Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Yimitasvir, Yimitasvir Phosphate Capsule
DAG181 · 5 trials · 4 indications
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after discontinuation of therapy
Collecting all adverse events during the whole study
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment
AUC is defined as the concentration of drug area under the curve
Cmax is defined as the maximum concentration of drug
Incidence of adverse events
Maximum plasma concentration of study drugs
Maximum plasma concentration of study drugs
Time of the maximum observed plasma concentration
Terminal elimination half-life
| Arm | Type | Description |
|---|---|---|
| SOF 400 mg+DAG181 100 mg | EXPERIMENTAL | Patients with genotype 1 HCV infection without cirrhosis will receive SOF 400 mg+DAG181 100 mg for 12 weeks. |
| SOF+DAG181 100 mg | EXPERIMENTAL | Patients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 100 mg for 12 weeks. |
| SOF+DAG181 200 mg | EXPERIMENTAL | Patients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 200 mg for 12 weeks. |
| Participants with renal impairment | EXPERIMENTAL | Participants with End-stage renal disease will receive a single dose of Yimitasvir Phosphate Capsule. |
| Participants with normal renal function | EXPERIMENTAL | Participants with normal renal function will receive a single dose of Yimitasvir Phosphate Capsule. |
| Yimitasvir Phosphate Capsules | EXPERIMENTAL | The mechanism of action of Yimitasvir is the specific inhibition of HCV non-structural protein NS5A |
| 30 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 30 mg yimitasvir(N=6) or placebo(N=2) |
| 100 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 100 mg yimitasvir (N=6) or placebo(N=2) |
| 200 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 200 mg yimitasvir (N=6) or placebo(N=2) |
| 400 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 400 mg yimitasvir (N=6) or placebo(N=2) |
| 600 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 600 mg yimitasvir (N=6) or placebo(N=2) |
| 800 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 800 mg yimitasvir (N=6) or placebo(N=2) |
| 1000 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 1000 mg yimitasvir (N=6) or placebo(N=2) |
| Name | Type | Description |
|---|---|---|
| SOF | DRUG | 400 mg tablet administered orally once daily |
| DAG181 | DRUG | 100 mg capsule administered orally once daily |
| Yimitasvir Phosphate Capsule | DRUG | DAG181 100 mg (100 mg Capsule) administered orally |
| Yimitasvir Phosphate | DRUG | Cohort A: On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects |
| yimitasvir | DRUG | Capsule administered orally once daily |
| placebo | DRUG | Matching Placebo Capsule |
Inclusion Criteria: 1. Willing and able to provide written informed consent; 2. Male or female, age≥18 years; 3. A female subject is eligible to enter the study if it is confirmed that she is: 1. Of non-childbearing potential (i.e., women who have had a hysterectomy, have both ovaries removed o...
DAG181 is being developed for the treatment of chronic hepatitis C virus (HCV) infection. It is an investigational small molecule antiviral candidate studied in adult patients aged 18 years and older. Both reported clinical trials enrolled participants with chronic HCV infection in China.
DAG181 is being developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company is the sponsor behind the clinical program evaluating the compound in chronic HCV infection.
DAG181 has reached Phase 3 clinical development. A Phase 3 trial and a Phase 2 trial have both been completed, and no trials are currently listed as active. DAG181 remains an investigational drug and has not been approved by the FDA.
Two completed trials have evaluated DAG181 in chronic HCV infection. NCT03487107 was a Phase 3 study of Yimitasvir Phosphate capsules that enrolled 362 patients in China. NCT03458481 was a Phase 2 study of the same capsules that enrolled 129 patients, also in China.
Yes, DAG181 is also known as Yimitasvir phosphate. The clinical trials are listed under the name Yimitasvir Phosphate Capsules, so searches for either name refer to the same investigational small molecule being developed for chronic HCV infection.
Across the two completed trials, 491 patients were enrolled in studies of DAG181 for chronic HCV infection. The Phase 3 trial NCT03487107 enrolled 362 patients, and the Phase 2 trial NCT03458481 enrolled 129 patients. Both studies were controlled and enrolled adults aged 18 years and older in China.