Pending Announced during: Premarket · announced Tue 6:00a ET (premarket); before = Mon close; first trade Tue 6:00a ET · The 24-hour price is filled in after 24 hours of trading time have passed.
Rapport Therapeutics (Nasdaq: RAPP) reported topline results from a Phase 2 trial of RAP-219 in bipolar mania on October 20, 2026. The company said the trial met its primary endpoint, reporting a 3.1-point placebo-adjusted improvement (p=0.045). ClinicalTrials.gov lists 253 enrolled participants (NCT07046494).
Trial details
- Drug
- RAP-219Type Drug Route oral
- Treats
- Studied as a treatment for bipolar mania (registry condition: Bipolar 1 Disorder).Condition Bipolar 1 Disorder
- Patients
- 253 patients (actual enrollment)2 arms · 20 sites in 1 country
- Phase
- Phase 2
- Design
- Randomized, quadruple-blind, placebo-controlled, parallel-group
- Primary endpoint
- Young Mania Rating Scale (YMRS) (Baseline to End of Treatment at Week 3)
- Key secondary endpoints
- Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness Mania score
- Treatment Emergent Adverse Events (TEAEs)
- Heart Rate
- Result
- Met endpointThe trial met its primary endpoint, with RAP-219 achieving a 3.1-point placebo-adjusted improvement in the Young Mania Rating Scale (YMRS) total score at Week 3 (mean reduction from baseline of 15.4 points with RAP-219 versus 12.3 points with placebo (p=0.045).Effect size 3.1-point placebo-adjusted improvement p-value p=0.045Figures as reported by the sponsor or registry; not calculated by DrugTrials.org.
- Safety
- RAP-219 was well-tolerated, with no severe treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) observed over the treatment period.
- Sponsor
- Rapport Therapeutics Nasdaq: RAPP
- Dates
- Study start Jul 25, 2025Primary completion Aug 5, 2026Announced Oct 20, 2026, 6:00 AM ET (Wire dateline)
- Trial ID
- NCT07046494 ClinicalTrials.gov
About this trial
This randomized, quadruple-blind, placebo-controlled, parallel-group Phase 2 trial (NCT07046494) tested RAP-219 in Bipolar 1 Disorder. Studied as a treatment for bipolar mania (registry condition: Bipolar 1 Disorder). It enrolled 253 patients across 2 arms at 20 sites in 1 country. The primary endpoint was Young Mania Rating Scale (YMRS) (Baseline to End of Treatment at Week 3). Rapport Therapeutics reported that the trial met its primary endpoint (effect size: 3.1-point placebo-adjusted improvement; p-value: p=0.045). The study started on Jul 25, 2025 and reached primary completion on Aug 5, 2026.
Sources
- Source: signalnewshartford.com
- ClinicalTrials.gov record: NCT07046494
For information only. Not investment or medical advice. Prices are historical, from consolidated market data, and may contain errors. Always check the original source.