Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Arhalofenate · 5 trials · 2 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 |
| 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 |
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...
| 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 |
Arhalofenate is an investigational small molecule being developed for the treatment of gout and hyperuricemia. It is designed to lower serum uric acid levels and prevent gout flares. As of the available data, it is in Phase 2 clinical development and has not been approved by regulatory authorities.
Arhalofenate is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. The drug is currently in Phase 2 clinical trials for gout and hyperuricemia, and it remains investigational.
Arhalofenate is in Phase 2 clinical development. It has completed three Phase 2 trials, with no active trials currently ongoing. The drug is investigational and has not received FDA approval for any indication.
Arhalofenate has been studied in three completed Phase 2 trials. These include NCT01336686, evaluating its safety and efficacy in hyperuricemia with gout; NCT01399008, testing it in combination with allopurinol in gout patients; and NCT02063997, assessing its effect on preventing flares and reducing serum uric acid in gout.
Yes, Arhalofenate is also known as MBX-102. Clinical trial records refer to the drug by both names, with early studies using the MBX-102 designation. This alternative name appears in trials such as NCT01336686 and NCT01399008.