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Label indication ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. FDA label
Also known as Uloric
Febuxostat IR · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Febuxostat IR 40 mg | ACTIVE_COMPARATOR | Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. |
| Febuxostat IR 80 mg | ACTIVE_COMPARATOR | Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. |
| Febuxostat XR 40 mg | EXPERIMENTAL | Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. |
| Febuxostat XR 80 mg | EXPERIMENTAL | Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. |
| Placebo | PLACEBO_COMPARATOR | Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. |
| Name | Type | Description |
|---|---|---|
| Febuxostat IR | DRUG | Febuxostat IR over-encapsulated tablets |
| Febuxostat XR | DRUG | Febuxostat XR over-encapsulated capsules |
| Febuxostat placebo | DRUG | Febuxostat placebo-matching capsules |
| Colchicine | DRUG | Colchicine tablets |
| Naproxen | DRUG | Naproxen tablets |
| Lansoprazole | DRUG | Lansoprazole capsules |
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any requi...
Top 3 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Amgen Inc. | AMGN | 1 | PHASE3 | Pegloticase |
| Protalix BioTherapeutics, Inc. (DE) | PLX | 1 | PHASE2 | PRX-115 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 1 | PHASE1 | NNC4004-0002 |
Febuxostat IR is used to treat gout, a form of inflammatory arthritis caused by elevated uric acid levels. It is an immediate-release small molecule developed by Takeda Pharmaceutical Company Limited. The clinical program studied adults with gout, including a trial in patients who also had moderate renal impairment.
Febuxostat IR targets xanthine dehydrogenase, also known as XDH. It acts as an inhibitor of this enzyme, which is involved in purine metabolism and uric acid production. Inhibiting XDH reduces uric acid formation, the mechanism relevant to treating gout.
Febuxostat IR is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the clinical trials evaluating the immediate-release and extended-release formulations of febuxostat in patients with gout.
Febuxostat IR has been studied in Phase 3 clinical development for gout. The program includes a completed Phase 3 trial and a completed Phase 2 trial. It is an investigational asset in this dataset rather than a marketed product.
Two completed trials studied Febuxostat IR. NCT02139046 was a Phase 3 trial of extended-release and immediate-release febuxostat in 1,790 participants with gout in the United States. NCT02128490 was a Phase 2 trial in 189 participants with gout and moderate renal impairment. Both were randomized, double-blind, and placebo-controlled.
The Febuxostat IR clinical program enrolled 1,979 participants across two completed trials. The larger Phase 3 study, NCT02139046, enrolled 1,790 adults with gout, while the Phase 2 study, NCT02128490, enrolled 189 adults with gout and moderate renal impairment. Both trials required participants to be at least 18 years old.