Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
dontinurad · 1 trial · 2 indications
To evaluate the Cmax of dotinurad 2mg, dotinturad 4mg, and allopurinol 300mg
To evaluate the AUC of dotinurad 2mg, dotinturad 4mg, and allopurinol 300mg
To evaluate the Tmax of dotinurad 2mg, dotinturad 4mg, and allopurinol 300mg
To evaluate the T1/2 of dotinurad 2mg, dotinturad 4mg, and allopurinol 300mg
| Arm | Type | Description |
|---|---|---|
| dotinurad 2mg | EXPERIMENTAL | dotinurad 2mg q.d. |
| dotinurad 4mg | EXPERIMENTAL | dotinurad 4mg q.d. |
| Name | Type | Description |
|---|---|---|
| dontinurad | DRUG | dotinurad alone |
| dotinurad + allopurinol | DRUG | dotinurad + allopurinol 300mg |
| allopurinol | DRUG | allopurinol 300 mg alone |
Inclusion Criteria: * 1\. In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements. 2\. Patients with a diagnosis of gout based on American College of Rheumatology criteria (1997). Patients must fulfill at least 3 of the following, with...
| 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 |
| Biogen Inc. | BIIB | 1 | PHASE2 | Plonmarlimab, Compound betamethasone |
Dontinurad is being developed for the treatment of gout, a form of inflammatory arthritis driven by elevated uric acid levels. It is a small molecule therapeutic candidate in the metabolic therapeutic area. Development is at the Phase 1 stage, so dontinurad is investigational and has not been approved for any use.
Dontinurad is being developed by Fortress Biotech, Inc., which trades under the ticker FBIO. The company is the sponsor behind the clinical program evaluating the drug candidate in gout. Fortress Biotech is a biopharmaceutical company that advances product candidates through clinical development.
Dontinurad is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. Because it remains in early-stage clinical testing, dontinurad is investigational and is not FDA approved for gout or any other indication.
Dontinurad has been evaluated in one completed Phase 1 trial, NCT06056570, titled Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients with Hyperuricemia. The trial enrolled 20 participants with gout and hyperuricemia in the United States, included adults 18 years and older of all sexes, and used a controlled design.
Dontinurad is also known as dotinurad, and the two names refer to the same drug candidate. The completed Phase 1 trial NCT06056570 is listed under the dotinurad spelling. Searches for either name point to the same Fortress Biotech gout program in Phase 1 development.