Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MN-001 BID, Tipelukast
MN-001 · 4 trials · 8 indications
Predicted forced vital capacity (FVC) is a reference value for lung function based on your age, height, sex, and ethnicity measured by a spirometer and is an established method of pulmonary function. FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters (L).
FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters (L). The mean relative change was calculated as 100\*\[FVC (L) at Week 26 - FVC (L) at baseline\].
FVC(%pred.) refers to the expected FVC for a healthy individual with the same age, sex, height, and weight. The actual FVC result is then expressed as a percentage of this predicted value; values of 80% or higher are generally considered normal and indicate no significant impairment.
FVC (%pred/) refers to the expected FVC for a healthy individual with the same age, sex, height, and weight. The actual FVC result is then expressed as a percentage of this predicted value; values of 80% or higher are generally considered normal and indicate no significant impairment. Relative change is measured as percent (%) change from FVC (%pred.).
The semiannual rates of change in FVC, measured in liters, were estimated using simple linear regression, with time measured in half-years.
Change from baseline to 12 weeks of MN-001 on Cholesterol Efflux Capacity (CEC) in NAFLD subjects with hypertriglyceridemia. CEC, a key step in reverse cholesterol transport, was inversely associated with the incidence of cardiovascular events and is considered to be a new biomarker to assess cardiovascular risk. Cholesterol efflux was calculated as the percent of cholesterol removed from the cells and appearing in the culture medium normalized to a reference serum pool. The ability of serum HDL to remove cholesterol from cultured cells was assessed as an in vitro method to evaluate functional changes in HDL mediated by changes due to MN-001 treatment.
Change from baseline to 8 weeks of MN-001 on serum triglyceride levels in NASH subjects with hypertriglyceridemia
The primary endpoint was the GRA overall change "in their condition" at Week 8. Each patient completed the questionnaire that rated the improvement in their IC symptoms based on responses to the GRA questions. Each question asked the patient to describe the OVERALL CHANGE in pain, urgency, frequency or overall change in their problem compared to the status before taking the study medication. Each parameter was rated on a 7 point scale: markedly worse, moderately worse, mildly worse, same, mildly improved, moderately improved and markedly improved.
| Arm | Type | Description |
|---|---|---|
| MN-001 | EXPERIMENTAL | - |
| MN-001 Placebo | PLACEBO_COMPARATOR | The placebo comparator is a tablet identical in appearance to MN-001. |
| MN-001 in Double-blind period for 26 weeks, then MN-001 in Open-Label period for 26 weeks | EXPERIMENTAL | MN-001 750 mg twice a day during the double-blind period (26 weeks) and MN-001 750 mg twice a day during the open-label period for 26 weeks. The arm title is shortened to MN-001/MN-001 for all results sections. |
| Placebo during Double-blind period for 26 weeks, then MN-001 in Open-Label period for 26 weeks | PLACEBO_COMPARATOR | Placebo twice a day during the double-blind period for 26 weeks and MN-001 750 mg twice daily during the open-label period for 26 weeks. The arm title is shortened to Placebo/MN-001 for all results sections. |
| open label arm | EXPERIMENTAL | All 40 subjects will receive MN-001 for the first 4 weeks. At Week 4 subjects will increase their dosage frequency for remaining 8 weeks. Subjects will receive MN-001 for a total of 12 weeks. |
| MN-001 once daily | PLACEBO_COMPARATOR | placebo tablets |
| Name | Type | Description |
|---|---|---|
| MN-001 | DRUG | MN-001 is a novel, orally bioavailable small molecule compound |
| MN-001 placebo | DRUG | The placebo tablet is identical in appearance to the MN-001 tablet, and contains excipients of MN-001. |
| Placebo | DRUG | Excipients of MN-001/tipelukast |
| MN-001 BID | DRUG | Eligible patients received 500 mg MN-001 bid |
Inclusion Criteria: * FibroScan® CAP score ≥ 248 dB/m within 8 weeks of randomization. * Diagnosis or history of Type 2 Diabetes mellitus with hemoglobin A1c (HbA1c) \>6.5 and ≤10% at Screening. * Fasting serum triglycerides (TG) at Screening \>150 mg/dL * On a stable dose of oral antidiabetic ther...
MN-001 is an investigational small molecule developed by MediciNova, Inc. (NASDAQ: MNOV). It is being studied in Phase 2 clinical trials for several conditions, including type 2 diabetes mellitus, idiopathic pulmonary fibrosis, interstitial cystitis, and non-alcoholic steatohepatitis. It is also known as MN-001 BID.
MN-001 is being evaluated for type 2 diabetes mellitus, idiopathic pulmonary fibrosis, interstitial cystitis, and non-alcoholic steatohepatitis. It has been studied in Phase 2 trials across these indications, including a completed Phase 2 study in interstitial cystitis with 296 patients and a completed Phase 2 study in idiopathic pulmonary fibrosis.
MN-001 is developed by MediciNova, Inc., a biopharmaceutical company that trades under the ticker MNOV. MediciNova is the sponsor of the Phase 2 clinical trials evaluating MN-001 in type 2 diabetes, idiopathic pulmonary fibrosis, interstitial cystitis, and non-alcoholic steatohepatitis.
MN-001 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. Multiple Phase 2 trials have been completed, and one Phase 2 trial, NCT05464784, is active but not recruiting. The completed studies include evaluations in interstitial cystitis, idiopathic pulmonary fibrosis, and non-alcoholic steatohepatitis.
MN-001 has been studied in Phase 2 trials including NCT05464784 in non-alcoholic fatty liver disease, type 2 diabetes, and hypertriglyceridemia; NCT02681055 in NASH and NAFLD; NCT02503657 in idiopathic pulmonary fibrosis; and NCT00295854 in interstitial cystitis. NCT05464784 is active but not recruiting, while the others are completed.
Yes, MN-001 BID is an alternative name for MN-001. Both refer to the same investigational small molecule developed by MediciNova, Inc. (MNOV). The BID designation reflects twice-daily dosing. MN-001 is also known by the name tipelukast, which appears in the title of its Phase 2 idiopathic pulmonary fibrosis trial.