ExoFlo

Phase 3Biologic

DDirect Biologics, LLC

ExoFlo is one of 21 biologic programs targeting Acute Respiratory Distress Syndrome. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Acute Respiratory Distress SyndromeRecruiting

Acute Respiratory Distress SyndromePhase 3

Recruiting

Competition

Competitive Landscape

33 competitors in Acute Respiratory Distress Syndrome

#DrugCompanyPhaseTrials

Revia

Bayer Aspirin

Decadron

AAspen Global Incorporated

Approved

2 4

Esbriet

LLegacy Health System

Foradil

Acetadote

AArbor Pharmaceuticals, Inc.

Approved

—7

Ketalar

AAultman Health Foundation

Duragesic

Brevibloc

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

1 10

Tavalisse

RRigel Pharmaceuticals

Phase 2

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

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

Acute Respiratory Distress Syndrome

NCT05354141

Clinical

Trials by Indication[1]

COVID-193 trials

Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19

Withdrawn·DDirect Biologics, LLC·Phase 2·NCT05125562

Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS

Completed·DDirect Biologics, LLC·Phase 2·NCT04493242·102 enrolled

Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS

No longer available·DDirect Biologics, LLC··NCT04657458

Acute Respiratory Distress Syndrome1 trial

Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)

Recruiting·DDirect Biologics, LLC·Phase 3·NCT05354141·970 enrolled

Ulcerative Colitis1 trial

Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis

Terminated·DDirect Biologics, LLC·Phase 1·NCT05176366·4 enrolled

Crohn's Disease1 trial

Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease

Terminated·DDirect Biologics, LLC·Phase 1·NCT05130983·3 enrolled

Solid Organ Transplant1 trial

Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients

No longer available·DDirect Biologics, LLC··NCT05215288

1 more indication

Perianal Fistula1 trial

A Phase IB/IIA Study of ExoFlo, an Ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Perianal Fistulizing Crohn's Disease

Terminated·DDirect Biologics, LLC·Preclinical·NCT05836883·5 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for ExoFlo. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ExoFlo compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ExoFlo. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Direct Biologics, LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 3[1]
Company: DDirect Biologics, LLC

ExoFlo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

COVID-193 trials

Acute Respiratory Distress Syndrome1 trial

Ulcerative Colitis1 trial

Crohn's Disease1 trial

Solid Organ Transplant1 trial

Perianal Fistula1 trial

References

Drug Info

Quick Facts

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