FDA Events for Onconetix (ONCO)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Onconetix (ONCO).
Over the past two years, Onconetix has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Proclarix. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Proclarix - FDA Regulatory Timeline and Events
Proclarix is a drug developed by Onconetix for the following indication: For prostate cancer diagnosis.
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:
- Proclarix
- Announced Date:
- March 19, 2025
- Indication:
- For prostate cancer diagnosis
Announcement
Onconetix, Inc. announced that an abstract has been accepted for presentation at the 2025 European Association of Urology (EAU) congress taking place March 21-24, 2025, in Madrid, Spain.
AI Summary
Onconetix, Inc. announced that its abstract has been accepted for the 2025 European Association of Urology (EAU) congress in Madrid, Spain, from March 21-24, 2025. The abstract, titled “Clinical Performance of Proclarix in Ruling Out Clinically Insignificant or No Prostate Cancer: Evaluation in a Danish Cohort,” will present data from a study involving over 800 patients at Lillebaelt Hospital in Denmark. The study focuses on the performance of Proclarix, a biomarker-based blood test designed for the early detection of prostate cancer. Results suggest that Proclarix can reliably reduce unnecessary biopsies by effectively ruling out patients who have insignificant or no prostate cancer while still detecting clinically significant cases. This presentation highlights the test’s potential benefits in improving prostate cancer diagnostics and reducing over-treatment, positioning Proclarix as a promising tool in the field of prostate cancer diagnosis.
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Onconetix FDA Events - Frequently Asked Questions
As of now, Onconetix (ONCO) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Onconetix (ONCO) has reported FDA regulatory activity for Proclarix.
The most recent FDA-related event for Onconetix occurred on March 19, 2025, involving Proclarix. The update was categorized as "Abstract Presentation," with the company reporting: "Onconetix, Inc. announced that an abstract has been accepted for presentation at the 2025 European Association of Urology (EAU) congress taking place March 21-24, 2025, in Madrid, Spain."
Currently, Onconetix has one therapy (Proclarix) targeting the following condition: For prostate cancer diagnosis.
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:ONCO) was last updated on 7/13/2025 by MarketBeat.com Staff
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