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Trivastal (PIRIBEDIL)
Trivastal (generic name: PIRIBEDIL) is a piribedil drug. It is currently in Phase 3 development for Parkinsonism.
Trivastal works by blocking the alpha-2C adrenergic receptor, which helps to increase dopamine levels in the brain.
Trivastal (PIRIBEDIL) is a small molecule drug that targets the alpha-2C adrenergic receptor. It is classified as a piribedil and is used to treat Parkinsonism. The commercial status of Trivastal is unclear, but it is approved for use in certain countries. Key safety considerations include its potential effects on blood pressure and heart rate. Trivastal is not FDA-approved.
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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 | PIRIBEDIL |
|---|---|
| Drug class | piribedil |
| Target | Alpha-2C adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 3 |
Mechanism of action
Think of the brain as a busy city with many different streets and intersections. Dopamine is like a traffic cop that helps to keep everything moving smoothly. When alpha-2C receptors are blocked, it's like removing a traffic jam, allowing dopamine to flow more freely and helping to alleviate symptoms of Parkinsonism.
Approved indications
- Parkinsonism
Common side effects
- Fall
- Facial bones fracture
- Dropped head syndrome
Key clinical trials
- PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term Therapy
- Influence of Piribedil (Clarium®) on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Non-Ergot Dopamine Agonists (PHASE3)
- SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's Disease
- SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K)
- Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography (NA)
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:
- Trivastal CI brief — competitive landscape report
- Trivastal updates RSS · CI watch RSS
Frequently asked questions about Trivastal
What is Trivastal?
How does Trivastal work?
What is Trivastal used for?
What is the generic name of Trivastal?
What drug class is Trivastal in?
What development phase is Trivastal in?
What are the side effects of Trivastal?
What does Trivastal target?
Related
- Drug class: All piribedil drugs
- Target: All drugs targeting Alpha-2C adrenergic receptor
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Parkinsonism
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing