Last reviewed · How we verify
ALZT-OP1b
ALZT-OP1b is a Small molecule disease-modifying agent 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: ibuprofen, Ibuprofen.
ALZT-OP1b is a small molecule that modulates tau pathology and neuroinflammation to slow cognitive decline in Alzheimer's disease.
ALZT-OP1b is a treatment being studied in a Phase 1 clinical trial for Alzheimer's Disease. The study is a randomized, open-labeled pharmacokinetic study of ALZT-OP1 in normal healthy volunteers.
-
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-OP1b |
|---|---|
| Also known as | ibuprofen, Ibuprofen |
| Sponsor | AZTherapies, Inc. |
| Drug class | Small molecule disease-modifying agent |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
ALZT-OP1b targets multiple pathways implicated in Alzheimer's disease neurodegeneration, including tau protein aggregation and neuroinflammatory processes. By addressing these underlying disease mechanisms rather than amyloid alone, the drug aims to provide disease-modifying benefits in early symptomatic Alzheimer's disease patients.
Approved indications
- Early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia stage)
Common side effects
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 Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease (PHASE3)
- 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-OP1b CI brief — competitive landscape report
- ALZT-OP1b updates RSS · CI watch RSS
- AZTherapies, Inc. portfolio CI
Frequently asked questions about ALZT-OP1b
What is ALZT-OP1b?
How does ALZT-OP1b work?
What is ALZT-OP1b used for?
Who makes ALZT-OP1b?
Is ALZT-OP1b also known as anything else?
What drug class is ALZT-OP1b in?
What development phase is ALZT-OP1b in?
Related
- Drug class: All Small molecule disease-modifying agent 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: ibuprofen, Ibuprofen
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing