Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Technosphere · 2 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| T Inhalation powder in diabetic subjs w/ normal renal func | EXPERIMENTAL | T inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units |
| T Inhalation powder diabetic subj w/mild or moderate nephrop | EXPERIMENTAL | T Inhalation powder in diabetic subjects w/mild or moderate nephropathy - Single dose, 30 units |
| Name | Type | Description |
|---|---|---|
| Technosphere Inhalation Powder (FDKP) | DRUG | Technosphere® Inhalation Powder 20mg |
| Moxifloxacin | DRUG | Tablets 400mg |
| Placebo | DRUG | Placebo cartridges |
| Technosphere Inhalation Powder | DRUG | Technosphere Inhalation Powder |
Inclusion Criteria: * Pulmonary Function Tests (PFTs) results within study specified limits. * Female subjects of childbearing potential must be non-pregnant and non-lactating and have a negative serum pregnancy test prior to enrollment into the trial. * Body Mass Index = 19 and = 30 kg/m2 * Absenc...
Technosphere is an inhaled insulin delivery technology being studied for use in Type 2 Diabetes Mellitus, as well as in healthy subjects, and in patients with mild nephropathy, moderate nephropathy, or chronic obstructive pulmonary disease (COPD). It is an investigational small molecule product developed by MannKind Corporation.
Technosphere is being developed by MannKind Corporation, a biopharmaceutical company traded under the ticker symbol MNKD. The company is conducting clinical trials to evaluate the inhaled insulin formulation in various patient populations.
Technosphere is in Phase 1 clinical development. The most recent trials listed are Phase 1 studies, including one completed trial in healthy subjects and another in diabetic patients with kidney disease. Earlier Phase 2 studies have also been completed.
Technosphere has been studied in several completed trials, including NCT00419302 in Type 2 Diabetes, NCT00626249 in diabetic patients with kidney disease, NCT00721344 in healthy subjects, and NCT01021891 in patients with COPD. All trials listed are completed.
Technosphere is not FDA approved. It is an investigational product still in clinical development, with all listed trials completed. No approval status has been granted based on the available clinical trial information.