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Medicinova (MNOV)
NASDAQ:MNOV
Mn-001
Diabetes Mellitus, Type 2, Hypertriglyceridemia, Non-Alcoholic Fatty Liver Disease
Phase II
Recruiting
MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
Jun 28, 2022
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Ibudilast
Pneumonia, Viral
Phase II
Completed
Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN-166) in Patients Hospitalized With COVID-19 at Risk for ARDS
Jun 09, 2020
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Mn-166
Healthy Volunteers
Phase I
Completed
Relative Bioavailability of MN-166 (Ibudilast) in Extended Release Tablet vs. Intermediate-release Capsule in Healthy Volunteers
Aug 06, 2019
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Mn-166
Amyotrophic Lateral Sclerosis
Phase II/III
Active Not Recruiting
Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS
Aug 06, 2019
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Temozolomide, Mn-166
Glioblastoma, Gbm, Recurrent Glioblastoma, Newly Diagnosed Glioblastoma
Phase I/II
Completed
Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma
Dec 17, 2018
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Mn-166
Healthy Volunteers
Phase I
Completed
Study of MN-166 (Ibudilast) Extended Release Tablet Formulations Compared With Capsules in Healthy Volunteers
Apr 18, 2018
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Ibudilast
Amyotrophic Lateral Sclerosis
Phase I/II
Completed
A Biomarker Study to Evaluate MN-166 in Subjects With Amyotrophic Literal Sclerosis (ALS)
Mar 09, 2016
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Mn-001
Hypercholesterolemia, Hypertriglyceridemia, Non-Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
Phase II
Completed
Open-Label Study To Evaluate MN-001 on HDL & Triglyceride in NASH & NAFLD Subjects
Feb 05, 2016
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Mn-001
Idiopathic Pulmonary Fibrosis, Ipf
Phase II
Completed
Safety, Tolerability, and Efficacy of MN-001 (Tipelukast) in Patients With Idiopathic Pulmonary Fibrosis
Jul 14, 2015
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Mn-166, Riluzole
Amyotrophic Lateral Sclerosis
Phase II
Completed
Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Sep 04, 2014
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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 Medicinova (MNOV) have in its pipeline
MNOV is currently developing the following drugs: Mn-001, Ibudilast, Mn-166. These drug candidates are in various stages of clinical development as the company works toward FDA approval.