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Dronabinol Capsules
Dronabinol Capsules is a Cannabinoid receptor agonist Small molecule drug developed by Montefiore Medical Center. It is currently in Phase 3 development for Chemotherapy-induced nausea and vomiting (CINV), Anorexia associated with weight loss in HIV/AIDS patients, Cancer-related cachexia and appetite stimulation. Also known as: Marinol, delta-9-tetrahydrocannabinol, Syndros.
Dronabinol is a synthetic cannabinoid that acts as a partial agonist at cannabinoid CB1 and CB2 receptors in the central and peripheral nervous systems.
Dronabinol is a synthetic cannabinoid that acts as a partial agonist at cannabinoid CB1 and CB2 receptors in the central and peripheral nervous systems. Used for Chemotherapy-induced nausea and vomiting (CINV), Anorexia associated with weight loss in HIV/AIDS patients, Cancer-related cachexia and appetite stimulation.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | Dronabinol Capsules |
|---|---|
| Also known as | Marinol, delta-9-tetrahydrocannabinol, Syndros |
| Sponsor | Montefiore Medical Center |
| Drug class | Cannabinoid receptor agonist |
| Target | CB1 receptor, CB2 receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology, Gastroenterology, Neurology |
| Phase | Phase 3 |
Mechanism of action
Dronabinol (delta-9-tetrahydrocannabinol, THC) binds to and activates cannabinoid receptors, which modulate neurotransmitter release and neuronal signaling. This activation produces appetite stimulation, antiemetic effects, and analgesic properties. The drug crosses the blood-brain barrier and has psychoactive effects due to CB1 receptor activation in the central nervous system.
Approved indications
- Chemotherapy-induced nausea and vomiting (CINV)
- Anorexia associated with weight loss in HIV/AIDS patients
- Cancer-related cachexia and appetite stimulation
Common side effects
- Dizziness
- Drowsiness
- Euphoria
- Anxiety
- Dry mouth
- Tachycardia
- Abdominal pain
- Hallucinations
Key clinical trials
- Dronabinol in Total Knee Arthroplasty (TKA) (PHASE4)
- Dronabinol as an Adjunct for Reducing Pain (PHASE2)
- Dronabinol As an Adjunct for Reducing Pain (DARP)-Texas Children's Hospital (PHASE2)
- Unique Treatment of Oncology Pain in Advanced Cancer (PHASE2)
- Pregnenolone as a Treatment for Cannabis Intoxication (PHASE2)
- Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial (PHASE3)
- Sex Differences in Neurobehavioral Response to THC (PHASE2)
- Tetrahydrocannabinol (THC) and Sleep (EARLY_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:
- Dronabinol Capsules CI brief — competitive landscape report
- Dronabinol Capsules updates RSS · CI watch RSS
- Montefiore Medical Center portfolio CI
Frequently asked questions about Dronabinol Capsules
What is Dronabinol Capsules?
How does Dronabinol Capsules work?
What is Dronabinol Capsules used for?
Who makes Dronabinol Capsules?
Is Dronabinol Capsules also known as anything else?
What drug class is Dronabinol Capsules in?
What development phase is Dronabinol Capsules in?
What are the side effects of Dronabinol Capsules?
What does Dronabinol Capsules target?
Related
- Drug class: All Cannabinoid receptor agonist drugs
- Target: All drugs targeting CB1 receptor, CB2 receptor
- Manufacturer: Montefiore Medical Center — full pipeline
- Therapeutic area: All drugs in Oncology, Gastroenterology, Neurology
- Indication: Drugs for Chemotherapy-induced nausea and vomiting (CINV)
- Indication: Drugs for Anorexia associated with weight loss in HIV/AIDS patients
- Indication: Drugs for Cancer-related cachexia and appetite stimulation
- Also known as: Marinol, delta-9-tetrahydrocannabinol, Syndros
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing