Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MP-424 · 2 trials · 1 indication
Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.
Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.
Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.
Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.
Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.
| Arm | Type | Description |
|---|---|---|
| MP-424 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MP-424 | DRUG | 750 mg every 8 hours for 12 weeks |
| Ribavirin | DRUG | 600 - 1000 mg/day based on body weight for 24 weeks |
| Peginterferon Alfa-2b | DRUG | 1.5 mcg/kg/week for 24 weeks |
| MP-424 (Telaprevir) | DRUG | Three tablets of MP-424 250mg tablet at a time, every 8 hours, 12 weeks administration (dose in a day: 2250 mg) |
Inclusion Criteria: * Genotype 1, chronic hepatitis C * Relapsers (patient who relapsed after previous treatment) * Able and willing to follow contraception requirements Exclusion Criteria: * Cirrhosis of the liver or hepatic failure * Hepatitis B surface antigen-positive or HIV antibodies-positi...
MP-424 is an investigational small molecule being developed for the treatment of Hepatitis C and Chronic Hepatitis C. It is being studied in combination with peginterferon alfa-2b and ribavirin in patients with chronic Hepatitis C who have relapsed after prior interferon-based therapy.
MP-424 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company has conducted clinical trials of MP-424 in Japan for the treatment of Hepatitis C.
MP-424 is in Phase 3 clinical development. A Phase 3 trial, NCT00780910, has been completed, evaluating the efficacy and safety of MP-424 in combination with peginterferon alfa-2b and ribavirin in patients with chronic Hepatitis C who relapsed after previous interferon-based therapy.
MP-424 has been studied in four completed clinical trials in Japan. These include NCT00591214 (Phase 1 safety and pharmacokinetics), NCT00621296 (Phase 2 safety and efficacy), NCT00630058 (Phase 1 combination study), and NCT00780910 (Phase 3 efficacy and safety study). All trials enrolled adult patients with Hepatitis C.
MP-424 is not FDA approved. It is an investigational drug that has completed clinical trials but remains in clinical development. The available data shows completed Phase 1, Phase 2, and Phase 3 trials, but no approval status has been reported.