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Soticlestat 300 mg
Soticlestat 300 mg is a Small molecule drug developed by Takeda. It is currently in Phase 1 development.
Soticlestat is a small molecule inhibitor of the enzyme cholesterol 24-hydroxylase. It is being studied in clinical trials for various conditions, including Lennox Gastaut Syndrome (LGS), and has been evaluated in a Phase 1 study to assess its pharmacokinetics in healthy adults.
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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). -
Big-pharma sponsor
+3.0pp
Takeda 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 | 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 | Soticlestat 300 mg |
|---|---|
| Sponsor | Takeda |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Nasopharyngitis
- Pyrexia
- Somnolence
- Change in seizure presentation
- Upper respiratory tract infection
- Fatigue
- Decreased appetite
- Constipation
- Fall
- COVID-19
- Headache
- Insomnia
Key clinical trials
- A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome (PHASE3)
- A Study of Soticlestat in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System (CNS) Depressant Experience (PHASE1)
- A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome (PHASE3)
- A Study of Soticlestat Tablets in Healthy Adults (PHASE1)
- A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function (PHASE1)
- A Study of Soticlestat and Rifampin in Healthy Adults (PHASE1)
- A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults (PHASE1)
- A Study of Soticlestat in Healthy Adults To Evaluate the Effect on QTc Interval (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:
- Soticlestat 300 mg CI brief — competitive landscape report
- Soticlestat 300 mg updates RSS · CI watch RSS
- Takeda portfolio CI
Frequently asked questions about Soticlestat 300 mg
What is Soticlestat 300 mg?
Who makes Soticlestat 300 mg?
What development phase is Soticlestat 300 mg in?
What are the side effects of Soticlestat 300 mg?
Related
- Manufacturer: Takeda — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing