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...
| 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 |
Ulodesine is an investigational small molecule being developed for gout. It is studied as an add-on to allopurinol in patients with gout and hyperuricemia, including those with moderate renal insufficiency. Ulodesine is in Phase 2 clinical development and is not approved by the FDA.
Ulodesine is a small molecule that targets the purine metabolism pathway to lower serum uric acid levels. It is designed to be used in combination with allopurinol to reduce uric acid production in patients with gout and hyperuricemia.
Ulodesine is being developed by BioCryst Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BCRX. The company is conducting clinical trials to evaluate the safety and efficacy of ulodesine for the treatment of gout.
Ulodesine is in Phase 2 clinical development. Two Phase 2 trials have been completed, both evaluating the drug as an add-on to allopurinol in patients with gout and hyperuricemia. Ulodesine is investigational and has not received FDA approval.
Ulodesine has been studied in two completed Phase 2 trials. NCT01265264 enrolled 279 participants to evaluate the safety and efficacy of oral ulodesine added to allopurinol. NCT01407874 enrolled 20 participants with gout and moderate renal insufficiency to assess the uric acid effects of the combination.
Ulodesine is also known by the code name BCX4208. It is a small molecule purine nucleoside phosphorylase inhibitor being developed by BioCryst Pharmaceuticals for the treatment of gout and hyperuricemia.