Acute Respiratory Distress Syndrome Pipeline

DelveInsight’s, “Acute Respiratory Distress Syndrome (ARDS) - Pipeline Insight, 2025” report provides comprehensive insights about 45+ companies and 50+ pipeline drugs in Acute Respiratory Distress Syndrome (ARDS) 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 (ARDS): Understanding

Acute Respiratory Distress Syndrome (ARDS): Overview

Acute respiratory distress syndrome (ARDS) is a severe, life-threatening inflammatory lung condition that typically develops within seven days of an inciting event and is marked by acute onset of bilateral lung infiltrates, severe hypoxemia, and poor oxygenation not caused by cardiac failure. Defined by the Berlin criteria, ARDS presents with a PaO2/FiO2 ratio below 300 mm Hg, non-cardiac pulmonary opacities on imaging, and a requirement for PEEP or CPAP of at least 5 cm H₂O. The condition involves capillary endothelial injury, diffuse alveolar damage, and often pulmonary artery vasoconstriction, which can progress to pulmonary hypertension. Despite its high mortality, effective treatment options remain limited.

ARDS typically presents with sudden and severe breathing difficulties, including rapid, shallow, and labored respiration, often accompanied by bluish skin or lips from low blood oxygen. Patients may experience rapid heart rate, fatigue, confusion, dizziness, and low blood pressure as the body struggles to circulate oxygen. Additional signs can include cough with phlegm, chest pain on deep breaths, crackling sounds in the lungs from fluid buildup, and extreme exhaustion, reflecting both the underlying lung injury and the body’s intense effort to maintain oxygenation. Symptoms usually progress quickly, often within hours to days of the triggering event, and can worsen rapidly without immediate medical intervention. In severe cases, respiratory failure may occur, requiring mechanical ventilation and intensive care. The severity and combination of symptoms often depend on the underlying cause, the patient’s overall health, and the speed of diagnosis and treatment.

ARDS is a stereotypical response to diverse causes, progressing from initial alveolar-capillary damage to a proliferative healing phase and, in some cases, a fibrotic phase marking the end of the acute process. The condition involves inflammation, apoptosis, necrosis, and increased alveolar-capillary permeability, leading to alveolar edema and proteinosis that impair gas exchange and cause hypoxemia. Lung injury is patchy, often affecting the bases more than the apices, resulting in uneven compliance and variable responses to oxygenation strategies such as higher PEEP, which may improve oxygenation in damaged areas but risk volutrauma or atelectrauma in healthier regions. This localized injury pattern ultimately produces impaired gas exchange, reduced lung compliance, and pulmonary hypertension.

The primary treatment for ARDS is supportive care focused on reducing shunt fraction, improving oxygen delivery, decreasing oxygen demand, and preventing further injury. Most patients require mechanical ventilation with a lung-protective strategy per ARDSnet protocol, using low tidal volumes, controlled plateau pressures, and appropriate PEEP to optimize oxygenation while minimizing volutrauma, barotrauma, and atelectrauma. Non-invasive ventilation may be used in mild to moderate cases, but rapid escalation to intubation is essential if deterioration occurs. Adjunctive measures include prone positioning, conservative fluid management, and neuromuscular blockade in select patients, nutritional support, thromboprophylaxis, stress ulcer prevention, and treatment of reversible causes of poor lung compliance. ECMO may be considered as salvage therapy for refractory hypoxemia, though mortality benefits remain unclear, and glucocorticoids are reserved for steroid-responsive conditions or early refractory cases. Preventing complications such as pressure ulcers and initiating rehabilitation when stable are also key to recovery.

"Acute Respiratory Distress Syndrome (ARDS)- 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 (ARDS) pipeline landscape is provided which includes the disease overview and Acute Respiratory Distress Syndrome (ARDS) treatment guidelines. The assessment part of the report embraces, in depth Acute Respiratory Distress Syndrome (ARDS) 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 (ARDS) 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 (ARDS) R&D. The therapies under development are focused on novel approaches to treat/improve Acute Respiratory Distress Syndrome (ARDS).

