Hansoh Pharma Initiates First Phase III Clinical Trial of Class 1 New Drug HS-10506 for Insomnia Treatment

On April 24, Hansoh Pharma registered a Phase III clinical trial in China to evaluate its Class 1 new drug HS-10506.Chinese Adults with Insomnia DisorderCNEfficacy and safety.

Source: Official Website of the Drug Clinical Trial Registration and Information Disclosure Platform

HS-10506 was discovered and developed by Hansoh Pharma.An Innovative, Highly Selective OX2R Antagonist，Intended to be developed for the treatment of insomniaAn increasing body of evidence suggests that OX2R-mediated signaling plays a primary role in promoting wakefulness. According to the Hansoh Pharma press release, as a selective OX2R antagonist, HS-10506 is expected to minimize off-target effects, offering a novel orexin-targeted therapeutic option for the treatment of insomnia.

This launch is a multi-center, randomized, double-blind, placebo-controlled Phase III clinical study.（CTR20261617）. The main purpose of the study is: to evaluate HS-10506 in Chinese adult participants with insomnia disorder, following continuous administration for 1 month and 3 months, using polysomnography monitoring.（PSG）Improvement in objectively measured sleep parameters. The study will be conducted at 50 medical institutions, with a target enrollment of 732 participants.

Source: Insight Database

On April 21, 2026, Hansoh Pharma at the 2026 American Academy of Neurology（AAN）Data from the Phase Ib/II Study of HS-10506 for the Treatment of Insomnia Patients Released at the Annual Meeting. In the Phase Ib portion, participants were randomly assigned in a 3:1 ratio to receive either HS-10506 or placebo, with escalating multiple doses of 10 mg, 20 mg, 40 mg, and 80 mg.(8 cases per group)。

In Phase II, participants were randomly assigned on average to receive 20 mg, 40 mg, or 60 mg of HS-10506 or a placebo once nightly for 28 days. The primary endpoints of Phase II were Day 13 and Day 14.（D13/14）Continuous Sleep Latency in Polysomnography Monitoring（LPS）Change in mean value compared to baseline.

The research results show:

• In terms of efficacy, in Phase II, compared with the placebo group, HS-10506 20 mg, 40 mg, and 60 mg groups LPS(D13/14)The change from baseline in mean was -13.7 min, respectively.(95%CI,-21.0, -6.4;P<0.001)、-16.6 min(95%CI,-23.8,-9.3P<0.001)and -18.8 min(95% CI,-26.1,-11.6；P<0.001), with significant differences and clinical significance. HS-10506 also demonstrated sustained improvements in other objective and subjective sleep measurement indicators.

• In terms of safety, HS-10506 demonstrated good safety at all doses. No adverse effects on alertness, cognitive function, depressive or anxiety symptoms were observed after HS-10506 treatment. No rebound insomnia occurred after discontinuation.

According to the Insight database, there are currently two new drugs targeting orexin receptors approved for marketing in China, namely Eisai's Lemborexant.(Targeting OX1R and OX2R)Daridorexant introduced by Simcere from Idorsia(Targeting OX1R and OX2R)They were both approved last year for the treatment of insomnia.

In addition, two new drugs targeting orexin receptors have been submitted for marketing in China, respectively: Fazanerine from Yangtze River Pharmaceutical.(Targeting OX1R and OX2R), used to treat insomnia; Takeda's Orexin Receptor Antagonist Tablets（OX2R Agonist）, used to treat type 1 narcolepsy. Hansoh Pharma'sHS-10506 has entered Phase III, with relatively advanced research progress among similar drugs produced in China.

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