FDA Events for Zentalis Pharmaceuticals (ZNTL)
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. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- 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
- 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
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- 2025-H1
- 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. 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- Drug:
- azenosertib
- Announced Date:
- September 16, 2024
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on studies of azenosertib, the Company's novel, selective, and orally bioavailable inhibitor of WEE1.
AI Summary
Zentalis Pharmaceuticals announced that the FDA has lifted the partial clinical hold on its studies of azenosertib, a novel, selective, and orally available inhibitor of WEE1. This decision allows the company to resume enrollment in all ongoing clinical studies without any changes to its clinical development plan. Zentalis is now working closely with clinical trial investigators to quickly restart study activities across its azenosertib program.
Dr. Kimberly Blackwell, CEO of Zentalis, expressed gratitude for the FDA’s thorough review and collaborative approach, emphasizing that the complete safety assessment was crucial in resolving the hold. The company remains confident in the therapeutic potential of azenosertib, particularly for patients facing gynecologic cancers. Zentalis plans to share updated clinical data on azenosertib later this year, reinforcing its commitment to addressing unmet medical needs in cancer treatment.
Read Announcement- Drug:
- azenosertib
- Announced Date:
- September 9, 2024
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals, Inc. announced that the company will present preclinical data from its selective WEE1 inhibitor azenosertib at the European Society of Medical Oncology (ESMO) 2024 Congress, occurring September 13-17 in Barcelona, Spain.
AI Summary
Zentalis Pharmaceuticals, Inc. announced it will showcase preclinical data at the European Society of Medical Oncology (ESMO) 2024 Congress in Barcelona, Spain, from September 13 to 17. The data focuses on azenosertib, the company’s selective WEE1 inhibitor, and its potential when paired with other cancer therapies.
Preclinical studies have shown that azenosertib, in combination with topoisomerase I inhibitors and antibody-drug conjugates (ADCs), can enhance antitumor effects. In several models, including HER2-positive breast and ovarian cancers, the combination led to significantly improved outcomes, such as complete tumor regression in some cases. These promising results, which will be detailed in Poster #35P by Jianhui Ma on September 15, highlight a potential new therapeutic approach for treating advanced solid tumors.
Read Announcement- Drug:
- azenosertib
- Announced Date:
- June 18, 2024
- Indication:
- Wee1 inhibitor.
Announcement
Zentalis® Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the following studies of azenosertib: the Phase 1 ZN-c3-001 dose-escalation study in solid tumors, the Phase 2 ZN-c3-005 (DENALI) study in platinum-resistant ovarian cancer (PROC) and the Phase 2 ZN-c3-004 (TETON) study in uterine serous carcinoma (USC). This action follows two recent deaths due to presumed sepsis in the DENALI study.
AI Summary
Zentalis® Pharmaceuticals, Inc. announced that the FDA has placed a partial clinical hold on its studies of azenosertib due to two recent deaths from presumed sepsis in the DENALI trial. The halted studies include the Phase 1 ZN-c3-001 dose-escalation study in solid tumors, the Phase 2 DENALI study for platinum-resistant ovarian cancer, and the Phase 2 TETON study for uterine serous carcinoma. Patient safety is a top priority, and the company is working closely with the FDA to resolve the issue quickly. Despite these events, over 500 patients have received azenosertib monotherapy to date, and preliminary data suggest that the treatment demonstrates a favorable therapeutic index, potentially benefiting women with PROC and USC.
The company plans to further present monotherapy data in the second half of 2024, and additional updates on the clinical development timeline will follow once the partial hold is resolved.
Read Announcement
Zentalis Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, Zentalis Pharmaceuticals (ZNTL) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Zentalis Pharmaceuticals (ZNTL) has reported FDA regulatory activity for azenosertib.
The most recent FDA-related event for Zentalis Pharmaceuticals occurred on April 28, 2025, involving azenosertib. The update was categorized as "Dose Update," with the company reporting: "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)."
Currently, Zentalis Pharmaceuticals has one therapy (azenosertib) targeting the following condition: Wee1 inhibitor..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ZNTL) was last updated on 7/10/2025 by MarketBeat.com Staff
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