Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-6325 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| GT1-HCV 200 mg | EXPERIMENTAL | - |
| GT1-HCV 400 mg | EXPERIMENTAL | - |
| GTI-HCV 800 mg | EXPERIMENTAL | - |
| GT3-HCV 200 mg | EXPERIMENTAL | - |
| GT3-HCV 400 mg | EXPERIMENTAL | - |
| GT3-HCV 800 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MK-6325 | DRUG | Two 100 mg capsules, orally, once per day for 7 days |
| Placebo to MK-6325 | DRUG | Two 100 mg capsules, orally, once per day for 7 days |
Inclusion criteria: * Body mass index (BMI) of 18 to ≤37 kg/m\^2. * Stable health * No clinically significant abnormality on electrocardiogram (ECG) * Clinical diagnosis of chronic HCV infection (G1 or G3) for at least 6 months and detectable HCV RNA in peripheral blood. Exclusion criteria: * Pre...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | - | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Undisclosed |
MK-6325 is an investigational small molecule being developed for the treatment of Hepatitis C. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in humans.
MK-6325 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety, pharmacokinetics, and pharmacodynamics in patients with Hepatitis C.
MK-6325 is in Phase 1 clinical development. A Phase 1 trial has been completed, which enrolled 36 participants with Hepatitis C. The drug is investigational and has not been approved by the FDA or any other regulatory agency.
MK-6325 has one completed clinical trial registered under NCT01329913, titled "Safety, Pharmacokinetics, and Pharmacodynamics of MK-6325 in Hepatitis C Virus (HCV) Infections (MK-6325-003)." This Phase 1 study enrolled 36 participants and was a randomized, double-blind, controlled trial.
No, MK-6325 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Hepatitis C. The completed Phase 1 trial was designed to evaluate safety, pharmacokinetics, and pharmacodynamics, and further studies would be needed before any approval could be considered.