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naltrexone implant
naltrexone implant is a Small molecule drug developed by Go Medical Industries Pty Ltd. It is currently in Phase 2 development. Also known as: OLANI, O'Neil Long Acting Naltrexone Implant, DNI, Prodetoxon.
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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 | naltrexone implant |
|---|---|
| Also known as | OLANI, O'Neil Long Acting Naltrexone Implant, DNI, Prodetoxon |
| Sponsor | Go Medical Industries Pty Ltd |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Evaluate the Efficacy and Safety of Naltrexone Hydrochloride Implant in Patients With Alcohol Use Disorder (PHASE3)
- Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons (PHASE2)
- iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers (PHASE1)
- Phase II Clinical Study on the Efficacy and Safety of Naltrexone Implant in Patients With Alcohol Use Disorder (PHASE2)
- Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol (PHASE1)
- Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults (PHASE1)
- A Randomized, Double-Blind, Single-Center Clinical Study on the Efficacy of Naltrexone Implant in Antagonizing Opioid Agonist Hydromorphone (PHASE2)
- Safety, Tolerability, and Pharmacokinetics of Naltrexone Implant (DLP-160) (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:
- naltrexone implant CI brief — competitive landscape report
- naltrexone implant updates RSS · CI watch RSS
- Go Medical Industries Pty Ltd portfolio CI
Frequently asked questions about naltrexone implant
What is naltrexone implant?
Who makes naltrexone implant?
Is naltrexone implant also known as anything else?
What development phase is naltrexone implant in?
Related
- Manufacturer: Go Medical Industries Pty Ltd — full pipeline
- Also known as: OLANI, O'Neil Long Acting Naltrexone Implant, DNI, Prodetoxon
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing