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Silexan
Silexan is a Small molecule drug developed by Deakin University. It is currently in Phase 3 development.
Silexan is a standardized oral preparation of lavender oil used for the treatment of anxiety disorders. It has been studied in various clinical trials for its effects on postoperative nausea and vomiting, gynecological disease, anxiety, pain, and ankyloglossia, among other conditions.
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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).
| 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 | Silexan |
|---|---|
| Sponsor | Deakin University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Aromatherapy for Mental Health Promotion in IVF Patients (NA)
- Metabolic and Epigenetic Impact of FAAH Inhibitors and OEA (NA)
- Effect of Lavender Aromatherapy Massage on Pain and Wrist Mobility in Rheumatoid Arthritis (NA)
- Effects of Lavender Aromatherapy on Patient Anxiety During Mohs Micrographic Surgery (NA)
- Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder (NA)
- Lavender Aromatherapy for Preoperative Anxiety in Melanoma and Epithelioma Patients (NA)
- Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic Surgery (NA)
- Effect of Aromatherapy on Anxiety in Relatives of Emergency Patients. (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:
- Silexan CI brief — competitive landscape report
- Silexan updates RSS · CI watch RSS
- Deakin University portfolio CI
Frequently asked questions about Silexan
What is Silexan?
Who makes Silexan?
What development phase is Silexan in?
Related
- Manufacturer: Deakin University — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing