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Rotigotine PR 2.2.1
Rotigotine PR 2.2.1 is a Small molecule drug developed by UCB Pharma. It is currently in Phase 1 development. Also known as: Neupro.
Rotigotine PR 2.2.1 is a small molecule used in the treatment of Parkinson's Disease. It is administered via a transdermal patch, which is a formulation of the drug.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Rotigotine PR 2.2.1 |
|---|---|
| Also known as | Neupro |
| Sponsor | UCB Pharma |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Bioequivalence Study of Rotigotine Transdermal Patch With Two Different Formulations in Healthy Japanese Subjects (PHASE1)
- Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations (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:
- Rotigotine PR 2.2.1 CI brief — competitive landscape report
- Rotigotine PR 2.2.1 updates RSS · CI watch RSS
- UCB Pharma portfolio CI
Frequently asked questions about Rotigotine PR 2.2.1
What is Rotigotine PR 2.2.1?
Who makes Rotigotine PR 2.2.1?
Is Rotigotine PR 2.2.1 also known as anything else?
What development phase is Rotigotine PR 2.2.1 in?
Related
- Manufacturer: UCB Pharma — full pipeline
- Also known as: Neupro
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing