Hansoh Pharma Announces Positive Phase 1b/2 Data for HS-10506, a Selective OX2R Antagonist, in Insomnia Treatment

On April 21, Hansoh Pharma announced the release at the 2026 American Academy of Neurology (AAN) Annual MeetingOX2R AntagonistHS-10506 is used forInsomnia PatientsData from the Phase 1b/2 study. The study showed that HS-10506 demonstrated significant efficacy in improving sleep onset and maintenance, with a favorable safety and pharmacokinetic profile.

HS-10506 is a selective orexin-2 receptor (OX2R) antagonist developed by Hansoh Pharma. It is currently in the clinical research stage for the treatment of sleep disorders. Increasing evidence suggests that OX2R-mediated signaling plays a major role in promoting wakefulness. Insomnia is a globally prevalent sleep disorder, with core symptoms including difficulty falling asleep, difficulty maintaining sleep, early awakening, lack of restorative sleep, reduced total sleep time, and significant daytime dysfunction.

The AAN 2026 conference announced data from a multicenter, randomized, double-blind, placebo-controlled Phase 1b/2 study of HS-10506 for the treatment of patients with insomnia.

In Phase 1b, participants were randomized 3:1 to receive either HS-10506 or placebo in multiple ascending doses of 10mg, 20mg, 40mg, and 80mg (8 participants per group). In Phase 2, participants were equally randomized to receive 20mg, 40mg, or 60mg of HS-10506 or placebo once nightly for 28 days. The primary endpoint for Phase 2 was the change from baseline in mean Latency to Persistent Sleep (LPS) as measured by polysomnography on Days 13 and 14 (D13/14).

The research results show:

Efficacy Results: In Phase 2, compared with the placebo group, HS-10506 20mg, 40mg, and 60mg groupsThe changes in LPS(D13/14) mean from baseline were -13.7min, -16.6min, and -18.8min, respectively., with significant differences and clinical significance. HS-10506 also demonstrated sustained improvements in other objective and subjective sleep measurement indicators.

Good Safety: HS-10506 demonstrated good safety at all doses. No adverse effects on alertness, cognitive function, depression, or anxiety symptoms were observed after HS-10506 treatment. No rebound insomnia occurred after discontinuation.

Hansoh Pharma's press release stated that data reported at the 37th ECNP Congress previously demonstrated HS-10506’s favorable safety profile and expected pharmacodynamic effects in healthy subjects. These findings will support the ongoing Phase 3 clinical development of HS-10506.

References:
[1]AAN 2026 | Hansoh Pharma's OX2R Antagonist HS-10506 Phase Ib/II Study Data for Insomnia Treatment Released. From https://mp.weixin.qq.com/s/Ye4S_Z9UZocRyD3Qm7rmNA

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