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SSGJ-613 Q12W · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SSGJ-613 100 mg Q12W | EXPERIMENTAL | - |
| SSGJ-613 200 mg Q12W | EXPERIMENTAL | - |
| Colchicine 0.5mg | ACTIVE_COMPARATOR | - |
| SSGJ-613 100 mg Q4W | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SSGJ-613 100 mg Q12W | DRUG | Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12 |
| SSGJ-613 200 mg Q12W | DRUG | Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12 |
| SSGJ-613 100 mg Q4W | DRUG | Participants will receive one s.c. injection of SSGJ-613 on Day 1、W4、W8、W12 |
| Colchicine 0.5 mg | DRUG | Participants will receive 0.5mg bid Colchicine for 24 weeks. |
Inclusion Criteria: * Must be 18 Years to 75 Years, both male and female. * BMI ≤40 kg/m2. * Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of gouty arthritis. * ≥4 acute gout flares within 1 year prior to screening Exclusion Criteria: * Gout caused by rad...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 5 | PHASE4 | Undisclosed |
| Smith & Nephew plc Sponsored ADR | SNN | 3 | PHASE4 | Undisclosed |
| Johnson & Johnson | JNJ | 1 | PHASE4 | Undisclosed |
SSGJ-613 Q12W is an investigational small molecule being developed for gout arthritis. It is administered once every 12 weeks and is currently in Phase 2 clinical development. The drug is being studied in patients with gout who are initiating urate-lowering treatment.
The molecular target of SSGJ-613 Q12W has not been disclosed. It is a small molecule modality being developed for gout arthritis, and its mechanism of action is not publicly specified in available clinical trial information.
SSGJ-613 Q12W is being developed by Sunshine Biopharma Inc., a company traded on the NASDAQ under the ticker symbol SBFM. The company is conducting a Phase 2 clinical trial of the drug for gout arthritis.
SSGJ-613 Q12W is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 study is designed to evaluate its safety and efficacy in patients with gout arthritis.
SSGJ-613 Q12W is being studied in a single Phase 2 clinical trial with the identifier NCT07708181, titled 'A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment.' The trial is not yet recruiting and plans to enroll approximately 200 participants with gout arthritis.
Yes, SSGJ-613 Q12W is also known as SSGJ-613 100 mg Q12W. The two names refer to the same drug product, with the latter specifying the dose of 100 mg administered every 12 weeks.