Clinical Stage · 505(b)(2) · Acute Cardiovascular

The World's First Injectable Clopidogrel under clinical development.

Physician monitoring a patient in a cardiac intensive care unit

AcuteBio is solving the 28-year formulation gap in acute antiplatelet therapy — developing the world's first IV clopidogrel formulation for patients who cannot receive oral P2Y12 inhibitors.

Program Highlights

Lead AssetASD-002 · IV Clopidogrel

IND StatusCleared June 2023

Regulatory Path505(b)(2) NDA

Clinical StagePhase 1a Ready

IP ProtectionUS 9,480,680 · 2034

PrecedentBendeka · CINVANTI · Sotalol IV

IV P2Y12 Market$350M · Cangrelor

Investment Thesis

Why ASD-002. Why Now.

Unmet Need

No approved injectable clopidogrel exists despite 28 years of oral use. 570,000–950,000 PCI patients per year cannot receive oral P2Y12 agents. The clinical gap is documented. The regulatory pathway is defined.

Solved Formulation

Ascendia's EmulSol® nanoemulsion overcame the chemical instability challenge that defeated every prior program — simultaneous hydrolysis, oxidation, and chiral degradation protection without organic solvents.

De-Risked Pathway

505(b)(2) NDA referencing oral clopidogrel NDA 20839. Three Phase 1 studies, ~180 healthy volunteers, no Phase 2/3 required. 64.5% first-cycle approval rate.

Pipeline

Four Programs. Two Platforms.

Preclin.

IND

Ph 1a

Ph 1b

Ph 2

Ph 3

NDA

Approved

ASD-002

Coronary PCI · PAD Endovascular

ASD-005

Heart Failure / Post-MI · NPO/Intubated

ASD-004

Chronic Dry Eye Disease

ASD-002 Oral

Dysphagia · Pediatric · NG Tube

Active / Complete

Current Stage

Planned

$350M

Cangrelor market — IV P2Y12 precedent

64.5%

505(b)(2) first-cycle FDA approval rate

3.8M

US PCI procedures annually

$34M

Seed round to NDA filing