Last reviewed 2026-06-02 · How we verify

AI-700

Acusphere · Phase 3 active Small molecule Under review

AI-700 is a Ultrasound contrast agent Small molecule drug developed by Acusphere. It is currently in Phase 3 development for Contrast-enhanced ultrasound imaging for tissue perfusion assessment, Cardiac imaging and left ventricular opacification.

AI-700 is an ultrasound contrast agent designed to enhance imaging of blood perfusion and tissue characterization.

AI-700 is being studied in clinical trials for various conditions, including Hepatocellular Carcinoma, Coronary Artery Disease, Endometrial Carcinoma Stage I, Hepatocellular Carcinoma (HCC), and Congestive Heart Failure. The exact mechanism of AI-700 is not specified in the provided facts, but it is being tested alongside other interventions such as contrast enhanced ultrasound and Perflubutane Microspheres for Injection.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	AI-700
Sponsor	Acusphere
Drug class	Ultrasound contrast agent
Modality	Small molecule
Therapeutic area	Diagnostic Imaging
Phase	Phase 3

Mechanism of action

AI-700 consists of lipid-encapsulated microbubbles that reflect ultrasound waves, improving visualization of vascular flow and tissue perfusion during diagnostic ultrasound imaging. The microbubbles are engineered to remain stable in circulation and provide enhanced contrast for extended imaging windows, enabling better detection and characterization of lesions and perfusion abnormalities.

Approved indications

Contrast-enhanced ultrasound imaging for tissue perfusion assessment
Cardiac imaging and left ventricular opacification

Common side effects

Headache
Flushing
Chest discomfort

Key clinical trials

Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer (PHASE1, PHASE2)
Y-90 Treatment Response Using Transarterial Radioembolization (PHASE2)
Gynecological Sentinel Lymph Nodes CEUS (EARLY_PHASE1)
Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer (EARLY_PHASE1)
SHAPE of Portal Hypertension in Children (PHASE2)
Contrast Enhanced Ultrasonography to Detect Human Renal Transplant Rejection (PHASE2)
Contrast Ultrasound Detection of Sentinel Lymph Nodes (PHASE1, PHASE2)
Role of Perfluorobutane in Lesion Detection, Targeting and Response Assessment for Ablation of HCC (NA)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

AI-700 CI brief — competitive landscape report
AI-700 updates RSS · CI watch RSS
Acusphere portfolio CI

Frequently asked questions about AI-700

What is AI-700?

AI-700 is a Ultrasound contrast agent drug developed by Acusphere, indicated for Contrast-enhanced ultrasound imaging for tissue perfusion assessment, Cardiac imaging and left ventricular opacification.

How does AI-700 work?

AI-700 is an ultrasound contrast agent designed to enhance imaging of blood perfusion and tissue characterization.

What is AI-700 used for?

AI-700 is indicated for Contrast-enhanced ultrasound imaging for tissue perfusion assessment, Cardiac imaging and left ventricular opacification.

Who makes AI-700?

AI-700 is developed by Acusphere (see full Acusphere pipeline at /company/acusphere).

What drug class is AI-700 in?

AI-700 belongs to the Ultrasound contrast agent class. See all Ultrasound contrast agent drugs at /class/ultrasound-contrast-agent.

What development phase is AI-700 in?

AI-700 is in Phase 3.

What are the side effects of AI-700?

Common side effects of AI-700 include Headache, Flushing, Chest discomfort.

Drug class: All Ultrasound contrast agent drugs
Manufacturer: Acusphere — full pipeline
Therapeutic area: All drugs in Diagnostic Imaging
Indication: Drugs for Contrast-enhanced ultrasound imaging for tissue perfusion assessment
Indication: Drugs for Cardiac imaging and left ventricular opacification

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing