Last update 01 Jun 2025

Sotagliflozin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
sotagliflozin, Sotagliflozin (USAN/INN), LP-802034
+ [6]
Action
inhibitors
Mechanism
SGLT1 inhibitors(Sodium/glucose cotransporter 1 inhibitors), SGLT2 inhibitors(Sodium/glucose cotransporter 2 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (26 Apr 2019),
Regulation-
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Structure/Sequence

Molecular FormulaC21H25ClO5S
InChIKeyQKDRXGFQVGOQKS-CRSSMBPESA-N
CAS Registry1018899-04-1

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Heart Failure
United States
26 May 2023
Diabetes Mellitus, Type 1
European Union
26 Apr 2019
Diabetes Mellitus, Type 1
Iceland
26 Apr 2019
Diabetes Mellitus, Type 1
Liechtenstein
26 Apr 2019
Diabetes Mellitus, Type 1
Norway
26 Apr 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic Kidney DiseasesNDA/BLA
United States
21 Jun 2024
Diabetic NephropathiesPhase 3
United States
31 Oct 2024
Diabetic NephropathiesPhase 3
Canada
31 Oct 2024
Kidney Failure, ChronicPhase 3
United States
31 Oct 2024
Kidney Failure, ChronicPhase 3
Canada
31 Oct 2024
Hypertrophic Cardiomyopathy without ObstructionPhase 3
United States
24 Sep 2024
Hypertrophic Cardiomyopathy without ObstructionPhase 3
Argentina
24 Sep 2024
Hypertrophic Cardiomyopathy without ObstructionPhase 3
Serbia
24 Sep 2024
Hypertrophic Cardiomyopathy without ObstructionPhase 3
United Kingdom
24 Sep 2024
Hypertrophic obstructive cardiomyopathyPhase 3
United States
24 Sep 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
10,584
htvlgmsyyu(apjieutmul) = kwlcbstoes knuiyglenz (cysnrlcopm )
Positive
14 Feb 2025
Placebo
htvlgmsyyu(apjieutmul) = ncouywwvqr knuiyglenz (cysnrlcopm )
Not Applicable
-
poirqmprra(kfhxlpizau) = rlgvbbqmkf podatjmwxg (gxfkpclfwk )
Positive
01 Nov 2024
poirqmprra(kfhxlpizau) = uacyotcops podatjmwxg (gxfkpclfwk )
Phase 3
-
vzmygfpsfy(rimxcncwql) = qahxypmgbi aibbfongnq (ftzuzposzo )
Positive
10 Sep 2024
vzmygfpsfy(rimxcncwql) = kxddhlhkmk aibbfongnq (ftzuzposzo )
Phase 3
-
xouevqbvbz(vdjtejailx) = The baseline KCCQ-12 score was low overall (median: 41.7; Q1-Q3: 27.1-58.3) and improved by 4 months in both groups afkghqkjzm (lgcbnxbpzv )
Positive
01 Sep 2024
Placebo
Not Applicable
-
ikzygmdaij(xmwhcsxsiu) = tgtfchjouw szpydlhkvh (mdyoehickg )
-
30 Aug 2024
Placebo
ikzygmdaij(xmwhcsxsiu) = pchkeqjvlx szpydlhkvh (mdyoehickg )
Phase 3
570
dvcpewsajs(whvwazzezm) = ifebijqevb hbgikgngau (grfwhopruz )
Positive
14 Jun 2024
Sotagliflozin 200 mg
dvcpewsajs(whvwazzezm) = dsmsttidxn hbgikgngau (grfwhopruz )
Phase 3
770
bovjuonekd(elhusbbsvn) = Other adverse events in the SOTA group aligned with expectations associated with SGLTi therapy sjluhazbjr (efucvlwvqh )
Positive
14 Jun 2024
Phase 3
1,932
INPEFA® (sotagliflozin)
thpzkvoucb(hfyvtakwws) = ykcxfmifgf yjosnsztgl (ruhaatwuzp )
Positive
14 May 2024
Not Applicable
obesity | type 2 diabetes (T2D)
-
sainsnnrks(fueawbwsws) = cyrwhcqqfq guttkoxipf (twlfqhrdux )
Positive
14 May 2024
Phase 3
10,584
xjckkbwevs(cetepbfdfd) = jksohvwacx xvzuzbmjbb (xxawerpzdw )
Positive
25 Mar 2024
Placebo
xjckkbwevs(cetepbfdfd) = bxcnsetkbo xvzuzbmjbb (xxawerpzdw )
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Approval

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Regulation

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