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Rivastigmine 5 cm^2 transdermal patch
Rivastigmine 5 cm^2 transdermal patch is a Cholinesterase inhibitor Small molecule drug developed by Novartis. It is currently in Phase 3 development for Mild to moderate Alzheimer's disease, Mild to moderate Parkinson's disease dementia.
Rivastigmine inhibits acetylcholinesterase and butyrylcholinesterase enzymes, increasing acetylcholine levels in the brain to improve cognitive function.
Rivastigmine is used to treat Alzheimer's Disease, Alzheimer Disease, and Parkinson's Disease Dementia, as indicated by ClinicalTrials.gov. The transdermal patch is available in various strengths, including 4.6 mg/24 h, 9.5 mg/24 h, and 13.3 mg/24 h, delivered through patches of different sizes, such as 5 cm^2.
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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). -
Big-pharma sponsor
+3.0pp
Novartis is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Rivastigmine 5 cm^2 transdermal patch |
|---|---|
| Sponsor | Novartis |
| Drug class | Cholinesterase inhibitor |
| Target | Acetylcholinesterase and butyrylcholinesterase |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
By blocking the breakdown of acetylcholine, a neurotransmitter critical for memory and cognition, rivastigmine increases its availability in the central nervous system. This is particularly beneficial in Alzheimer's disease where acetylcholine-producing neurons degenerate. The transdermal patch formulation provides sustained drug delivery over 24 hours, improving tolerability compared to oral dosing.
Approved indications
- Mild to moderate Alzheimer's disease
- Mild to moderate Parkinson's disease dementia
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Headache
- Dizziness
- Application site erythema
- Syncope
Key clinical trials
- Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease (PHASE3)
- Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease (PHASE3)
- Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44 (PHASE4)
- Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline (PHASE3)
- Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD) (PHASE3)
- A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA) (PHASE4)
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:
- Rivastigmine 5 cm^2 transdermal patch CI brief — competitive landscape report
- Rivastigmine 5 cm^2 transdermal patch updates RSS · CI watch RSS
- Novartis portfolio CI
Frequently asked questions about Rivastigmine 5 cm^2 transdermal patch
What is Rivastigmine 5 cm^2 transdermal patch?
How does Rivastigmine 5 cm^2 transdermal patch work?
What is Rivastigmine 5 cm^2 transdermal patch used for?
Who makes Rivastigmine 5 cm^2 transdermal patch?
What drug class is Rivastigmine 5 cm^2 transdermal patch in?
What development phase is Rivastigmine 5 cm^2 transdermal patch in?
What are the side effects of Rivastigmine 5 cm^2 transdermal patch?
What does Rivastigmine 5 cm^2 transdermal patch target?
Related
- Drug class: All Cholinesterase inhibitor drugs
- Target: All drugs targeting Acetylcholinesterase and butyrylcholinesterase
- Manufacturer: Novartis — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Mild to moderate Alzheimer's disease
- Indication: Drugs for Mild to moderate Parkinson's disease dementia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing