NDAORALTABLETPriority Review
Approved
Apr 2018
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
JYNARQUE (tolvaptan) by Otsuka is vasopressin v2 receptor antagonists [moa]. Approved for vasopressin v2 receptor antagonist [epc]. First approved in 2018.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
JYNARQUE (tolvaptan) is an oral vasopressin V2 receptor antagonist approved in 2018 for autosomal dominant polycystic kidney disease (ADPKD). It works by blocking vasopressin signaling in the kidney's collecting duct, slowing cyst growth and disease progression. The drug represents a significant therapeutic advance in a rare genetic disorder with limited prior treatment options.
$0.076BPart D
Peak3.5 years to LOEProduct is at peak commercial stage with $76M in Part D spending, suggesting mature market presence but limited near-term growth upside for team expansion.
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
Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease
Started Sep 2020
7 enrolled
Polycystic Kidney Disease, AdultADPKD
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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.