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Technosphere Insulin SAR439065 Afrezza · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Afrezza® | EXPERIMENTAL | Two-period, replicate single dose, euglycemic clamp study. There will be 2 treatment periods with a replicate administration of 1 dose of Afrezza TI (40U) in both periods. Each patient will be given a replicate administration of 1 dose level of Afrezza TI with washout duration between treatment periods (5-19 days between periods, ie, 7 to 21 days between dosing occasions). |
| Name | Type | Description |
|---|---|---|
| Technosphere Insulin SAR439065 Afrezza® | DRUG | Pharmaceutical form: dry powder Route of administration: oral inhalation |
Inclusion criteria : * Body weight between 50 and 95 kg, inclusive, body mass index between 18.5 and 29 kg/m², inclusive. * Fasting serum C-peptide \<0.3 nmol/L. * Glycohemoglobin (HbA1c) ≤75 mmol/mol (≤9%). * Stable insulin regimen for at least 2 months prior to study (with respect to safety of th...
Technosphere Insulin SAR439065 Afrezza is an investigational inhaled insulin being developed for the treatment of Type 1 Diabetes Mellitus. It is a small molecule therapeutic in the metabolic area. The drug is currently in Phase 1 clinical development and has not been approved by the FDA.
Technosphere Insulin SAR439065 Afrezza is an inhaled insulin formulation. Insulin works by replacing the body's natural insulin to help regulate blood glucose levels. The drug is being studied for its pharmacokinetic and pharmacodynamic properties in patients with Type 1 Diabetes Mellitus.
Technosphere Insulin SAR439065 Afrezza is being developed by MannKind Corporation, a biopharmaceutical company listed on the NASDAQ under the ticker symbol MNKD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 1 Diabetes Mellitus.
Technosphere Insulin SAR439065 Afrezza is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The drug has been granted Breakthrough Therapy designation by the FDA, which is intended to expedite the development and review of drugs for serious conditions.
Technosphere Insulin SAR439065 Afrezza has one completed Phase 1 clinical trial, NCT02485327, which studied the pharmacokinetic and pharmacodynamic within-subject variability of a single dose in patients with Type 1 Diabetes Mellitus. The trial enrolled 22 participants in Germany and was not randomized or double-blinded.
Yes, Technosphere Insulin SAR439065 Afrezza is also known as Afrezza. The drug is an inhaled insulin formulation being developed by MannKind Corporation for the treatment of Type 1 Diabetes Mellitus. It is currently in Phase 1 clinical development and has Breakthrough Therapy designation from the FDA.