Osaka, Japan — October 29, 2026
Ono Pharmaceutical Co., Ltd. announced results from five Phase 2 clinical studies of ONO-1110, an orally available endocannabinoid modulator being investigated for chronic pain and selected psychiatric conditions. The studies evaluated the candidate in postherpetic neuralgia (PHN), fibromyalgia (FM), Hunner-type interstitial cystitis (HIC), major depressive disorder (MDD) and social anxiety disorder (SAD). Although the three studies in pain-related indications did not meet their primary endpoints, prespecified subgroup analyses and exploratory post hoc analyses identified efficacy signals suggesting improvements in pain scores measured using the Numerical Rating Scale (NRS). Ono reported a favourable safety profile across all five studies. Based on these findings, the company plans further clinical studies in PHN, FM and HIC, while discontinuing clinical development of ONO-1110 for MDD and SAD because no efficacy signals were observed in those indications.
ONO-1110 Shows Pain-Relief Signals Across Three Phase 2 Studies
The Phase 2 programme included three multicentre, randomised, placebo-controlled studies conducted in Japan to assess ONO-1110 in chronic pain conditions. The ONO-1110-04 study evaluated the candidate in postherpetic neuralgia, with a target enrolment of 140 patients receiving once-daily oral ONO-1110 or placebo for eight weeks. The ONO-1110-05 study investigated fibromyalgia in a target population of 160 patients, also using an eight-week treatment period. The ONO-1110-06 study assessed Hunner-type interstitial cystitis in a target population of 50 patients, with treatment administered once daily for 12 weeks. All three studies were designed to evaluate efficacy, safety, tolerability and pharmacokinetics. While none achieved its primary endpoint, analyses identified potential improvements in pain scores in selected patient subgroups. These findings provide a basis for further investigation, but they remain exploratory and do not establish clinical efficacy. Ono plans additional clinical studies to determine whether the observed signals can be confirmed in appropriately designed trials.
Endocannabinoid Modulation Targets Chronic Pain Mechanisms
ONO-1110 is an orally available investigational endocannabinoid modulator developed by Ono to regulate the body’s endogenous signalling system. Endocannabinoids are naturally produced substances involved in several physiological processes, including the regulation of pain transmission and emotional responses within the central nervous system. The candidate is designed to modulate endocannabinoids produced in response to neuronal activity, potentially influencing pain-related signalling pathways. This mechanism is being investigated as a possible alternative approach to managing chronic pain, particularly in conditions where existing treatments may provide inadequate relief or cause tolerability concerns. Postherpetic neuralgia is a persistent neuropathic pain condition that can develop following herpes zoster infection and may involve burning, sharp or electric shock-like sensations. Fibromyalgia is characterised by chronic widespread pain, stiffness, fatigue and associated sleep disturbances, while Hunner-type interstitial cystitis involves bladder-related pain and urinary symptoms associated with Hunner lesions. These conditions can substantially affect daily functioning and quality of life. Ono is exploring whether endocannabinoid modulation could offer a new therapeutic approach, although further clinical evidence is required to establish its potential benefits.
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Ono Continues Development in Pain Indications but Stops MDD and SAD Programmes
In addition to the three chronic pain studies, Ono conducted Phase 2 clinical studies of ONO-1110 in major depressive disorder and social anxiety disorder. Unlike the findings in PHN, FM and HIC, the studies in these psychiatric indications showed no efficacy signals, and the company confirmed that it does not plan further clinical development for either condition. The overall safety findings were favourable across all five studies, according to the company. However, detailed study results have not yet been presented, and further information will be shared at future scientific conferences and through other appropriate channels. The decision to continue development in three pain-related indications reflects the exploratory signals identified in the analyses, rather than achievement of the primary endpoints. Future trials will be important to confirm whether ONO-1110 can deliver meaningful and reproducible improvements in pain outcomes, while providing additional evidence on safety, tolerability and pharmacokinetics. The programme highlights Ono’s continued investigation of endocannabinoid-based therapeutic approaches and the potential role of this biological pathway in addressing unmet needs in chronic pain management.
Source: Ono Pharmaceutical,Press release
