Tolvaptan clinical trials
Tolvaptan is named as an intervention in 2 current clinical trials in our UK, USA, Germany, Spain, Belgium, Poland and Japan registers. 1 is recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Otsuka Pharmaceutical Development & Commercialization, Inc (1). The most-studied condition is Autosomal Recessive Polycystic Kidney (ARPKD).
Where Tolvaptan is approved
All regulators →Of the three regulators tracked here, the first to approve Tolvaptan was the US, on 19 May 2009. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of autosomal dominant polycystic kidney disease (5 Aug 2013, withdrawn)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Tolvaptan patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Tolvaptan, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 1 listed patent; the last listed expires 7 Apr 2030 (US 10905694).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Tolvaptan
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Tolvaptan works
All drug targets →- Vasopressin V2 receptor antagonist AntagonistTarget: AVPR2 arginine vasopressin receptor 2✓ In ChEMBL and the Guide to Pharmacology
- DyspneaPhase 3
- Autosomal recessive polycystic kidney diseasePhase 3
- Cardiac edemaPhase 3
- Chronic kidney diseasePhase 3
- Congestive heart failurePhase 3
- EdemaPhase 3
- AscitesPhase 2/3
- CarcinomaPhase 2
- Chronic renal failure syndromePhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL344159, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 2226, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Tolvaptan
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Tolvaptan. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Tolvaptan for treating autosomal dominant polycystic kidney disease NICE TA358 | Optimised | 28 Oct 2015 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Tolvaptan
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 11 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Jinarc, Samsca, Tolvaptan Accord (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Tolvaptan
- ATC code
- C03XA01
- ChEMBL
- CHEMBL344159
- PubChem CID
- 216237
- CAS number
- 150683-30-0
- FDA UNII
- 21G72T1950
- Wikidata
- Q426132
- Wikipedia
- Tolvaptan
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Tolvaptan
2 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
NCT04782258 · Autosomal Recessive Polycystic Kidney (ARPKD)
|
Phase 3 | Recruiting | Otsuka Pharmaceutical Development & Commercialization, Inc | UK, USA, Germany, Spain, Belgium, Poland |
|
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
NCT04790175 · ClinicalTrials.gov ↗ · Antidiuretic Hormone, Inappropriate Secretion
|
Observational | Active, closed | Otsuka Pharmaceutical Co., Ltd | Japan |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Tolvaptan across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
11 single-substance products containing Tolvaptan on the HPRA medicines list.
- Jinarc 15 mg tabletsOtsuka Pharmaceutical Netherlands B.V. · EU/1/15/1000/001-002
- Jinarc 15 mg tablets + Jinarc 45 mg tabletsOtsuka Pharmaceutical Netherlands B.V. · EU/1/15/1000/005-007
- Jinarc 30 mg tabletsOtsuka Pharmaceutical Netherlands B.V. · EU/1/15/1000/003-004
- Jinarc 30 mg tablets + Jinarc 60 mg tabletsOtsuka Pharmaceutical Netherlands B.V. · EU/1/15/1000/008-010
- Jinarc 30 mg tablets + Jinarc 90 mg tabletsOtsuka Pharmaceutical Netherlands B.V. · EU/1/15/1000/011-013
Supply shortages
No entry for Tolvaptan in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Tolvaptan
2 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc | 1 |
| Otsuka Pharmaceutical Co., Ltd | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in UK | 1 | 1 |
| Clinical trials in USA | 1 | 1 |
| Clinical trials in Germany | 1 | 1 |
| Clinical trials in Spain | 1 | 1 |
| Clinical trials in Belgium | 1 | 1 |
| Clinical trials in Poland | 1 | 1 |
| Clinical trials in Japan | 1 | 0 |
A trial with sites in more than one country appears in each of those registers.
Questions about Tolvaptan trials
How many clinical trials are testing Tolvaptan?
2 current trials in our UK, USA, Germany, Spain, Belgium, Poland and Japan registers name Tolvaptan as a drug or biological intervention, as of the registry sync on 12 November 2026. Completed and withdrawn studies are not counted.
Are Tolvaptan trials recruiting patients?
Yes. 1 of the 2 trials is recruiting: 1 with sites in UK, 1 with sites in USA, 1 with sites in Germany, 1 with sites in Spain, 1 with sites in Belgium and 1 with sites in Poland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Tolvaptan clinical trials?
Otsuka Pharmaceutical Development & Commercialization, Inc (1) and Otsuka Pharmaceutical Co., Ltd (1). The number in brackets is how many trials each organisation leads.
Is Tolvaptan licensed in Ireland?
Yes. The HPRA medicines list includes 11 single-substance products containing Tolvaptan, for example Jinarc 15 mg tablets (Otsuka Pharmaceutical Netherlands B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Tolvaptan shortage?
Not in the lists we track: Tolvaptan has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Tolvaptan works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Tolvaptan works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Tolvaptan (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 12 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.