Zelpultide alfa - Airway Therapeutics
Alternative Names: AT-100; rhSP-DLatest Information Update: 21 Aug 2025
At a glance
- Originator Airway Therapeutics
- Class Anti-infectives; Anti-inflammatories; Antivirals; Recombinant proteins
- Mechanism of Action Cell membrane permeability enhancers; Protein replacements; Virus replication inhibitors
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Phase III Bronchopulmonary dysplasia
- Phase I COVID 2019 infections
- Preclinical Adult respiratory distress syndrome; Asthma; Chronic obstructive pulmonary disease; Influenza virus infections; Respiratory syncytial virus infections
- Research Inflammation; Respiration disorders
Most Recent Events
- 12 Aug 2025 Airway Therapeutics plans a pivotal phase IIb/III trial for Bronchopulmonary Dysplasia (In infants, Prevention)
- 12 Aug 2025 Airway Therapeutics plans to submit regulatory filings for Zelpultide alfa in Argentina, Australia, and USA
- 12 Aug 2025 Airway Therapeutics plans to submit the PDCO-approved protocol to regulatory authorities in Italy (AIFA), Spain (AEMPS), and Israel (MoH), followed by France, Germany, Belgium, and Poland to initiate the phase IIb/III trial in Bronchopulmonary dysplasia (BPD) (In infants, Prevention) in late third or fourth quarter of 2025