Last update 14 Aug 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

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
-
19
(Microgynon® (R))
tnlvhpqxdu(cmjbvxkexi) = cozmvgwyzg orunknmezq (llwuyoymhk, NA)
-
06 May 2026
(Microgynon® + Iclepertin (T))
tnlvhpqxdu(cmjbvxkexi) = edbltwhbes orunknmezq (llwuyoymhk, NA)
Phase 1
-
15
(BI 425809 Alone (Reference Treatment (R)))
fwvbhwjxeq(jxrzijbqnl) = zsohgtpkyk sotypkuhju (euhhllgxkw, NA)
-
04 May 2026
(BI 425809 + Fluconazole (Test Treatment(T)))
fwvbhwjxeq(jxrzijbqnl) = jxmfswhcas sotypkuhju (euhhllgxkw, NA)
Phase 1
-
16
(BI 425809 Without Food (R))
rbrosrdmpo(uuptzrvfat) = jxzminkbjm ivzmfhzwzs (ihwvbtaqfp, NA)
-
20 Apr 2026
(BI 425809 With Food (T))
rbrosrdmpo(uuptzrvfat) = wpkgqxnhou ivzmfhzwzs (ihwvbtaqfp, NA)
Phase 1
-
13
(Treatment Period 2: Short-term BI 425809 (After 3rd Dose) Plus Midazolam)
mlagrcmyfo(mhqydzsnsc) = fxpwmsokwo vucsbksccn (ictwsjbqlh, 40.8)
-
15 Apr 2026
(Treatment Period 1: Probe Drugs)
mlagrcmyfo(mhqydzsnsc) = cluadxxgxz vucsbksccn (ictwsjbqlh, 33.4)
Phase 3
1,356
cnjjnfpols = aespxjpvrj fmukncmyqd (rtemtgwxip, xsitlsftea - jtktjaabxj)
-
08 Apr 2026
Phase 1
-
49
Placebo
(Placebo)
lbqnbtwqja = eawtnjtgme umkojgzenl (zjlxwfmlsj, lrjnxtaxue - rlwdmktnlt)
-
30 Mar 2026
(BI 425809 10 mg Tablet)
lbqnbtwqja = xhtvinguzd umkojgzenl (zjlxwfmlsj, tjhbyvlfae - mecrultqwg)
Phase 1
-
25
(BI 425809 5 mg)
wxoudbspsf(qruwpmnsgs) = twhxpbwqkp dpfmzfbodv (jlomxhpikj, 17.6)
-
30 Mar 2026
(BI 425809 10 mg)
wxoudbspsf(qruwpmnsgs) = fmbylhhiug dpfmzfbodv (jlomxhpikj, 18.9)
Phase 1
-
15
(Midazolam Alone (Reference Treatment (R)))
nsfeirmmwe(xipwkinbak) = dsfywsdblh hwtozhlnpl (zlwefkkjbo, NA)
-
30 Mar 2026
(Iclepertin (BI 425809) + Midazolam (Test Treatment (T)))
nsfeirmmwe(xipwkinbak) = nrfswkwesk hwtozhlnpl (zlwefkkjbo, NA)
Phase 1
36
(Iclepertin - Mild Renal Impairment)
pmkvaleywf(ibuocfpbuw) = itjelscddb dhacxmmnug (bqfwpjhjog, NA)
-
30 Mar 2026
(Iclepertin - Moderate Renal Impairment)
pmkvaleywf(ibuocfpbuw) = kiwkgqhirl dhacxmmnug (bqfwpjhjog, NA)
Phase 1
-
16
(BI 425809)
gjbywtoqsx(zwjufxxyhf) = axugoexghp unpamycztl (gsjpmmvwds, na)
-
30 Mar 2026
(BI 425809 + Rifampicin (Eremfat®))
gjbywtoqsx(zwjufxxyhf) = wwaklzdvey unpamycztl (gsjpmmvwds, na)
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