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Tolvaptan Oral Tablet

Phase 3
OTSUKA (OTSKF)

Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

3

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Syndrome of Inappropriate Antidiuretic Hormone Secretion

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Drug Information

Target Indication

Syndrome of Inappropriate Antidiuretic Hormone Secretion

Clinical Trial

NCT03048747

Last updated: 12/17/2025

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMAPending

Tolvaptan Accord

Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

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EMA5/27/2015

Jinarc

Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.

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EMA8/2/2009

Samsca

Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH).

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Drug Science
Mechanism of action & safety profile
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