DDAVP (desmopressin acetate)
DDAVP is indicated for the treatment of Central Diabetes Insipidus; Polyuria; Polydipsia; Hemophilia A; von Willebrand's Disease.
How DDAVP Works
Desmopressin acetate acts as a replacement for antidiuretic hormone by stimulating V2 receptors in the kidneys, which increases water re-absorption and reduces urine production. In patients with Hemophilia A and von Willebrand's disease Type I, it increases plasma levels of Factor VIII activity. The structural modification of natural arginine vasopressin to desmopressin results in a longer duration of action and a significant reduction in vasopressor activity and effects on visceral smooth muscle.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1978-02-21
- Routes
- NASAL, INJECTION, ORAL
- Dosage Forms
- SOLUTION, SPRAY, METERED, INJECTABLE, TABLET
DDAVP Approval History
What DDAVP Treats
5 indicationsDDAVP is approved for 5 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Central Diabetes Insipidus
- Polyuria
- Polydipsia
- Hemophilia A
- von Willebrand's Disease
DDAVP Boxed Warning
HYPONATREMIA DDAVP can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death [see Warnings and Precautions (5.1) ] . DDAVP is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids [see Contraindications (4) and Warnings and Precautions (5.1...
WARNING: HYPONATREMIA DDAVP can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death [see Warnings and Precautions (5.1) ] . DDAVP is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids [see Contraindications (4) and Warnings and Precautions (5.1) ] . Ensure the serum sodium concentration is normal before starting or resuming DDAVP. Measure serum sodium within 7 days and approximately 1 month after initiating therapy, and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ] . If hyponatremia occurs, DDAVP may need to be temporarily or permanently discontinued [see Warnings and Precautions (5.1) ] . WARNING: HYPONATREMIA See full prescribing information for complete boxed warning. DDAVP can cause hyponatremia, which may be life-threatening if severe. ( 5.1 ) DDAVP is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids. ( 4 , 5.1 ) Ensure serum sodium concentration is normal before starting or resuming DDAVP. Measure serum sodium within 1 week and approximately 1 month after starting therapy and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia. ( 2.1 , 5.1 ) If hyponatremia occurs, interrupt or discontinue DDAVP. ( 5.1 )
DDAVP Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06020495 DASSOH | APHP220676 | Ph 3 | recruiting | Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia |
| NCT01982760 results posted | 07-10-21 | Ph 2 | terminated | DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty |
| NCT00748072 results posted | DDAVP 01 | Ph 4 | completed | 1-deamino 8-d-arginine Vasopressin (DDAVP) in Percutaneous Ultrasound-guided Renal Biopsy |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DDAVP FDA Label Details
Indications & Usage
FDA Label (PDF)DDAVP is indicated for the treatment of Central Diabetes Insipidus; Polyuria; Polydipsia; Hemophilia A; von Willebrand's Disease.
WARNING: HYPONATREMIA DDAVP can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death [see Warnings and Precautions (5.1) ] . DDAVP is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excess...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment