A Phase 2 interventional study of FXS5626 tablet and FXS5626 tablet in Active Non-anterior, Non-infectious Uveitis, sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (part of Fosun Pharma) · Phase 2, Interventional, and Treatment
The purpose of this study is to find out the efficacy and safety of oral FXS5626 in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).
This study is a multicenter, randomized, double-blind, placebo-controlled study conducted in china, aimed at evaluating the efficacy, safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of FXS5626 administered twice daily for 24 weeks in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis(NIU).
This study plans to enroll 40 patients with active non-anterior NIU. Patients who sign the informed consent form will be screened according to the enrollment criteria, and randomly allocated into 3 groups in a 2:1:1 ratio. Participants in groups 1 and 2 will receive different doses of FXS5626. Participants in group 3 will receive placebo.
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's planned enrollment of 40 is above the median of 30 across 175 interventional studies indexed under Uveitis.
Browse Uveitis studies →Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. is the lead sponsor of 34 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1) Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion 2) ≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria) 3) ≥ 2+ vitreous haze (National Eye Institute [NEI]/SUN criteria) ; [6] Participants and their partners must have no plans for reproduction, sperm donation, or egg donation from the start of treatment until at least one month after the last dose of the drug, and must voluntarily employ an effective method of as determined by the investigator.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive FXS5626 50 mg twice daily (BID) , for 24 weeks. Pharmaceutical form: Tablets Route of administration: Oral
Drug: FXS5626 tablet
Participants will receive FXS5626 25 mg twice daily (BID) , for 24 weeks. Pharmaceutical form: Tablets Route of administration: Oral
Other: FXS5626 tablet
Participants will receive placebo twice daily (BID) , for 24 weeks. Pharmaceutical form: Tablets Route of administration: Oral
Other: Placebo
Administered twice per day for 24 weeks.
Administered twice per day for 24 weeks.
Administered twice per day for 24 weeks.
The percentage of patients meeting treatment failure criteria from week 6 to week 24.
Time frame: 24 weeks
Time to Treatment Failure from week 6 to week 24.
Time frame: 24 weeks
At each visit,change in Anterior Chamber (AC) cells grade for each eye from the best state achieved prior to Week 6.
Time frame: 24 weeks
At each visit, change in Vitreous Haze (VH) grade for each eye from the best state achieved prior to Week 6.
Time frame: 24 weeks
At each visit, change in BCVA for each eye from the best state achieved prior to Week 6.
Time frame: 24 weeks
Time to Optical Coherence Tomography (OCT) evidence of macular edema in at least 1 eye from Week 6.
Time frame: 24 weeks
At each visit, change in Central Retinal Thickness (CRT) for each eye from the best state achieved prior to Week 6.
Time frame: 24 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Feb 2027, 12 months after the start.
Of 17 phase 2 interventional studies under Uveitis, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 37. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: FXS5626
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