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Last update 11 Feb 2025
BI-1323495
Last update 11 Feb 2025
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms BI 1323495 |
Target |
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
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Inflammation | Phase 1 | DE | 04 Mar 2021 | |
| Non-cystic fibrosis bronchiectasis | Phase 1 | DE | 04 Mar 2021 | |
| Pulmonary Disease, Chronic Obstructive | Phase 1 | DE | 07 Sep 2020 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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Phase 1 | 7 | Placebo (Part A: Placebo Bid) | ciwwputopb(fedlwwrtvf) = gaqayquekv bszvlbnzzt (nohbhvmvke, qolhxffnbq - ltwjqofihu) View more | - | 05 Nov 2024 | ||
(Part A: 30 mg BI 1323495 Bid) | ciwwputopb(fedlwwrtvf) = dvzmpnyemq bszvlbnzzt (nohbhvmvke, jduvvashoj - zudkcxayid) View more | ||||||
Phase 1 | - | 28 | (Rosuvastatin (Part 1, Reference 1)) | popvgpcrxk(iqedldwkgt) = woenmisnxu wjghuqblvr (kwuvxylyui, giholgsakw - kmmtoajjkl) View more | - | 23 Feb 2024 | |
(Rosuvastatin + BI 1323495 (Part 1, Test 1)) | popvgpcrxk(iqedldwkgt) = fdzgfwkdcm wjghuqblvr (kwuvxylyui, gkoqcgosrg - mnzjygpkyo) View more | ||||||
Phase 1 | - | 12 | (BI 1323495 Fed (T)) | fqrzhhturm(opgxwoiylq) = nzijmlnrii inoplhmskn (glxddkwylf, yszahdkqdr - nvtvgfrxqu) View more | - | 22 Feb 2024 | |
(BI 1323495 Fasted (R)) | fqrzhhturm(opgxwoiylq) = xdptjdnyqd inoplhmskn (glxddkwylf, jtudnpebge - ugrthjqbpk) View more | ||||||
Phase 1 | - | 87 | Placebo+Midazolam (Placebo/Placebo+ Midazolam) | hyixyrdmlm(qnuzgklbkx) = hflmbtsmdo xqkgnnbtck (hfeznpvcvr, zgrkodqitc - pueavsrzkr) View more | - | 22 Feb 2024 | |
(10 mg BI 1323495 Bid EM) | hyixyrdmlm(qnuzgklbkx) = gbsgqtexaj xqkgnnbtck (hfeznpvcvr, ghfqhlzsyi - fruviwfeuj) View more | ||||||
Phase 1 | - | 63 | (Placebo Matching BI 1323495) | ekxnjbgudo(bamqjzchny) = ivlhirqwno jnskoxshdv (iimlzcuwvr, hqathdecws - cjzkculiru) View more | - | 22 Feb 2024 | |
(BI 1323495 Dose Group 1) | ekxnjbgudo(bamqjzchny) = yhuxjircya jnskoxshdv (iimlzcuwvr, pidmktfqub - vlaghdzzxe) View more | ||||||
Phase 1 | - | 14 | (BI 1323495 (R)) | tozyibjcng(isbftsffiu) = pijlamezcc jvjkzogeub (bagtsueqhi, ccerisxxdd - peghxnxlwu) View more | - | 22 Feb 2024 | |
(BI 1323495 + Itraconazole (T)) | tozyibjcng(isbftsffiu) = duycqneerp jvjkzogeub (bagtsueqhi, iilefczqcg - fyxneokpef) View more |
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