Drugs / RAP-219
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | neuropathy, painful | 2024-11-07 | “In the fourth quarter of 2024, the IND submitted to the FDA for RAP-219 in DPNP was placed on clinical hold” rapportrx.com ↗ “Investigational New Drug Application (IND) in diabetic peripheral neuropathic pain placed on clinical hold” rapportrx.com ↗ “The IND for a Phase 2 proof-of-concept trial of RAP-219 in DPNP is currently on clinical hold with the FDA” rapportrx.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT07219407 | Dec 2025 → Feb 2028 expected | focal epilepsy | Rapport Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07046494 | Jul 2025 → Sep 2026 overdue | bipolar I disorder | Rapport Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT06377930 | Oct 2024 → Sep 2025 | focal epilepsy | Rapport Therapeutics Inc. | Completed | Met primary |
| Phase 32 trials | ||||||
| Phase 3 | NCT07563881 | Jun 2026 → Jul 2029 expected | focal epilepsy | Rapport Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07594119 | Jun 2026 → Jul 2029 expected | focal epilepsy | Rapport Therapeutics Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-04-21 | Rapport Therapeutics Inc. | Results Rapport Therapeutics Presents RAP-219 Focal Onset Seizure Phase 2a Follow-up Period Results Demonstrating Sustained Seizure Reduction at the 2026 American Academy of Neurology Annual Meeting rapportrx.com ↗ |
| 2026-01-07 | Rapport Therapeutics Inc. | Regulatory Rapport Therapeutics Announces Accelerated Initiation of RAP-219 Phase 3 Program, Expansion of Epilepsy Portfolio, and Continued Progress Across the Pipeline rapportrx.com ↗
Additionally, the Company announced progress across its pipeline, including its Phase 2 bipolar mania trial, long-acting injectable development, FDA’s removal of the clinical hold on its Phase 2 diabetic peripheral neuropathic pain (DPNP) trial, and advancement of additional pipeline programs. |
| 2025-12-05 | Rapport Therapeutics Inc. | Results Rapport Therapeutics Announces New Data and Post Hoc Analysis Demonstrating the Magnitude and Consistency of RAP-219’s Clinical Response in Patients with Focal Onset Seizures rapportrx.com ↗ |
| 2025-11-25 | Rapport Therapeutics Inc. | Results Rapport Therapeutics to Present New Phase 2a Data Analysis Further Characterizing RAP-219 in Focal Onset Seizures at 2025 American Epilepsy Society Annual Meeting rapportrx.com ↗ |
| 2025-09-08 | Rapport Therapeutics Inc. | Results Rapport Announces Positive Topline Results from Phase 2a Clinical Trial of RAP-219 in Patients with Focal Onset Seizures rapportrx.com ↗
In the trial, RAP-219 also demonstrated a statistically significant and clinically meaningful reduction in clinical seizures compared with baseline. |
| 2025-01-09 | Rapport Therapeutics Inc. | Results Rapport Therapeutics Announces New Phase 1 Data, Further Supporting RAP-219's Transformative Potential for CNS Disorders rapportrx.com ↗
Data from the trials demonstrated that RAP-219 achieved target receptor occupancy (RO) associated with maximal efficacy in prior preclinical models within five days of dosing while maintaining a differentiated tolerability profile. |
| 2024-12-06 | Rapport Therapeutics Inc. | Results Rapport Therapeutics Presents Data Demonstrating Consistent Association Between Decreases in RNS Measured Long Episodes and Meaningful Reductions in Clinical Seizures rapportrx.com ↗
The analysis demonstrated a linear relationship between changes in long episode (LE) frequency and clinical seizure frequency and identified the benchmark to predict clinically meaningful seizure reduction. |
| 2024-11-07 | Rapport Therapeutics Inc. | Regulatory Rapport Therapeutics Reports Third Quarter Financials and Provides Business Update rapportrx.com ↗
Investigational New Drug Application (IND) in diabetic peripheral neuropathic pain placed on clinical hold while the Company addresses U.S. Food and Drug Administration (FDA) Phase 2a trial protocol feedback |
All press releases naming this drug 12 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RAP-219 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06377930 ↗ |
| Route | Oral | “RAP-219 oral tablet” NCT06377930 ↗ |