Acute Respiratory Distress Syndrome

Respiratory
10
Pipeline Programs
14
Companies
11
Clinical Trials
3 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
4
0
2
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
267%
Monoclonal Antibody
133%
+ 9 programs with unclassified modality

On Market (1)

Approved therapies currently available

Recordati
SYLVANTApproved
siltuximab
Recordati
Interleukin-6 Antagonist [EPC]injection2014

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Recordati
RecordatiFrance - Saint-Victor
1 program
1
1
SiltuximabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT04616586Terminated555Est. Apr 2021
Direct Biologics
Direct BiologicsTX - Austin
1 program
1
ExoFloPhase 31 trial
Active Trials
NCT05354141RecruitingEst. Dec 2027
Vasomune Therapeutics
1 program
1
AV-001 InjectionPhase 21 trial
Active Trials
NCT05123755RecruitingEst. Jun 2026
Pliant Therapeutics
Pliant TherapeuticsCA - South SF
1 program
1
PLN-74809Phase 21 trial
Active Trials
NCT04565249Terminated6Est. Aug 2021
Akebia Therapeutics
Akebia TherapeuticsCAMBRIDGE, MA
1 program
1
vadadustatPhase 2Small Molecule
United Therapeutics
United TherapeuticsMD - Silver Spring
1 program
1
vadadustatPhase 2Small Molecule1 trial
Active Trials
NCT04478071Completed448Est. Mar 2022
Bayer
BayerLEVERKUSEN, Germany
1 program
1
BAY1211163Phase 11 trial
Active Trials
NCT04609943Terminated16Est. Sep 2023
GC Biopharma
GC BiopharmaKorea - Yongin
1 program
1
CT303Phase 11 trial
Active Trials
NCT05238532WithdrawnEst. Feb 2023
Cartesian Therapeutics
1 program
1
Descartes 30Phase 11 trial
Active Trials
NCT04524962TerminatedEst. Sep 2023
Lungpacer Medical
Lungpacer MedicalBC - Vancouver
1 program
Lungpacer PROTECT Diaphragm Pacing TherapyN/A1 trial
Active Trials
NCT04844892CompletedEst. Feb 2023
Getinge
GetingeChina - Suzhou
1 program
Ultraprotective ventilation with Extracorporeal CO2 removalN/A1 trial
Active Trials
NCT04903262Recruiting230Est. Mar 2027
Alliance Pharmaceuticals
1 program
V/Q SystemN/A1 trial
Active Trials
NCT04369599Enrolling By Invitation15Est. May 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Direct BiologicsExoFlo
RecordatiSiltuximab
Vasomune TherapeuticsAV-001 Injection
Pliant TherapeuticsPLN-74809
United Therapeuticsvadadustat
GC BiopharmaCT303
Cartesian TherapeuticsDescartes 30
BayerBAY1211163
GetingeUltraprotective ventilation with Extracorporeal CO2 removal
Lungpacer MedicalLungpacer PROTECT Diaphragm Pacing Therapy
Alliance PharmaceuticalsV/Q System

Clinical Trials (11)

Total enrollment: 1,270 patients across 11 trials

NCT05354141Direct BiologicsExoFlo

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

Start: Jul 2022Est. completion: Dec 2027
Phase 3Recruiting
NCT04616586RecordatiSiltuximab

SILtuximab in Viral ARds (SILVAR) Study

Start: Nov 2020Est. completion: Apr 2021555 patients
Phase 3Terminated
NCT05123755Vasomune TherapeuticsAV-001 Injection

Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.

Start: Dec 2021Est. completion: Jun 2026
Phase 2Recruiting
NCT04565249Pliant TherapeuticsPLN-74809

Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19

Start: Oct 2020Est. completion: Aug 20216 patients
Phase 2Terminated
NCT04478071United Therapeuticsvadadustat

Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)

Start: Aug 2020Est. completion: Mar 2022448 patients
Phase 2Completed
NCT05238532GC BiopharmaCT303

Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With ARDS

Start: Jan 2022Est. completion: Feb 2023
Phase 1Withdrawn
NCT04524962Cartesian TherapeuticsDescartes 30

Study of Descartes-30 in Acute Respiratory Distress Syndrome

Start: Feb 2021Est. completion: Sep 2023
Phase 1Terminated
NCT04609943BayerBAY1211163

Study to Find the Highest Safe Dose of Soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 Administered as Multiple Doses by Inhalation to Patients Who Cannot Breathe by Their Own and Suffer From a Type of Lung Failure That Causes Fluid to Build up in the Lungs Making Breathing Difficult (ARDS)

Start: Nov 2020Est. completion: Sep 202316 patients
Phase 1Terminated
NCT04903262GetingeUltraprotective ventilation with Extracorporeal CO2 removal

Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for Moderate ARDS

Start: Dec 2024Est. completion: Mar 2027230 patients
N/ARecruiting
NCT04844892Lungpacer MedicalLungpacer PROTECT Diaphragm Pacing Therapy

Phrenic Nerve Stimulation-Induced Lung ReAeration Trial

Start: Aug 2021Est. completion: Feb 2023
N/ACompleted
NCT04369599Alliance PharmaceuticalsV/Q System

Trans Thoracic Manipulation of Ventilation/Perfusion: the V/Q System

Start: Aug 2020Est. completion: May 202615 patients
N/AEnrolling By Invitation

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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
3 actively recruiting trials targeting 1,270 patients
14 companies competing in this space

Related Indications

Asthma(378)Pulmonary Disease, Chronic Obstructive(263)Chronic Obstructive Pulmonary Disease(123)Idiopathic Pulmonary Fibrosis(90)COPD(74)Chronic Obstructive Pulmonary Disease (COPD)(38)Pulmonary Embolism(27)Respiratory Syncytial Virus Infections(26)Severe Asthma(21)Lung Diseases, Interstitial(19)