐resistant ovarian cancer. This next phase of the trial is structured in two parts: Part 2a aims to confirm the key dose-of-interest using two dosing levels (400mg QD 5:2 and 300mg QD 5:2) with approximately 30 patients at each level. Part 2b will then enroll around 70 patients at the dose selected based on Part 2a’s outcomes, with final endpoints subject to further FDA guidance.
The study is expected to start enrolling patients in the first half of 2025, and topline data is anticipated by the end of 2026. If the trial successfully demonstrates clear efficacy and safety, it could potentially support an accelerated approval, offering a new treatment option for this challenging patient population.
Read Announcement- Drug:
- azenosertib
- Announced Date:
- January 29, 2025
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals, Inc. today presented updated azenosertib monotherapy clinical data from its ZN-c3-001, MAMMOTH and DENALI studies and shared details on future clinical development and potential registration plans for patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC).
AI Summary
Zentalis® Pharmaceuticals presented updated clinical data for its azenosertib monotherapy from the ZN-c3-001, MAMMOTH, and DENALI studies. The data shows promising results for patients with Cyclin E1+ platinum-resistant ovarian cancer, reporting an objective response rate of about 35% and a median duration of response of roughly 5.5 months. These encouraging findings support the potential of azenosertib as a treatment option for a patient population with significant unmet needs.
The company also shared its future clinical development plans, including details on the DENALI Part 2 study. This new study, which has been aligned with the FDA for a seamless design, will begin enrolling patients in the first half of 2025. Topline data from this registration-intent trial is expected by the end of 2026, and if successful, the study may support an accelerated approval pathway.
Read Announcement- Drug:
- azenosertib
- Announced Date:
- January 29, 2025
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals, Inc. announced that Topline data from registration-intent DENALI Part 2 anticipated by year end 2026
AI Summary
Zentalis Pharmaceuticals announced that it has aligned with the FDA on the seamless design for its DENALI Part 2 study, which targets patients with Cyclin E1+ platinum-resistant ovarian cancer. The trial is divided into two parts: Part 2a will help confirm the optimal dose, and Part 2b will enroll additional patients based on those results. The company plans to start enrollment in the first half of 2025. Topline data from this registration-intent trial is anticipated by the end of 2026. If the study meets its endpoints, the results could support accelerated approval for the therapy. This new approach marks an important step toward offering patients with this difficult-to-treat form of ovarian cancer a promising treatment option, addressing a critical unmet need in this patient population.
Read Announcement- Drug:
- azenosertib
- Announced Date:
- January 9, 2025
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals, Inc announced that the FDA has granted Fast Track Designation to azenosertib for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (PROC) who are positive via Cyclin E1 immunohistochemistry for protein levels.
AI Summary
Zentalis® Pharmaceuticals has received Fast Track Designation from the FDA for its investigational drug azenosertib. This designation targets patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who show high levels of Cyclin E1 protein via immunohistochemistry. The Fast Track status is designed to speed up the development and review process for treatments that address serious conditions and unmet medical needs.
This decision highlights the urgent need for more effective treatments in this patient population, as these cancers have historically been difficult to treat with standard chemotherapy. Zentalis believes that azenosertib, which works by inhibiting WEE1 to disrupt cancer cell cycles, could offer a new therapeutic option for these patients. The company continues to advance clinical studies that may lead to quicker access to this targeted therapy for individuals with Cyclin E1 positive cancers.
Read Announcement
DENALI FDA Regulatory Events
DENALI is a drug developed by Zentalis Pharmaceuticals for the following indication: in patients with platinum-resistant ovarian cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DENALI
- Announced Date:
- October 18, 2026
- Indication:
- in patients with platinum-resistant ovarian cancer
Announcement
Zentalis® Pharmaceuticals, Inc. announced that overall survival (OS) data from an interim analysis of the DENALI Part 1b study (GOG-3066) have been published in the abstract for the upcoming rapid oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026.
Read Announcement
