This section highlights FDA-related milestones and regulatory updates for drugs developed by Rapport Therapeutics (RAPP).
Over the past two years, Rapport Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
RAP-219 and RTX-1738. 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.
RAP-219 FDA Regulatory Timeline and Events
RAP-219 is a drug developed by Rapport Therapeutics for the following indication: For CNS Disorders.
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:
- RAP-219
- Announced Date:
- September 8, 2025
- Indication:
- For CNS Disorders
Announcement
Rapport Therapeutics, Inc announced that the Phase 2a clinical trial of RAP-219 (RAP-219-FOS-201) in patients with drug-resistant focal onset seizures met its primary endpoint, demonstrating a statistically significant reduction in long episodes (LEs) – an objective electrographic biomarker for clinical seizure reduction – compared with baseline over the 8-week treatment period. In the trial, RAP-219 also demonstrated a statistically significant and clinically meaningful reduction in clinical seizures compared with baseline.
AI Summary
Rapport Therapeutics reported that its Phase 2a trial of RAP-219 in patients with drug-resistant focal onset seizures met the primary endpoint by achieving a statistically significant reduction in long episodes (LEs)—an electrographic biomarker tied to clinical seizure activity—over the eight-week treatment. In the modified intent-to-treat group, 85.2% of patients saw at least a 30% reduction in LEs (p<0.0001), with a median 71% drop from baseline (p=0.0001).
RAP-219 also delivered a clinically meaningful cut in actual seizure events. Patients experienced a median 77.8% decrease in clinical seizures (p=0.01), 72% achieved at least a 50% reduction (p<0.0001), and 24% reached seizure freedom for the full eight weeks (p<0.0001).
The medication was generally well tolerated, with mostly mild or moderate side effects and a low discontinuation rate. Based on these results, Rapport plans to initiate two Phase 3 registrational trials starting in the third quarter of 2026.
Read Announcement- Drug:
- RAP-219
- Announced Date:
- June 2, 2025
- Indication:
- For CNS Disorders
Announcement
Rapport Therapeutics, Inc today will host its inaugural Investor and Analyst Day, featuring presentations from Rapport's executive team on the Company's strategic priorities and updates from its clinical pipeline, including progress on the RAP-219 Phase 2a trial in focal epilepsy.
AI Summary
Rapport Therapeutics announced that it will host its inaugural Investor and Analyst Day, where the executive team will share the company’s strategic priorities and offer updates on its clinical pipeline. A key focus of the event is the progress on the RAP-219 Phase 2a trial in focal epilepsy. This trial, which is now fully enrolled, is designed to assess the potential of RAP-219 in treating refractory focal epilepsy using intracranial EEG data as a measure of its effect on long episodes that correlate with clinical seizures. The event will also feature a fireside chat with Dr. Jacqueline French, a leading epilepsy expert from NYU Langone, who will discuss the trial design and the unmet needs in focal epilepsy. Materials and a live stream will be available on the company website, providing investors and analysts with in-depth insights into the company’s developments.
Read Announcement- Drug:
- RAP-219
- Announced Date:
- March 21, 2025
- Indication:
- For CNS Disorders
Announcement
Rapport Therapeutics, Inc. announced two encore poster presentations at the 2025 American Academy of Neurology (AAN) Annual Meeting, taking place from April 5 to April 9, 2025, in San Diego, California. The data from these posters was originally presented at the American Epilepsy Society (AES) Annual Meeting in December 2024.
AI Summary
Rapport Therapeutics, Inc. announced two encore poster presentations at the 2025 American Academy of Neurology (AAN) Annual Meeting in San Diego, California, scheduled for April 5–9, 2025. These presentations revisit data first shared at the American Epilepsy Society Annual Meeting in December 2024 and focus on the company's ongoing research and development of RAP-219, an AMPA receptor negative allosteric modulator now in Phase 2 trials for refractory focal epilepsy.
