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Namisol
Namisol is a Small molecule drug developed by Radboud University Medical Center. It is currently in Phase 2 development. Also known as: Dronabinol, THC, delta-9-tetrahydrocannabinol.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Namisol |
|---|---|
| Also known as | Dronabinol, THC, delta-9-tetrahydrocannabinol |
| Sponsor | Radboud University Medical Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain (PHASE2)
- Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain (PHASE2)
- Delta-THC in Dementia (PHASE2)
- Delta-THC in Behavioral Disturbances in Dementia (PHASE2)
- Safety and Tolerability of Namisol in the Elderly (PHASE1)
- Perioperative Δ9-THC for Postsurgical Pain (PHASE2)
- Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain (PHASE2)
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:
- Namisol CI brief — competitive landscape report
- Namisol updates RSS · CI watch RSS
- Radboud University Medical Center portfolio CI
Frequently asked questions about Namisol
What is Namisol?
Who makes Namisol?
Is Namisol also known as anything else?
What development phase is Namisol in?
Related
- Manufacturer: Radboud University Medical Center — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Dronabinol, THC, delta-9-tetrahydrocannabinol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing