Acute Respiratory Distress Syndrome- Pipeline Insight, 2025

DelveInsight's, "Acute Respiratory Distress Syndrome- Pipeline Insight, 2025" report provides comprehensive insights about 50+ companies and 50+ 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.

Geography Covered:

• Global coverage

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.

Usually, the first symptom of ARDS is shortness of breath, cough, and fever. Other signs and symptoms of ARDS are low blood oxygen, rapid breathing, and clicking, bubbling, or rattling sounds in the lungs when breathing. ARDS is generally characterized by three stages such as exudative stage, fibroproliferative (or proliferative) stage, resolution, and recovery stage. The exudative stage is the accumulation of protein, excessive fluid and inflammatory cells in the alveoli occur in the exudative stage. This phase usually is seen within the first 2 to 4 days after the onset of lung injury. Fibroproliferative (or proliferative) stage is the proliferation of connective tissue and other structural elements in the lungs in response to the initial lung injury. The chances of a patient having pneumonia sepsis and rupture of the lungs are very high in this stage. Resolution and Recovery are in this stage, the lung reorganizes and recovers. During this stage, lung function may continue to improve in patients. The fourth phase of ARDS is also seen according to some experts in which when some patients due to acute illness have continued health problems while some may experience anxiety, depression, and flashback memories of their critical illness, which are very similar to post-traumatic stress disorder. This stage is still an area under research.

Acute Respiratory Distress Syndrome (ARDS) is diagnosed based on a combination of clinical criteria, imaging studies, and exclusion of other potential causes. Clinically, ARDS presents with rapid onset of severe shortness of breath, often within hours to days of an initial insult, such as sepsis, pneumonia, trauma, or inhalation injury. Diagnostic imaging, typically a chest X-ray or CT scan, reveals bilateral pulmonary infiltrates, indicating fluid accumulation in the lungs. Importantly, ARDS is characterized by hypoxemia, where oxygen levels in the blood are critically low despite adequate oxygen supplementation.

"Acute Respiratory Distress Syndrome- Pipeline Insight, 2025" report by DelveInsight 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

• ExoFlo: Direct Biologics

ExoFlo, derived from bone marrow mesenchymal stem cells (BM-MSCs), is a therapeutic product being investigated for its potential to treat moderate to severe acute respiratory distress syndrome (ARDS), particularly in the context of COVID-19. This treatment utilizes extracellular vesicles (EVs) that convey the immunomodulatory and regenerative properties of BM-MSCs, aiming to reduce inflammation and promote tissue repair in patients suffering from ARDS. Currently the drug is in Phase III stage of clinical trial for the treatment of Acute Respiratory Distress Syndrome.

• GEn 1124: GEn1E Lifesciences

GEn 1124 is an investigative small molecule drug being developed in collaboration with GEn1E Lifesciences and Biomedical Advanced Research and Development Authority (BARDA),part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services to support the development of the company's novel therapy for Acute Respiratory Distress Syndrome (ARDS), The drug candidate is mitogen activated protein kinase 14 inhibitors .Currently, the drug is in Phase II stage of its development for the treatment of Acute Respiratory Distress Syndrome.

• ALT-100: Aqualung Therapeutics Corp.

ALT-100 is an innovative mAb therapy, that is designed to be prophylactically-administered at the time of patient intubation for respiratory failure and initiation of mechanical ventilation. Delivered intravenously, ALT-100 neutralizes circulating eNAMPT, thus reducing the potential for development of unchecked inflammation that affect the mortality of diverse inflammatory diseases such as Acute Respiratory Distress Syndrome, Ventilator-Induced Lung Injury, and Trauma-Induced Lung Injury. Currently, the drug is in the Phase II stage of its development for the treatment of Acute Respiratory Distress Syndrome.

• Rhu-pGSN: BioAegis Therapeutics Inc

Rhu-pGSN (recombinant human plasma gelsolin) is an investigational therapy developed by BioAegis Therapeutics for treating severe inflammatory and infectious diseases, notably Acute Respiratory Distress Syndrome (ARDS) and severe pneumonia, including COVID-19. Currently, the drug is in Phase II stage of its development for the treatment of Acute Respiratory Distress Syndrome.

• AVM0703: AVM Biotechnology

AVM0703 is a proprietary formulation of dexamethasone developed by AVM Biotechnology, designed to treat Acute Respiratory Distress Syndrome (ARDS) associated with conditions such as COVID-19 and influenza. This innovative drug allows for the administration of very high doses of dexamethasone, which is typically limited due to potential side effects at standard doses. AVM0703 works by triggering the production and release of these supercharged immune cells shortly after administration. These cells are believed to home in on and attack infected or cancerous cells while sparing normal lymphocytes, thus potentially minimizing side effects commonly associated with other therapies, such as chemotherapy. Currently the drug is in Phase I stage of clinical trial for the treatment of Acute Respiratory Distress Syndrome.

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. 50+ 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. phase III include, Direct Biologics
• Phases

DelveInsight's report covers around 50+ 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
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• 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?

Key Players

• Direct Biologics
• Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Vasomune Therapeutics
• GEn1E Lifesciences
• Aqualung Therapeutics Corp.
• Theratome Bio
• Meridigen Biotech Co., Ltd.
• Dompe Farmaceutici S.p.A
• Windtree Therapeutics
• MiNK Therapeutics
• Avalo Therapeutics, Inc
• AVM Biotechnology
• Arch Biopartners
• RS BioTherapeutics

Key Products

• ExoFlo
• AV 001
• STSA 1002
• GEn 1124
• ALT-100
• Thera 101
• UMC119-06
• Reparixin
• Sinapultide
• AGENT 797
• CERC-002
• AVM0703
• Metablok
• RSBT-001