Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Yimitasvir Phosphate, Yimitasvir Phosphate Capsule, DAG181
Yimitasvir · 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...
Yimitasvir is an investigational small molecule being studied for the treatment of chronic hepatitis C, a viral infection of the liver. It is also being evaluated in people with hepatic impairment and renal impairment to understand how the drug behaves in these populations. It has not been approved for any use and remains in clinical development.
Yimitasvir is being developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company is the sponsor of the clinical studies evaluating the drug in chronic hepatitis C and in patients with liver or kidney impairment.
Yimitasvir is in Phase 1 clinical development. The studies conducted so far are early-stage pharmacokinetic and safety trials in healthy volunteers and in subjects with hepatic or renal impairment. It is investigational and has not received regulatory approval for any indication.
Yimitasvir has been studied in three completed Phase 1 trials. NCT03462173 evaluated safety, tolerability, and pharmacokinetics in healthy adults. NCT04552808 assessed pharmacokinetics and safety in subjects with moderate to severe liver impairment. NCT04565171 examined pharmacokinetics in subjects with normal renal function and end-stage renal disease. All were conducted in China.
Yes. Yimitasvir Phosphate is an alternative name for Yimitasvir, and the drug is also referred to as Yimitasvir Phosphate Capsule, reflecting its oral capsule formulation. These names refer to the same investigational compound developed by Sunshine Biopharma Inc.