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ALZ-1101

Alleanza Pharmaceuticals, Inc. · Phase 2 active Small molecule Under review

ALZ-1101 is a Small molecule drug developed by Alleanza Pharmaceuticals, Inc.. It is currently in Phase 2 development for Alzheimer's disease (Phase 2).

ALZ-1101 is an investigational therapeutic targeting Alzheimer's disease pathology, likely through modulation of amyloid or tau protein aggregation.

ALZ-1101 is a medication being studied for the treatment of Primary Open Angle Glaucoma, Ocular Hypertension, and Elevated Intraocular Pressure. A clinical trial (NCT01896180) compared the safety and efficacy of ALZ-1101 to Latanoprost in patients with intraocular pressure inadequately controlled by Latanoprost.

Likelihood of approval
12.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • CNS / neurology attrition -3.0pp
    CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameALZ-1101
SponsorAlleanza Pharmaceuticals, Inc.
ModalitySmall molecule
Therapeutic areaNeurology
PhasePhase 2

Mechanism of action

While specific mechanistic details for ALZ-1101 are limited in public disclosures, Alleanza Pharmaceuticals' pipeline focuses on neurodegenerative diseases. The drug is in Phase 2 development, suggesting it has demonstrated preliminary efficacy and safety in early clinical trials for Alzheimer's disease or related cognitive decline.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about ALZ-1101

What is ALZ-1101?

ALZ-1101 is a Small molecule drug developed by Alleanza Pharmaceuticals, Inc., indicated for Alzheimer's disease (Phase 2).

How does ALZ-1101 work?

ALZ-1101 is an investigational therapeutic targeting Alzheimer's disease pathology, likely through modulation of amyloid or tau protein aggregation.

What is ALZ-1101 used for?

ALZ-1101 is indicated for Alzheimer's disease (Phase 2).

Who makes ALZ-1101?

ALZ-1101 is developed by Alleanza Pharmaceuticals, Inc. (see full Alleanza Pharmaceuticals, Inc. pipeline at /company/alleanza-pharmaceuticals-inc).

What development phase is ALZ-1101 in?

ALZ-1101 is in Phase 2.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing