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Naltrexone 25mg
Naltrexone 25mg is a Small molecule drug developed by Yale University. It is currently in Phase 1 development.
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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 | Naltrexone 25mg |
|---|---|
| Sponsor | Yale University |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Oral Naltrexone In Pediatric Eating Disorders (PHASE2, PHASE3)
- Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults (PHASE4)
- Opioid Modulation and Neural Reward Activation in Healthy Adults (PHASE1, PHASE2)
- Drug Treatment for Pathologic Gambling Disorder (PHASE3)
- The Effect of Regular Naltrexone Dosing on Disordered Gamblers (PHASE1)
- Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia (PHASE4)
- Naltrexone for Antipsychotic-Induced Weight Gain (NA)
- RCT for Gambling and Naltrexone, Using Use Eye-tracking Analysis to Predict Treatment Response (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:
- Naltrexone 25mg CI brief — competitive landscape report
- Naltrexone 25mg updates RSS · CI watch RSS
- Yale University portfolio CI
Frequently asked questions about Naltrexone 25mg
What is Naltrexone 25mg?
Who makes Naltrexone 25mg?
What development phase is Naltrexone 25mg in?
Related
- Manufacturer: Yale University — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing