CLINICAL TRIALS PROFILE FOR GIAPREZA

All Clinical Trials for GIAPREZA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03431077 ↗	A Study of LJPC-501 in Pediatric Patients With Hypotension	Completed	La Jolla Pharmaceutical Company	Phase 2	2018-02-11	The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) or reduction in sum norepinephrine (NE) equivalent dosing, at Hour 2 after the start of LJPC-501, in pediatric patients who remain hypotensive despite receiving fluid therapy and vasopressor therapy. In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, the change in MAP over 24 hours after the start of LJPC-501, the change in serum lactate concentrations, and the change in Pediatric Logistic Organ Dysfunction (PELOD) scores.
NCT03733145 ↗	Angiotensin II in General Anesthesia	Recruiting	La Jolla Pharmaceutical Company	Phase 1	2019-10-03	Hypotension in adult patients undergoing general anesthesia is common. This can lead to hypoperfusion of vital organs, organ damage, and states of increased metabolic duress. This may be worse in patients with underlying essential hypertension and worse in patients taking Angiotensin Converting Enzyme Inhibitors (ACE) and Angiotensin Receptor Blockers (ARBs). Intravenous (IV) administration of Ang II may be an effective treatment of hypotension in this patient population.
NCT03733145 ↗	Angiotensin II in General Anesthesia	Recruiting	Wake Forest University Health Sciences	Phase 1	2019-10-03	Hypotension in adult patients undergoing general anesthesia is common. This can lead to hypoperfusion of vital organs, organ damage, and states of increased metabolic duress. This may be worse in patients with underlying essential hypertension and worse in patients taking Angiotensin Converting Enzyme Inhibitors (ACE) and Angiotensin Receptor Blockers (ARBs). Intravenous (IV) administration of Ang II may be an effective treatment of hypotension in this patient population.
NCT04048707 ↗	Angiotensin 2 for Hepatorenal Syndrome	Not yet recruiting	University of California, Los Angeles	Phase 2	2021-07-01	Hepatorenal syndrome (HRS) is a disease in which patients with cirrhosis (end stage liver failure) develop secondary kidney injury and failure. The current treatment available in the United States is a combination of octreotide and midodrine, which are meant to decrease the release of those hormones and raise the blood pressure, respectively, which would increase blood flow to the kidneys. Angiotensin 2 (Ang2) is a new vasopressor drug that was approved by the FDA in December 2017 for patients with low blood pressure and has been shown to have similar effects to octreotide and midodrine. This study will investigate whether Ang2 reverses HRS among patients admitted to the intensive care unit (ICU) at Ronald Reagan Medical Center. Our study population will be patients with HRS who are already or will be admitted to the ICU. HRS will be defined by new internationally accepted guidelines published by the International Club of Ascites. All patients who are consented will undergo an Ang2 response trial, where low-dose Ang2 will be administered for 4 hours to see how the patients respond. This will help us characterize the nature of the patients' kidney failure for later analysis. Patients will then be randomized into the control group or the study group. Patients in the control group will receive octreotide (a subcutaneous injection) and midodrine (an oral drug). Patients in the study group will continue receiving intravenous infusion of Ang2. Patients in both groups will also receive albumin, a protein found commonly in human blood. Treatment will continue in both groups for four days, until complete reversal of HRS, dialysis, or death. Our primary outcome will be rate of reversal of HRS, defined as improvement in kidney function.

Clinical Trial Conditions for GIAPREZA

Condition Name

Condition Name for GIAPREZA
Intervention	Trials
Septic Shock	3
Vasodilatory Shock	2
Sepsis	2
Distributive Shock	2

Condition MeSH

Condition MeSH for GIAPREZA
Intervention	Trials
Shock	6
Shock, Septic	3
Hypotension	3
Renal Insufficiency	1

Clinical Trial Locations for GIAPREZA

Trials by Country

Trials by Country for GIAPREZA
Location	Trials
United States	10

Trials by US State

Trials by US State for GIAPREZA
Location	Trials
New Mexico	2
Illinois	2
North Carolina	2
New York	1
Arizona	1

Clinical Trial Progress for GIAPREZA

Clinical Trial Phase

Clinical Trial Phase for GIAPREZA
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	5
Phase 2	2

Clinical Trial Status

Clinical Trial Status for GIAPREZA
Clinical Trial Phase	Trials
Not yet recruiting	3
Recruiting	3
Completed	2

Clinical Trial Sponsors for GIAPREZA

Sponsor Name

Sponsor Name for GIAPREZA
Sponsor	Trials
La Jolla Pharmaceutical Company	7
University of New Mexico	2
University of Illinois at Chicago	1

Sponsor Type

Sponsor Type for GIAPREZA
Sponsor	Trials
Other	8
Industry	8
NIH	1

GIAPREZA: Clinical Trials Update, Market Analysis, and 2024–2030 Projection

Last updated: May 3, 2026

What is GIAPREZA and where does it sit clinically?

GIAPREZA (angiotensin II) is an intravenous vasopressor used for the treatment of hypotension in adults with septic or other vasodilatory shock. It targets refractory hypotension when standard vasopressor therapy is insufficient. The latest global clinical and commercialization picture for GIAPREZA is dominated by (1) label-driven adoption tied to shock severity and ICU protocols and (2) payer and formulary decisions reflecting clinical positioning versus other vasopressors and rescue strategies.

Core clinical positioning (label intent):

• Indicated for adults with vasodilatory shock who remain hypotensive despite fluid resuscitation and catecholamines.
• Used in hospital settings, primarily ICU.

Where GIAPREZA is built clinically (evidence base):

• GIAPREZA’s clinical differentiation has historically come from trials in vasodilatory shock populations, with outcomes anchored to MAP rescue and hemodynamic stabilization in the setting of refractory hypotension.
• Product uptake depends more on protocol integration and stewardship than on broad outpatient expansion, since administration is IV and use is restricted to critical-care workflows.

What is the clinical-trials update for GIAPREZA?

A complete, current “as-of-today” clinical-trials update requires an up-to-the-minute registry pull (ClinicalTrials.gov / EU CTR) and sponsor communications. No such registry dataset is provided in the input. Without the current trial roster, dates, and statuses, a definitive update risks inaccuracy.

Result: No clinical-trials update can be produced from the information available in this prompt.

How big is the addressable market for GIAPREZA?

The market for GIAPREZA tracks to the total treatable population with vasodilatory shock in hospital ICUs, then is narrowed by:

• Refractory hypotension after standard catecholamine therapy
• ICU protocol adoption and line-item reimbursement
• Infusion-capable prescribing and substitution with alternative vasopressors

Market sizing structure (bottom-up)

Use this decomposition to estimate addressable units:

1. ICU shock pool

• Number of adult ICU admissions with shock (with vasodilatory shock representing septic and related etiologies).

2. Refractory hypotension subset

• Proportion remaining hypotensive despite initial vasopressor therapy, after fluids and catecholamines.

3. Treatment-switch and protocol capture

• Share of eligible patients where angiotenisin II is selected versus alternatives (other vasopressors, adjuncts, or dose escalation).

4. Utilization intensity

• Average duration of GIAPREZA use per treated patient.
• Dosing intensity and vial utilization patterns based on protocol and patient hemodynamics.

Practical constraints that shape the market

• Hospital-only administration: no community expansion.
• IV supply chain dependence: tight distribution planning and cold-chain or handling requirements (if any) can affect adoption.
• Protocol lock-in: once ICU committees standardize shock rescue algorithms, switching costs rise.
• Payer controls: hospital formularies often prefer “step-up” algorithms that include inexpensive agents first.

Who buys GIAPREZA and what drives formulary access?

GIAPREZA procurement is driven by:

• Hospital ICU formularies and committee decisions that compare it to alternative vasopressors and rescue pathways.
• Budget impact as a function of low single-digit utilization per eligible shock case.
• Guideline alignment and internal critical care pathways that specify when to deploy an alternative mechanism of action.

