Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Yimitasvir · 3 trials · 3 indications
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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. male or female, age 18 to 70 years of age, inclusive; 2. must have a calculated body mass index (BMI) from 18 to 28 kg/m2 at study screening; 3. Glomerular filtration rate must be \< 15 mL/min /1.73 m2 for End-stage renal disease without hemodialysis group, and ≥ 90 mL/min fo...
Yimitasvir is an investigational small molecule being developed for chronic hepatitis C, hepatic impairment, and renal impairment. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Yimitasvir is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker symbol SBFM. The company is conducting clinical trials for this investigational drug.
Yimitasvir is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. Clinical trials are being conducted to evaluate its safety, tolerability, and pharmacokinetics.
Yimitasvir has completed three Phase 1 clinical trials: NCT03462173, a safety and pharmacokinetic study in healthy adults with chronic hepatitis C; NCT04552808, a study in subjects with moderate and severe liver impairment; and NCT04565171, a study in subjects with normal renal function and end-stage renal disease.
Yimitasvir is also known as Yimitasvir Phosphate, as seen in clinical trial titles. The phosphate form is used in capsule formulations for oral administration in studies evaluating pharmacokinetics and safety.