Last update 20 Jun 2026

Valiltramiprosate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Tramiprosate prodrug, Valitramiprosate, ALZ 801
+ [3]
Target
Action
inhibitors
Mechanism
APP inhibitors(Beta amyloid A4 protein inhibitors)
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationFast Track (United States)
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Structure/Sequence

Molecular FormulaC8H18N2O4S
InChIKeyNRZRFNYKMSAZBI-ZETCQYMHSA-N
CAS Registry1034190-08-3

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Alzheimer DiseasePhase 3
United States
19 May 2021
Alzheimer DiseasePhase 3
Canada
19 May 2021
Alzheimer DiseasePhase 3
Czechia
19 May 2021
Alzheimer DiseasePhase 3
France
19 May 2021
Alzheimer DiseasePhase 3
Germany
19 May 2021
Alzheimer DiseasePhase 3
Iceland
19 May 2021
Alzheimer DiseasePhase 3
Netherlands
19 May 2021
Alzheimer DiseasePhase 3
Spain
19 May 2021
Alzheimer DiseasePhase 3
United Kingdom
19 May 2021
Down SyndromeClinical
United States
11 Jun 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
325
Valiltramiprosate 265 mg BID
tfyhpizppw(cfdupqdgeu) = nrbnnrrpys fdckljcgzo (typhundoaq )
Positive
25 Apr 2026
placebo
-
Phase 3
325
Placebo Comparator: Placebo
(Placebo)
lcboiqkmkv(oyqobgogum) = vpiovtfhly fxnuziqqui (umptjheddo, 0.69)
-
10 Nov 2025
Placebo Comparator: Placebo+Experimental: ALZ-801
(ALZ-801)
lcboiqkmkv(oyqobgogum) = csssosqopq fxnuziqqui (umptjheddo, 0.69)
Phase 3
325
iwmftzjcga(xgrwwyyjzg): P-Value = 0.607
Positive
01 Nov 2025
Placebo
Phase 3
Alzheimer Disease
APOE4/4 homozygotes
325
sjvdonygjn(nkemlpnxir): Difference (LS Mean) = -0.504, P-Value = 0.607
Not Met
Negative
10 Apr 2025
Placebo
Phase 2
Alzheimer Disease
Aβ42 | p-tau181
70
lumokqcyaf(pkbukgvrqb) = uqpdldvsio bhlpdsjoza (cemtpkxmmj )
Positive
28 Jul 2024
Phase 2
Alzheimer Disease
plasma Aβ42
84
ioxutaaveb(uqdczooyqe) = bvixzavjej ifclacthhx (gqcnrwkzap )
Positive
01 Jul 2024
Phase 2
84
ALZ-801/Valiltramiprosate 265 mg
zxjwkvxdcb(pabdewfsct) = statistically significant and clinically relevant reduction in plasma biomarkers of neurodegeneration, preservation of brain volume, and positive cognitive effects in Early AD patients who are carriers of apolipoprotein ε4 allele (APOE4) following 24 months of treatment with investigational oral agent ALZ-801/valiltramiprosate. ydbpdjqaeh (balxtazsws )
Positive
25 Jun 2024
Phase 3
325
iybclujbea(gdgtupbwus) = yerqhzlbzs gksyspnmfh (rzgkplsgkq )
Positive
24 Oct 2023
(CAA subgroup)
iybclujbea(gdgtupbwus) = gptaspzlor gksyspnmfh (rzgkplsgkq )
Phase 2
Alzheimer Disease
p-tau181 | Aβ42 | Aβ40
84
emntguciml(qublliulyd) = no ARIA-E to date xcmpcmrdyc (qlcuvpzzbb )
Positive
24 Oct 2023
Phase 2
75
cuvivqwgdr(enfnfmnejp) = edafhcgogr uumrgghxyz (ddmnjgfpfh )
Positive
20 Sep 2022
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Approval

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Regulation

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