Giapreza

(Angiotensin II)

ApprovedSmall molecule

Giapreza is a small molecule that works as a Type-1 Angiotensin II Receptor Agonist.[2] It is being used across 17 indications, with its most advanced program in Approved.[1]

Giapreza is one of 365 small molecule programs targeting HIV infection. It is currently in Approved.

Indications

Total Trials

Active Trials

364

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

HIV InfectionActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Liver TransplantActive, not recruiting

Orthostatic IntoleranceApproved

TachycardiaActive, not recruiting

ShockNot yet recruiting

Kidney InjuryActive, not recruiting

Kidney TransplantActive, not recruiting

Increased Blood PressureActive, not recruiting

SepsisActive, not recruiting

HIV InfectionPreclinical

Active, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Liver TransplantPhase 2/Phase 3

Active, not recruiting

Orthostatic IntoleranceApproved

Approved

TachycardiaPhase 1

Active, not recruiting

ShockApproved

Not yet recruiting

Kidney InjuryPhase 2

Active, not recruiting

Kidney TransplantApproved

Active, not recruiting

Increased Blood PressureApproved

Active, not recruiting

SepsisApproved

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

566 competitors in Hypertension

#DrugCompanyPhaseTrials

Giapreza

LLa Jolla Pharmaceutical Company

Approved

1 2

Apresoline

Novartis

Preclinical

7 3

Zebeta

Teva

Preclinical

6 4

Edarbi

Takeda

Preclinical

4 5

Aceon

Institut de Recherches Internationales Servier

Preclinical

5 6

Winrevair

Alphagan

Deltavit

HHyundai Pharmaceutical Co., LTD.

Preclinical

2 9

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 10

Disalcid

JJoslin Diabetes Center

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Vascular Dysfunction

NCT01426529

Post-ApprovalRecruiting

ART

NCT06693726

Q1 2027

Phase 2/3Active, not recruiting

Liver Transplant

NCT04901169

Q2 2027

Phase 3Recruiting

Acute Kidney Injury

NCT06615102

Q4 2027

Phase 2Not yet recruiting

Tumor

NCT07312292

Phase 3Recruiting

Efficacy and Safety

NCT06351150

Clinical

Trials by Indication[1]

Septic Shock5 trials

Angiotensin II vs. Vasopressin in Septic Shock

Withdrawn·UUniversity of New Mexico·Phase 4·NCT05193370

Dysfunctional Renin-Angiotensin System in Septic Shock

Not yet recruiting·WWake Forest University Health Sciences·Phase 4·NCT06746753·78 enrolled

The Effect of Vasopressor Therapy on Renal Perfusion in Septic Shock

Recruiting·KKing's College Hospital NHS Trust·N/A·NCT06234592·45 enrolled

Show 2 more trials

Angiotensin II for Septic Shock Treatment

Suspended·—·Phase 3·NCT03302650·20 enrolled

DPP3, Angiotensin II, and Renin Kinetics in Sepsis (DARK-Sepsis) Pilot: Serum Biomarkers to Predict Response to Angiotensin II vs. Standard-of-care Vasopressor Therapy in the Treatment of Septic Shock, a Randomized Controlled Pilot Trial

Completed·UUniversity of New Mexico·Approved·NCT05824767·42 enrolled

Hypotension3 trials

A Study of LJPC-501 in Pediatric Patients With Hypotension

Completed·LLa Jolla Pharmaceutical Company·Phase 2·NCT03431077·2 enrolled

Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study

Completed·GGeorge Washington University·Phase 1·NCT01393782·20 enrolled

Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension

Enrolling by invitation·TTodd Sweberg·Phase 4·NCT07212686·30 enrolled

Acute Kidney Injury2 trials

Reducing Acute Kidney Injury Occurence by Administering Angiotensin II

Completed·UUniversität Münster·Phase 3·NCT05199493·64 enrolled

Reducing Cardiac-surgery Associated Acute Kidney Injury Occurence by Administering Angiotensin II

Recruiting·UUniversität Münster·Phase 3·NCT06615102·1,022 enrolled

Vascular Dysfunction2 trials

Vascular Dysfunction in Diabetes: Genes and Hormones

Terminated·—··NCT01511042·100 enrolled

Caveolin-1 and Vascular Dysfunction

Active, not recruiting·—·Phase 1·NCT01426529·120 enrolled

Interaction2 trials

Interaction of Apelin and Angiotensin in the Systemic Circulation

Completed·UUniversity of Edinburgh·N/A·NCT01049646·12 enrolled

Interaction of Apelin and Angiotensin in the Human Forearm Circulation

Completed·UUniversity of Edinburgh·N/A·NCT00901745·12 enrolled

18 more indications

Shock2 trials

Angiotensin II for Distributive Shock

Unknown status·NNorthwestern University·Phase 4·NCT04904562·40 enrolled

Angiotensin II for Post Cardiac Surgery Vasoplegia (ANGII_V)

