Drugs / glasmacinal
last change 6 days ago re-read 9 days ago

glasmacinal

also known as EP395 · EP395 FREE BASE

Small molecule

Developed for
chronic obstructive pulmonary disease
Investigated by
EpiEndo Pharmaceuticals · FGK Clinical Research GmbH · CTC Clinical Trial Consultants AB

Trials 5

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials · 1 missed
Phase 1 NCT06677918 Feb → Aug 2025 — EpiEndo Pharmaceuticals Completed No outcome recorded
Phase 1 NCT06118684 Oct 2023 → Jan 2024 chronic obstructive pulmonary disease EpiEndo Pharmaceuticals Completed No outcome recorded
Phase 1 NCT05516316 Oct 2022 → Jun 2023 chronic obstructive pulmonary disease EpiEndo Pharmaceuticals Completed Missed primary
Phase 1 NCT04819854 Apr 2021 → Mar 2022 adult acute lymphoblastic leukemia EpiEndo Pharmaceuticals Completed No outcome recorded
Phase 21 trial
Phase 2 NCT05572333 Nov 2022 → Nov 2023 chronic obstructive pulmonary disease EpiEndo Pharmaceuticals Completed No outcome recorded

News releases announcing trial results or a regulatory action · 13

DateIssuerRelease
2026-10-05 EpiEndo Pharmaceuticals Results ERJ Open Research publication shows glasmacinal enhances antiviral responses in airway cells from asthma patients epiendo.com ↗
The article shows that glasmacinal enhances the antiviral response while reducing viral load in rhinovirus-infected bronchial epithelial cells obtained from asthma patients with moderate disease.
2026-03-24 EpiEndo Pharmaceuticals Results New publication shows glasmacinal reduces eosinophilic airway inflammation in preclinical models epiendo.com ↗
The article shows that glasmacinal reduces eosinophilic inflammation in two established preclinical models of allergic airway disease.
2026-03-18 EpiEndo Pharmaceuticals Results British Journal of Clinical Pharmacology article reports two clinical pharmacology trials of glasmacinal (EP395) epiendo.com ↗
Glasmacinal, a macrolide with negligible antimicrobial activity but with anti-inflammatory and immunomodulatory properties, was well tolerated in healthy participants and has limited potential for clinically relevant drug interactions.
2025-12-08 EpiEndo Pharmaceuticals Results ERJ Open Research article reports first clinical trial of glasmacinal (EP395) in COPD patients epiendo.com ↗
Glasmacinal was well-tolerated and reduced neutrophilic inflammation in sputum.
2025-11-17 EpiEndo Pharmaceuticals Results Data presentation at British Thoracic Society Winter Meeting epiendo.com ↗
The presentation, ‘EP395, a novel non-antibiotic macrolide, enhances antiviral responses in bronchial epithelial cells from asthma patients’, will highlight preclinical data produced through EpiEndo’s collaboration with Lund University.
2025-06-11 EpiEndo Pharmaceuticals Results Clinical and pre-clinical data on the novel Barriolide, EP395 (glasmacinal), published in three articles in Pulmonary Pharmacology and Therapeutics epiendo.com ↗
The article “Effect of EP395, a novel anti-inflammatory macrolide, in an inhaled lipopolysaccharide challenge model in healthy volunteers: a randomised controlled trial” reports that EP395 enhances the host defence response to inhaled LPS whilst reducing pro-inflammatory mediators.
2024-08-15 EpiEndo Pharmaceuticals Results EpiEndo to present three posters at ERS Congress 2024 epiendo.com ↗
The first poster details preclinical data, some of which was produced in collaboration with King’s College London, showing that EP395 is effective in the reduction of eosinophilic inflammation.
2024-04-10 EpiEndo Pharmaceuticals Results EpiEndo reports Phase 2A results for lead asset, EP395, in COPD epiendo.com ↗
2023-10-23 EpiEndo Pharmaceuticals Results Completion of proof of pharmacology study for lead asset EP395 epiendo.com ↗
Although the primary endpoint (a statistically significant effect on IL-8) was not met, there were positive effects seen on a number of markers of inflammation and epithelial function with EP395 treatment.
2023-08-16 EpiEndo Pharmaceuticals Results Poster presentations at ERS Milan 2023 International Congress epiendo.com ↗
The second poster presentation outlines the in vivo inflammation resolving effect of EP395, particularly its role in host-microbe interactions, and its ability to alleviate inflammation and inhibit vascular permeability.
2022-11-14 EpiEndo Pharmaceuticals Regulatory Commencement of Ph2a trial for EP395 in COPD patients epiendo.com ↗
EpiEndo Pharmaceuticals has received regulatory approval to commence a Phase 2a clinical trial with lead molecule EP395 in COPD (Chronic Obstructive Pulmonary Disease) patients.
2022-05-18 EpiEndo Pharmaceuticals Results Successful completion of Phase I Study for lead asset EP395 epiendo.com ↗
EP395 was well tolerated and with pharmacokinetics consistent with once daily dosing.

All press releases naming this drug 20 releases

DateIssuerRelease

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as glasmacinal “EP395 (glasmacinal), a novel macrolide, is being developed as a treatment to reduce exacerbations of COPD without inducing antimicrobial resistance.” PMID 42206016 ↗ May 2026
2

“glasmacinal (EP395): tolerability, pharmacokinetics and drug interactions.” PMID 41845869 ↗ Mar 2026

“glasmacinal (EP395): tolerability, pharmacokinetics and drug interactions.” PMID 41845869 ↗ Mar 2026

Known as EP395 “glasmacinal (EP395): tolerability, pharmacokinetics and drug interactions.” PMID 41845869 ↗ Mar 2026
4

NCT05516316 ↗

NCT05572333 ↗

NCT04819854 ↗

NCT06677918 ↗

Known as EP395 FREE BASE ChEMBL registry synonym — accepted as the source's own label CHEMBL6068055 ↗
Modality Small molecule “oral anti-inflammatory macrolide” PMID 41845869 ↗ Mar 2026
1

CHEMBL6068055 ↗

Route Oral “administered by oral capsules” NCT04819854 ↗