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Acute Respiratory Distress Syndrome (ARDS) - Pipeline Insight, 2025

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    Clinical Trials

  • 100 Pages
  • April 2025
  • Region: Global
  • DelveInsight
  • ID: 4037026
This “Acute Respiratory Distress Syndrome - Pipeline Insight, 2025,” report provides comprehensive insights about 120+ companies and 120+ pipeline drugs in Acute Respiratory Distress Syndrome pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Acute Respiratory Distress Syndrome Understanding

Acute Respiratory Distress Syndrome: Overview

Acute respiratory distress syndrome (ARDS) is a serious lung condition that causes low blood oxygen. People who develop ARDS are usually ill due to another disease or a major injury. In ARDS, fluid builds up inside the lungs’ tiny air sacs, and surfactant breaks down. A surfactant is a foamy substance that keeps the lungs fully expanded so that a person can breathe. These changes prevent the lungs from filling properly with air and moving enough oxygen into the bloodstream and throughout the body. The lung tissue may scar and become stiff. ARDS may develop over a few days, or it can get worse very quickly. The first symptom of ARDS is usually shortness of breath. ARDS's other signs and symptoms are low blood oxygen, rapid breathing, and clicking, bubbling, or rattling sounds in the lungs when breathing. ARDS most commonly affects hospitalized people who are very ill. It can also be caused by serious trauma. Symptoms usually occur within a day or two of the original illness or trauma, and they may include extreme shortness of breath and gasping for air. To diagnose ARDS, a doctor or pediatrics’ physician will do a physical exam, review the patient’s medical history, measure blood oxygen levels, and order a chest X-ray. Supplying oxygen is the main treatment for ARDS. Other treatments help make one more comfortable or aim to eliminate the cause of ARDS. Treatments for ARDS may help prevent serious or life-threatening complications, including organ damage or organ failure.

'Acute Respiratory Distress Syndrome - Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Acute Respiratory Distress Syndrome pipeline landscape is provided which includes the disease overview and Acute Respiratory Distress Syndrome treatment guidelines. The assessment part of the report embraces, in depth Acute Respiratory Distress Syndrome commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Acute Respiratory Distress Syndrome collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Acute Respiratory Distress Syndrome R&D. The therapies under development are focused on novel approaches to treat/improve Acute Respiratory Distress Syndrome.

Acute Respiratory Distress Syndrome Emerging Drugs Chapters

This segment of the Acute Respiratory Distress Syndrome report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Acute Respiratory Distress Syndrome Emerging Drugs

Itolizumab: Biocon

Itolizumab is a non-depleting anti-CD6 humanized IgG1 monoclonal antibody. Itolizumab was launched in India in 2013 under the brand name ALZUMAb. Itolizumab has received emergency use approval in India to treat cytokine release syndrome in COVID-19 patients with moderate to severe acute respiratory distress syndrome. Itolizumab is also evaluated in multiple clinical trials in patients with severe diseases, including acute graft-versus-host disease (aGVHD), lupus / lupus nephritis and uncontrolled asthma.

ZYESAMI: NRx Pharmaceuticals

ZYESAMI (Aviptadil) is a synthetic formulation of naturally occurring vasoactive intestinal polypeptide. The drug is currently being evaluated in Phase II/III clinical study to treat COVID-19 induced acute respiratory distress syndrome (ARDS). The drug is in development in collaboration with Relief therapeutics. NRx Pharmaceuticals had submitted an application to the US Food and Drug Administration (FDA) seeking Emergency Use Authorization (EUA) for the use of aviptadil in the treatment of critical COVID-19 in patients with respiratory failure.

Lenzilumab: Humanigen

Lenzilumab is a recombinant monoclonal antibody targeting circulating granulocyte-macrophage colony-stimulating factor (GM-CSF). The drug is currently being evaluated in Phase III clinical studies in patients with COVID-19 pneumonia and in Phase I/II clinical studies for the treatment of relapsed/refractory large B-cell lymphoma.

Remestemcel-L: Mesoblast

Remestemcel-L, an investigational mesenchymal stromal cell therapy derived from the bone marrow of an unrelated donor. The drug is approved for the treatment of acute graft versus host disease (aGVHD). Remestemcel-L is thought to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions by downregulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues. The drug is currently being evaluated in Phase III clinical trials to treat patients with COVID-19 ARDS.

Ravulizumab: Alexion Pharmaceuticals

Ravulizumab (Ultomiris) is a humanized monoclonal antibody that works by inhibiting the C5 protein in the terminal complement cascade. The drug is indicated for the treatment of haemolytic uraemic syndrome and paroxysmal nocturnal haemoglobinuria. Ravulizumab is currently being evaluated in Phase III clinical trials to treat patients with COVID-19 severe pneumonia, acute lung injury, or acute respiratory distress syndrome. The drug is also in clinical studies to treat acute lung injury, amyotrophic lateral sclerosis; myasthenia gravis; neuromyelitis optica; thrombotic microangiopathies, IgA nephropathy, and lupus nephritis.

SFX-01: Evgen Pharma

SFX-01 (Sulforadex) is an orally administered investigational medicinal product that activates Nrf2. It is a synthetic sulforaphane which is stabilized by an alpha-cyclodextrin. The drug is currently being evaluated in Phase II/III clinical study to treat acute respiratory distress syndrome (ARDS) including COVID-19.

DMX-200: Dimerix Bioscience

DMX-200 is a fixed dose combination product of irbesartan and propagermanium. The drug is currently being evaluated in Phase III clinical study to treat focal segmental glomerulosclerosis (FSGS) and acute respiratory distress syndrome (ARDS) in patients with COVID-19 and in Phase II clinical studies for the treatment of diabetic kidney disease.

Cholecalciferol: Mylan

Cholecalciferol (Vitamin D) is a secosteroid hormone produced by the skin during summer exposure to UVB rays. Research shows that vitamin D plays a role in balancing RAS and in reducing lung damage. University Hospital, Angers is currently evaluating Cholecalciferol, in collaboration with Mylan, in Phase III clinical studies in high-risk COVID-19 patients.

Acute Respiratory Distress Syndrome: Therapeutic Assessment

This segment of the report provides insights about the different Acute Respiratory Distress Syndrome drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Acute Respiratory Distress Syndrome

There are approx. 120+ key companies which are developing the therapies for Acute Respiratory Distress Syndrome. The companies which have their Acute Respiratory Distress Syndrome drug candidates in the most advanced stage, i.e. Registered include, Biocon.

Phases

The report covers around 120+ products under different phases of clinical development like

  • Late stage products (Phase III)
  • Mid-stage products (Phase II)
  • Early-stage product (Phase I) along with the details of
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates

Route of Administration

Acute Respiratory Distress Syndrome pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
  • Oral
  • Parenteral
  • Intravenous
  • Subcutaneous
  • Topical

Molecule Type

Products have been categorized under various Molecule types such as

  • Monoclonal Antibody
  • Peptides
  • Polymer
  • Small molecule
  • Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Acute Respiratory Distress Syndrome: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Acute Respiratory Distress Syndrome therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Acute Respiratory Distress Syndrome drugs.

Acute Respiratory Distress Syndrome Report Insights

  • Acute Respiratory Distress Syndrome Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Acute Respiratory Distress Syndrome Report Assessment

  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Inactive drugs assessment
  • Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

  • How many companies are developing Acute Respiratory Distress Syndrome drugs?
  • How many Acute Respiratory Distress Syndrome drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Acute Respiratory Distress Syndrome?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Acute Respiratory Distress Syndrome therapeutics?
  • What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Acute Respiratory Distress Syndrome and their status?
  • What are the key designations that have been granted to the emerging drugs?

