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Jynarque / Samsca tolvaptan APPROVED
Drug Profile
ModalitySmall molecule
RouteORAL
Therapy AreaRare Disease
Launch2009-05-19
US LOE2030-04-01
Peak Sales Est$1000M
Formulations[{"id":"jynarque-oral","route":"ORAL","device":"Tablet (15/15mg, 30/15mg, 45/15mg, 60/30mg, 90/30mg
Companies
4578 (ORIGINATOR)100%
Mechanism: Vasopressin V2 Receptor Antagonist
Expert: Selective antagonist of the arginine vasopressin V2 receptor in renal collecting ducts. Inhibits aquaporin-2 insertion, promoting aquaresis (electrolyte-free water excretion). In ADPKD, reduces cAMP-mediated cyst growth and fluid secretion.
Everyday: Blocks a hormone signal that tells your kidneys to hold onto water. By blocking it, the kidneys release more water while keeping salt, which corrects low sodium levels and reduces fluid buildup in cystic kidneys.
Targets: []
Revenue History
PeriodRevenue ($M)
2024$870M
Programs (3)
IndicationStageKey StudyRegional Status
ADPKDAPPROVEDTEMPO 3:4 / REPRISE[{"stage":"APPROVED","region":"US","approval_date":"2018-04-23"},{"stage":"APPRO
HyponatremiaAPPROVEDSALT-1/SALT-2[{"stage":"APPROVED","region":"US","approval_date":"2009-05-19"},{"stage":"APPRO
Pediatric ARPKDPHASE3Study 204/307[]
Notes
Jynarque brand for ADPKD, Samsca brand for hyponatremia. Orphan exclusivity for Jynarque expired Apr 2025 -- key LOE risk.
Data from Supabase · Updated 2026-03-24