Miv-818 (Fostroxacitabine Bralpamide) + Pembrolizumab, Miv-818 (Fostroxacitabine Bralpamide) + Lenvatinib
Hepatocellular Carcinoma, Liver Metastases, Intrahepatic Cholangiocarcinoma
Phase I/II
Completed
A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations
Nov 07, 2018
―
Miv-711
Healthy
Phase I
Completed
A Bioavailability Study of MIV-711 Oral Formulations in Healthy Volunteers
Jan 22, 2018
―
Miv-711
Osteoarthritis, Knee
Phase II
Completed
A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Dec 22, 2016
―
Miv-711
Osteoarthritis, Knee
Phase II
Completed
A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Mar 07, 2016
―
Pembrolizumab, Birinapant
Solid Tumors
Phase I/II
Terminated
Dose-escalation Study of Birinapant and Pembrolizumab in Solid Tumors
Oct 21, 2015
―
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Medivir AB (MVR0) have in its pipeline
MVR0 is currently developing the following drugs: Miv-818 (Fostroxacitabine Bralpamide) + Pembrolizumab, Miv-818 (Fostroxacitabine Bralpamide) + Lenvatinib, Miv-711, Miv-711. These drug candidates are in various stages of clinical development as the company works toward FDA approval.