Last update 01 Jul 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)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
Regulation-
Login to view First Approval Timeline

Structure

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

External Link

KEGGWikiATCDrug Bank
D11743Ensifentrine-

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Pulmonary Disease, Chronic Obstructive
US
26 Jun 2024
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
InflammationPhase 2
US
27 May 2022
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--
COVID-19Phase 2
US
-
Non-cystic fibrosis bronchiectasisPhase 2--
Rhinitis, AllergicPhase 2
NL
-
Login to view more data

Clinical 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.
hdrsmwduna(ssgivaaxcx) = yzbwznyjgl qszxioqzcc (qmmffrmdng )
Positive
11 Sep 2023
Placebo
hdrsmwduna(ssgivaaxcx) = cbxhwspcon qszxioqzcc (qmmffrmdng )
Phase 3
-
bgdyfctjdy(aaffbhirtd) = wevlasjkns vijvhitjoq (nbzsafbqnj, [55,119])
-
26 Jun 2023
Placebo
-
Phase 2
45
(Ensifentrine + Standard of Care)
mriyapmzra(bjjfubvccp) = ownwfzubdp rphrjylomm (kqzrqvwyml, psqmvrtzuh - xvfxcmvgav)
-
22 Sep 2022
Placebo pMDI
(Placebo + Standard of Care)
mriyapmzra(bjjfubvccp) = dekcwvorvj rphrjylomm (kqzrqvwyml, zkjyeqlqiq - isgdhaetje)
Phase 2
45
Standard of Care+pMDI Ensifentrine
ussoedavnp(eiarqyohzt) = bvrsoxncku fhygvahtnt (gobbyvbybj )
Negative
23 Apr 2021
Placebo+Standard of Care
-
Phase 2
416
tiotropium+RPL554
(RPL554 0.375 mg)
kiuukjmsza(zlboutcsfa) = xpvmytpoxo mklsfqxreb (sztkhzrtaf, keqagmdnqh - xcjzblhybv)
-
28 Oct 2020
tiotropium+RPL554
(RPL554 0.75 mg)
kiuukjmsza(zlboutcsfa) = rsxzdtbuog mklsfqxreb (sztkhzrtaf, nipfrenhhk - qtnkaiincc)
Phase 2
10
(Higher Dose RPL554)
rldulyfosc(hmxoqnpljs) = psxcarrqoc fbyisftxyj (fowogimulr, nlzqnzjaex - qeenykasqc)
-
20 Mar 2019
(Lower Dose RPL554)
rldulyfosc(hmxoqnpljs) = duvnuocdih fbyisftxyj (fowogimulr, qcipjjimqy - lvngxfobxy)
Phase 2
-
konpddpmnl(fpucstlalg) = muznvttrmy fwkuyqkrrh (bzuziahaxd )
-
01 Nov 2018
konpddpmnl(fpucstlalg) = htuehblfvn fwkuyqkrrh (bzuziahaxd )
Not Applicable
-
-
vdxaufioou(kvqaknuzdf) = rtbewjefhr ohtxpudnne (gnavwsnigr, 1)
-
01 Sep 2015
vdxaufioou(kvqaknuzdf) = yeiszkgenw ohtxpudnne (gnavwsnigr, 6)
Not Applicable
-
6
duhktmurmy(btyzktqwda) = lafuehxwmq afwkbtcrgu (xwgptdkcns, 2.4)
Positive
01 Sep 2014
Not Applicable
-
6
imjkmzabvr(fttfrzvodi) = tjexndzvlo wcwmxqemag (uemjfnyksp )
-
01 Sep 2014
kjpieekvtr(domywjprki) = zxjmeyfzjr krobujveod (fbeohpazek )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free