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Label indication DESMODA is indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients. Limitations of Use • DESMODA is not indicated for the treatment of nephrogenic diabetes insipidus. DESMODA is a vasopressin analog indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients. FDA label
Desmopressin · 1 trial · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUCinf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Desmopressin Acetate 0.2 mg Tablets | DRUG | 4 x 0.2 mg, single-dose fasting |
| DDAVP® 0.2 mg Tablets | DRUG | 4 x 0.2 mg, single-dose fasting |
Inclusion Criteria: * Healthy adult non-smoker (for at least 3 months) or light smoking (less than 10 cigarettes per day for at least 3 months) male or female subjects, 18-55 years of age; * Weighing at least 60 kg for males and 52 kg for females; * Subjects who had a body mass index (BMI) less tha...
Desmopressin is a small molecule drug developed by Teva Pharmaceutical Industries Limited (ticker: TEVA). It is also known as Desmopressin Acetate 0.2 mg Tablets. The drug is in Phase 1 clinical development, with one completed trial in healthy volunteers. Its therapeutic area is classified as Other, and the specific indication is undisclosed.
Desmopressin targets the vasopressin receptors AVPR2, AVPR1A, and AVPR1B. It acts as an agonist at these receptors, meaning it activates them. This mechanism is characteristic of desmopressin, a synthetic analog of vasopressin, which regulates water retention and blood pressure.
Desmopressin is developed by Teva Pharmaceutical Industries Limited, a pharmaceutical company traded under the ticker TEVA. Teva is responsible for the development and testing of this drug candidate.
Desmopressin is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials at this time. As a Phase 1 drug, it is investigational and has not been approved by the FDA for any indication.
Desmopressin has been studied in one completed Phase 1 clinical trial, NCT00835211, titled "Desmopressin Acetate 0.2 mg Tablets, Fasting." The trial enrolled 48 healthy volunteers in Canada, was randomized and active-controlled, and has been completed.