Drugs / Zelpultide alfa
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Zelpultide alfa

also known as AT-100 · Recombinant sp-d

Protein / enzyme biologic

Developed for
bronchopulmonary dysplasia · COVID-19
Investigated by
Airway Therapeutics, Inc.

Trials 3

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT04662151 Sep 2021 → Aug 2023 bronchopulmonary dysplasia Airway Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT04659122 Aug 2021 → Feb 2023 COVID-19 Airway Therapeutics, Inc. Terminated No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT06897839 Feb 2025 → Mar 2028 expected bronchopulmonary dysplasia Airway Therapeutics, Inc. Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2025-08-28 Airway Therapeutics, Inc. Regulatory Airway Therapeutics Receives European Medicines Agency Pediatric Committee Approval for Zelpultide Alfa’s Study Plan in Bronchopulmonary Dysplasia for Very Preterm Infants airwaytherapeutics.com ↗
2024-06-24 Airway Therapeutics, Inc. Results Airway Therapeutics Wins 2024 ATS Whitsett Award for Abstract of Positive Phase 1b Results of Zelpultide Alfa in Preterm Neonates at Risk of Bronchopulmonary Dysplasia airwaytherapeutics.com ↗
No dose limiting toxicities were found while indications of efficacy were observed.

All press releases naming this drug 7 releases

DateIssuerRelease

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as Zelpultide alfa ClinicalTrials.gov intervention name — accepted as the source's own label NCT06897839 ↗
Known as AT-100 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04659122 ↗
1

NCT04662151 ↗

Known as Recombinant sp-d ChEMBL registry synonym — accepted as the source's own label CHEMBL4650375 ↗
Modality Protein / enzyme biologic “recombinant human surfactant protein D” PMID 41018057 ↗ Sep 2025
Route Other “intratracheal administration” NCT04659122 ↗