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Placebo zonisamide
Placebo zonisamide is a Sulfonamide anticonvulsant Small molecule drug developed by Rose Research Center, LLC. It is currently in Phase 3 development for Partial seizures, Generalized seizures.
Zonisamide is an anticonvulsant that works by blocking voltage-sensitive sodium channels in the brain.
Placebo zonisamide is a control intervention used in clinical trials for various conditions, including fibromyalgia, migraine, epilepsy, and post-traumatic stress disorder. Zonisamide, a small molecule sodium channel alpha subunit blocker, is a medication used to treat conditions such as epilepsy and has also been studied for other indications.
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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 | Placebo zonisamide |
|---|---|
| Sponsor | Rose Research Center, LLC |
| Drug class | Sulfonamide anticonvulsant |
| Target | Voltage-sensitive sodium channels |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
This action stabilizes neuronal membranes and suppresses the spread of seizure activity. Additionally, zonisamide may have a role in modulating glutamate release and inhibiting excitatory neurotransmission.
Approved indications
- Partial seizures
- Generalized seizures
Common side effects
- Dizziness
- Headache
- Fatigue
- Nausea
- Somnolence
Key clinical trials
- Noise-Induced Hearing Loss-Acute Exposure Treatment (UA) (PHASE2)
- The Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette (PHASE3)
- Noise-Induced Hearing Loss-Acute Exposure Treatment (PHASE2)
- The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study (PHASE2)
- Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism (PHASE3)
- Role of Zonisamide in Advanced Parkinson's Disease (PD) in Egyptian Population: Pilot Study (NA)
- Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action (PHASE3)
- Study of Zonisamide in Early Parkinson Disease (PHASE2, PHASE3)
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:
- Placebo zonisamide CI brief — competitive landscape report
- Placebo zonisamide updates RSS · CI watch RSS
- Rose Research Center, LLC portfolio CI
Frequently asked questions about Placebo zonisamide
What is Placebo zonisamide?
How does Placebo zonisamide work?
What is Placebo zonisamide used for?
Who makes Placebo zonisamide?
What drug class is Placebo zonisamide in?
What development phase is Placebo zonisamide in?
What are the side effects of Placebo zonisamide?
What does Placebo zonisamide target?
Related
- Drug class: All Sulfonamide anticonvulsant drugs
- Target: All drugs targeting Voltage-sensitive sodium channels
- Manufacturer: Rose Research Center, LLC — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Partial seizures
- Indication: Drugs for Generalized seizures
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing