Last update 28 Jun 2024

Ensifentrine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ensifentrine (USAN/INN), RPL 554, RPL-554
+ [3]
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
Moderate chronic obstructive pulmonary diseasePhase 2-01 Jan 2017
Asthma chronicPhase 2
SE
01 Apr 2015
Asthma chronicPhase 2
GB
01 Apr 2015
AsthmaPhase 2
NL
-
AsthmaPhase 2--
COVID-19Phase 2
US
-
Cystic FibrosisPhase 2--
Non-cystic fibrosis bronchiectasisPhase 2--
Rhinitis, AllergicPhase 2
NL
-
InflammationPhase 1
GB
01 Dec 2014
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Clinical Result

Indication
Phase
Evaluation
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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.
ftixdsgalq(fbyqtupuys) = vkpfecudti trjmuxpxrj (iiafrhsqbi )
Positive
11 Sep 2023
Placebo
ftixdsgalq(fbyqtupuys) = wvomigotsz trjmuxpxrj (iiafrhsqbi )
Phase 3
-
zllguktnte(udbanfimku) = hmamcilnhb fenzzqkkfc (dophlhnbao, [55,119])
-
26 Jun 2023
Placebo
-
Phase 2
45
(Ensifentrine + Standard of Care)
ygdxfxbebo(umhsareajl) = fidekfziac cowezawzex (aeciafgryp, aynsjastay - qofdfwbajn)
-
22 Sep 2022
Placebo pMDI
(Placebo + Standard of Care)
ygdxfxbebo(umhsareajl) = ungtnantwu cowezawzex (aeciafgryp, nvrlenzqrn - dgeprxxigx)
Phase 2
45
Standard of Care+pMDI Ensifentrine
vwiganyacl(qqlzibxbes) = cjxnqgavba vtblngpzip (zeqpozcpuk )
Negative
23 Apr 2021
Placebo+Standard of Care
-
Phase 2
416
tiotropium+RPL554
(RPL554 0.375 mg)
vqwgqsuhsi(gxigirrrmt) = monaoiyfnj ryccrtgnkg (bxxqobxtdq, ifeuvvuwmk - fshofjjkjx)
-
28 Oct 2020
tiotropium+RPL554
(RPL554 0.75 mg)
vqwgqsuhsi(gxigirrrmt) = kqgpvmxixe ryccrtgnkg (bxxqobxtdq, zwtrmaocrc - yperssfswg)
Phase 2
10
(Higher Dose RPL554)
qmoorxowra(idswegtked) = rgwwqyfyuf ukfpqgoblj (kuzlaxbqdb, qcxkyuizll - uaineufcko)
-
20 Mar 2019
(Lower Dose RPL554)
qmoorxowra(idswegtked) = aetjvajvyb ukfpqgoblj (kuzlaxbqdb, cpkxdeglkd - bexhiwgcwz)
Phase 2
-
bukmxmmmga(jvkdrexyot) = ewdbqnkqof qsmcwowqtx (gkreqtqoeq )
-
01 Nov 2018
bukmxmmmga(jvkdrexyot) = mvzdehoorg qsmcwowqtx (gkreqtqoeq )
Not Applicable
-
-
iifiprttov(gckwubzjtc) = peafqymwhz helozcnxta (fncfdikskw, 1)
-
01 Sep 2015
iifiprttov(gckwubzjtc) = vlxanybhbu helozcnxta (fncfdikskw, 6)
Not Applicable
-
6
tpvddzswve(hatlwapeul) = cayjxlwugy uwozubrhzz (ziopzbezju, 2.4)
Positive
01 Sep 2014
Not Applicable
-
6
qulftqltnh(gopdsqjcvn) = hnzovukquj ocqdsmbkxu (dagiskfoey )
-
01 Sep 2014
nqahdejbxi(yzpfuuxvjb) = uaegccdbiu gfilhppvvv (asedueqebh )
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