TheraRadar
Data updated: Jun 28, 2026

VASOSTRICT (vasopressin) · PH HEALTH

Cardiovascular Approved 2014-04-17

VASOSTRICT is FDA-approved to treat 2 conditions (same as VASOPRESSIN).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
12
Years on Market

Details

Status
Discontinued
First Approved
2014-04-17
Patent Cliff
2035

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

PH HEALTH
Active Ingredient: VASOPRESSIN

VASOSTRICT Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
90 FDA actions from 2014 to 2023
Apr 2023 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Dec 2022 SUPPL
Label · Labeling
FDA Letter Label
Nov 2022 SUPPL
Label · Labeling
FDA Letter Label

What VASOSTRICT Treats

2 indications

VASOSTRICT is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as VASOPRESSIN (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

22 trials
Trial Sponsor ID Phase Status Title
NCT05958342 CAVALIER STUDY23040043 W81XWH-6-D-0024 Ph 2 recruiting CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
NCT05738148 Pro00122275 Ph 1 active not recruiting Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation
NCT02118467 14-0047 Ph 4 recruiting Vasoactive Drugs in Intensive Care Unit
NCT05568160 NOVACC GUINOT PHRCI 2019 Ph 3 active not recruiting Evaluation of the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation
NCT06217562 VASSPR 1052518 Ph 4 active not recruiting Vasopressin for Septic Shock Pragmatic Trial
NCT06547892 NOVA-AKI NOVA-AKI Ph 2 recruiting Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU
NCT04501861 results posted 20-301 Ph 3 completed Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients:
NCT06419075 TEXAS 23-0273 Ph 4 withdrawn Tranexamic Acid in Vaginal Reconstructive Surgery
NCT02975999 results posted HRP-530 Ph 2, Ph 3 completed Use of Vasopressin Following the Fontan Operation
NCT05193370 21-040 UL1TR001449 Ph 4 withdrawn Angiotensin II vs. Vasopressin in Septic Shock
NCT03483753 VANCSIII 62586316.6.0000.0065 Ph 2, Ph 3 withdrawn Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery
NCT01093768 100068 10-M-0068 Ph 1 completed Brain Imaging Study of Adults With Autism Spectrum Disorders
NCT00628550 Vasopressin 082007-065 Ph 1 completed Trial of Vasopressin and Epinephrine to Epinephrine Only for In-Hospital Pediatric Cardiopulmonary Resuscitation
NCT01962870 results posted IRB-26034 R21MH100387-01 Ph 2 completed The Role of Vasopressin in the Social Deficits of Autism
NCT01611935 AVERTShock results posted 811293 Ph 2 completed AVERT Shock: Arginine Vasopressin During the Early Resuscitation of Traumatic Shock
NCT03930069 Hysterscopioc myomectomy Ph 2, Ph 3 completed Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.
NCT01718613 VANCS II NP 1079/17 Ph 3 completed Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients
NCT01393704 results posted 2011-P-000264/1 Ph 4 completed Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial
NCT02454348 NOVEL 204265 Ph 4 withdrawn NOrepinephrine and VasoprEssin Versus Norepinephrine aLone in Critically Ill Patients With Septic Shock
NCT01861015 KNC13-013 Ph 3 completed Vasopressin Versus Epinephrine in Myomectomy
NCT00379522 Vitris Ph 2, Ph 3 completed Vasopressin in Traumatic Hemorrhagic Shock Study
NCT07614438 VANOPE 2025-525153-39-00 Ph 2 not yet recruiting Effect of Vasopressin Versus Norepinephrine on Post-operative Mean Pulmonary Arterial Pressure Following Pulmonary Endarterectomy Surgery,
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

VASOSTRICT FDA Label Details

Indications & Usage

FDA Label (PDF)

VASOSTRICT is FDA-approved to treat 2 conditions — same approved indications as VASOPRESSIN.

View full patent landscape →
15 OB patents · 7 families · 57 international docs across 1 countries

VASOSTRICT Patents & Exclusivity

Latest Patent: Jan 2035

Patents (15 active)

US9375478 Expires Jan 30, 2035
US9744209 Expires Jan 30, 2035
US9937223 Expires Jan 30, 2035
US9744239 Expires Jan 30, 2035
US10010575 Expires Jan 30, 2035
US9981006 Expires Jan 30, 2035
US9974827 Expires Jan 30, 2035
US9968649 Expires Jan 30, 2035
US9962422 Expires Jan 30, 2035
US9925234 Expires Jan 30, 2035
US9925233 Expires Jan 30, 2035
US9687526 Expires Jan 30, 2035
US12186362 Expires Jan 30, 2035
US9919026 Expires Jan 30, 2035
US9750785 Expires Jan 30, 2035
Source: FDA Orange Book

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Patent Timeline

  • • Cliff: 2035
  • • 282 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

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  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA204485 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.