 

Acute Respiratory Distress Syndrome (ARDS) Emerging Drugs Chapters

This segment of the Acute Respiratory Distress Syndrome (ARDS) report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, 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 (ARDS) Emerging Drugs

• Paridiprubart: Edesa Biotech

Paridiprubart is a first-in-class host-directed monoclonal antibody that targets and inhibits Toll-like receptor 4 (TLR4) to modulate the excessive innate immune response underlying ARDS. In a Phase II substudy involving critically ill, mechanically ventilated patients, paridiprubart plus standard of care produced an 84% reduction in 28-day mortality compared to placebo. Its robust efficacy and threat-agnostic mechanism have earned it inclusion in a US government-funded Phase II platform trial led by BARDA, with parallel Phase III trials ongoing in Canada and the US. Currently, the drug is in Phase III stage of its development for the treatment of Acute Respiratory Distress Syndrome (ARDS).

 

• Rhu-Pgsn: BioAegis Therapeutics Inc.

Plasma gelsolin’s non-immunosuppressive mechanism enables the host to mount a pathogen-agnostic response to infection while also avoiding the dysfunction of uncontrolled inflammation. In multiple animal disease models, administration of rhu-pGSN improves survival, reduces morbidity and protects critical organs. pGSN travels to the site of injury and clears actin that is released from cells and is a cause of many inflammatory and immunosuppressive functions.  This also clears biofilms and cell-free DNA/NETs. pGSN directly interacts with the white blood cells (macrophages) and activates a NOS3 pathway within the cell. This enhances the macrophage killing of a wide range of microbial pathogens – antibiotic sensitive or antibiotic resistant. The US Food and Drug Administration (FDA) has granted Fast Track designation to recombinant human plasma gelsolin (rhu-pGSN) for the treatment of acute respiratory distress syndrome (ARDS). Currently, the drug is in Phase II stage of its development for the treatment of Acute Respiratory Distress Syndrome (ARDS).

 

• AV-001: Vasomune Therapeutics, Inc.

Originally discovered and designed at Sunnybrook Research Institute at Sunnybrook Hospital in Toronto, AV-001 is being developed by Vasomune Therapeutics, Inc. under a co-development agreement with AnGes, Inc. [TYO: 4563]. AV-001 is a novel investigational medicine that targets the Tie2 receptor, a transmembrane protein most highly expressed on the surface of endothelial cells in the vasculature. AV-001 activates the nonredundant Tie2-Angiopoietin signaling axis, and through stimulation of multiple downstream pathways normalizes the vasculature by enhancing endothelial cell stability, restoring normal barrier defense, and blocking vascular leak. Vascular dysfunction contributes to the underlying disease pathophysiology in patients with bacterial and viral acute respiratory distress syndrome, sepsis, hemorrhagic shock, acute kidney injury, stroke, and vascular dementia. Importantly, in multiple pre-clinical studies AV-001 tightened endothelial cell-cell junctions and promoted endothelial cell survival, which reduced pulmonary edema, and improved lung function compared to untreated controls translating into significantly improved survival. Currently, the drug is in Phase II stage of its development for the treatment of Acute Respiratory Distress Syndrome (ARDS).

 

• Atibuclimab: Implicit Bioscience

IC14 is the only clinical-stage drug targeting CD14. IC14 is an immunomodulatory monoclonal antibody (mAb), which targets a master regulator of the damaging immune responses to pathogens and injury. Unlike mAbs that target single downstream cytokines in the inflammatory cascade, IC14 targets an upstream master regulator of the immune response. This target receptor, called CD14, alerts the immune system to the presence of a wide range of pathogens, including viruses. It also amplifies this response by alerting the immune system to signs of damage that result from stressed or dying cells. Thus, CD14 is a single point at which a wide range of downstream pathways and damaging cytokines may be controlled. Currently, the drug is in Phase II stage of its development for the treatment of Acute Respiratory Distress Syndrome (ARDS).

Further product details are provided in the report……..

 

Acute Respiratory Distress Syndrome (ARDS): Therapeutic Assessment

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

 

Major  Players in Acute Respiratory Distress Syndrome (ARDS)

• There are approx. 45+ key companies which are developing the therapies for Acute Respiratory Distress Syndrome (ARDS). The companies which have their Acute Respiratory Distress Syndrome (ARDS) drug candidates in the most advanced stage, i.e. Phase III include, Edesa Biotech.

 

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 (ARDS) 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 (ARDS): Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Acute Respiratory Distress Syndrome (ARDS) 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 (ARDS) drugs.

 

Acute Respiratory Distress Syndrome (ARDS) Report Insights

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

Acute Respiratory Distress Syndrome (ARDS) 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 (ARDS) drugs?
• How many Acute Respiratory Distress Syndrome (ARDS) 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 (ARDS)?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Acute Respiratory Distress Syndrome (ARDS) 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 (ARDS) and their status?
• What are the key designations that have been granted to the emerging drugs?