TheraRadar
Data updated: May 26, 2026

GIAPREZA (angiotensin ii acetate)

Trial Activity: Mature 7 active trials
First-in-Class Priority Review
Cardiovascular Approved 2017-12-21
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Wake Forest University Health Sciences conducting 2 trials (10%)
26 indications explored (Broad Platform)
→ septic shock (6 trials)
→ vasoplegia (3 trials)
→ hypertension (3 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
8
Years on Market

Details

Status
Discontinued
First Approved
2017-12-21
Patent Cliff
2037

Pro Metrics

Patent cliff and revenue data

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

LA JOLLA PHARMA
Active Ingredient: ANGIOTENSIN II ACETATE

GIAPREZA Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2017 to 2017
Dec 2017 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What GIAPREZA Treats

1 FDA approvals

Originally approved for its first indication in 2017 .

  • Other (1)
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Clinical Trial Registry

19 trials
Trial Sponsor ID Phase Status Title
NCT04904562 results posted STU00211528 Ph 4 terminated Angiotensin II for Distributive Shock
NCT06746753 MANTRA IRB00115287 R01HL177834 Ph 4 not yet recruiting Mechanistic Assessment of Norepinephrine Therapy vs. Angiotensin-II in Septic Shock
NCT04901169 AngLT-1 20-30948 Ph 2, Ph 3 active not recruiting Angiotensin II in Liver Transplantation
NCT05824767 DARK-Sepsis 22-111 Ph 4 completed Serum Biomarkers to Predict Response to Angiotensin II in Septic Shock
NCT06487585 00109542 Ph 4 recruiting ANG-First Trial (Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery)
NCT01426529 2010P002187 1R01HL104032-01 Ph 1 active not recruiting Caveolin-1 and Vascular Dysfunction
NCT00962949 results posted 081398 PF334 Ph 1 completed The Renin-Aldosterone Axis in Postural Tachycardia Syndrome
NCT04592744 20-001402 Ph 4 enrolling by invitation Angiotensin 2 for AKI After OLT
NCT03733145 results posted IRB00054661 HL-051952, AG070371 Ph 4 completed Angiotensin II in General Anesthesia
NCT06615102 PAN-AKI UniMS23_0019 542931418 Ph 3 recruiting Reducing Cardiac-surgery Associated Acute Kidney Injury Occurence by Administering Angiotensin II
NCT04558359 results posted 57411 Ph 4 completed Renin and Renal Biomarker Response to Angiotensin II
NCT01393782 ATHOS results posted 111016 Ph 1 completed Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study
NCT05193370 21-040 UL1TR001449 Ph 4 withdrawn Angiotensin II vs. Vasopressin in Septic Shock
NCT04048707 ANTHEM #19-005718 Ph 2 withdrawn Angiotensin 2 for Hepatorenal Syndrome
NCT05199493 AIDED WWU20_0016 2021-003088-87, 06-AnIt-20 Ph 3 completed Reducing Acute Kidney Injury Occurence by Administering Angiotensin II
NCT04529005 results posted 2020-0526 Ph 4 completed Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients
NCT01502787 results posted STU 062011-072 Ph 4 completed Comparison of Nebivolol and Metoprolol With Exercise and Angiotensin II in Hypertensive Patients
NCT03302650 N-68-2017 Ph 3 suspended Angiotensin II for Septic Shock Treatment
NCT03431077 LJ501-CRH02 Ph 2 completed A Study of LJPC-501 in Pediatric Patients With Hypotension
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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

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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.

GIAPREZA FDA Label Details

View full patent landscape →
11 OB patents · 3 families · 104 international docs across 26 countries

GIAPREZA Patents & Exclusivity

Latest Patent: Jan 2037

Patents (11 active)

US11219662 Expires Jan 6, 2037
US9220745 Expires Dec 18, 2034
US10028995 Expires Dec 18, 2034
US10493124 Expires Dec 18, 2034
US11559559 Expires Dec 18, 2034
US11096983 Expires Dec 18, 2034
US9572856 Expires Jul 18, 2031
US9867863 Expires Dec 16, 2029
US10335451 Expires Dec 16, 2029
US10548943 Expires Dec 16, 2029
US10500247 Expires Dec 16, 2029
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for GIAPREZA

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2037
  • • 135 active patents

Trial Analysis

  • • 20 total trials
  • • Stage: Mature

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA209360 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment