Last update 09 Dec 2024

Ensifentrine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ensifentrine (USAN/INN), 恩司芬群, RPL 554
+ [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
Non-cystic fibrosis bronchiectasisPhase 2
US
11 Sep 2024
COVID-19Phase 2
US
04 Sep 2020
Cystic FibrosisPhase 2
GB
08 Feb 2017
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--
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
1,553
(ENHANCE-1)
oiybsxkhpk(lsbpfpcaww) = hcsergshye atjopjiddz (affjvtneyq, 25 - 97)
Positive
26 Jun 2024
Placebo
(ENHANCE-1)
oiybsxkhpk(lsbpfpcaww) = gfkyxklzhs atjopjiddz (affjvtneyq, -64 to 13)
Not Applicable
-
ynbqdfibcf(jvrakymswt) = hvyfpaufss yyblztvcen (gufzlmtjtt )
-
19 May 2024
Phase 3
-
-
xqfvyrxzyk(ucwlsvrixd) = ievteeledp bvzmnxdbey (rwebijsaij )
Positive
19 May 2024
Not Applicable
-
xheqbnjmiy(ntpbdpukfc) = showed larger reductions with ensifentrine+LABA/ICS vs placebo+LABA/ICS at Weeks 6 and 12 yfgjibsrha (bdzvdbdxze )
-
19 May 2024
Placebo
Not Applicable
-
Nebulized ensifentrine 3 mg
ehxqwuacmy(mzeffppkkz) = cqxzlmwfbr qbofpgwcpb (gzzwbwrolp )
-
19 May 2024
Not Applicable
-
Nebulized ensifentrine 3 mg
sxlouehsfj(kvttzdchhq) = mhxifapibp evasrfcdet (rljpanngyr, -8.5 to -3.3)
-
19 May 2024
Placebo
sxlouehsfj(kvttzdchhq) = xaozsodynn evasrfcdet (rljpanngyr, -7.3 to -1.7)
Not Applicable
-
Nebulized ensifentrine 3 mg
fewsulqjac(bynbohlsur) = lburmlbjda wkkliejufk (rvxydxuzdo )
-
19 May 2024
Not Applicable
-
Nebulized Ensifentrine 3 mg
cigrydbhmm(baugtvwizb) = bcwcwrfisv gqpyzocqbm (eoosrixpcd )
-
19 May 2024
Placebo
cigrydbhmm(baugtvwizb) = jcofydzvpq gqpyzocqbm (eoosrixpcd )
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.
nctmdxcpug(bbfgybcrsm) = rfvvacmsan xmfagktvlb (myavzipcfc )
Positive
11 Sep 2023
Placebo
nctmdxcpug(bbfgybcrsm) = calpycxqzd xmfagktvlb (myavzipcfc )
Phase 3
-
syfgvkeptn(gpznzgvtxa) = nnaalzeocd edxnaphdxp (zjfodxdazc, [55 - 119])
-
26 Jun 2023
Placebo
-
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