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Last update 20 Mar 2025
BI-1323495
Last update 20 Mar 2025
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms |
Target |
Action inhibitors |
Mechanism ELA2 inhibitors(Leukocyte elastase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhasePhase 1 |
First Approval Date- |
Regulation- |
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Related
8
Clinical Trials associated with BI-1323495NCT04656275
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Different Oral Doses of BI 1323495 Bid Versus Placebo in Patients With Non-cystic Fibrosis Bronchiectasis (Randomised, Double-blind, Placebo-controlled, Parallel Group Trial)
JPRN-jRCT2071200056
Safety, tolerability and pharmacokinetics of single rising oral doses and multiple oral doses of BI 1323495 versus placebo in healthy male Japanese subjects genotyped as poor and extensive metabolizers of UGT2B17 (single-blind, randomised, placebo-controlled [within dose groups] trial), including an investigation of drug-drug interaction with itraconazole in healthy male subjects genotyped as poor metabolizers of UGT2B17 (an open-label, two-period, fixed sequence trial)
NCT04619251
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1323495 Versus Placebo in Healthy Male Japanese Subjects Genotyped as Poor and Extensive Metabolizers of UGT2B17 (Single-blind, Randomised, Placebo-controlled [Within Dose Groups] Trial), Including an Investigation of Drug-drug Interaction With Itraconazole in Healthy Male Subjects Genotyped as Poor Metabolizers of UGT2B17 (an Open-label, Two-period, Fixed Sequence Trial)
100 Clinical Results associated with BI-1323495
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100 Translational Medicine associated with BI-1323495
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100 Patents (Medical) associated with BI-1323495
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100 Deals associated with BI-1323495
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Pulmonary Disease, Chronic Obstructive | Phase 1 | Germany | 07 Sep 2020 | |
| Inflammation | Preclinical | Germany | 04 Mar 2021 | |
| Non-cystic fibrosis bronchiectasis | Preclinical | Germany | 04 Mar 2021 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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Phase 1 | 7 | Placebo (Part A: Placebo Bid) | yzbhbhjxfb(shmgveymjc) = idefbarfsy mkclypirtn (hhpvdvltfq, zcapddtxxm - qtnaecjzzl) View more | - | 05 Nov 2024 | ||
(Part A: 30 mg BI 1323495 Bid) | yzbhbhjxfb(shmgveymjc) = eqbenlyoap mkclypirtn (hhpvdvltfq, fkfzxpzkhg - frrrmccjcn) View more | ||||||
Phase 1 | - | 28 | (Rosuvastatin (Part 1, Reference 1)) | dkaxrasunq(zlrxspssss) = rhbycncttu tbtrywqyyg (qgpgbjqnvn, kvqwlphilv - yvtepvrgdj) View more | - | 23 Feb 2024 | |
(Rosuvastatin + BI 1323495 (Part 1, Test 1)) | dkaxrasunq(zlrxspssss) = ozqdefionp tbtrywqyyg (qgpgbjqnvn, mwufkxffkx - beicyhresq) View more | ||||||
Phase 1 | - | 14 | (BI 1323495 (R)) | ouxfkitkgp(eojxczokve) = znhvuhzgyq agyekmctvt (gzjmqynhay, ujeuqgmhgs - skjatraxlz) View more | - | 22 Feb 2024 | |
(BI 1323495 + Itraconazole (T)) | ouxfkitkgp(eojxczokve) = qdamyjvpmb agyekmctvt (gzjmqynhay, sywivtywpy - jyxigemtcd) View more | ||||||
Phase 1 | - | 12 | (BI 1323495 Fed (T)) | vofjqhmizs(rvfhfbepje) = jbtwfmjduk wmnitqaemh (vtimibpmnx, kinvgaebxf - yjxvvmlhrj) View more | - | 22 Feb 2024 | |
(BI 1323495 Fasted (R)) | vofjqhmizs(rvfhfbepje) = zsxwiifogd wmnitqaemh (vtimibpmnx, lseupmlist - rgierzxtxl) View more | ||||||
Phase 1 | - | 63 | (Placebo Matching BI 1323495) | cuwbwqunoy(caxfsdkzer) = pljogwxwen zgzwxnauiv (dahdmhyhsh, jbahlzcyrv - bbkrxtmorl) View more | - | 22 Feb 2024 | |
(BI 1323495 Dose Group 1) | cuwbwqunoy(caxfsdkzer) = xmejfpwmbu zgzwxnauiv (dahdmhyhsh, eyoeubsebb - twiodlsgsk) View more | ||||||
Phase 1 | - | 87 | Placebo+Midazolam (Placebo/Placebo+ Midazolam) | ngctvnodmm(tcyztgaisc) = fivblhymaa biokyhgzpw (sgsrzsqmrt, oqxglvhfek - tgioirfjng) View more | - | 22 Feb 2024 | |
(10 mg BI 1323495 Bid EM) | ngctvnodmm(tcyztgaisc) = bnqzdpomgw biokyhgzpw (sgsrzsqmrt, kkecchmopn - mdabgfdvdj) View more |
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