Product Description
Tolvaptan is a new agent in the treatment of normovolemic and hypervolemic hyponatremia. It is a V(2) receptor antagonist inducing free water diuresis. It has been recently approved in USA and Europe for the treatment of hyponatremia associated with SIADH, cirrhosis as well as heart failure, while in hypovolemic hyponatremia its use is contraindicated. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/20868352/)
Mechanisms of Action: AVP Antagonist,V2 Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Canada | China | Croatia | Czech | Denmark | Dominican Republic | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Turkey | United Kingdom | United States | Vietnam
Approved Indications: Kidney Diseases | Polycystic Kidney, Autosomal Dominant | Heart Failure | Inappropriate ADH Syndrome | Hyponatremia
Known Adverse Events: Polyuria | Nocturia | Hyperglycemia | Asthenia | Constipation
Company: Otsuka
Company Location: NEW YORK NY 10271
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Belgium, China, France, Germany, Italy, Poland, Spain, United Kingdom, United States
Active Clinical Trial Count: 6
Highest Development Phases
Phase 3: Hyponatremia|Kidney Diseases|Kidney Diseases, Cystic|Polycystic Kidney Diseases|Polycystic Kidney, Autosomal Recessive
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| NCT04782258 | P3 |
Recruiting |
Kidney Diseases, Cystic|Polycystic Kidney, Autosomal Recessive|Polycystic Kidney Diseases |
2028-02-23 |
|
| NCT04786574 | P3 |
Recruiting |
Kidney Diseases, Cystic|Polycystic Kidney, Autosomal Recessive|Polycystic Kidney Diseases |
2027-10-11 |
49% |
| 156-12-204 | P3 |
Unknown Status |
Polycystic Kidney, Autosomal Recessive|Kidney Diseases |
2027-07-22 |
|
| 156-201-00307 | P3 |
Unknown Status |
Polycystic Kidney, Autosomal Recessive|Kidney Diseases |
2025-12-17 |