Asset profile

Cerebrolysin

Peptide

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Negativelead readout

Evidence outlook · lead readout

NCT00911807 · Alzheimer Disease

The lead readout missed its primary endpoint. The grade and rationale below record what the trial was designed to show and what it found.

NCT00911807: This was a randomized, quadruple-blinded, three-arm trial with 217 patients, comparing Cerebrolysin plus donepezil, Cerebrolysin alone, and donepezil alone. The primary endpoint, change in ADAS-Cog+ at week 28, did not show a statistically significant difference among the groups (overall p=0.6348; pairwise comparisons all non-significant), so the study did not meet its primary cognitive endpoint. Although the design was strong, the null primary result limits the evidence to a moderate level.

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Competitive landscape

65 competitors in this universe: 2 direct rivals (same mechanism and indication), 3 same-class, 60 same-indication; 6 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Cerebrolysin: this drugPhase 3PeptideMulti-target (ginsenoside)
MLC901 (NeuroAiD II)Phase 3BotanicalMulti-target (ginsenoside)
PM012Phase 2/3BotanicalMulti-target (ginsenoside)
Shenfu Injection (Shenfu Zhusheye)Phase 2/3BotanicalMulti-target (ginsenoside)
Jia Shen TabletPhase 2BotanicalMulti-target (ginsenoside)
QiShenYiQiPhase 2BotanicalMulti-target (ginsenoside)
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)

…and 50 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

(3 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2027 (2)
January 2027 (1)
Phase 4Intracerebral Hemorrhage, Hemorrhagic Stroke, Intracerebral, Hemorrhagic Stroke, StrokeNot yet recruiting
Est. primary completion 2027-01-01 · NCT06899464 · CT.gov ↗
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July 2027 (1)
Early phase / not applicableIschemic Stroke, Acute, Rehabilitation Outcome, CerebrolysinRecruiting
Est. primary completion 2027-07-15 · NCT07043686 · CT.gov ↗
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2029 (1)
December 2029 (1)
Phase 2Acute Ischemic StrokeNot yet recruiting
Est. primary completion 2029-12-31 · NCT06339411 · CT.gov ↗
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See the full readout calendar ↗

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 (2)
Phase 2 (7)
Phase 1/2 (2)
Phase 1 (2)
Phase 4 (14)
Early phase / not applicable (5)