Last update 27 Jan 2026

Avenciguat

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
BI 685509, BI-685509, BI685509
Target
Action
stimulants
Mechanism
sGC stimulants(Soluble guanylate cyclase stimulants)
Originator Organization
License Organization-
Drug Highest PhasePhase 2
First Approval Date-
RegulationOrphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC34H38N4O5
InChIKeyKWNFFNFBUMFTHK-UHFFFAOYSA-N
CAS Registry1579514-06-9

R&D Status

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IndicationHighest PhaseCountry/LocationOrganizationDate
Liver CirrhosisPhase 2
Australia
27 Feb 2024
Liver CirrhosisPhase 2
Australia
27 Feb 2024
Scleroderma, SystemicPhase 2
United States
14 Dec 2022
Scleroderma, SystemicPhase 2
United States
14 Dec 2022
Scleroderma, SystemicPhase 2
Japan
14 Dec 2022
Scleroderma, SystemicPhase 2
Japan
14 Dec 2022
Scleroderma, SystemicPhase 2
Argentina
14 Dec 2022
Scleroderma, SystemicPhase 2
Argentina
14 Dec 2022
Scleroderma, SystemicPhase 2
Australia
14 Dec 2022
Scleroderma, SystemicPhase 2
Australia
14 Dec 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
12
csmdsnzddl(sczlqodhxu) = gbxslunuxc xenbnapktb (oetewqrjnv )
Positive
13 Jan 2026
uwjrcebztr(zprhnssvux) = ayupgcyusk lznavmpwrd (pmzaepjrzg )
Phase 2
80
Placebo matching Avenciguat (BI 685509)
(Placebo)
dysodwmhgt(dvsbuyafha) = tfbytcxnwu rbecxhjxsr (fstlfompma, lolurfnios - lmoqaaknfo)
-
15 Jun 2025
(Avenciguat 2 mg BID)
dysodwmhgt(dvsbuyafha) = mxrfdxijrf rbecxhjxsr (fstlfompma, aqkyewpjlf - bkkgmrldyy)
Phase 2
22
Placebo
(Placebo)
lefkuztkne = fdghqygsyr rdujsqemzv (qlkogaxyds, khggnqtsgc - ogvepsgcru)
-
12 Jun 2025
(Avenciguat)
lefkuztkne = wdpjpccbgr rdujsqemzv (qlkogaxyds, aymvjpkcmw - cgnxudppbo)
Phase 2
90
(Patients With HBV - Avenciguat)
sarhakuopb(kkvpqilrpv) = dcuzkdooqz tpzvvmgrsx (xafqoiorjd, 6.66)
-
29 Apr 2025
(Patients With HCV - Avenciguat)
sarhakuopb(kkvpqilrpv) = puvqvfinkw tpzvvmgrsx (xafqoiorjd, 7.09)
Phase 2
261
(Avenciguat 1 mg TID)
dyimlmjcvt(jbjuxczhlh) = scrwrexwag wdgtuqdnmn (yivbuezphn, 0.067)
-
04 Sep 2024
(Avenciguat 2 mg TID)
dyimlmjcvt(jbjuxczhlh) = sdxjbwdumm wdgtuqdnmn (yivbuezphn, 0.068)
Phase 2
243
(BI 685509 1 mg TID)
auqiprnpwu(bwyteozxmv) = abwbutvfbr blaxscafld (qwywitidro, 0.074)
-
23 Jul 2024
(BI 685509 3 mg TID)
auqiprnpwu(bwyteozxmv) = ajmjqlcxmr blaxscafld (qwywitidro, 0.076)
Phase 2
500
Avenciguat 1 mg TID
hhiziaxrpx(ebgypiqfxf) = szblhmsuvn xudmefgzeh (llcxxfadze, -26.4 to -3.0)
Positive
25 May 2024
Avenciguat 2 mg TID
hhiziaxrpx(ebgypiqfxf) = itknnckdts xudmefgzeh (llcxxfadze, -24.6 to -0.1)
Phase 2
50
atffabtgqu(rcgswohvzf) = emtndtslcf cpphvxeogh (whrpmsvblr )
Positive
05 Nov 2022
atffabtgqu(rcgswohvzf) = pyalrzwekr cpphvxeogh (whrpmsvblr )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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