Friday, July 10, 2026

Drug profile · INN

tolvaptan

tolvaptan (JINARC) is a vasopressin v2 receptor antagonist. Associated with Otsuka Beijing Research Institute. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved NMPA: clinical trials Cardiovascular system (C03) C03XA01
US status approved
Patents linked 0
Pipeline programs 5
News articles 0
Drug details — tolvaptan
US status
approved
Class
Cardiovascular system (C03)
Route
ORAL
Patents
0
Programs
5
Data quality
0.84

Quick answer

tolvaptan (JINARC) is a vasopressin v2 receptor antagonist. Associated with Otsuka Beijing Research Institute. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN tolvaptan
Brand JINARC
Mechanism Vasopressin V2 receptor antagonist
Target Vasopressin V2 receptor
Therapeutic class Cardiovascular system (C03)
Route ORAL
Formulation TABLET
ATC code C03XA01

Mechanism of action

Vasopressin V2 receptor antagonist

Primary target: Vasopressin V2 receptor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved
NMPA clinical trials

Pipeline programs

  1. 156-201-00307 Phase 3 · Otsuka Beijing Research · Autosomal Recessive Polycystic Kidney Disease
  2. Tolvaptan Phase 3 · Otsuka Beijing Research · Cardiac Edema
  3. Tolvaptan Phase 3 · Otsuka Beijing Research · Autosomal Recessive Polycystic Kidney Disease
  4. Tolvaptan 15mg or 30mg or 60mg or Placebo Phase 1 · Otsuka Beijing Research · Healthy
  5. Tolvaptan Approved · Otsuka Beijing Research · Hyponatremia and Extracellular Fluid in Cirrhotic

Related & competitor drugs

  1. alirocumab Cardiovascular system (C10)
  2. aliskiren Cardiovascular system (C09)
  3. azilsartan medoxomil Cardiovascular system (C09)
  4. bempedoic acid Cardiovascular system (C10)
  5. bosentan Cardiovascular system (C02)
  6. dofetilide Cardiovascular system (C01)

Frequently asked questions

What is tolvaptan?

tolvaptan (JINARC) is a vasopressin v2 receptor antagonist. Associated with Otsuka Beijing Research Institute. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for tolvaptan?

JINARC is a marketed brand name for tolvaptan. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of tolvaptan?

tolvaptan has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.