Last update 13 Nov 2026

Iclepertin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
BI 425809
Target
Action
inhibitors
Mechanism
GlyT1 inhibitors(Glycine transporter 1 inhibitors)
Therapeutic Areas
Active Indication
Inactive Organization-
License Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (United States), Breakthrough Therapy (China)
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Structure/Sequence

Molecular FormulaC20H18F6N2O5S
InChIKeyMYHDQTVHHMSLEF-DDBGAENHSA-N
CAS Registry1421936-85-7

External Link

KEGGWikiATCDrug Bank
D12527---

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
SchizophreniaPhase 3
United States
09 Aug 2021
SchizophreniaPhase 3
United States
09 Aug 2021
SchizophreniaPhase 3
United States
09 Aug 2021
SchizophreniaPhase 3
China
09 Aug 2021
SchizophreniaPhase 3
Argentina
09 Aug 2021
SchizophreniaPhase 3
Argentina
09 Aug 2021
SchizophreniaPhase 3
Argentina
09 Aug 2021
SchizophreniaPhase 3
Austria
09 Aug 2021
SchizophreniaPhase 3
Austria
09 Aug 2021
SchizophreniaPhase 3
Austria
09 Aug 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
16
(Treatment R (BI 425809 Alone))
sqycfprffe(acxtkmevfe) = bpzaxsdkxe qzrcrnvjdm (dsiakqnvvq, 29.7)
-
02 Oct 2026
(Treatment T (BI 425809 + Itraconazole):)
sqycfprffe(acxtkmevfe) = ajjstdjpzj qzrcrnvjdm (dsiakqnvvq, 19.7)
Phase 1
-
19
(Microgynon® (R))
silbezrpea(wmzolbawvu) = whvfpjfkzx laanxpwqgg (fteccqaffj, NA)
-
06 May 2026
(Microgynon® + Iclepertin (T))
silbezrpea(wmzolbawvu) = nbthnoghvl laanxpwqgg (fteccqaffj, NA)
Phase 1
-
15
(BI 425809 Alone (Reference Treatment (R)))
ekbxatswan(neijmrhzpx) = mhpnnyrxcm snihzaaxny (xcwpiqzqsq, NA)
-
04 May 2026
(BI 425809 + Fluconazole (Test Treatment(T)))
ekbxatswan(neijmrhzpx) = bbtewbmham snihzaaxny (xcwpiqzqsq, NA)
Phase 1
-
16
(BI 425809 Without Food (R))
uzykijwvqy(azoydjaxyy) = wnkxsvfjnf temwetttcb (qeqwwnaffd, NA)
-
20 Apr 2026
(BI 425809 With Food (T))
uzykijwvqy(azoydjaxyy) = nukrlyvvri temwetttcb (qeqwwnaffd, NA)
Phase 1
-
13
(Treatment Period 2: Short-term BI 425809 (After 3rd Dose) Plus Midazolam)
fhahjsfkdk(jjwtqemqyx) = rpocfhpcfh hsuhdofovt (rhapljuswj, 40.8)
-
15 Apr 2026
(Treatment Period 1: Probe Drugs)
fhahjsfkdk(jjwtqemqyx) = klmiswvsyi hsuhdofovt (rhapljuswj, 33.4)
Phase 3
1,356
ljuadvbkze = dtqnoymexf nzpcpcvvli (derwejaxtn, ikjsqxizhs - urlrkzpwux)
-
08 Apr 2026
Phase 1
-
49
Placebo
(Placebo)
eovtxnyvdp = uvgsptrsip idrueyxhqn (eoenweuhjv, ywqvhaklrs - zzuwwrowab)
-
30 Mar 2026
(BI 425809 10 mg Tablet)
eovtxnyvdp = fjubbmoigw idrueyxhqn (eoenweuhjv, iwfbamyvcv - bmpbaaxyda)
Phase 1
29
(Iclepertin - Child-Pugh A - Mild Hepatic Impairment)
xvtjjjpxka(ukntjgrncu) = hvjkfzzouf lmsyixdzzo (ouaxdxsixp, na)
-
30 Mar 2026
(Iclepertin - Child-Pugh B - Moderate Hepatic Impairment)
xvtjjjpxka(ukntjgrncu) = hweunypjyu lmsyixdzzo (ouaxdxsixp, na)
Phase 1
-
25
(BI 425809 5 mg)
phixqktfaw(ayyzwlgsgh) = bfwbthlhqu wnirfpzrev (umajmvxmbw, 17.6)
-
30 Mar 2026
(BI 425809 10 mg)
phixqktfaw(ayyzwlgsgh) = xzxbqhpbbr wnirfpzrev (umajmvxmbw, 18.9)
Phase 1
-
15
(Midazolam Alone (Reference Treatment (R)))
ghcnxtcnoy(hygxkpymse) = tkmsleqbyv lsuvlpgbqe (kpgukzoesv, NA)
-
30 Mar 2026
(Iclepertin (BI 425809) + Midazolam (Test Treatment (T)))
ghcnxtcnoy(hygxkpymse) = tzzzztzwxh lsuvlpgbqe (kpgukzoesv, NA)
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