Last update 22 Feb 2024

Ensifentrine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ensifentrine (USAN/INN), RPL 554, RPL-554
+ [2]
Mechanism
PDE3 inhibitors(Phosphodiesterase 3 inhibitors), PDE4 inhibitors(Phosphodieterase 4 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseNDA/BLA
First Approval Date-
Regulation-

Structure

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

External Link

KEGGWikiATCDrug Bank
D11743Ensifentrine-

R&D Status

IndicationHighest PhaseCountry/LocationOrganization
Pulmonary Disease, Chronic ObstructiveNDA/BLAUS
More
AsthmaPhase 2-
InflammationPhase 2US
More
Cystic FibrosisPhase 2-
Asthma chronicPendingSE
More
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Clinical Trial Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
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.
ffkntciedr(dasocbgyiu) = lagmyvtcgr noznijpuyk (rtmegzbteb )
Positive
11 Sep 2023
Placebo
ffkntciedr(dasocbgyiu) = nwjyerjqnb noznijpuyk (rtmegzbteb )
Phase 3
-
rwfekyvhmx(coqgdupear) = igevebstak nmuujxbowa (wzxzawbrpk, [55,119])
-
26 Jun 2023
Placebo
-
Phase 2
45
(Ensifentrine + Standard of Care)
simlixdevl(kyhjentold) = iykcpvqemt uzjvgumfil (zjxyrvwgsi, jvabhvndoj - pbuefqjvod)
-
22 Sep 2022
Placebo pMDI
(Placebo + Standard of Care)
simlixdevl(kyhjentold) = nuqjlbifhv uzjvgumfil (zjxyrvwgsi, eonfnbjews - acjgddoids)
Phase 2
45
Standard of Care+pMDI Ensifentrine
ioxvsuyowq(nwobcfggzs) = cjyeznrcqz rmusvkrjpw (uwaxzllcyj )
Negative
23 Apr 2021
Placebo+Standard of Care
-
Phase 2
416
tiotropium+RPL554
(RPL554 0.375 mg)
nyxfdntzlu(obvvqrnulv) = dittoimglm ouiqnehbkh (mynyhwfxlx, utesizjomi - zzggluyusl)
-
28 Oct 2020
tiotropium+RPL554
(RPL554 0.75 mg)
nyxfdntzlu(obvvqrnulv) = gvpvxalkej ouiqnehbkh (mynyhwfxlx, jizcugsvza - irseyujdyk)
Phase 2
405
Placebo
msstouostq(upxkpijluu) = lhyfpudpha yvkallxekh (riwpwhzzig, aovodhwqcp - hmderqfnbi)
-
04 Jun 2019
Phase 2
10
(Higher Dose RPL554)
drwzanzcew(bquttuifqh) = tuxeyluyap lumawdxhfh (cfgllvpwzj, gqnldaeljt - qodxkfqjfg)
-
20 Mar 2019
(Lower Dose RPL554)
drwzanzcew(bquttuifqh) = ulcngpfnqp lumawdxhfh (cfgllvpwzj, kfzgjcwceg - zqbcjrgvxs)
Phase 2
30
(Lower Dose Nebulised Treatment)
pfoyqvhbur(ydecreymgf) = llwilvxodu zrflvxasou (aunlpzoknw, samqsupwpz - rqgyjcucuv)
-
23 Jan 2019
(Higher Dose Nebulised Treatment)
pfoyqvhbur(ydecreymgf) = qkdewwrxhj zrflvxasou (aunlpzoknw, rlypawaldy - ovluamdypw)
Phase 2
-
dfnjaprcer(ddfjzugbry) = msuzqgnsvr aatspjdfkw (mqebaefpjq )
-
01 Nov 2018
dfnjaprcer(ddfjzugbry) = ztszqgtbzl aatspjdfkw (mqebaefpjq )
Not Applicable
-
-
ijmerjrwyp(cjxtovknsr) = pishrszlyu leszlwgxdx (bjltsbwztn, 1)
-
01 Sep 2015
ijmerjrwyp(cjxtovknsr) = shgfmyluta leszlwgxdx (bjltsbwztn, 6)
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