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ALZT-OP1a
ALZT-OP1a is a Multi-target small molecule Small molecule drug developed by AZTherapies, Inc.. It is currently in Phase 3 development for Early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia stage). Also known as: Cromolyn, Intal, Cromolyn.
ALZT-OP1a is a small molecule that modulates tau pathology and neuroinflammation to slow cognitive decline in Alzheimer's disease.
ALZT-OP1a is a small molecule that modulates tau pathology and neuroinflammation to slow cognitive decline in Alzheimer's disease. Used for Early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia stage).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 name | ALZT-OP1a |
|---|---|
| Also known as | Cromolyn, Intal, Cromolyn |
| Sponsor | AZTherapies, Inc. |
| Drug class | Multi-target small molecule |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
ALZT-OP1a targets multiple pathways implicated in Alzheimer's disease pathogenesis, including tau protein aggregation and neuroinflammatory processes. By addressing these mechanisms, the drug aims to slow the progression of cognitive decline in early symptomatic Alzheimer's disease patients. The compound represents a multi-target approach to disease modification rather than targeting a single molecular entity.
Approved indications
- Early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia stage)
Common side effects
- Amyloid-related imaging abnormalities (ARIA)
- Headache
- Nausea
Key clinical trials
- Randomized I/II Phase Study of ALZT-OP1 Combination Therapy in Alzheimer's Disease and Normal Healthy Volunteers (PHASE1)
- Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI) (PHASE2)
- Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease (PHASE3)
- A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease (PHASE2)
- Phase 1 Study of ALZT-OP1 Combination Therapy in Normal Healthy Volunteers (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial 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:
- ALZT-OP1a CI brief — competitive landscape report
- ALZT-OP1a updates RSS · CI watch RSS
- AZTherapies, Inc. portfolio CI
Frequently asked questions about ALZT-OP1a
What is ALZT-OP1a?
How does ALZT-OP1a work?
What is ALZT-OP1a used for?
Who makes ALZT-OP1a?
Is ALZT-OP1a also known as anything else?
What drug class is ALZT-OP1a in?
What development phase is ALZT-OP1a in?
What are the side effects of ALZT-OP1a?
Related
- Drug class: All Multi-target small molecule drugs
- Manufacturer: AZTherapies, Inc. — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia stage)
- Also known as: Cromolyn, Intal, Cromolyn
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing