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Hyponatremia

25
Pipeline Programs
7
Companies
20
Clinical Trials
5
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
17
8
Early DiscoveryClinical DevelopmentMarket

On Market (5)

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
Cumberland Pharmaceuticals
VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINERApproved
conivaptan hydrochloride
Cumberland Pharmaceuticals
intravenous2005
Cumberland Pharmaceuticals
VAPRISOLApproved
conivaptan hydrochloride
Cumberland Pharmaceuticals
intravenous2005

Competitive Landscape

7 companies ranked by most advanced pipeline stage

Otsuka
OtsukaJapan - Tokushima
8 programs
7
1
TolvaptanPhase 41 trial
TolvaptanPhase 31 trial
TolvaptanPhase 31 trial
TolvaptanPhase 31 trial
TolvaptanPhase 31 trial
+3 more programs
Active Trials
NCT02012959Terminated9Est. Jul 2017
NCT02442674Withdrawn0Est. Jun 2017
NCT02020278Terminated3Est. Oct 2017
+5 more trials
Cumberland Pharmaceuticals
7 programs
6
1
ConivaptanPhase 41 trial
ConivaptanPhase 31 trial
Conivaptan hydrochloridePhase 31 trial
YM087Phase 3
YM087 oralPhase 31 trial
+2 more programs
Active Trials
NCT00478192Completed50Est. Aug 2008
NCT01451411Terminated4Est. Jan 2014
NCT00492037Completed83Est. Feb 2002
+3 more trials
Astellas
AstellasChina - Shenyang
3 programs
2
1
ConivaptanPhase 41 trial
ConivaptanPhase 31 trial
YM087Phase 31 trial
Active Trials
NCT00684164Withdrawn0Est. Jun 2010
NCT00380575Completed84Est. Feb 2003
NCT00727090Terminated6Est. Feb 2010
Syneos Health
Syneos HealthNC - Morrisville
2 programs
2
TolvaptanPhase 3
TolvaptanPhase 3
Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
1 program
PEG-SDN/A1 trial
Active Trials
NCT01299779Completed460Est. Sep 2012
Spine BioPharma
Spine BioPharmaNY - New York
1 program
Water LoadN/A1 trial
Active Trials
NCT02727686Completed30Est. Dec 2018
Biogen
BiogenCAMBRIDGE, MA
1 program
lixivaptanPHASE_31 trial
Active Trials
NCT00578695Completed652

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
OtsukaTolvaptan
AstellasConivaptan
Cumberland PharmaceuticalsConivaptan
OtsukaTolvaptan
OtsukaTolvaptan
OtsukaTolvaptan
Cumberland PharmaceuticalsConivaptan hydrochloride
Otsukatolvaptan
Cumberland Pharmaceuticalsconivaptan
AstellasConivaptan
OtsukaTolvaptan
Cumberland PharmaceuticalsConivaptan
Biogenlixivaptan
OtsukaTolvaptan
Cumberland Pharmaceuticalsconivaptan

Showing 15 of 20 trials with date data

Clinical Trials (20)

Total enrollment: 2,299 patients across 20 trials

Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia

Start: Mar 2012Est. completion: Mar 20152 patients
Phase 4Terminated

Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients

Start: Aug 2008Est. completion: Feb 20106 patients
Phase 4Terminated

A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

Start: Jan 2007Est. completion: Sep 2008121 patients
Phase 4Completed

An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia

Start: Apr 2016Est. completion: Oct 20173 patients
Phase 3Terminated

A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia

Start: Nov 2015Est. completion: Jun 20170
Phase 3Withdrawn

Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia

Start: Sep 2015Est. completion: Jul 20179 patients
Phase 3Terminated

A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia

Start: Feb 2012Est. completion: Jan 20144 patients
Phase 3Terminated

Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia

Start: Oct 2010Est. completion: May 2013124 patients
Phase 3Terminated

Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF)

Start: Apr 2009Est. completion: Aug 20099 patients
Phase 3Terminated

Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients

Start: May 2008Est. completion: Jun 20100
Phase 3Withdrawn

Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients

Start: Aug 2007Est. completion: Mar 200957 patients
Phase 3Completed

Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

Start: Apr 2007Est. completion: Aug 200850 patients
Phase 3Completed

THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation

Start: Jan 2007652 patients
Phase 3Completed

International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia

Start: May 2004Est. completion: Oct 2009111 patients
Phase 3Completed

An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia

Start: Feb 2004Est. completion: Jun 2005251 patients
Phase 3Completed

"SALT-2 Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia

Start: Nov 2003Est. completion: Jul 2005243 patients
Phase 3Completed

Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

Start: Aug 2000Est. completion: Feb 200384 patients
Phase 3Completed

Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia

Start: Jan 2000Est. completion: Feb 200283 patients
Phase 3Completed

Post-Operative Water Load Following Transsphenoidal Pituitary Surgery

Start: Mar 2016Est. completion: Dec 201830 patients
N/ACompleted

Incidence of Hyponatremia in PEG-SD Compared to PEG-ELS

Start: Jun 2010Est. completion: Sep 2012460 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

17 late-stage (Phase 3) programs, potential near-term approvals
7 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.