Regulatory Approval

Nxera's daridorexant hits sTST goal in South Korea Phase 3, eyes 2027 nod

The Phase 3 trial met all primary and secondary endpoints on subjective sleep time, positioning an MAA filing and a Q1 2027 approval target for an already-approved insomnia drug.

By AppliedXLJuly 13, 2026Trial NCT07028697

Executive Summary

Nxera Pharma's South Korean Phase 3 trial of daridorexant met its primary sleep-time endpoint and both secondary measures, giving the company a positive topline to carry into a marketing application.
Because daridorexant is already an approved insomnia treatment elsewhere, the regulatory bar in South Korea is reproducing that established effect and safety profile in a new population, not proving a new mechanism.
The company is targeting a marketing authorization filing followed by approval in the first quarter of 2027, extending its commercial footprint for the drug into another Asian market alongside its existing insomnia franchise in Japan.
The OX1R-targeting insomnia field carries few active peers, and no Phase 3 program sharing this target and indication has failed on record, a landscape that favors execution risk over scientific risk for this filing.

The readout

Nxera Pharma disclosed in a February 13, 2026 operational update that the Phase 3 trial of daridorexant registered as NCT07028697 met all primary and secondary efficacy endpoints in South Korea. The trial's single primary endpoint was subjective total sleep time (sTST), a patient-reported measure of how long a participant believes they slept, with two secondary endpoints tracking subjective latency to sleep onset and subjective wake time after sleep onset. The trial enrolled 164 adults against a target of 164, completed enrollment on September 11, 2025, and moved to Completed status on January 21, 2026. Nxera+1

Probability of Success

Endpoint Met91%

Completes100%

Clinical Significance25%

Regulatory94%

What the trial tests

Daridorexant already holds US approval as QUVIVIQ for insomnia, and Nxera's own release describes 2025 progress on manufacturing scale-up for that approved product in Japan, where net sales grew 223.9% year over year to JPY 4,327 million. The South Korean study is a randomized, placebo-controlled Phase 3 trial with one experimental and one placebo arm, run under oral dosing in adults meeting DSM-5 insomnia disorder criteria with an Insomnia Severity Index score of 15 or higher. Because the drug's mechanism, an oral dual orexin receptor antagonist blocking OX1R and OX2R signaling that promotes wakefulness, is already established through prior approvals, the trial's role is to reproduce that known effect in a South Korean population ahead of a local filing, not to test a new hypothesis. Nxera+1

Regulatory path

Nxera said it plans to submit a marketing authorization application in South Korea and expects approval in the first quarter of 2027. No FDA or other designation events attach to this specific filing, and the company has not disclosed label scope, review type, or confirmatory-trial requirements for the South Korean submission. Daridorexant's existing US approval record, held under NDA 214985 for the oral tablet formulation, gives regulators in a new market an approved reference product with an established efficacy and safety record to weigh against the local trial data. Nxera

Competitive field

The OX1R-targeting insomnia field is not crowded: a landscape assessment counted one other active trial studying OX1R in insomnia disorder and no terminated Phase 3 programs sharing this target and indication. Jiangsu Simcere Pharmaceutical Co., Ltd. ran a separate Phase 3 daridorexant trial in Chinese patients with insomnia disorder, the closest direct comparator sharing both the drug and the target. Other orexin-pathway competitors in the broader field, including Takeda's danavorexton and Janssen's seltorexant, target OX2R rather than OX1R and sit in different indications, making them mechanism neighbors rather than direct comparators. NCT07028697

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.