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Drug

Tolvaptan

Approved · FDA / EMA
Emerging researchLate-stage development
Also known as Jynarque, Jynarque 45 mg + 15 mg, Jynarque 60 mg + 30 mg, Jynarque 90 mg + 30 mg+1 more

Jynarque, Jynarque 45 mg + 15 mg, Jynarque 60 mg + 30 mg, Jynarque 90 mg + 30 mg, Samsca.

RxNorm358257ChEMBLCHEMBL4303142UNII1E2497LPNY
2
Research papers
1
Active clinical trials
5
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: TOLVAPTAN (ANDA216933)

Regulatory2026-07-21FDA

A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 18 Years of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

Clinical trial2026-07-15Results expected Q3 2028 · ClinicalTrials.gov

A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 12 Weeks of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

Clinical trial2025-12-10Withdrawn · ClinicalTrials.gov

An Open Label, Tolvaptan-controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Ascending Dose of HRS-9057 in Heart Failure With Volume Overload

Clinical trial2025-10-29Completed · ClinicalTrials.gov

Acute Heart Failure With High Copeptin Levels Treated With Tolvaptan Targets Increased AVP Activation for Treatment Efficacy

Clinical trial2024-11-20Withdrawn · ClinicalTrials.gov

A Multicenter, Open-labeled, Dose-defining Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload

Clinical trial2024-08-23Results posted · ClinicalTrials.gov

Tolvaptan add-on Therapy to Overcome Loop Diuretic Resistance in Acute Heart Failure With Renal Dysfunction

Clinical trial2023-06-30Primary completion · ClinicalTrials.gov

Approval: Jinarc (EMA)

Regulatory2015-05-27EMA

Drug Safety Update: Tolvaptan (Samsca▼): over-rapid increase in serum sodium risking serious neurological events

Regulatory2014-12-11MHRA

Drug Safety Update: Tolvaptan (Samsca▼): risk of liver injury

Regulatory2014-12-11MHRA

Tolvaptan in autosomal dominant polycystic kidney disease: three years' experience.

Research2011-09-08Clinical journal of the American Society of Nephrology : CJASN

Oral tolvaptan is safe and effective in chronic hyponatremia.

Research2010-02-25Journal of the American Society of Nephrology : JASN

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tolvaptan
Aliases & brands
JynarqueJynarque 45 mg + 15 mgJynarque 60 mg + 30 mgJynarque 90 mg + 30 mgSamsca
RxNorm CUI
358257
ChEMBL ID
CHEMBL4303142
UNII
1E2497LPNY
Regulatory jurisdictions
emamhrafda

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2009-08-02
Latest approval
2026-07-21
Authorities
FDA · EMA · MHRA
Total events
5
fdaU.S. Food and Drug Administration· 1 event
2026-07-21Approval
Approval: TOLVAPTAN (ANDA216933)
Evidence ↗
emaEuropean Medicines Agency· 2 events
2015-05-27Approval
Approval: Jinarc (EMA)
Indication: 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… Show full indication

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.

Evidence ↗
2009-08-02Approval
Approval: Samsca (EMA)

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

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2014-12-11Safety communicationSafety
Drug Safety Update: Tolvaptan (Samsca▼): risk of liver injury
Evidence ↗
2014-12-11Safety communicationSafety
Drug Safety Update: Tolvaptan (Samsca▼): over-rapid increase in serum sodium risking serious neurological events
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

76 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
76
registered trials across all phases
LATEST COMPLETION 2025
1
Active studies
1
Recruiting
55
Late-stage (III+)
52
Completed
23
Discontinued
PHASE DISTRIBUTIONn = 76
Phase 17Phase 1 / 21Phase 213Phase 2 / 32Phase 328Phase 418Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease

CompletedPH IVKorea Otsuka Pharmaceutical Co., Ltd.n=1182022

Tolvaptan Treatment to Reverse Worsening Outpatient Heart Failure: Possible Role of Copeptin In Identifying Responders (TROUPER)

CompletedPH IVUniversity of North Carolina, Chapel Hilln=402021

Tolvaptan for the Management of Acute Decompensated Heart Failure in Patients With Advanced or Refractory Heart Failure

TerminatedPH IVUniversity of Calgaryn=92020

Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease

Unknown statusPH IVLisbet Brandin=902020

Regional Tolvaptan Registry

Unknown statusPH IVCardiology Research UBCn=252020

Recent completions

Trials that read out recently, adding to the completed evidence base.

An Open Label, Tolvaptan-controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Ascending Dose of HRS-9057 in Heart Failure With Volume Overload

CompletedPH IFujian Shengdi Pharmaceutical Co., Ltd.n=252025

Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease

CompletedPH IVKorea Otsuka Pharmaceutical Co., Ltd.n=1182022

A Pilot, Phase II Study With a Prospective, Randomized, Cross-Over, Placebo-Controlled, Double-Blind Design to Assess the Short-Term Effects of Tolvaptan Plus Placebo vs Tolvaptan Plus Octreotide LAR Combination Therapy in ADPKD Patients With Normal Kidney Function or Hyperfiltration

CompletedPH IIMario Negri Institute for Pharmacological Researchn=202021

A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan Followed by a Two Year Open-label Extension in Children and Adolescent Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

CompletedPH IIIOtsuka Pharmaceutical Development & Commercialization, Inc.n=912021

A Multicenter, Open-labeled, Dose-defining Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload

CompletedPH IIIOtsuka Pharmaceutical Co., Ltd.n=602021

Tolvaptan Treatment to Reverse Worsening Outpatient Heart Failure: Possible Role of Copeptin In Identifying Responders (TROUPER)

CompletedPH IVUniversity of North Carolina, Chapel Hilln=402021

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20102011
Most influential

Oral tolvaptan is safe and effective in chronic hyponatremia.

Journal of the American Society of Nephrology : JASN · 2010 · 225 cites

Tolvaptan in autosomal dominant polycystic kidney disease: three years' experience.

Clinical journal of the American Society of Nephrology : CJASN · 2011 · 113 cites
Recent papers

Tolvaptan in autosomal dominant polycystic kidney disease: three years' experience.

Clinical journal of the American Society of Nephrology : CJASN · 2011 · 113 cites

Oral tolvaptan is safe and effective in chronic hyponatremia.

Journal of the American Society of Nephrology : JASN · 2010 · 225 cites
Major research themes1
Antidiuretic Hormone Receptor Antagonists2
Journals, researchers & institutions
Top journals
  • Clinical journal of the American Society of Nephrology : CJASN1
  • Journal of the American Society of Nephrology : JASN1
Leading researchers
  • Czerwiec FS2
  • Ouyang J2
  • Bae K1
  • Berl T1
  • Bichet DG1
  • Chapman AB1
  • Grantham JJ1
  • Higashihara E1
Leading institutions
free-text, unnormalised
  • Kyorin University School of Medicine1
  • University of Colorado Denver1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.