FDA Events for OnKure Therapeutics (OKUR)
This section highlights FDA-related milestones and regulatory updates for drugs developed by OnKure Therapeutics (OKUR).
Over the past two years, OnKure Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
OKI-219. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
OKI-219 - FDA Regulatory Timeline and Events
OKI-219 is a drug developed by OnKure Therapeutics for the following indication: For Breast 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:
- OKI-219
- Announced Date:
- December 10, 2024
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- H2 2025
- Indication:
- For Breast Cancer
Announcement
OnKure Therapeutics, Inc. announced that initial data are expected in 2H-2025
AI Summary
OnKure Therapeutics, Inc. recently shared promising early clinical results for its lead drug candidate, OKI-219, which is under evaluation as a mutant-selective inhibitor for cancer. In the initial phase of their ongoing trial, the drug has been well tolerated at all tested doses, with only minor side effects and no treatment interruptions reported. The drug’s exposure levels have even surpassed those linked to strong antitumor activity in preclinical studies.
Building on these encouraging findings, OnKure has now begun Part 1b of the PIKture-01 trial, which will test OKI-219 in combination with fulvestrant in patients with advanced cancers. The company expects to release mature single-agent and early combination data during the second half of 2025, offering further insight into the drug’s potential in oncology treatments.
Read Announcement- Drug:
- OKI-219
- Announced Date:
- December 10, 2024
- Indication:
- For Breast Cancer
Announcement
OnKure Therapeutics, Inc. announced encouraging safety, tolerability, and pharmacokinetic data from the ongoing first-in-human trial of OKI-219, a potential best-in-class, mutant-selective PI3KαH1047R inhibitor.
AI Summary
OnKure Therapeutics, Inc. announced promising early results from its first-in-human study of OKI-219, a potential best-in-class, mutant-selective PI3KαH1047R inhibitor. In the trial, OKI-219 demonstrated a favorable safety and tolerability profile across all dose levels, with no reported dose interruptions, delays, or reductions, and only minor (Grade 1) treatment-related adverse events. The pharmacokinetic data showed that patients reached steady-state exposures that exceed levels associated with strong antitumor activity in preclinical models. These encouraging findings support the progression into Part 1b of the PIKture-01 trial, which will evaluate OKI-219 in combination with fulvestrant in patients with advanced breast cancer. The results indicate that OKI-219 may provide a new, effective treatment option for cancer patients with the PI3KαH1047R mutation.
Read Announcement
OnKure Therapeutics FDA Events - Frequently Asked Questions
As of now, OnKure Therapeutics (OKUR) has not received any FDA approvals for its therapy in the last two years.
In the past two years, OnKure Therapeutics (OKUR) has reported FDA regulatory activity for OKI-219.
The most recent FDA-related event for OnKure Therapeutics occurred on December 10, 2024, involving OKI-219. The update was categorized as "Initial Data," with the company reporting: "OnKure Therapeutics, Inc. announced that initial data are expected in 2H-2025"
Currently, OnKure Therapeutics has one therapy (OKI-219) targeting the following condition: For Breast Cancer.
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:OKUR) was last updated on 7/13/2025 by MarketBeat.com Staff
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