Table of Contents

IntroductionExecutive Summary
Acute Respiratory Distress Syndrome: Overview
  • Causes
  • Mechanism of Action
  • Signs and Symptoms
  • Diagnosis
  • Disease Management
Pipeline Therapeutics
  • Comparative Analysis
Therapeutic Assessment
  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type
Late Stage Products (Registered)
  • Comparative Analysis
Itolizumab: Biocon
  • Product Description
  • Research and Development
  • Product Development Activities
Mid Stage Products (Phase II/III)
  • Comparative Analysis
EB05: Edesa Biotech
  • Product Description
  • Research and Development
  • Product Development Activities
Early stage products (Phase I/II)
  • Comparative Analysis
RAPA 501: Rapa Therapeutics
  • Product Description
  • Research and Development
  • Product Development Activities
Preclinical stage products
  • Comparative Analysis
TP-317: Thetis Pharmaceuticals
  • Product Description
  • Research and Development
  • Product Development Activities
Inactive Products
  • Comparative Analysis
Acute Respiratory Distress Syndrome Key CompaniesAcute Respiratory Distress Syndrome Key ProductsAcute Respiratory Distress Syndrome- Unmet NeedsAcute Respiratory Distress Syndrome- Market Drivers and BarriersAcute Respiratory Distress Syndrome- Future Perspectives and ConclusionAcute Respiratory Distress Syndrome Analyst ViewsAcute Respiratory Distress Syndrome Key CompaniesAppendix
List of Table
Table 1 Total Products for Acute Respiratory Distress Syndrome
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products
List of Figures
Figure 1 Total Products for Acute Respiratory Distress Syndrome
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Biocon
  • NRx Pharmaceuticals
  • Humanigen
  • Mesoblast
  • Alexion Pharmaceuticals
  • Laboratoire français de Fractionnement et de Biotechnologies (LFB)
  • Sage Therapeutics
  • Evgen Pharma
  • Dimerix Bioscience
  • Mylan
  • Vanda Pharmaceuticals
  • EUSA Pharma
  • Veru Inc.
  • BioMarck Pharmaceuticals
  • CTI BioPharma
  • Athersys
  • Foresee Pharmaceuticals
  • Boehringer Ingelheim
  • Staidson (Beijing) Biopharmaceuticals
  • Biohaven Pharmaceuticals
  • Chimerix
  • Edesa Biotech
  • Biophytis
  • US Biotest
  • Pliant Therapeutics
  • Windtree Therapeutics
  • Exvastat
  • Acticor Biotech
  • Roivant Sciences
  • Direct Biologics
  • Arch Biopartners
  • Faron Pharmaceuticals
  • Edesa Biotech
  • F4 Pharma
  • Apeiron Biologics
  • Trevena
  • Synact Pharma
  • Pluristem Therapeutics
  • Asklepion Pharmaceuticals
  • Kiniksa Pharmaceuticals
  • UCB Pharma
  • Oryzon Genomics
  • Sorrento Therapeutics
  • Cerecor Inc.
  • Bayer Healthcare
  • APEPTICO Forschung und Entwicklung
  • Amyndas Pharmaceuticals
  • Enlivex Therapeutics
  • ILTOO Pharma
  • Palisade Bio
  • Orgenesis
  • Ampio Pharmaceuticals
  • Akebia Therapeutics
  • NextCell Pharma
  • Jazz Pharmaceuticals
  • Implicit Bioscie
  • Aerogen Pharma
  • Noorik Biopharmaceuticals
  • Enzychem Lifesciences
  • Chiesi Farmaceutici
  • Savara Pharmaceuticals
  • MediciNova
  • Organicell Regenerative Medicine
  • Reven Pharmaceuticals
  • Rapa Therapeutics
  • AVEM HealthCare
  • Cellular Biomedicine Group
  • Baylx
  • Histocell
  • Cartesian Therapeutics
  • Cynata Therapeutics
  • Immunovative Therapies
  • Orbsen Therapeutics
  • Celularity
  • Bonus BioGroup
  • Diffusion Pharmaceuticals
  • Meridigen Biotech
  • Longeveron
  • Cellenkos
  • Bayer
  • AVM Biotechnology
  • AgenTus Therapeutics, Inc.
  • SFA Therapeutics
  • NEUTROLIS
  • ImmunityBio
  • LTT Bio-Pharma Co Ltd
  • Vasomune Therapeutics
  • Noxopharm
  • Revolo Biotherapeutics
  • GEn1E Lifesciences
  • Abbreos
  • Novellus
  • Tetra Bio-Pharma
  • BioCardia
  • Aqualung Therapeutics
  • Aptahem
  • Thetis Pharmaceuticals LLC
  • SolAeroMed
  • PharmAbcine
  • Lamellar Biomedical
  • In2cure AB
  • Incannex
  • Curacle Co Ltd
  • CohBar Inc
  • BrainStorm Cell Therapeutics
  • AyuVis Research
  • Northern Therapeutics Inc
  • FibroGenesis