The first poster demonstrates that a 30% reduction in long episode frequency correlates with a clinically meaningful (≥50%) decrease in seizure activity. The second poster details how RAP-219 showed strong, dose-dependent antiseizure effects in preclinical models. These findings highlight the potential of RAP-219 as a precision treatment for epilepsy and underline Rapport Therapeutics’ commitment to advancing innovative therapies for neurological disorders.
Read Announcement- Drug:
- RAP-219
- Announced Date:
- January 9, 2025
- Indication:
- For CNS Disorders
Announcement
Rapport Therapeutics, Inc. announced results from its positron emission tomography (PET) trial and second multiple ascending dose (MAD-2) trial for RAP-219.
AI Summary
Rapport Therapeutics, Inc. announced promising results from two Phase 1 trials for RAP-219. In the positron emission tomography (PET) trial, RAP-219 reached and exceeded the target receptor occupancy needed for maximal efficacy within five days using the same dosing regimen as the current Phase 2a trial in focal epilepsy. The trial also confirmed that the targeted protein, TARP8, is mainly found in the hippocampus and cerebral cortex, with little expression in the cerebellum and brain stem. In the second multiple ascending dose (MAD-2) trial, RAP-219 was generally well tolerated even with faster dose titration and higher exposure levels compared to earlier studies. These results support the dosing strategy and highlight RAP-219’s broad therapeutic index, reinforcing its potential as a treatment in the ongoing clinical evaluation for focal epilepsy.
Read Announcement- Drug:
- RAP-219
- Announced Date:
- January 9, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- For CNS Disorders
Announcement
Rapport Therapeutics, Inc Ongoing Phase 2a trial of RAP-219 in focal epilepsy is on track and topline data is expected in mid-2025
AI Summary
Rapport Therapeutics, Inc. announced promising updates from its trials for RAP-219, a treatment aimed at focal epilepsy. In the ongoing Phase 2a trial, RAP-219 is showing great promise with the current dosing regimen. Recent PET trial data confirmed that RAP-219 quickly reached and exceeded the target receptor occupancy needed for maximum efficacy within five days. This supports the approach used in the Phase 2a trial, and the drug was well tolerated by participants. The targeted action of RAP-219, focusing on TARP8 in key brain regions such as the hippocampus and cerebral cortex, suggests the potential for effective treatment with fewer side effects. Topline data from this trial is expected in mid-2025, marking an important milestone in developing a new option for patients struggling with refractory focal epilepsy.
Read Announcement
RTX-1738 FDA Regulatory Events
RTX-1738 is a drug developed by Rapport Therapeutics for the following indication: Lead product candidate RAP-219, across a variety of acute and chronic pain.
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:
- RTX-1738
- Announced Date:
- July 29, 2024
- Indication:
- Lead product candidate RAP-219, across a variety of acute and chronic pain
Announcement
Rapport Therapeutics announced that the Company will present preclinical data on RTX-1738, an analog to Rapport's lead product candidate RAP-219, across a variety of acute and chronic pain models at the upcoming International Association for the Study of Pain (IASP) 2024 World Congress on Pain taking place August 5-9, 2024, in Amsterdam, Netherlands. RTX-1738 demonstrated analgesic activity across a broad range of preclinical pain models.
AI Summary
Rapport Therapeutics recently announced that it will present preclinical data on RTX-1738 at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain in Amsterdam from August 5-9, 2024. RTX-1738, an analog to the company’s lead candidate RAP-219, has shown promising analgesic effects in a variety of acute and chronic pain models, highlighting its potential in addressing diverse pain conditions, including peripheral neuropathic pain.
During the conference, the company will feature a poster presentation titled “RTX-1738 Exhibits Analgesic Activity Across a Broad Range of Preclinical Pain Models” on August 6, 2024, led by Dr. Jose Matta, Senior Director of Biology Discovery. This presentation is a key step in advancing research on precision neuromedicines for central nervous system disorders.
Read Announcement
