Rapport's RAP-219 clears Phase 2 trial in bipolar mania

Rapport Therapeutics said RAP-219, an oral drug it licensed from Johnson and Johnson, met the primary endpoint in a Phase 2 trial in acute bipolar mania, beating placebo by 3.1 points on the Young Mania Rating Scale at three weeks, and the shares rose sharply in premarket trading.

Why it matters: Bipolar mania has seen no new drug mechanism in decades, and a candidate whose adverse events were all mild or moderate would address the tolerability problem that drives patients off existing treatments.

Data as of Rapport Therapeutics press release via GlobeNewswire, October 20, 2026; topline results are company reported and have not been peer reviewed. Developing item.

Rapport Therapeutics announced positive topline results from its Phase 2 trial of RAP-219 in 253 adults with acute bipolar mania, with the drug achieving a 3.1 point placebo adjusted improvement in Young Mania Rating Scale total score at week three (a mean reduction of 15.4 points against 12.3 on placebo, p=0.045) and a statistically significant 0.4 point improvement on the CGI-BP severity of mania scale (p=0.024). The company said all treatment emergent adverse events were mild or moderate, with no severe or serious adverse events over the three week treatment period, and chief executive Abraham Ceesay called the results clinical proof of concept for the drug’s TARP gamma 8 selective mechanism. Rapport plans to meet the FDA in the first quarter of 2027 and expects Phase 3 trials in bipolar mania to begin in the second half of 2027, alongside its ongoing Phase 3 epilepsy programs.

Rapport's RAP-219 clears Phase 2 trial in bipolar mania

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