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Radiprodil oral
Radiprodil oral is a Small molecule drug developed by UCB Biopharma S.P.R.L.. It is currently in Phase 1 development. Also known as: UCB3491.
Radiprodil is an oral medication being studied in clinical trials for various conditions, including GRIN-related Disorders, GRIN-related Neurodevelopmental Disorder, Tuberous Sclerosis Complex, Focal Cortical Dysplasia, and Hepatic Impairment. According to ChEMBL, Radiprodil is a vaccine component that induces an immune response, but its exact mechanism in treating these conditions is not specified.
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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 | Radiprodil oral |
|---|---|
| Also known as | UCB3491 |
| Sponsor | UCB Biopharma S.P.R.L. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Phase 1 Open-Label Study of Radiprodil Pharmacokinetics, Safety, and Tolerability in Hepatically Impaired Participants (PHASE1)
- Beeline: A Phase 3 Study in GRIN-related Neurodevelopmental Disorder (PHASE3)
- Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of Carbamazepine or Itraconazole With Radiprodil in Healthy Adults (PHASE1)
- Astroscape: A Study of Radiprodil on Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms in Patients With TSC or FCD Type II (PHASE1, PHASE2)
- Honeycomb: Evaluation of Radiprodil in Children with GRIN-related Disorder (PHASE1)
- Study to Evaluate Properties of Radiprodil Given in Oral Solution to 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:
- Radiprodil oral CI brief — competitive landscape report
- Radiprodil oral updates RSS · CI watch RSS
- UCB Biopharma S.P.R.L. portfolio CI
Frequently asked questions about Radiprodil oral
What is Radiprodil oral?
Who makes Radiprodil oral?
Is Radiprodil oral also known as anything else?
What development phase is Radiprodil oral in?
Related
- Manufacturer: UCB Biopharma S.P.R.L. — full pipeline
- Also known as: UCB3491
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing