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High dose THC marijuana
High dose THC marijuana is a Small molecule drug developed by Yale University. It is currently in Phase 1 development. Also known as: THC, cannabis, THC, Cannabis.
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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 | High dose THC marijuana |
|---|---|
| Also known as | THC, cannabis, THC, Cannabis |
| Sponsor | Yale University |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Cannabis and Polysubstance Use: Response Inhibition and Stress Exposure (PHASE1)
- Pregnenolone as a Treatment for Cannabis Intoxication (PHASE2)
- Tetrahydrocannabinol (THC) and Sleep (EARLY_PHASE1)
- Cannabinoids as a Treatment for Insomnia in Major Depression (PHASE2)
- Effect of Cannabis on Cigarette Use Behavior (PHASE1)
- A Study Testing the Effects of Different THC Doses on Psychological and Biological Function (PHASE1)
- Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration (PHASE2)
- High Potency Cannabis: Acute and Protracted Effects (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:
- High dose THC marijuana CI brief — competitive landscape report
- High dose THC marijuana updates RSS · CI watch RSS
- Yale University portfolio CI
Frequently asked questions about High dose THC marijuana
What is High dose THC marijuana?
Who makes High dose THC marijuana?
Is High dose THC marijuana also known as anything else?
What development phase is High dose THC marijuana in?
Related
- Manufacturer: Yale University — full pipeline
- Also known as: THC, cannabis, THC, Cannabis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing