BP-205

BP-205 is the newest orexin-2 agonist to report human data, and the only compound on this list from a company that already sells a narcolepsy drug. Harmony markets pitolisant as WAKIX, which brought in $261.3 million in the second quarter of 2026, and has named BP-205 the centrepiece of its pipeline.

The Phase 1 single-ascending-dose study randomised 72 healthy volunteers across nine cohorts of eight, six on drug and two on placebo, at single oral doses from 0.2 to 6.0 mg. Harmony reported dose-proportional exposure, a mean half-life of about 25 hours, time to peak plasma concentration of 30 to 75 minutes, and no serious or severe treatment-emergent adverse events. The most common were headache, fatigue and diarrhoea, in roughly 10%, 4% and 3% of participants.

No indication has been named. Harmony says only that Phase 2 studies beginning in mid-2027 will evaluate multiple CNS indications, and the Phase 1b starting in the third quarter of 2026 enrols sleep-deprived healthy volunteers rather than patients.

The compound is absent from ClinicalTrials.gov under this or any related name, so the sponsor’s filing with the SEC is the only public record of the study design. That is a stronger source than a press release, because it is filed rather than published and cannot be quietly edited afterwards.

Harmony describes BP-205 as the most potent OX2R agonist in clinical development. That ranking comes from the sponsor’s own in vitro comparison against rival compounds, presented in an investor deck, and has not been tested head to head in humans.

This entry was last checked against its primary source on 4 Aug 2026 by Simon Stawski: https://www.sec.gov/Archives/edgar/data/1802665/000110465926090086/hrmy-20260804xex99d1.htm

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