Active-ingredient Dossier

Tolvaptan

Active-ingredient Dossier for Tolvaptan (vasopressin receptor antagonist). Australian brands, products, PBS listings, PBAC outcomes — compiled by…

Brand: JINARC
Brand: SAMSCA
Brand: TOLVAPTAN
Therapeutic area: Renal
Therapeutic area: Endocrinology

What is

Tolvaptan Tolvaptan is a vasopressin receptor antagonist.

Australian brands containing

Tolvaptan — JINARC — TOLVAPTAN — SAMSCA

Therapeutic areas

Tolvaptan is registered in two therapeutic areas: urology, where two brands are registered, and endocrinology, where one brand is registered.

Sponsor landscape

Two sponsors market tolvaptan-containing products in Australia: Otsuka Australia Pharmaceutical and Lupin.

PBS and regulatory activity

One brand containing tolvaptan has PBS-listed items, with the latest schedule date of 1 May 2026. The latest PBAC outcome was recorded on 1 November 2021, and the latest AusPAR was issued on 10 March 2017.