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# FDA Approves Ironwood Pharma NDA for Gout Patients
- URL: https://www.fdaweb.com/fda-approves-ironwood-pharma-nda-for-gout-patients/
- Published: 2017-08-21T12:00:00.000Z
- Updated: 2026-09-14T22:42:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139435

FDA has approved an Ironwood Pharmaceuticals NDA for Duzallo (allopurinol and lesinurad) as a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone. The fixed-dose combination is designed to provide a dual mechanism of action in a single tablet that can address both underlying causes of hyperuricemia – overproduction and underexcretion of serum uric acid, according to the company.

The efficacy and safety of lesinurad plus allopurinol were demonstrated in two pivotal Phase 3 clinical trials, CLEAR 1 (n=402) and CLEAR 2 (n=410). Data showed that a significant number of adult patients with gout who failed to achieve target sUA levels on allopurinol alone achieved desirable sUA targets through month 12 on the combination therapy, according to the company. The most common adverse reactions in clinical trials were headache, influenza, higher levels of blood creatinine (a measure of kidney function), and heartburn. Duzallo has a boxed warning regarding the risk of acute renal failure, it says.