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Asset / Drug

Tolvaptan

Drug and asset intelligence for Tolvaptan with 5 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals
4
Catalysts
1
Stage
Development stage unavailable

Sponsor company

Alkem Labs →

Mechanism of action

Vasopressin Antagonist

Recent signals(4)

ClinicalAugust 16, 2026

Study to Evaluate Hydrochlorothiazide in ADPKD Patients to Enhance Tolvaptan Efficacy

A clinical trial is currently being conducted by the University Medical Center Groningen to evaluate the co-administration of hydrochlorothiazide with tolvaptan in approximately 300 patients diagnosed with autosomal dominant polycystic kidney disease (ADPKD).

RegulatoryJuly 28, 2026

FDA Approval Process Update for Tolvaptan by Alkem Labs

The FDA has received an application (ANDA220147) for Tolvaptan from Alkem Labs, currently under standard review.

Strategy
July 25, 2026

FDA Grants Approval for Teva's Tolvaptan ANDA216933

Teva Pharmaceuticals has received an approval for their Abbreviated New Drug Application (ANDA216933) for Tolvaptan.

StrategyJuly 5, 2026

FDA Accepts ANDA for Tolvaptan by Alkem Labs

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Tolvaptan submitted by Alkem Labs.

Upcoming milestones

No catalysts indexed for this entity yet.

Related catalysts(1)

Topline Data

Alkem Labs — Tolvaptan

July 5, 2026 · N/A

Indications

Polycystic Kidney Disease →

Therapeutic areas

Nephrology →
Nephrology · Vasopressin Antagonist →
Polycystic Kidney Disease →
Vasopressin Antagonist →

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