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Sativex Oromucosal Spray
Sativex Oromucosal Spray is a Small molecule drug developed by King's College London. It is currently in Phase 1 development. Also known as: Sativex.
Sativex Oromucosal Spray is a small molecule medication used to treat conditions such as pain, spasticity, and anxiety, as well as postoperative nausea and vomiting. It contains tetrahydrocannabinol, a compound that has been studied for its effects on various health conditions.
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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 | Sativex Oromucosal Spray |
|---|---|
| Also known as | Sativex |
| Sponsor | King's College London |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids (PHASE2)
- A Phase IIb Study of Nabiximols for Spasticity Due to Neuromyelitis Optica Spectrum Disorders (PHASE2)
- Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis (PHASE3)
- Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis (PHASE3)
- Anesthetic Premedication With a Cannabis Extract (Cannapremed) (PHASE2, PHASE3)
- Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis (PHASE3)
- A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS) (PHASE3)
- Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis (PHASE3)
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:
- Sativex Oromucosal Spray CI brief — competitive landscape report
- Sativex Oromucosal Spray updates RSS · CI watch RSS
- King's College London portfolio CI
Frequently asked questions about Sativex Oromucosal Spray
What is Sativex Oromucosal Spray?
Who makes Sativex Oromucosal Spray?
Is Sativex Oromucosal Spray also known as anything else?
What development phase is Sativex Oromucosal Spray in?
Related
- Manufacturer: King's College London — full pipeline
- Also known as: Sativex
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing