Approval Probability
TA Base Rate
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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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Amgen Inc. | AMGN | 1 | PHASE3 | Pegloticase, Methotrexate |
| Protalix BioTherapeutics, Inc. (DE) | PLX | 1 | PHASE2 | PRX-115, Methotrexate |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 1 | PHASE1 | NNC4004-0002 |
| TJ Biopharma Co., Ltd. | IMAB | 1 | PHASE2 | Plonmarlimab, Compound betamethasone |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE1 | Pegylated Recombinant Candida Utilis Uricase |
Febuxostat IR is an investigational small molecule being developed for the treatment of gout. It is an immediate release formulation of febuxostat. The drug is currently in Phase 3 clinical development, though the trials listed are completed.
Febuxostat IR is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with gout.
Febuxostat IR is in Phase 3 clinical development for gout. The most advanced trial, NCT02139046, is a Phase 3 study that has been completed. The drug is investigational and has not been approved by regulatory authorities.
Febuxostat IR has been studied in two completed trials. NCT02128490 was a Phase 2 study in patients with gout and moderate renal impairment, enrolling 189 participants. NCT02139046 was a Phase 3 study in patients with gout, enrolling 1790 participants. Both were conducted in the United States.
Febuxostat IR is an immediate release formulation of febuxostat. The drug name indicates the immediate release version, distinguishing it from extended release versions. The clinical trials listed compare the efficacy and safety of extended release and immediate release febuxostat.