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New pill ONO-1110 tested for fibromyalgia pain relief

NCT ID NCT06752590

Symptom relief Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This Phase IIa trial tests whether a new drug called ONO-1110 can safely reduce pain in people with fibromyalgia. About 160 Japanese adults will take either the drug or a placebo once daily for 8 weeks. Researchers will measure changes in pain scores and watch for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ONO-1110
What this could lead to
If it works, this could point toward a new daily pill to reduce fibromyalgia pain.
What could go wrong
This is an early Phase IIa trial with only 160 Japanese participants. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

175 people

The number who actually took part.

Started

Mar 2025

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Japanese (both sexes) * Outpatient * Patients who are considered capable of understanding the study procedures and completing the pain diary and questionnaires appropriately by the investigator (sub-investigator) * Patients who meet the American College of Rheumatology Fibromyalgia Criteria Exclusion Criteria: * Patients with inflammatory arthritis, infectious arthritis, or autoimmune disease * Patients with pain other than FM that may affect assessments in this study * Patients with a past history of or concurrent neurologic diseases that may affect assessments in this study * Patients with a past history of or concurrent malignant tumor within 3 years * Patients who are pregnant, nursing, or possibly pregnant, or intending to become pregnant during the study period.

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Conditions

The condition(s) this trial relates to.

fibromyalgia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromyalgia

Contacts and locations

Locations

  • Ai Sakura Clinic

    Fukuoka, Fukuoka, Japan

  • Aichi Medical University Hospital

    Nagakute, Aichi-ken, Japan

  • Fukuwa Clinic

    Tokyo, Tokyo, Japan

  • Ginza Neurological Clinic

    Tokyo, Tokyo, Japan

  • Hayaishi Hospital

    Osaka, Osaka, Japan

  • Himenotomomi Clinic

    Tokyo, Tokyo, Japan

  • Ikebukuro Internal Medicine

    Tokyo, Tokyo, Japan

  • Japanese Red Cross Okayama Hospital

    Okayama, Okayama-ken, Japan

  • Juntendo Tokyo Koto Geriatric Medical Center

    Tokyo, Tokyo, Japan

  • Juntendo University Hospital

    Tokyo, Tokyo, Japan

  • Juntendo University Nerima Hospital

    Tokyo, Tokyo, Japan

  • Junwakai Memorial Hospital

    Miyazaki, Miyazaki, Japan

  • Kimura Clinic

    Nagoya, Aichi-ken, Japan

  • Kokorotoitami Clinic

    Kawasaki, Kanagawa, Japan

  • Kyushu University Hospital

    Fukuoka, Japan

  • Mayflower Hospital

    Katō, Hyōgo, Japan

  • Medical Corporation Fujigaki Clinic

    Ōita, Oita Prefecture, Japan

  • Miyashita Rheumatology Clinic

    Ōmura, Nagasaki, Japan

  • Morimoto Clinic

    Osaka, Osaka, Japan

  • National Hospital Organization Shimoshizu National Hospital

    Yotsukaidō, Chiba, Japan

  • Nihonbashi Medical

    Tokyo, Tokyo, Japan

  • Nishiogi Pain Clinic

    Tokyo, Tokyo, Japan

  • Sanno Hospital

    Tokyo, Tokyo, Japan

  • Sapporo City General Hospital

    Sapporo, Hokkaido, Japan

  • Shirasawa Orthopedic Clinic

    Morioka, Iwate, Japan

  • Shizuoka Rehab Pain Clinic

    Shizuoka, Shizuoka, Japan

  • Tokyo-Eki Center-Building Clinic

    Tokyo, Tokyo, Japan

  • Toyama University Hospital

    Toyama, Toyama, Japan

  • Women's Clinic Luna

    Yokohama, Kanagawa, Japan

  • Yakushinkai Healthcare Association Kandasudacho Dermatology

    Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.