Approval Probability
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Adjusted LOA
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Also known as MBX-102
Arhalofenate · 6 trials · 3 indications
Percent change from baseline in serum uric acid in Per Protocol population
| Arm | Type | Description |
|---|---|---|
| Arhalofenate with febuxostat (PK cohort) | EXPERIMENTAL | - |
| Arhalofenate with febuxostat (non-PK cohort) | EXPERIMENTAL | - |
| Arhalofenate 600 mg | EXPERIMENTAL | - |
| Arhalofenate 800 mg | EXPERIMENTAL | - |
| Allopurinol 300 mg; colchicine 0.6 mg | ACTIVE_COMPARATOR | - |
| Allopurinol 300 mg | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Arhalofenate with febuxostat and colchicine | OTHER | - |
| Arhalofenate 400 mg | EXPERIMENTAL | Arhalofenate 400 mg plus allopurinol 300 mg |
| Allopurinol | ACTIVE_COMPARATOR | Placebo plus Allopurinol 300 mg |
| MBX-102 200 mg | EXPERIMENTAL | MBX-102 200 mg once daily for 16 weeks |
| MBX-102 400 mg | EXPERIMENTAL | MBX-102 400 mg once daily for 16 weeks |
| MBX-102 600 mg | EXPERIMENTAL | MBX-102 600 mg once daily for 16 weeks |
| Sugar Pill | PLACEBO_COMPARATOR | Placebo comparator once daily for 16 weeks |
| Actos | ACTIVE_COMPARATOR | Actos 30 mg once daily for 16 weeks |
| Name | Type | Description |
|---|---|---|
| Arhalofenate | DRUG | 800 mg once daily orally for four weeks |
| Febuxostat | DRUG | 40 mg once daily orally for 1 week then up-titrated to 80 mg once daily orally for another three weeks |
| Colchicine | DRUG | 0.6 mg daily |
| Arhalofenate 600 mg | DRUG | Arhalofenate 600 mg tablets once daily for 12 weeks |
| Allopurinol 300 mg | DRUG | Allopurinol 300 mg tablets once daily for 12 weeks |
| Colchicine 0.6 mg | DRUG | Colchicine 0.6 mg over-encapsulated tablets once daily for 12 weeks |
| Placebo | DRUG | Placebo tablets once daily for 12 weeks |
| Arhalofenate 800 mg | DRUG | Arhalofenate 800 mg tablets once daily for 12 weeks |
| Allopurinol | DRUG | Allopurinol 300 mg as active comparator |
| Placebo comparator | DRUG | Matching placebo once daily for 4 weeks |
| MBX-102 | DRUG | MBX-102 200 mg once daily for 16 weeks |
| Actos | DRUG | Actos 30 mg once daily for 16 weeks |
Inclusion Criteria: * Male or female patient, 18 to 75 years of age, inclusive * Known gout diagnosis (per criteria of the American Rheumatism Association) * Has an sUA ≥ 7.5 mg/dL * A female patient must be surgically sterile or post-menopausal (at least 45 years of age with no history of menses f...
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 |
Arhalofenate is an investigational small molecule being studied for the treatment of gout and hyperuricemia. It has been evaluated in Phase 2 clinical trials for reducing serum uric acid levels and preventing gout flares in patients with gout. It is not approved for any indication.
Arhalofenate targets SLC22A12 (also known as URAT1) and PPARG (peroxisome proliferator-activated receptor gamma). It acts as an inhibitor of these targets. SLC22A12 is a urate transporter involved in renal uric acid reabsorption, while PPARG is a nuclear receptor that regulates metabolic and inflammatory pathways.
Arhalofenate is being developed by Gilead Sciences, Inc. (ticker: GILD). The company has sponsored Phase 2 clinical trials evaluating the drug in gout and hyperuricemia.
Arhalofenate is in Phase 2 clinical development. It has completed three Phase 2 trials, with no active trials currently listed. The drug remains investigational and has not been approved by the FDA for any indication.
Arhalofenate has been studied in completed Phase 2 trials including NCT02252835, which evaluated it in combination with febuxostat for hyperuricemia in gout patients; NCT02063997, which assessed efficacy and safety for preventing flares and reducing serum uric acid; NCT01416402, an open-label safety and efficacy study with febuxostat; and NCT01399008, which tested MBX-102 with allopurinol in gout patients.