Drug Type Small molecule drug |
Synonyms BDP/FF, 倍氯米松福莫特罗, CHF-1535 + [3] |
Action agonists |
Mechanism GR agonists(Glucocorticoid receptor agonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date China (04 Feb 2013), |
Regulation- |
Molecular FormulaC28H37ClO7 |
InChIKeyKUVIULQEHSCUHY-XYWKZLDCSA-N |
CAS Registry5534-09-8 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Pulmonary Disease, Chronic Obstructive | European Union | 23 Apr 2018 | |
| Pulmonary Disease, Chronic Obstructive | Iceland | 23 Apr 2018 | |
| Pulmonary Disease, Chronic Obstructive | Liechtenstein | 23 Apr 2018 | |
| Pulmonary Disease, Chronic Obstructive | Norway | 23 Apr 2018 | |
| Asthma | China | 04 Feb 2013 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Bronchiectasis | Phase 3 | Netherlands | 29 Jan 2019 | |
| Childhood asthma | Phase 3 | Denmark | 01 Sep 2011 | |
| Persistent asthma | Phase 3 | - | 01 Aug 2004 | |
| Idiopathic Pulmonary Fibrosis | Phase 2 | United Kingdom | 01 Mar 2014 | |
| Mild persistent asthma | Phase 2 | United Kingdom | 01 Feb 2008 |
Phase 3 | 78 | Beclomethasone dipropionate+Formoterol fumarate (Inhaler A) | cdurpepxlr(ptuinuwphf) = ybvavxhspp fprmwvxrsj (agetkwpzat, njyzaaeqif - wdufcacpfy) View more | - | 27 Mar 2026 | ||
Beclomethasone dipropionate+Formoterol fumarate (Inhaler B) | cdurpepxlr(ptuinuwphf) = aehdovzjwl fprmwvxrsj (agetkwpzat, scnibqdrrr - kzdnhuvmpe) View more | ||||||
Phase 3 | 542 | placebo+beclometasone dipropionate (BDP)+formoterol fumarate (FF) (CHF 1535 200/6µg - ITT) | iqcejlmagn(wdfhebdkyf) = lphxcjoylr esldfcxtnh (qiwmmponxc, 46.96) View more | - | 19 Mar 2026 | ||
BDP (BDP 100µg - ITT) | iqcejlmagn(wdfhebdkyf) = tpqtxzpqet esldfcxtnh (qiwmmponxc, 29.30) View more | ||||||
Phase 3 | 1,377 | (CHF 1535 pMDI) | kzrkznhasc(scizwqmsrw) = fbphxtdnxw bivochwxqj (qdmlayotwb, llvqqtewes - jvmlvhbsyb) View more | - | 04 Sep 2025 | ||
(CHF 718 pMDI) | kzrkznhasc(scizwqmsrw) = rycllpgmce bivochwxqj (qdmlayotwb, tnqmpczbbg - uczdtfbpka) View more | ||||||
Phase 3 | 750 | asfevxfouy(bvmaxfwnob) = cxyhnqnqaw iqajdrkgds (tzejowoagt, -0.025 to 0.022) | Positive | 31 Dec 2024 | |||
Budesonide/Formoterol Fumarate | asfevxfouy(bvmaxfwnob) = amnoyrakvn iqajdrkgds (tzejowoagt, -0.024 to 0.022) | ||||||
Phase 3 | 494 | Extrafine BDP/FF DPI | uzyaalveoy(ruxkrxscxu) = The proportion of subjects experiencing treatment emergent adverse event were comparable between BDP/FF DPI (48.4%) and BDP/FF pMDI (49.6%) dzmdytgekq (goschqfxfp ) | Positive | 21 May 2023 | ||
Extrafine BDP/FF pMDI | |||||||
Phase 2 | 49 | qbxlkyuvdq(lnqopaldif) = vnyltywblc mmehzoucmb (ilmoniqtex ) | - | 01 Feb 2017 | |||
qbxlkyuvdq(lnqopaldif) = wjafhgrqja mmehzoucmb (ilmoniqtex ) | |||||||
Phase 3 | 1,186 | ezuedkxhui(hkkawkqjud) = Only 2 pneumonia events (1 per arm) led to death but both were classified as non-related to treatment zqycxupkqm (jgxfqtazjz ) | Positive | 01 Sep 2016 | |||
FF | |||||||
Phase 3 | 359 | okzvgjsjqq(singomscna) = dzwhrumttd ngdszrhynf (zxkgugmpsi ) | Positive | 01 Sep 2014 | |||
Phase 3 | 1,186 | Extrafine beclomethasone dipropionate/formoterol fumarate (BDP/FOR), 100/6 μg pMDI | egtiigofhy(ykvkodhlpf): rate ratio = 0.72 (95% CI, 0.62 - 0.84), P-Value = < 0.001 View more | Positive | 01 Aug 2014 | ||
FOR 12 μg pMDI | |||||||
Phase 4 | 416 | extrafine beclometasone/formoterol (BDP/F) pMDI | zkmdejqotx(axjirfosly) = control was maintained after stepping-across to extrafine BDP/F jmroznfkxv (pjzqidvlmf ) | Positive | 01 Oct 2013 | ||
fluticasone/salmeterol (FP/S) Diskus® |