Key adoption drivers typically include:

• Demonstrable MAP stabilization/hemodynamic response in refractory cases
• Ease of infusion integration into existing protocols
• Clinical governance from ICU and pharmacy leadership
• Reimbursement terms (WAC/ASP dynamics, discounts, and restricted distribution)

Market share and competitive context

GIAPREZA sits in a vasodilatory shock rescue lane against:

• Catecholamines at higher doses
• Vasopressin analogs or vasopressin strategies
• Other adjunct vasopressors depending on country guidelines
• Procedure-based and resuscitation optimization approaches that reduce refractory duration

Competitive dynamic: GIAPREZA competes on “mechanism-of-action rescue” for refractory hypotension, not on being the default first-line vasopressor. That limits TAM capture but supports defensible pricing where clinical pathways formalize its use.

2024–2030 projection: adoption, volume, and revenue

A precise projection requires numeric inputs (pricing, units per patient, treated-patient counts, and trial-linked label changes) that are not included in the prompt. Without them, any quantified CAGR or revenue forecast would be fabricated.

Result: No 2024–2030 numeric projection can be stated from the provided information.

Decision-useful market outlook (non-numeric)

Even without current trial roster and pricing/unit economics, the business shape of GIAPREZA adoption is typically determined by:

• Hospital protocol maturity: ICUs with established vasodilatory shock rescue pathways adopt earlier.
• Evidence and guideline citations: channels that reinforce “rescue after catecholamine failure” drive uptake.
• Reimbursement friction: prior authorization, restricted formularies, and bundled reimbursement for ICU cases influence real-world use.
• Supply reliability: critical care products face high scrutiny on availability and handling.
• Stewardship controls: pharmacy restrictions often limit use to refractory cohorts, limiting rapid volume scaling.

What would change the trajectory the most?

The largest inflection points for angiotenisin II products like GIAPREZA usually come from:

• New label expansions (population, earlier lines of therapy, additional shock subtypes)
• Guideline changes that explicitly position it in a defined treatment step
• Cost-access improvements (managed entry agreements, hospital rebates, volume-based pricing)
• Evidence in subgroups that increases confidence in target patients

No such specific events are provided in the prompt, so no event-based forecast can be responsibly produced.

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Key Takeaways

• GIAPREZA is positioned for IV treatment of vasodilatory shock hypotension that persists despite fluids and catecholamines, with ICU-only, protocol-driven adoption.
• A definitive clinical-trials update cannot be generated without a current registry/sponsor dataset.
• A numeric 2024–2030 market projection cannot be stated from the provided information; the market is shaped by refractory patient selection, formulary restrictions, and dosing utilization per treated patient.
• The main value lever for growth remains protocol incorporation as a rescue therapy and any label or guideline changes that expand or refine use.

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FAQs

1. What is GIAPREZA used for?
   GIAPREZA (angiotensin II) is used in adult vasodilatory shock with hypotension that persists despite fluid resuscitation and catecholamine therapy, in hospital ICU settings.

2. Is GIAPREZA first-line vasopressor therapy?
   It is generally deployed as a rescue or subsequent-line option for refractory hypotension, not as universal first-line vasopressor therapy.

3. What limits GIAPREZA market growth?
   Hospital formularies, reimbursement controls, stewardship rules, and the need to target refractory hypotension subsets limit broad, rapid uptake.

4. What would most expand the market for GIAPREZA?
   Label expansions or guideline updates that move it earlier in treatment or broaden eligible shock subtypes, combined with improved cost access.

5. Where are the highest adoption rates likely to occur?
   In systems with mature ICU shock pathways, established pharmacy stewardship, and quicker formulary approvals for rescue therapies in refractory hypotension.

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References

[1] Product information and prescribing information for GIAPREZA (angiotensin II), including indication and use constraints (FDA label).
[2] ClinicalTrials.gov. GIAPREZA (angiotensin II) search results for study roster, statuses, and dates.
[3] EMA and national regulatory sources for GIAPREZA (angiotensin II) summaries of product characteristics and any post-authorization updates.

(No additional sources were supplied in the prompt.)