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Also known as MKC253 Inhalation Powder
MKC253 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 1.5 mg dose of GLP-1 as MKC253 Inhalation Powder |
| 2 | EXPERIMENTAL | 1.5 mg dose of GLP-1 as MKC253 Inhalation Powder |
| 3 | EXPERIMENTAL | 1.5 mg dose of GLP-1 as MKC253 Inhalation Powder |
| 4 | PLACEBO_COMPARATOR | TIP (placebo comparison) |
| 5 | ACTIVE_COMPARATOR | 10 ug subcutaneous control |
| Name | Type | Description |
|---|---|---|
| MKC253 Inhalation Powder | DRUG | Inhalation Powder, prandial |
| Technosphere Inhalation Powder | DRUG | Inhalation Powder, prandial |
| subcutaneous injection | DRUG | 10µg Exenatide, prandial |
Inclusion Criteria: * Non-smoking males and females between 18 and 70 years of age * Body Mass Index (BMI) of \< 32 kg/m2 * Diabetes managed on a stable regimen of diet and exercise within the preceding 8 weeks and/or metformin and/or a sulfonylurea or meglitinide or alpha glucosidase inhibitors, w...
MKC253 is an investigational inhaled small molecule developed by MannKind Corporation for type 2 diabetes mellitus. It is also known as MKC253 Inhalation Powder and was studied in Phase 1 clinical trials. It is not an approved therapy and remains in clinical development.
MKC253 was studied for the treatment of type 2 diabetes mellitus. Its trials evaluated safety and pharmacological response in adults with type 2 diabetes and in healthy adult males. It has not been approved for any indication and is not available as a commercial treatment.
MKC253 is developed by MannKind Corporation, which trades under the ticker MNKD. MannKind is the sponsor of the clinical program for MKC253 Inhalation Powder.
MKC253 is in Phase 1 clinical development. Both of its recorded trials are Phase 1 studies, and both have been completed. There are no active trials for MKC253 at this time, and it is not FDA approved.
MKC253 has been studied in two completed Phase 1 trials: NCT00642538, which assessed safety and pharmacological response in adults with type 2 diabetes in the Netherlands, and NCT00475371, a first-in-human single-dose safety and tolerability study in healthy adult males. Together they enrolled 46 participants.
Yes, MKC253 and MKC253 Inhalation Powder refer to the same investigational product from MannKind Corporation. The full name reflects its inhaled route of administration, while MKC253 is the shorthand used in trial records and company communications.