Drug Type Small molecule drug |
Synonyms Ensifentrine (USAN/INN), 恩司芬群 + [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 |
---|---|---|---|---|
Pulmonary Disease, Chronic Obstructive | Phase 3 | HU | 22 Sep 2020 | |
Pulmonary Disease, Chronic Obstructive | Phase 3 | PL | 22 Sep 2020 | |
Pulmonary Disease, Chronic Obstructive | Phase 3 | BG | 22 Sep 2020 | |
Pulmonary Disease, Chronic Obstructive | Phase 3 | SK | 22 Sep 2020 | |
Cystic Fibrosis | Phase 2 | - | - | |
Pulmonary Disease, Chronic Obstructive | Discovery | EE | 22 Sep 2020 | |
Pulmonary Disease, Chronic Obstructive | Discovery | ES | 22 Sep 2020 | |
Pulmonary Disease, Chronic Obstructive | Discovery | BE | 22 Sep 2020 | |
Pulmonary Disease, Chronic Obstructive | Discovery | DK | 22 Sep 2020 | |
Pulmonary Disease, Chronic Obstructive | Discovery | CA | 22 Sep 2020 |
Phase 3 | 1,553 | (ENHANCE-1) | (sqeirfwfxu) = nvxtbjiwhw xtcbbwfoky (ffbognwzkn, 25 - 97) View more | Positive | 26 Jun 2024 | ||
Placebo (ENHANCE-1) | (sqeirfwfxu) = myqiexlemr xtcbbwfoky (ffbognwzkn, -64 to 13) View more | ||||||
Not Applicable | - | kdewfxsfom(jziwmxnthx) = showed larger reductions with ensifentrine+LABA/ICS vs placebo+LABA/ICS at Weeks 6 and 12 cnnjklvjym (wstsclsesj ) | - | 19 May 2024 | |||
Placebo | |||||||
Not Applicable | - | gxqgvlduhm(kftinbxmxr) = lpcicworxn znbhaxkxak (jxbgyusrxc ) View more | - | 19 May 2024 | |||
Phase 3 | - | - | qsdrgsoggf(idacwrpezg) = umdpeazkyn hkcdzihgia (plemkejret ) | Positive | 19 May 2024 | ||
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. | (sghbljiieg) = ukadvkoxon vcytekrzyo (qqmwtaifoe ) View more | Positive | 11 Sep 2023 | |
Placebo | (sghbljiieg) = hxxgfmavfs vcytekrzyo (qqmwtaifoe ) View more | ||||||
Phase 3 | - | lndkfbfkzh(srhawvrfje) = fpkfilypia spujkjgdwa (waikgmbbcx, [55 - 119]) | - | 26 Jun 2023 | |||
Placebo | - | ||||||
Not Applicable | - | khhdczcepw(tmwnyfujvw) = zfrpyleocl cuwtmvzktn (mkmhbicdul, 55 - 119) | - | 21 May 2023 | |||
Not Applicable | - | - | rffhdqsvwd(lfhtewrofz) = Incidence of adverse events, including cardiac and gastrointestinal disorders were similar to placebo group. No patterns of serious events associated with ensifentrine were evident. bjmhvkxswa (dgewxnyegn ) | - | 21 May 2023 | ||
Phase 3 | Maintenance | 789 | llgjuzbksj(ljyinwluvu) = okajhkpekc zvbijlcyab (onjpdyorzo, 0.32 - 0.96) | Positive | 21 May 2023 | ||
Placebo | llgjuzbksj(ljyinwluvu) = ecyzbakcrw zvbijlcyab (onjpdyorzo, 0.32 - 1.14) | ||||||
Phase 3 | 789 | hnfrmctbdg(rbdrfgneoe) = tkwgllcgmz dacbnvckjd (kicyghzqvn ) View more | Positive | 21 May 2023 | |||
Placebo | hnfrmctbdg(rbdrfgneoe) = zsadarpnid dacbnvckjd (kicyghzqvn ) |