Asset profile

alvelestat

Small molecule

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Evidence outlook · lead readout

ASTRAEUS (NCT03636347) · Alpha 1-Antitrypsin Deficiency, Emphysema, COPD

The completed lead evidence is positive, with design limits that temper confidence; the rationale below says which.

ASTRAEUS (NCT03636347): This was a randomized, double-blind, placebo-controlled study in 99 adults with alpha-1-antitrypsin-related lung disease; both alvelestat doses significantly reduced a blood biomarker of neutrophil elastase activity compared with placebo. Because the primary measure was a laboratory biomarker rather than a direct measure of lung symptoms or function, this is supportive but not definitive clinical evidence.

Also in development:Alpha-1 Antitrypsin Deficiency · Phase 2

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Competitive landscape

47 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 47 same-indication; 25 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Alvelestat: this drugPhase 2Small moleculeNeutrophil elastase
Aclidinium Bromide (Tudorza Pressair)ApprovedSmall moleculeMuscarinic acetylcholine receptor (M3)
Aclidinium Bromide / Formoterol Fumarate (Duaklir Pressair)ApprovedSmall moleculeMuscarinic acetylcholine receptor (M3), Beta-2 adrenergic receptor
Benralizumab (Fasenra)ApprovedMonoclonal antibodyIL-5 receptor alpha, IL-5 receptor alpha (IL-5Rα / CD125); Fc region additionally engages FcγRIIIa on NK cells (ADCC), IL-5 receptor alpha (IL5RA) on eosinophils/basophils
Budesonide / Glycopyrrolate / Formoterol Fumarate (Breztri Aerosphere)ApprovedSmall moleculeGlucocorticoid receptor; Muscarinic M3; Beta-2 adrenergic
DepemokimabApprovedMonoclonal antibodyIL-5
Ensifentrine (Ohtuvayre)ApprovedSmall moleculePDE3/PDE4
Fluticasone Furoate / Umeclidinium / Vilanterol (Trelegy Ellipta)ApprovedSmall moleculeMuscarinic acetylcholine receptor (M3), Beta-2 adrenergic receptor, Glucocorticoid receptor, Glucocorticoid receptor / Beta-2 adrenergic receptor / Muscarinic M3 receptor (ICS/LABA/LAMA triple combination)
Glycopyrrolate / Formoterol Fumarate (Bevespi Aerosphere)ApprovedSmall moleculeMuscarinic acetylcholine receptor (M3), Beta-2 adrenergic receptor
Mepolizumab (Nucala)ApprovedMonoclonal antibodyIL-5, Interleukin-5 (IL-5), ligand-neutralizing
OlodaterolApprovedSmall moleculeBeta-2 adrenergic receptor
Olodaterol / Tiotropium BromideApprovedSmall moleculeMuscarinic acetylcholine receptor (M3), Beta-2 adrenergic receptor
Revefenacin (Yupelri)ApprovedSmall moleculeMuscarinic receptors (antagonist)
Tiotropium BromideApprovedSmall moleculeMuscarinic acetylcholine receptor (M3)
Umeclidinium (Incruse Ellipta)ApprovedSmall moleculeMuscarinic acetylcholine receptor (M3), M3 muscarinic acetylcholine receptor
Umeclidinium / VilanterolApprovedSmall moleculeMuscarinic acetylcholine receptor (M3), Beta-2 adrenergic receptor

…and 32 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(1 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2027 (1)
December 2027 (1)
Phase 1/2Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease, Bronchiolitis Obliterans SyndromeActive not recruiting
Est. primary completion 2027-12-01 · NCT02669251 · CT.gov ↗
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All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 2 (2)
Phase 1/2 (3)