Not yet recruiting·MMethodist Healthcare System of San Antonio·Approved·NCT07671365·329 enrolled

ART1 trial

Early Angiotensin II in the Emergency Department

Recruiting·BBrett A Faine·Phase 4·NCT06693726·20 enrolled

Biomarker1 trial

Renin and Renal Biomarker Response to Angiotensin II

Completed·AAlexander Flannery·Phase 4·NCT04558359·30 enrolled

General Anesthesia1 trial

Angiotensin II in General Anesthesia

Completed·WWake Forest University Health Sciences·Phase 4·NCT03733145·32 enrolled

HIV1 trial

Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV

Completed·MMassachusetts General Hospital··NCT01407237·30 enrolled

Tachycardia1 trial

The Renin-Aldosterone Axis in Postural Tachycardia Syndrome

Completed·VVanderbilt University Medical Center·Phase 1·NCT00962949·28 enrolled

Kidney Injury1 trial

Angiotensin in Septic Kidney Injury Trial

Unknown status·AAustin Health·Phase 2·NCT00711789·12 enrolled

Hypertension1 trial

Genetic Mechanisms in Human Hypertension

Terminated·—··NCT01456208·150 enrolled

Preeclampsia1 trial

Balance of Angiotensin II Receptors in Vessel Function After Preeclampsia

Completed·—·Phase 1·NCT06157580·24 enrolled

Hepatorenal Syndrome1 trial

Angiotensin 2 for Hepatorenal Syndrome

Withdrawn·UUniversity of California, Los Angeles·Phase 2·NCT04048707

Cardiac Surgery1 trial

ANG-First Trial (Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery)

Recruiting·—·Phase 4·NCT06487585·100 enrolled

Hypertensive1 trial

Comparison of Nebivolol and Metoprolol With Exercise and Angiotensin II in Hypertensive Patients

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT01502787·46 enrolled

Acute Respiratory Distress Syndrome1 trial

Efficacy and Safety of Angiotensin II Use in Coronavirus Disease(COVID)-19 Patients With Acute Respiratory Distress Syndrome

Unknown status·GGuy's and St Thomas' NHS Foundation Trust··NCT04408326·50 enrolled

Kidney Transplant1 trial

Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients

Completed·UUniversity of Illinois at Chicago·Phase 4·NCT04529005·20 enrolled

Liver Transplant1 trial

Angiotensin II in Liver Transplantation

Active, not recruiting·UUniversity of California, San Francisco·Phase 2/3·NCT04901169·50 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Angiotensin II Injection Versus Placebo in Patients With Refractory Distributed Shock

Recruiting· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 3·NCT06351150·214 enrolled

Tumor1 trial

Radioembolization With Intra-arterial Angiotensin II to Improve Tumor-absorbed Dose (RADIANT)

Not yet recruiting·NNiek Wijnen·Phase 2·NCT07312292·15 enrolled

Unspecified3 trials

Angiotensin 2 for AKI After OLT

Enrolling by invitation·UUniversity of California, Los Angeles·Phase 4·NCT04592744·30 enrolled

Role of Angiotensin II in Insulin-induced Microvascular Activity

Completed·MMaastricht University Medical Center·N/A·NCT01024543·18 enrolled

Evaluation of Lysine-Specific Demethylase 1

Withdrawn·—·N/A·NCT01702688

Regulatory

FDA Approval Timeline[4]

Dec 23, 2021

GIAPREZA

NDA NDA209360

Sources

References

[1]
ClinicalTrials.gov — 35 trial records for Angiotensin II. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Angiotensin II compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Angiotensin II. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209360). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Giapreza. U.S. Food & Drug Administration.
[6]
SEC EDGAR — La Jolla Pharmaceutical Company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Type-1 Angiotensin II Receptor Agonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: LLa Jolla Pharmaceutical Company

Patent Landscape[5]

Patent Cliff

Dec 16, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10548943Dec 16, 2029

9867863Dec 16, 2029

10500247Dec 16, 2029

10335451Dec 16, 2029

9572856Jul 18, 2031

6 more patents

11096983Dec 18, 2034

10028995Dec 18, 2034

10493124Dec 18, 2034

11559559Dec 18, 2034

9220745Dec 18, 2034

11219662Jan 6, 2037

Giapreza

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q4 2027

Trials by Indication[1]

Septic Shock5 trials

Hypotension3 trials

Acute Kidney Injury2 trials

Vascular Dysfunction2 trials

Interaction2 trials

Shock2 trials

ART1 trial

Biomarker1 trial

General Anesthesia1 trial

HIV1 trial

Tachycardia1 trial

Kidney Injury1 trial

Hypertension1 trial

Preeclampsia1 trial

Hepatorenal Syndrome1 trial

Cardiac Surgery1 trial

Hypertensive1 trial

Acute Respiratory Distress Syndrome1 trial

Kidney Transplant1 trial

Liver Transplant1 trial

Efficacy and Safety1 trial

Tumor1 trial

Unspecified3 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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