Tolvaptan is under clinical development by Otsuka Pharmaceutical and currently in Phase III for Polycystic Kidney Disease. According to GlobalData, Phase III drugs for Polycystic Kidney Disease have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Tolvaptan’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Tolvaptan overview

Tolvaptan (Samsca, Samtasu) is a diuretic, belongs to vasopressin antagonists. It is formulated as tablets and granules for oral route of administration and powder for solution for intravenous route of administration. Samsca is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). Tolvaptan 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. Samsca is also indicated for the treatment of fluid retention in heart failure, fluid retention in cirrhosis, and hyponatraemia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH) in adults.

It is under development for autosomal recessive polycystic kidney disease (ARPKD) in pediatric population.

It was under development for carcinomatous edema, hepatic edema and chronic renal failure (on volume overload in peritoneal dialysis and hemodialysis)

Otsuka Pharmaceutical overview

Otsuka Pharmaceutical (OPC), a subsidiary of Otsuka Holdings Co Ltd, is a manufacturer and supplier of pharmaceuticals, food products, clinical testing, and medical equipment. The company develops formulations for diagnosis and treatment of central nervous system, oncology, cardiovascular and renal, gastrointestinal, ophthalmology disorders and infectious diseases through its pharmaceutical business. It’s nutraceutical segment offers rehydration, nutrition, vitamin supplements and cosmetics. OPC is investigating drugs for psychiatry and neurology; oncology; cardiovascular and other therapeutic indications in collaboration with academia and venture companies. The company operates branch offices, research facilities and factories in Japan. OPC is headquartered in Chiyoda-ku, Tokyo, Japan.

For a complete picture of Tolvaptan’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.