• Willing to participate in the study and provide written informed consent.

• Women of childbearing potential and sexually active must use an acceptable contraceptive method (barrier and/or hormonal) as determined by the investigator.

• History of hyperuricemia diagnosis (uric acid \> 7 mg/dL) reported in medical history or patient interview.

• Clinical diagnosis of acute gouty arthritis with a score of at least 4 based on the following criteria: Male (2 points), history of a similar episode (2 points), symptom onset within the last 24 hours (0.5 points), joint redness (1 point), involvement of the first metatarsophalangeal joint (2.5 points), and hypertension or at least one cardiovascular disease (1.5 points).

• Acute episode characterized by severe pain, inflammation, edema, and erythema in the affected joint (≤ 48 hours before study inclusion).

• In the opinion of the Principal Investigator or treating physician, the patient is eligible for treatment with the investigational product and may benefit clinically