NDAORALTABLET
Approved
May 2009
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
6/8 — Strong
SAMSCA (tolvaptan) by Otsuka is vasopressin v2 receptor antagonists [moa]. Approved for vasopressin v2 receptor antagonist [epc]. First approved in 2009.
Drug data last refreshed 31m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SAMSCA (tolvaptan) is an oral vasopressin V2 receptor antagonist approved in 2009 for treating hyponatremia (low sodium levels) in hospitalized patients and those with chronic conditions. It works by blocking V2 receptors in the kidney's collecting duct, increasing free water excretion and normalizing serum sodium. This mechanism directly addresses fluid retention disorders driven by inappropriate antidiuretic hormone (ADH) activity.
$12MPart D
LOE ApproachingStable
3.4 years to LOENear-term LOE (3.5 years) with modest Part D footprint signals a contracted team focused on revenue defense rather than expansion initiatives.
Mechanism of Action
Vasopressin V2 Receptor Antagonists
Pharmacologic Class:
Vasopressin V2 Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
Started Jan 2023
20 enrolled
Autosomal Recessive Polycystic Kidney (ARPKD)
Probenecid (PB) to Treat Hereditary Nephrogenic Diabetes Insipidus (NDI), ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration
Started Sep 2022
36 enrolled
Autosomal Dominant Polycystic Kidney DiseaseNephrogenic Diabetes InsipidusAcquired Nephrogenic Diabetes Insipidus+1 more
A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
Started Jul 2022
0Autosomal Recessive Polycystic Kidney Disease (ARPKD)
Tolvaptan add-on Therapy to Overcome Loop Diuretic Resistance in Acute Heart Failure With Renal Dysfunction
Started Dec 2021
128 enrolled
Acute Heart Failure
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
Started Mar 2021
300 enrolled
Antidiuretic Hormone, Inappropriate Secretion
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.