Approval Probability
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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, 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 |
Dontinurad is an investigational small molecule being developed for the treatment of gout. It is being studied in patients with gout and hyperuricemia, a condition of elevated uric acid levels in the blood. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Dontinurad is being developed by Fortress Biotech, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol FBIO. The company is conducting clinical research on this investigational drug for the treatment of gout and hyperuricemia.
Dontinurad is in Phase 1 clinical development. A Phase 1 clinical trial has been completed, and the drug remains investigational. It has not been approved by the FDA or any other regulatory agency, and it is still in the early stages of clinical testing.
Dontinurad has one completed Phase 1 clinical trial registered as NCT06056570, titled "Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients with Hyperuricemia." The trial enrolled 20 participants in the United States and studied the drug's pharmacokinetics, pharmacodynamics, and drug-drug interactions with allopurinol.
Yes, dontinurad and dotinurad refer to the same investigational drug. The clinical trial NCT06056570 uses the spelling "Dotinurad" in its title, while the drug name is listed as dontinurad. Both names refer to the same small molecule being developed for gout and hyperuricemia.
Dontinurad is a small molecule being developed for gout and hyperuricemia. The specific molecular target of dontinurad has not been disclosed in the available information, so its mechanism of action is not described here. It is being studied for its effects on uric acid levels in patients with gout.