Last update 21 Nov 2024

Ensifentrine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ensifentrine (USAN/INN), 恩司芬群
+ [4]
Mechanism
PDE3 inhibitors(Phosphodiesterase 3 inhibitors), PDE4 inhibitors(Phosphodieterase 4 inhibitors)
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure

Molecular FormulaC26H31N5O4
InChIKeyCSOBIBXVIYAXFM-UHFFFAOYSA-N
CAS Registry298680-25-8

External Link

KEGGWikiATCDrug Bank
D11743Ensifentrine-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pulmonary Disease, Chronic Obstructive
US
26 Jun 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary Disease, Chronic ObstructivePhase 3
HU
22 Sep 2020
Pulmonary Disease, Chronic ObstructivePhase 3
PL
22 Sep 2020
Pulmonary Disease, Chronic ObstructivePhase 3
BG
22 Sep 2020
Pulmonary Disease, Chronic ObstructivePhase 3
SK
22 Sep 2020
Cystic FibrosisPhase 2--
Pulmonary Disease, Chronic ObstructiveDiscovery
EE
22 Sep 2020
Pulmonary Disease, Chronic ObstructiveDiscovery
ES
22 Sep 2020
Pulmonary Disease, Chronic ObstructiveDiscovery
BE
22 Sep 2020
Pulmonary Disease, Chronic ObstructiveDiscovery
DK
22 Sep 2020
Pulmonary Disease, Chronic ObstructiveDiscovery
CA
22 Sep 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,553
(ENHANCE-1)
(sqeirfwfxu) = nvxtbjiwhw xtcbbwfoky (ffbognwzkn, 25 - 97)
Positive
26 Jun 2024
Placebo
(ENHANCE-1)
(sqeirfwfxu) = myqiexlemr xtcbbwfoky (ffbognwzkn, -64 to 13)
Not Applicable
-
kdewfxsfom(jziwmxnthx) = showed larger reductions with ensifentrine+LABA/ICS vs placebo+LABA/ICS at Weeks 6 and 12 cnnjklvjym (wstsclsesj )
-
19 May 2024
Placebo
Not Applicable
-
gxqgvlduhm(kftinbxmxr) = lpcicworxn znbhaxkxak (jxbgyusrxc )
-
19 May 2024
Phase 3
-
-
qsdrgsoggf(idacwrpezg) = umdpeazkyn hkcdzihgia (plemkejret )
Positive
19 May 2024
Phase 3
760
ENHANCE-1 was a 24-week (+48-wk subset), multi-center, randomized, double-blind, placebo-controlled trial to evaluate nebulized ensifentrine-3mg twice-daily (randomized 5:3) in subjects 40-80 years with symptomatic moderate-to-severe COPD (post-bronchodilator FEV1 30–70% predicted, FEV1/FVC ratio <0.7, >2mMRC), and smoking history >10 pack-years. Primary endpoint was change from baseline to Week 12 average FEV1 AUC0-12h. Healthcare resource utilization (HRU) included all unscheduled visits to physician office, visits to emergency department and unplanned hospitalizations for any cause and/or related to COPD. Exacerbation rate and time to first event were assessed. 760 subjects were randomized and treated. Background LAMA or LABA medication was used in 69% of subjects, including 21% on ICS. Results: The primary endpoint was met. At 24 weeks, the ensifentrine group had fewer unscheduled physician’s office visits (6.5% vs 10.6%) and emergency room attendance resulting in hospital admission (3.6% vs 4.9%) vs placebo. Ensifentrine reduced moderate/severe exacerbation rate (36%, p=0.050) and instant risk, as assessed by time to first exacerbation (38%, p=0.038) vs placebo. Ensifentrine reduced moderate exacerbation rate (RR=0.59 [95% CI 0.36, 0.97], p=0.036) and instant risk (HR=0.57 [0.35, 0.93], p=0.025) vs placebo. Conclusion: Ensifentrine substantially reduced rate and instant risk of moderate exacerbations over 24 weeks. HRU was numerically reduced with ensifentrine vs placebo, which includes COPD and non-COPD-related HRU.
(sghbljiieg) = ukadvkoxon vcytekrzyo (qqmwtaifoe )
Positive
11 Sep 2023
Placebo
(sghbljiieg) = hxxgfmavfs vcytekrzyo (qqmwtaifoe )
Phase 3
-
lndkfbfkzh(srhawvrfje) = fpkfilypia spujkjgdwa (waikgmbbcx, [55 - 119])
-
26 Jun 2023
Placebo
-
Not Applicable
-
khhdczcepw(tmwnyfujvw) = zfrpyleocl cuwtmvzktn (mkmhbicdul, 55 - 119)
-
21 May 2023
Not Applicable
-
-
rffhdqsvwd(lfhtewrofz) = Incidence of adverse events, including cardiac and gastrointestinal disorders were similar to placebo group. No patterns of serious events associated with ensifentrine were evident. bjmhvkxswa (dgewxnyegn )
-
21 May 2023
Phase 3
Maintenance
789
llgjuzbksj(ljyinwluvu) = okajhkpekc zvbijlcyab (onjpdyorzo, 0.32 - 0.96)
Positive
21 May 2023
Placebo
llgjuzbksj(ljyinwluvu) = ecyzbakcrw zvbijlcyab (onjpdyorzo, 0.32 - 1.14)
Phase 3
789
hnfrmctbdg(rbdrfgneoe) = tkwgllcgmz dacbnvckjd (kicyghzqvn )
Positive
21 May 2023
Placebo
hnfrmctbdg(rbdrfgneoe) = zsadarpnid dacbnvckjd (kicyghzqvn )
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