Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ulodesine · 2 trials · 5 indications
Level of CD4+ lymphocytes to be measured at Day 85 compared to baseline.
Level of serum uric acid levels be measured at Day 85 to evaluate in subjects with Gout.
| Arm | Type | Description |
|---|---|---|
| Placebo | EXPERIMENTAL | Placebo + Allopurinol 200mg |
| Ulodesine (BCX4208) 5mg | EXPERIMENTAL | BCX4208 5mg + Allopurinol 200 mg |
| Ulodesine (BCX4208) 10mg | EXPERIMENTAL | BCX4208 10mg + Allopurinol 200mg |
| ulodesine Placebo + Allopurinol 300mg | EXPERIMENTAL | Oral dose administered daily for 84 days. |
| ulodesine 5mg + Allopurinol 300mg | EXPERIMENTAL | Oral dose administered daily for 84 days. |
| ulodesine 10mg + Allopurinol 300mg | EXPERIMENTAL | Oral dose administered daily for 84 days. |
| ulodesine 20mg + Allopurinol 300mg | EXPERIMENTAL | Oral dose administered daily for 84 days. |
| ulodesine 40mg + Allopurinol 300mg | EXPERIMENTAL | Oral dose administered daily for 84 days. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Oral dose administered daily for 84 days. |
| Ulodesine (BCX4208) 5 mg | DRUG | Oral dose administered daily for 84 days. |
| Ulodesine (BCX4208) 10 mg | DRUG | Oral dose administered daily for 84 days. |
| ulodesine | DRUG | Oral dose administered daily for 84 days. |
Inclusion Criteria: 1. Age ≥ 18 to \< 70 years 2. Have read and signed the Informed Consent Form 3. Documented diagnosis of gout 4. Documented moderate renal insufficiency 5. Calculated creatinine clearance of ≥ 30 and \< 60 mL/min 6. Willing and able to take allopurinol 200 mg every day for the du...
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 |
Ulodesine is an investigational oral small molecule developed for the treatment of gout, a form of inflammatory arthritis linked to elevated serum uric acid. It has been studied as an add-on to allopurinol in patients with gout and hyperuricemia, including those with moderate renal insufficiency, to further lower serum uric acid levels.
Ulodesine targets purine nucleoside phosphorylase, or PNP, and acts as an inhibitor of that enzyme. By inhibiting PNP, ulodesine is designed to reduce uric acid production in the body. It is a small molecule and was studied in gout as an oral add-on therapy to allopurinol.
Ulodesine is being developed by BioCryst Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker BCRX. The company sponsored the Phase 2 clinical trials of ulodesine in gout, including studies of the drug added to allopurinol in patients with gout and hyperuricemia.
Ulodesine is in Phase 2 clinical development and is investigational. Two Phase 2 trials have been completed, and no trials are currently active. The studies were randomized, double-blind, and controlled, and enrolled a total of 299 participants with gout and related conditions such as hyperuricemia and arthritis.
Ulodesine has been studied in two completed Phase 2 trials. NCT01265264 evaluated serum uric acid lowering activity, safety, and efficacy of oral ulodesine added to allopurinol, enrolling 279 participants. NCT01407874 was a randomized, double-blind, dose-response study of oral ulodesine added to allopurinol in gout patients with moderate renal insufficiency, enrolling 20 participants.
Yes, ulodesine is also known as BCX4208. The name BCX4208 5 mg refers to a dose strength of the same compound used in clinical study. Both names refer to the PNP inhibitor developed by BioCryst Pharmaceuticals for gout and hyperuricemia.