INFASURF

(Calfactant)

Phase 3Small molecule

GGrit Biotechnology

INFASURF is one of 61 small molecule programs targeting Acute Lung Injury. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Acute Lung InjuryActive, not recruiting

Acute Respiratory Distress SyndromeActive, not recruiting

Acute Lung InjuryPhase 2/Phase 3

Active, not recruiting

Acute Respiratory Distress SyndromePhase 3

Active, not recruiting

Competition

Competitive Landscape

146 competitors in Acute Respiratory Distress Syndrome

#DrugCompanyPhaseTrials

Medrol

Pfizer

Phase 3

3 2

Plaquenil

Alnylam Pharmaceuticals

Phase 3

1 3

Zulresso

Biogen

Phase 3

1 4

Activase

Ultomiris

Cortef

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

Phase 3

3 7

Inomax

MMallinckrodt

Phase 3

2 8

Vafseo

AAkebia Therapeutics

Phase 3

2 9

Aurlumyn

BBTG International Inc.

Phase 3

1 10

Brevibloc

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

Phase 3

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

Timeline

Expected Milestones

Q1 2027

Post-ApprovalNot yet recruiting

Respiratory Distress Syndrome

NCT07350018

Q1 2029

Phase 1/2Not yet recruiting

Study completion

NCT06855043

Clinical

Trials by Indication[1]

Respiratory Distress Syndrome2 trials

Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome

Not yet recruiting·UUludag University·Phase 4·NCT07350018·234 enrolled

Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome

Completed·UUniversity of Missouri-Columbia·N/A·NCT02834624·30 enrolled

Acute Respiratory Distress Syndrome1 trial

Calfactant for Direct Acute Respiratory Distress Syndrome

Terminated·PPneuma Pharmaceuticals Incorporated·Phase 3·NCT00682500·332 enrolled

Drug1 trial

Self-dispersing Liquids as Aerosol Drug Carriers

Completed·UUniversity of Pittsburgh·N/A·NCT00628134·8 enrolled

Acute Lung Injury1 trial

CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients

Completed·MMilton S. Hershey Medical Center·Phase 2/3·NCT00999713·43 enrolled

Unspecified1 trial

Little Lungs Study

Not yet recruiting·UUniversity of Wisconsin, Madison·Phase 1/2·NCT06855043·24 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 1, 1998

INFASURF

BLA BLA020521

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Calfactant. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Calfactant compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Calfactant. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA020521). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Grit Biotechnology company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: GGrit Biotechnology

INFASURF

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q1 2029

Trials by Indication[1]

Respiratory Distress Syndrome2 trials

Acute Respiratory Distress Syndrome1 trial

Drug1 trial

Acute Lung Injury1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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