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Acute Lung Injury

10
Pipeline Programs
14
Companies
19
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
1
3
0
2
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 13 programs with unclassified modality

Competitive Landscape

14 companies ranked by most advanced pipeline stage

Ono Pharmaceutical
Ono PharmaceuticalJapan - Osaka
1 program
1
Sivelestat sodium hydratePhase 41 trial
Active Trials
NCT00219375Completed649
Leo Pharma
Leo PharmaDenmark - Ballerup
1 program
1
HL 10Phase 31 trial
Active Trials
NCT00742482Terminated418Est. Jun 2005
Asklepion Pharmaceuticals
1 program
1
L-citrullinePhase 35 trials
Active Trials
NCT06989567Not Yet Recruiting120Est. Jun 2029
NCT05253209Terminated64Est. May 2024
NCT04852172Terminated30Est. Feb 2024
+2 more trials
APEPTICO
APEPTICOAustria - Vienna
1 program
1
AP301Phase 21 trial
Active Trials
NCT01627613Completed40Est. Aug 2014
Oregon Therapeutics
Oregon TherapeuticsFrance - Paris
1 program
1
DiuresisPhase 21 trial
Active Trials
NCT00624650Completed33Est. Jan 2011
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
1
Pirfenidone/PlaceboPhase 21 trial
Active Trials
NCT05704166Recruiting214Est. May 2026
Faron Pharmaceuticals
Faron PharmaceuticalsFinland - Turku
1 program
1
Interferon BetaPhase 1/21 trial
Active Trials
NCT00789685Completed37Est. Sep 2011
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
1 program
1
Nebulized hypertonic salinePhase 11 trial
Active Trials
NCT01667666Terminated13Est. Nov 2018
ReAlta Life Sciences
1 program
1
RLS-0071 10 mg/kgPhase 11 trial
Active Trials
NCT04574869Withdrawn0Est. Dec 2022
Biocorp
BiocorpFrance - Issoire
1 program
1
VIB7734Phase 11 trial
Active Trials
NCT04526912Terminated10Est. May 2021
ViiV Healthcare
ViiV HealthcareNC - Durham
1 program
Local standard of careN/A
GSK
GSKLONDON, United Kingdom
1 program
Local standard of careN/A1 trial
Active Trials
NCT03212690Terminated57Est. Jul 2019
Abbott
AbbottABBOTT PARK, IL
1 program
OxepaN/A1 trial
Active Trials
NCT02208700Unknown40
Parexel
ParexelMA - Boston
1 program
ImatinibPHASE_1Small Molecule1 trial
Active Trials
NCT03328117Completed47Est. Mar 2018

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Ono PharmaceuticalSivelestat sodium hydrate
Asklepion PharmaceuticalsL-citrulline
Asklepion PharmaceuticalsL-citrulline
Asklepion PharmaceuticalsL-citrulline
Asklepion PharmaceuticalsL-citrulline
Leo PharmaHL 10
UNION therapeuticsPirfenidone/Placebo
Asklepion PharmaceuticalsL-citrulline
APEPTICOAP301
Oregon TherapeuticsDiuresis
Asklepion PharmaceuticalsL-citrulline
Asklepion PharmaceuticalsL-citrulline
Faron PharmaceuticalsInterferon Beta
ReAlta Life SciencesRLS-0071 10 mg/kg
BiocorpVIB7734

Showing 15 of 19 trials with date data

Clinical Trials (19)

Total enrollment: 2,125 patients across 19 trials

NCT00219375Ono PharmaceuticalSivelestat sodium hydrate

Study of Sivelestat Sodium Hydrate in Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS) in Japan

Start: Jun 2004649 patients
Phase 4Completed
NCT06989567Asklepion PharmaceuticalsL-citrulline

A Study of Intravenous L-Citrulline in Patients Aged 6-21 Years Old With Sickle Cell Disease Presenting to Emergency Departments in Acute Vaso-Occlusive Crisis

Start: Jul 2025Est. completion: Jun 2029120 patients
Phase 3Not Yet Recruiting
NCT05253209Asklepion PharmaceuticalsL-citrulline

A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects

Start: Jun 2022Est. completion: May 202464 patients
Phase 3Terminated
NCT02891837Asklepion PharmaceuticalsL-citrulline

L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects

Start: Aug 2016Est. completion: Jul 2019189 patients
Phase 3Completed
NCT00335244Asklepion PharmaceuticalsL-citrulline

Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery

Start: May 2006Est. completion: Dec 200977 patients
Phase 3Completed
NCT00742482Leo PharmaHL 10

Efficacy and Safety of 3 Doses of HL10 Given at Fixed Time Intervals Compared to Standard Therapy

Start: Jan 2003Est. completion: Jun 2005418 patients
Phase 3Terminated
NCT05704166UNION therapeuticsPirfenidone/Placebo

PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients

Start: Mar 2023Est. completion: May 2026214 patients
Phase 2Recruiting
NCT04570384Asklepion PharmaceuticalsL-citrulline

Intravenous L-Citrulline Influence on the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failure in Patients With COVID-19

Start: Oct 2020Est. completion: Sep 202165 patients
Phase 2Completed
NCT01627613APEPTICOAP301

Study in Intensive Care Patients to Investigate the Clinical Effect of Repetitive Orally Inhaled Doses of AP301 on Alveolar Liquid Clearance in Acute Lung Injury

Start: Jul 2012Est. completion: Aug 201440 patients
Phase 2Completed
NCT00624650Oregon TherapeuticsDiuresis

Hemodynamics and Extravascular Lung Water in Acute Lung Injury

Start: Feb 2008Est. completion: Jan 201133 patients
Phase 2Completed
NCT04852172Asklepion PharmaceuticalsL-citrulline

L-citrulline Injection in Patients Aged 6-21 Years Old with Sickle Cell Disease Presenting with Vaso-Occlusive Crisis (VOC)

Start: Apr 2021Est. completion: Feb 202430 patients
Phase 1/2Terminated
NCT01120964Asklepion PharmaceuticalsL-citrulline

Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol

Start: Sep 2010Est. completion: Apr 201222 patients
Phase 1/2Completed
NCT00789685Faron PharmaceuticalsInterferon Beta

Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II

Start: Feb 2009Est. completion: Sep 201137 patients
Phase 1/2Completed
NCT04574869ReAlta Life SciencesRLS-0071 10 mg/kg

A Study of RLS-0071 in Patients With Acute Lung Injury Due to COVID-19 Pneumonia in Early Respiratory Failure

Start: Jan 2021Est. completion: Dec 20220
Phase 1Withdrawn
NCT04526912BiocorpVIB7734

Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection

Start: Aug 2020Est. completion: May 202110 patients
Phase 1Terminated
NCT03328117ParexelImatinib

A Study to Investigate the Effects of Imatinib on Pulmonary Vascular Dysfunction in a Human Model of Lung Injury

Start: Nov 2017Est. completion: Mar 201847 patients
Phase 1Completed
NCT01667666Colorado TherapeuticsNebulized hypertonic saline

Clinical Trial of Nebulized Hypertonic Saline to Attenuate Post-Traumatic Acute Lung Injury

Start: May 2012Est. completion: Nov 201813 patients
Phase 1Terminated
NCT03212690GSKLocal standard of care

Study of Renin-angiotensin System in Mechanically Ventilated Subjects

Start: Jun 2018Est. completion: Jul 201957 patients
N/ATerminated
NCT02208700AbbottOxepa

Efficacy of Oxepa Enteral Feeding in LTAC (Long Term Acute Care Hospital) Patients on Chronic Ventilation- a Pilot Study

Start: Jan 201440 patients
N/AUnknown

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 2,125 patients
14 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.