Asset profile

Hydromethylthionine mesylate

Small molecule

Phase 3Tau aggregation; AcetylcholineNo recent registered activity
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Partialdesign only

Evidence outlook · results not reported

NCT03446001 · Alzheimer Disease

The lead study's design has limits that temper confidence (see the rationale below), and its results have not been reported. This tier describes the design, not an outcome.

NCT03446001: This was a large randomized, quadruple-blind, placebo-controlled trial with 598 participants and clinical primary measures of cognition and activities of daily living. The 16-mg dose numerically favored treatment on both measures at 52 weeks, but the registry does not state whether either primary comparison was statistically significant, so the findings provide meaningful but inconclusive evidence.

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Competitive landscape

60 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 6 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Hydromethylthionine Mesylate: this drugPhase 3Small moleculeTau aggregation; Acetylcholine
Benzgalantamine (Zunveyl)ApprovedSmall moleculeAcetylcholinesterase/nicotinic receptor (prodrug)
Brexpiprazole (Rexulti)ApprovedSmall moleculeDopamine D2/D3 and serotonin 5-HT1A receptor
Dextromethorphan / Bupropion (Auvelity)ApprovedSmall moleculesigma-1/NMDA
Donanemab (Kisunla)ApprovedMonoclonal antibodyAmyloid-beta (monoclonal antibody)
Lecanemab (Leqembi)ApprovedMonoclonal antibodyAmyloid-beta (monoclonal antibody)
Xanomeline / Trospium Chloride (Cobenfy)ApprovedSmall moleculeMuscarinic M1/M4 receptor (agonist/antagonist combination)
ACP-204Phase 3Small moleculeSerotonin 5-HT2A receptor (antagonist / inverse agonist)
AR1001Phase 3Small moleculePDE5
BezisterimPhase 3Small moleculeERK/NF-kB inflammatory
BlarcamesinePhase 3Small moleculeSigma-1 receptor / muscarinic receptor (dual)
BuntanetapPhase 3Small moleculeAPP/tau/alpha-synuclein/TDP-43 (translation)
CerebrolysinPhase 3PeptideMulti-target (ginsenoside)
GV1001Phase 3PeptideTelomerase (hTERT)
Lemborexant (Dayvigo)Phase 3Small moleculeOrexin receptor (repositioned)
MasitinibPhase 3Small moleculec-Kit/Lyn/Fyn tyrosine kinases (mast cell/microglia), c-Kit (CD117); also PDGFR, Lck, FAK, FGFR3, CSF1R, KIT (c-Kit), also PDGFR and Lyn/Fyn kinases

…and 45 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

No upcoming readouts on record for this asset.

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (5)
Phase 2 (3)
Phase 1 (2)