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Ascites

7
Pipeline Programs
5
Companies
11
Clinical Trials
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
2
0
1
4
Early DiscoveryClinical DevelopmentMarket

On Market (3)

Approved therapies currently available

Otsuka
JYNARQUEApproved
tolvaptan
Otsuka
Vasopressin V2 Receptor Antagonist [EPC]oral2018
76M Part D
Otsuka
SAMSCAApproved
tolvaptan
Otsuka
Vasopressin V2 Receptor Antagonist [EPC]oral2009
12M Part D
Otsuka
TOLVAPTANApproved
tolvaptan
Otsuka
oral2025
3M Part D

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Otsuka
OtsukaJapan - Tokushima
3 programs
1
1
1
TolvaptanPhase 41 trial
TolvaptanPhase 31 trial
TolvaptanPhase 21 trial
Active Trials
NCT01349335Completed180Est. Apr 2010
NCT01349348Completed535Est. Jul 2012
NCT01292304Completed10Est. Jan 2015
BioVie
BioVieNV - Carson City
1 program
1
BIV201 continuous infusionPhase 21 trial
Active Trials
NCT04112199Terminated15Est. May 2023
Sequana Medical
Sequana MedicalGermany - Munich
1 program
AlfapumpN/A1 trial
Active Trials
NCT03973866Active Not Recruiting110Est. Jun 2024
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
1 program
Portal venous pressureN/A1 trial
Active Trials
NCT01073345Unknown110Est. Dec 2010
Sanofi
SanofiPARIS, France
1 program
SatavaptanPHASE_35 trials
Active Trials
NCT00358878Completed463Est. Dec 2008
NCT00501384Completed151Est. May 2005
NCT00501566Completed148Est. Jan 2005
+2 more trials

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
OtsukaTolvaptan
OtsukaTolvaptan
SanofiSatavaptan
BioVieBIV201 continuous infusion
OtsukaTolvaptan
SanofiSatavaptan
SanofiSatavaptan
SanofiSatavaptan
SanofiSatavaptan
Sequana MedicalAlfapump
Heidelberg PharmaPortal venous pressure

Clinical Trials (11)

Total enrollment: 1,867 patients across 11 trials

NCT01292304OtsukaTolvaptan

Tolvaptan for Ascites in Cirrhotic Patients

Start: Mar 2012Est. completion: Jan 201510 patients
Phase 4Completed
NCT01349348OtsukaTolvaptan

Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites

Start: Oct 2010Est. completion: Jul 2012535 patients
Phase 3Completed
NCT00358878SanofiSatavaptan

Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)

Start: Jul 2006Est. completion: Dec 2008463 patients
Phase 3Completed
NCT04112199BioVieBIV201 continuous infusion

A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites

Start: Jun 2021Est. completion: May 202315 patients
Phase 2Terminated
NCT01349335OtsukaTolvaptan

Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites

Start: Apr 2009Est. completion: Apr 2010180 patients
Phase 2Completed
NCT00501722SanofiSatavaptan

Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites

Start: Apr 2004Est. completion: Mar 2005110 patients
Phase 2Completed
NCT00501384SanofiSatavaptan

Satavaptan Dose-Ranging Study in the Prevention of Ascites

Start: Apr 2004Est. completion: May 2005151 patients
Phase 2Completed
NCT00501566SanofiSatavaptan

Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites

Start: Apr 2004Est. completion: Jan 2005148 patients
Phase 2Completed
NCT00032734SanofiSatavaptan

Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

Start: Jun 2001Est. completion: Jul 200335 patients
Phase 2Completed
NCT03973866Sequana MedicalAlfapump

Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study)

Start: Sep 2019Est. completion: Jun 2024110 patients
N/AActive Not Recruiting
NCT01073345Heidelberg PharmaPortal venous pressure

Portal Venous Hemodynamic Changes After Hepatectomy

Start: Feb 2010Est. completion: Dec 2010110 patients
N/AUnknown

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
5 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.