Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BCX4208 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| BCX4208 placebo + Allopurinol placebo | PLACEBO_COMPARATOR | Administered daily for 21 days. |
| BCX4208 placebo + Allopurinol 100mg | ACTIVE_COMPARATOR | Administered daily for 21 days. |
| BCX4208 placebo + Allopurinol 200 mg | ACTIVE_COMPARATOR | Administered daily for 21 days. |
| BCX4208 Placebo + Allopurinol 300 mg | ACTIVE_COMPARATOR | Administered daily for 21 days. |
| BCX4208 20 mg + Allopurinol Placebo | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 20 mg + Allopurinol 100 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 20 mg + Allopurinol 200 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 20 mg + Allopurinol 300 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 40 mg + Allopurinol placebo | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 40 mg + Allopurinol 100 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 40 mg + Allopurinol 200 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 40 mg + Allopurinol 300 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 80 mg + Allopurinol Placebo | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 80 mg + Allopurinol 100 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 80 mg + Allopurinol 200 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 80 mg + Allopurinol 300 mg | EXPERIMENTAL | Administered daily for 21 days. |
| 40 mg | EXPERIMENTAL | 40 mg BCX4208 |
| 80 mg | EXPERIMENTAL | BCX4208 |
| 120 mg | EXPERIMENTAL | BCX4208 |
| sugar pill | PLACEBO_COMPARATOR | - |
| 160mg | EXPERIMENTAL | BCX4208 |
| 240mg | EXPERIMENTAL | BCX4208 |
| 320mg | EXPERIMENTAL | BCX4208 |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Administered daily for 21 days |
| Allopurinol | DRUG | Administered daily for 21 days. |
| BCX4208 | DRUG | Administered daily for 21 days. |
Inclusion Criteria: 1. Age ≥18 to \<70 years, with screening sUA \> 8.0 mg/dL. 2. Diagnosis of gout according to the criteria of the American Rheumatism Association (1977). 3. Be willing and able to take colchicine 0.6 mg per day or naproxen 250 mg twice daily (with proton pump inhibitor if needed)...
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 |
BCX4208 is an investigational oral small molecule being studied for the treatment of gout, a metabolic condition. It was evaluated in Phase 2 clinical trials in adults with gout, including studies of its serum uric acid lowering activity and safety. It is not an approved therapy.
BCX4208 is being developed by BioCryst Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker BCRX. The company sponsored the Phase 2 clinical program evaluating the drug in patients with gout in the United States.
BCX4208 is in Phase 2 development. Two Phase 2 trials in gout have been completed, and no trials are currently active. The drug remains investigational and has not been approved by the FDA for any indication.
BCX4208 has been studied in two completed Phase 2 trials in gout. NCT01129648 evaluated its serum uric acid lowering activity, safety, and pharmacokinetic interaction with oral allopurinol in 87 subjects. NCT00985127 evaluated its urate lowering activity and safety in 99 subjects. Both were randomized, double blind, and placebo controlled.
The two completed Phase 2 trials of BCX4208 in gout enrolled a total of 186 participants. NCT01129648 enrolled 87 subjects and NCT00985127 enrolled 99 subjects. Both studies required participants to be at least 18 years of age and enrolled both men and women.