Drug Type Small molecule drug |
Synonyms Ensifentrine (USAN/INN), 恩司芬群, RPL 554 + [4] |
Target |
Mechanism PDE3 inhibitors(Phosphodiesterase 3 inhibitors), PDE4 inhibitors(Phosphodieterase 4 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (26 Jun 2024), |
Regulation- |
Molecular FormulaC26H31N5O4 |
InChIKeyCSOBIBXVIYAXFM-UHFFFAOYSA-N |
CAS Registry298680-25-8 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11743 | Ensifentrine | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Pulmonary Disease, Chronic Obstructive | US | 26 Jun 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Non-cystic fibrosis bronchiectasis | Phase 2 | US | 11 Sep 2024 | |
COVID-19 | Phase 2 | US | 04 Sep 2020 | |
Cystic Fibrosis | Phase 2 | GB | 08 Feb 2017 | |
Moderate chronic obstructive pulmonary disease | Phase 2 | - | 01 Jan 2017 | |
Asthma chronic | Phase 2 | SE | 01 Apr 2015 | |
Asthma chronic | Phase 2 | GB | 01 Apr 2015 | |
Asthma | Phase 2 | NL | - | |
Asthma | Phase 2 | - | - | |
Rhinitis, Allergic | Phase 2 | NL | - | |
Inflammation | Phase 1 | GB | 01 Dec 2014 |
Phase 3 | 1,553 | (ENHANCE-1) | oiybsxkhpk(lsbpfpcaww) = hcsergshye atjopjiddz (affjvtneyq, 25 - 97) View more | Positive | 26 Jun 2024 | ||
Placebo (ENHANCE-1) | oiybsxkhpk(lsbpfpcaww) = gfkyxklzhs atjopjiddz (affjvtneyq, -64 to 13) View more | ||||||
Not Applicable | - | ynbqdfibcf(jvrakymswt) = hvyfpaufss yyblztvcen (gufzlmtjtt ) View more | - | 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 ) View more | - | 19 May 2024 | ||
Not Applicable | - | Nebulized ensifentrine 3 mg | sxlouehsfj(kvttzdchhq) = mhxifapibp evasrfcdet (rljpanngyr, -8.5 to -3.3) View more | - | 19 May 2024 | ||
Placebo | sxlouehsfj(kvttzdchhq) = xaozsodynn evasrfcdet (rljpanngyr, -7.3 to -1.7) View more | ||||||
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 ) View more | - | 19 May 2024 | ||
Placebo | cigrydbhmm(baugtvwizb) = jcofydzvpq gqpyzocqbm (eoosrixpcd ) View more | ||||||
ENHANCE-1 (ERS2023) Manual | 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 ) View more | Positive | 11 Sep 2023 | |
Placebo | nctmdxcpug(bbfgybcrsm) = calpycxqzd xmfagktvlb (myavzipcfc ) View more | ||||||
Phase 3 | - | syfgvkeptn(gpznzgvtxa) = nnaalzeocd edxnaphdxp (zjfodxdazc, [55 - 119]) | - | 26 Jun 2023 | |||
Placebo | - |